0001 State of Ohio, ) ) SS: 2 County of Hamilton.) 3 - - - 4 IN THE COURT OF COMMON PLEAS 5 - - - 6 Timothy Arthur, et al., ) ) 7 Plaintiffs, ) ) 8 vs. ) Case No.: A0307157 ) Judge Crouse 9 International Flavor & ) Fragrances, Inc., et al., ) 10 ) Defendants. ) 11 12 - - - 13 14 Videotaped deposition of Nancy Higley, a 15 witness, herein, called by the plaintiffs for cross- 16 examination pursuant to the Ohio Rules of Civil 17 Procedure, taken before Constance Versagi, Notary 18 Public in and for the State of Ohio, at the offices 19 of Squire, Sanders, 4900 Key Tower, Cleveland, Ohio, 20 on Thursday, April 6, 2006, commencing at 9:41 a.m. 21 - - - 22 23 24 25 0002 1 INDEX 2 WITNESS: CROSS REDIRECT RECROSS 3 Nancy Higley 4 By Mr. McClain 6 230,240,242 5 By Mr. Mace 175,238,241 6 - - - 7 E X H I B I T S 8 Exhibit: Marked 9 1 6 10 2 14 11 3 14 12 4 29 13 5 40 14 6 42 15 7 48 16 8 51 17 9 53 18 10 54 19 11 56 20 12 62 21 13 64 22 14 69 23 15 71 24 16 73 25 17 80 0003 1 E X H I B I T S (CON'T) 2 Exhibit: Marked 3 18 83 4 19 87 5 20 93 6 21 96 7 22 100 8 23 105 9 24 107 10 25 111 11 26 118 12 27 119 13 28 123 14 29 128 15 30 129 16 31 143 17 32 148 18 33 153 19 34 158 20 35 159 21 36 167 22 37 186 23 38 187 24 39 188 25 40 189 0004 1 E X H I B I T S (CON'T) 2 Exhibit: Marked 3 41 191 4 42 193 5 43 195 6 44 197 7 45 202 8 46 204 9 47 209 10 48 217 11 49 218 12 50 219 13 51 219 14 52 220 15 53 221 16 54 222 17 - - - 18 19 20 21 22 23 24 25 0005 1 APPEARANCES: 2 On behalf of the Plaintiffs: 3 Kenneth B. McClain, Esq. 4 Steven E. Crick, Esq. Humphrey, Farrington & McClain 5 221 West Lexington, Suite 400 Independence, Missouri 64051 6 816-836-5050 7 and 8 Mark Wintering, Esq. Robert E. Sweeney Company 9 1500 Illuminating Building Cleveland, Ohio 44113 10 216-696-0606 11 12 On behalf of the Defendants International Flavors & Fragrances and Bush Boake Allen Corporation: 13 Frank C. Woodside, III, Esq. 14 Dinsmore & Shohl 1900 Chemed Center 15 255 E. Fifth Street Cincinnati, Ohio 45215 16 513-977-8266 17 On behalf of the Defendant Givaudan: 18 Damond R. Mace, Esq. Squire, Sanders 19 4900 Key Tower 127 Public Square 20 Cleveland, Ohio 44114 216-479-8500 21 22 Also Present: 23 Steve Mengelkamp, videographer 24 - - - 25 0006 1 VIDEOGRAPHER: We're on the record 2 at 9:41. 3 NANCY HIGLEY 4 of lawful age, being first duly sworn, as 5 hereinafter certified, was examined and testified as 6 follows: 7 MR. WOODSIDE: I believe we have an 8 understanding that an objection made by one 9 defendant is as though made by all defendants 10 so we don't have to clutter up the record? 11 MR. McCLAIN: Yes, that's correct. 12 CROSS-EXAMINATION 13 By Mr. McClain: 14 Q Would you state your full name, please? 15 A Nancy Ann Higley. 16 Q Miss Higley, where do you live? 17 A In New York. 18 Q Who do you work for currently? 19 A PepsiCo. 20 Q How long have you been an employee of PepsiCo? 21 A A year-and-a-half. 22 Q What is your position at PepsiCo? 23 A Vice-president product safety, and regulatory 24 -- no, that is my old one. Excuse me. 25 Scientific and regulatory affairs. 0007 1 Q Did you recently change positions within 2 PepsiCo? 3 A No. 4 Q You've been at PepsiCo for a year-and-a-half, 5 where did you work before you worked at 6 PepsiCo? 7 A Givaudan. 8 Q What was you position at Givaudan? 9 A When I left I was vice-president product 10 safety and regulatory assurance. 11 (Exhibit Number 1 12 marked for identification.) 13 Q Let me hand you a copy of what we have been 14 provided by Givaudan's counsel, which I've 15 marked as Exhibit 1. Was that a copy of your 16 CV at one time? 17 A Yes. 18 Q Do you know approximately through what date 19 this was current? 20 A November of 2004. 21 Q From your CV, it appears that you have a Ph.D. 22 in biochemistry; is that correct? 23 A That's correct. 24 Q You did post doctoral work in toxicology? 25 A That's correct. 0008 1 Q Do you consider yourself to be a toxicologist? 2 A No, I don't. 3 Q Are you a member of any professional 4 societies? 5 A At the current, currently, no, I'm not. 6 Q You have published scientific papers, have you 7 not? 8 A Yes. 9 Q How many have you published in peer reviewed 10 scientific literature? 11 A Approximately 15, give or take a few more. 12 Q You have served on academic faculty; is that 13 correct? 14 A As a teaching instructor, yes. 15 Q Let's talk for a moment about some of your 16 employment. It is true you were at one time 17 an employee of International Flavors & 18 Fragrances? 19 A Yes, I was. 20 Q What was your position at International 21 Flavors & Fragrances? 22 A Senior research toxicologist. 23 Q So you were classified as a toxicologist at 24 IFF? 25 A Yes. 0009 1 Q You don't consider yourself to be a 2 toxicologist even though you were employed as 3 one? 4 A Yes, I'm not a Board certified toxicologist. 5 Q Is that the definition that you use? 6 A Yes, it is. 7 Q But you were employed in the capacity of a 8 toxicologist at International Flavors & 9 Fragrances; is that correct? 10 A That's correct. 11 Q One of the jobs you had at IFF was to prepare 12 toxicological assessments for the material 13 safety data sheet program; is that correct? 14 A That's correct. 15 Q You came to work at Givaudan or its 16 predecessor Tastemaker in 1991; is that 17 correct? 18 A Yes. 19 Q As of 1991, had there been any cases of 20 bronchiolitis obliterans diagnosed at the 21 Tastemaker plant? 22 A No. 23 Q Let's look at a document. You were involved 24 while you were at Tastemaker, which was from 25 1991 until what year? 0010 1 A 2004. 2 Q During that time period you were involved with 3 an organization called FEMA? 4 A Correct. 5 Q What is FEMA? 6 A Flavor Extract Manufacturers Association. 7 Q As I understand it, for a time you were on the 8 board of governors of FEMA; is that correct? 9 A That's correct. 10 Q During what years were you on the board of 11 governors of FEMA? 12 A April of 2004 until December 2004. 13 Q Did you have any contact with FEMA before 14 2004? 15 A Yes. 16 Q What committees did you serve on or what 17 involvement did you have? 18 A I sat on several committees, science 19 committee, labeling committee, safety 20 evaluation and coordination committee, alcohol 21 tax committee, trying to remember them all. 22 That is the main ones. 23 Q Approximately what year did you serve on the 24 science committee, years? 25 A Would have been 1991 to present. 0011 1 Q So you have been on the FEMA science committee 2 from 1991 onward? 3 A Yes. 4 Q In that capacity did you have interaction with 5 scientists from other flavoring companies? 6 A Yes. 7 Q Did you have interaction with scientists from 8 International Flavors & Fragrances? 9 A Yes. 10 Q Throughout the entire time period? 11 A Yes. 12 Q Did you have contact with scientists from 13 Bush, Boake & Allen before they were merged 14 into International Flavors & Fragrances? 15 A Not on the SECC. 16 MR. WOODSIDE: I'm sorry, I didn't 17 hear you. 18 THE WITNESS: Not on the SECC. 19 Q SECC is? 20 A Safety Evaluation Coordination Committee. 21 Q Did you have contact with other employees of 22 BBA on other committees? 23 A Yes. 24 Q On what committees did you have contact with 25 them? 0012 1 A The international regulatory affairs 2 committee. 3 Q Who in particular did you have? 4 A David Carol. 5 Q Did you have any interaction within FEMA with 6 Flavors of North America? 7 A Probably not until recently. I recall they 8 have a different name. 9 Q Are you saying that you had contact with them 10 under a different name? 11 A Possibly, but I don't remember what their name 12 is. 13 Q What about Sensient Flavors? 14 A Yes. 15 Q What about Fermaniche? 16 A Yes. 17 Q What about Sigma Aldrich? 18 A No. 19 Q Let's talk somewhat about the FEMA 20 involvements that you've had. FEMA has had 21 several conferences regarding respiratory 22 hazards in the flavoring industry, have they 23 not? 24 A I believe they had two to three, yes. 25 Q The first one was in 1997? 0013 1 A I don't recall the date. 2 Q There was one in 2002? 3 A Again, I can't recall the date. 4 Q Those were triggered by bronchiolitis 5 obliterans cases from the Givaudan/Tastemaker 6 plant -- 7 MR. MACE: Objection, compound. 8 Q -- in Cincinnati, Ohio, correct? 9 A I wouldn't characterize it that way. They 10 were triggered by FEMA looking at an activity 11 for which the flavor industry has not 12 addressed, which would be overall worker 13 protection. I wouldn't characterize it as 14 being triggered by bronchiolitis obliterans. 15 Q Isn't it true that FEMA characterized the 16 motivating factor to have the 1997 conference 17 reports of bronchiolitis obliterans in the 18 Tastemaker plant in Cincinnati? 19 MR. MACE: Objection, 20 foundation. 21 A I wouldn't characterize it that way. I've not 22 seen any documents that say it was due to that 23 fact. 24 Q Let's look at a couple of documents if we 25 can. Let's mark as Exhibit 2. 0014 1 (Exhibit Number 2 2 Marked for identification.) 3 Q Document 2 are course materials from a 4 conference held by FEMA called respiratory 5 safety in the flavor and fragrance workplace, 6 held on March 27th of 1997 at the Newark 7 Airport Marriott Hotel, are you familiar with 8 that conference? 9 A Yes, I am. 10 Q Was this the first conference that FEMA had on 11 respiratory safety in the flavor and fragrance 12 workplace? 13 A Yes. 14 Q Let me hand you what we will mark as Exhibit 15 3. 16 (Exhibit Number 3 17 Marked for identification.) 18 Q This Exhibit 3 is the respiratory safety in 19 the flavor and fragrance workplace course 20 materials from the seminar held on Thursday, 21 June 13, 2002 at the Newark Airport Marriott. 22 Are you familiar with this document? 23 A Yes. 24 Q Look over with me at Bates number 1261 at the 25 bottom of the page, please. I'm referring you 0015 1 to this because you said you were unaware that 2 it had been characterized that the Tastemaker 3 outbreak of bronchiolitis obliterans was the 4 reason for the 1997 conference, all right. 5 Are you in context with me? 6 A Yes, but the page you are referring me to is 7 2002. 8 Q You are going to have to wait. 9 A All right. 10 Q Now would you look down in the middle of the 11 page? 12 A Yes. 13 Q In 1996 a member company reported to FEMA on a 14 confidential basis that a worker developed a 15 respiratory illness identified as 16 bronchiolitis obliterans while working in the 17 manufacture of flavors. 18 That company was Tastemaker, was it 19 not? 20 A That is correct. 21 Q Due to patient confidentiality issues very 22 little information was available at the time, 23 the cause of the illness could not be 24 determined. Because of this initial report 25 FEMA and FMA sponsored a workshop in March of 0016 1 1997 to focus its members on respiratory 2 safety practices; do you see that? 3 A Yes. 4 Q Does that refresh your recollection that the 5 reason for the '97 conference was the report 6 by FEMA of bronchiolitis obliterans in its 7 Cincinnati plant? 8 MR. MACE: Objection to form. 9 MR. WOODSIDE: Your question, 10 Mr. McClain, you got your companies and words 11 jumbled in that question, I guarantee. 12 Q Let me restate it. Miss Higley, does that 13 refresh your recollection? 14 A Yes. 15 Q That the reason for the '97 conference was the 16 report that Tastemaker/Givaudan made to FEMA 17 in 1996? 18 MR. MACE: Objection, compound. 19 A It refreshes my memory that one of the reasons 20 for the conference in '97 could have been the 21 Tastemaker meeting. However -- 22 Q I didn't ask you anything else. I asked if it 23 refreshed your recollection. You said that 24 one of the reasons was. 25 Let me direct your attention to the 0017 1 language again. According to FEMA, because of 2 this initial report, FEMA and FMA sponsored a 3 workshop in March of 1997 to focus its members 4 on respiratory safety practices, true, that is 5 what they say? 6 MR. MACE: Objection to form, 7 hearsay, and characterization. 8 A I can't speculate on -- 9 Q I'm not asking you to speculate. I'm asking 10 you is that what it says? 11 A Yes, it says that. 12 Q We're going to look at this a little bit more 13 in depth. You were involved in this '96 14 meeting that is discussed within this document 15 at FEMA; is that correct? 16 A I was involved in the 1996 meeting, yes. 17 Q You went there with Dr. James Lockey; is that 18 correct? 19 A Not the initial meeting. 20 Q Did you attend the meeting with Dr. Lockey at 21 FEMA? 22 A Yes. 23 Q With Karen Duros, was she at the meeting also? 24 A Yes. 25 Q Was that with Mr. Hallagan, John Hallagan? 0018 1 A Yes. 2 Q From FEMA? 3 A Yes. 4 Q FEMA in Exhibit 2 discusses your cluster of 5 cases in the following way -- 6 MR. WOODSIDE: Could you direct us 7 to the page? 8 MR. McCLAIN: Same page, 1261? 9 A I believe that is Exhibit 3. You said Exhibit 10 2. 11 Q I'm going to number these on the document so 12 we keep them straight. Exhibit 3 then. 13 Would you look at Exhibit 3, at page 14 1261. Additional information related to this 15 incident was obtained in subsequent years and 16 was reported publicly for the first time in 17 2001 at a symposium on bronchiolitis 18 obliterans, BO, sponsored by NIOSH. At that 19 symposium a physician reported that five 20 workers at a flavor manufacturing facility 21 developed severe respiratory illness that may 22 be associated with exposure to flavors. You 23 see that? 24 MR. MACE: Objection to form. 25 A Um-hum. 0019 1 Q The physician later presented an abstract on 2 these cases at the annual meeting of the 3 American Thoracic Society in May of 2002 4 reporting, quote, an index case of BO in one 5 worker, and an additional four workers with 6 clinical findings consistent with BO." The 7 abstract made no reference to whether lung 8 biopsies were conducted on any of the five 9 workers. The abstract also noted that a 10 comprehensive review of the site identified 11 multiple agents as potential causative agents 12 and most prominently acetaldehyde. The 13 abstract concluded this case series indicates 14 that the manufacturing of food flavors in 15 relatively large amounts and in high 16 concentrations, and the use of an aerosolized 17 manufacturing process may represent a 18 respiratory hazard in susceptible workers; do 19 you see that? 20 MR. MACE: Objection to form. 21 A That is what is written. 22 Q You're aware, are you not, that that too 23 attempts or at least was thought by FEMA to be 24 a reference to workers within your plant? 25 MR. MACE: Objection. 0020 1 A I can't comment that that would be the 2 reference to our company. 3 Q You don't know that Dr. Lockey made a 4 presentation to the American Thoracic Society 5 in 2001, 2002 regarding an index case of BO 6 and four additional workers with clinical 7 findings consistent with BO; you don't know 8 that? 9 A I do know he gave a presentation. 10 Q In 2002? 11 A Yes. 12 Q Because in fact, Tastemaker had to waive a 13 confidentiality agreement he entered into for 14 him to make that presentation; isn't that 15 true? 16 MR. MACE: Objection. 17 A I wouldn't know about that. 18 Q This is the first time that any public 19 notification was made of bronchiolitis 20 obliterans in the Tastemaker/Givaudan plant 21 that is in 2002; am I right? 22 MR. MACE: Objection, 23 misstates. Objection, assumes. Objection to 24 form. 25 A I wouldn't know. 0021 1 Q Do you know of any other instance before 2002 2 when Givaudan or Tastemaker made public to the 3 world that an outbreak of bronchiolitis 4 obliterans had occurred in its flavoring 5 plant? 6 MR. MACE: Objection, assumes. 7 Objection to form. 8 A I wouldn't know. 9 Q What do you mean you wouldn't know? Do you 10 know of any, that is the question? 11 A Of any publication? 12 Q Yes. 13 A I wouldn't know of any publication in peer 14 reviewed literature that stated that. 15 Q Do you know of any publication, period, 16 newspaper, mimeographed, anything to anyone 17 outside of Tastemaker or FEMA? 18 MR. MACE: Objection. 19 A No, I don't. 20 Q Now, Cincinnati is where the Tastemaker plant 21 was; is that correct? 22 A Correct. 23 Q Carthage Road I think is the address? 24 A I can't remember, sorry. 25 MR. WOODSIDE: Mr. McClain, if you 0022 1 would like some help. 2 MR. McCLAIN: Yes. 3 MR. WOODSIDE: It is the 4 neighborhood known as Carthage, on either 69th 5 or 7th Street. 6 MR. McCLAIN: We have an expert in 7 Cincinnati. 8 A 69th Street. 9 Q The plant is located in the Carthage 10 neighborhood on 69th Street I'm informed by an 11 expert on the geography of Cincinnati. 12 Now, you're a toxicologist aren't 13 you? 14 MR. MACE: Objection. 15 A I am a biochemist. 16 Q Ph.D. chemist, right, trained in toxicology? 17 A Post doc toxicology. 18 Q Referred to as a toxicologist within IFF for a 19 period of time? 20 A Job title was toxicologist. 21 Q There is a group within our federal government 22 called NIOSH, isn't there? 23 A Yes. 24 Q What does NIOSH stand for? 25 A National Institute of Occupational Safety and 0023 1 Health. 2 Q Where is NIOSH headquartered? 3 A I believe Washington. 4 Q There is a large NIOSH facility in Cincinnati, 5 isn't there? 6 A I don't know. 7 Q You don't know that there is a large research 8 facility for NIOSH in Cincinnati? 9 A No, I don't. 10 Q You are a Ph.D. trained in what field? 11 A Biochemistry. 12 Q Worked as a toxicologist within a flavoring 13 company? 14 A My job title was toxicologist. 15 Q You were vice-president of what at Givaudan? 16 A Product safety and regulatory assurance. 17 Q One of the agencies that regulates hazards in 18 the workplace is NIOSH, don't they? 19 A NIOSH doesn't regulate, OSHA regulates 20 workplace hazards. 21 Q You don't know anything about NIOSH? 22 A I know about NIOSH. I don't know where they 23 are physically located. 24 Q Doesn't NIOSH investigate outbreaks of 25 occupational disease in workplace facilities? 0024 1 MR. MACE: Objection. 2 A Yes. 3 Q You can request NIOSH to come into any 4 workplace facility and investigate an outbreak 5 of disease if you would like them to? 6 A That is not my expertise. 7 Q You know that? 8 A Yes. 9 Q You were at Tastemaker from 1991; is that 10 right? 11 A Correct. 12 Q The first case of bronchiolitis obliterans at 13 the Tastemaker plant was in 1993; isn't that 14 true? 15 MR. MACE: Objection, assumes. 16 A No, I don't agree. 17 Q The first report of bronchiolitis obliterans 18 was in 1993, wasn't it? 19 A Report would say consistent with bronchiolitis 20 obliterans. It doesn't say bronchiolitis 21 obliterans. 22 Q The date is 1993, isn't it? 23 A I don't recall that date. 24 Q Isn't that consistent with your recollection? 25 A I can't recall that date. 0025 1 Q We will come back to that, we'll look at some 2 documents to refresh you on it. Tell me in 3 1993 how many phone calls you made to NIOSH? 4 A I made no phone calls to NIOSH. 5 Q In 1993 at all? 6 A No. 7 Q Did you make any to NIOSH in 1994? 8 A I made no phone calls to NIOSH. 9 Q You had outbreaks of more bronchiolitis 10 obliterans by 1995 than one case, didn't you? 11 MR. MACE: Objection. 12 A I don't agree. 13 Q Reports consistent with bronchiolitis 14 obliterans? 15 A And reports that would say it was not 16 workplace related. 17 Q Yeah, well, NIOSH investigates such things, do 18 they not? 19 MR. MACE: Objection. 20 A Yes. 21 Q They have research scientists capable of 22 figuring out what is causing workplace 23 disease; isn't that true? 24 MR. MACE: Objection. 25 A That is true. 0026 1 Q Tell the jury how many times in 1995 you 2 called NIOSH, asked them to please come in and 3 investigate whether or not you had an outbreak 4 of bronchiolitis obliterans in the Tastemaker 5 plant in Cincinnati. 6 MR. MACE: Objection to form. 7 Objection, asked and answered. 8 A I did not call NIOSH. 9 Q In 1996 we know you went to FEMA, the Flavor 10 and Extract Manufacturers Association with a 11 consultant you hired by the name of James 12 Lockey from the University of Cincinnati; 13 isn't that true? 14 A That's true. 15 Q Did you tell anyone within NIOSH in 1996 about 16 the outbreak which you clearly recognized by 17 that point in time? 18 MR. MACE: Objection, assumes. 19 Objection to form. Objection, argumentative. 20 Objection, asked and answered. 21 A Can you repeat the question? 22 Q Did you call anyone from NIOSH in 1996 -- 23 MR. MACE: Same objection. 24 Q -- tell them what Dr. Lockey found up to that 25 point? 0027 1 A I repeat my answer, I did not call NIOSH. 2 Q What about 1997? 3 MR. MACE: Objection. 4 Q Did you contact NIOSH in 1997? 5 A I repeat, I did not call NIOSH. 6 Q Did NIOSH receive an invitation to attend the 7 FEMA conference sparked by the outbreak of 8 bronchiolitis obliterans in the Tastemaker 9 plant in Cincinnati? 10 MR. MACE: Objection to form. 11 A I previously have answered that I do not have 12 evidence to say that the 1997 workshop was 13 sparked by Tastemaker. 14 Q Stop for a minute. I know that is what you 15 said, but it's not true you don't have 16 evidence. In fact you have Exhibit 2, but you 17 just don't choose to acknowledge it. 18 A I'm looking at Exhibit 2. 19 Q Look at Exhibit 3, which is the 2002 report of 20 what sparked the conference in '97. 21 MR. MACE: Objection. 22 Q It says only one thing, doesn't it, at page 23 1261, the report by a member company which we 24 identified as you of bronchiolitis obliterans, 25 that is what it says, right? 0028 1 MR. MACE: Objection. 2 A No, it does not say that. It says because of 3 an illness, could not be determined. 4 Q Says because of this initial report, right, 5 FEMA and FMA sponsored a workshop in March of 6 '97 to focus its members on respiratory safety 7 practices, true? 8 MR. MACE: Objection to form. 9 Q That is what it says? 10 A That is what it says. 11 Q When you say you don't have any evidence, you 12 do have this document which we marked as 13 Exhibit 3, do you not? 14 MR. MACE: Objection. 15 A Yes. 16 Q Now let's get back to our timeline. Then in 17 1996 did NIOSH receive an invitation to attend 18 the FEMA conference that was held regarding 19 this issue? 20 MR. MACE: Objection, 21 foundation. 22 A I don't know. 23 Q You didn't invite them? 24 A No. 25 Q You don't remember any representative of NIOSH 0029 1 being there, do you? 2 A I don't recall. 3 Q You were there? 4 A Yes, I was there. 5 Q In 1997, following the conference, did you 6 ever contact NIOSH to inform them of what 7 happened at the conference? 8 MR. MACE: Objection. Same 9 objections. 10 A No, I did not contact NIOSH. 11 Q In 1998 did you contact NIOSH? 12 MR. MACE: Same objections. 13 A I did not at any time contact NIOSH. 14 Q By 1998 eight cases, eight potential cases of 15 bronchiolitis obliterans had been identified 16 within the Tastemaker/Givaudan plant. I don't 17 know why I keep say plant. Let me try it 18 again. 19 By 1998 at least eight cases of 20 bronchiolitis obliterans had been identified 21 within the Tastemaker plant? 22 MR. MACE: Objection to form. 23 A I don't agree with that. 24 Q Good. Let me show you another document. 25 (Exhibit Number 4 0030 1 Marked for identification.) 2 Q Who is Mr. Andreas Fluckiger? 3 A He was with Roche. 4 Q Who was Roche? 5 A Givaudan owning company at the time. 6 Q Roche owned Givaudan, which had purchased 7 Tastemaker; is that right? 8 A That's correct. 9 Q Let see what Mr. Fluckiger who worked for the 10 owner of Givaudan had to say was known by 11 Tastemaker. 12 April 30, 2000 is this document. What 13 was Mr. Fluckiger's position? 14 A I don't recall. 15 Q He was somebody in the toxicology employee 16 health field? 17 A I cannot say whether he was a toxicologist or 18 not. He was in the employee health field. 19 Q Summary, when the Cincinnati facility of 20 Tastemaker was bought by Givaudan Roure, 21 several current and former employees were 22 affect by a rare, occupation lung disease, 23 bronchiolitis obliterans. 24 That is what he says? 25 MR. MACE: Objection to form, 0031 1 foundation, hearsay, best evidence rule. 2 A That is what is written. 3 Q A single cause of these lung diseases has 4 never been identified; however, exposure to a 5 combination of respiratory irritants appears 6 to be the most likely explanation for the 7 development of this cluster of cases; do you 8 see that? 9 MR. MACE: Same objection. 10 A That is what is written. 11 Q Up until now six cases of BO have been 12 recognized. The medical evidence in two 13 further cases indicates that BO is a possible 14 diagnosis; however, recognition as an 15 occupation illness is no longer possible; do 16 you see that? 17 MR. MACE: Same objection, move 18 to strike. 19 A That is what is written. 20 Q Goes on to say one further claim for BO from 21 another worker was turned down by Workers' 22 Comp in the spring of the year 2000. 23 MR. MACE: Same objection. 24 Q Is that right? 25 A That is what is written. 0032 1 Q So that is the ninth case, is that right? 2 MR. MACE: Objection. 3 A I can't interpret it that way. 4 Q That is the one further claim, eight plus one 5 is nine, right? 6 A I can't interpret it that way. 7 Q Do you, with your background, you've had some 8 math courses, have you not? 9 A I don't interpret it that it would be nine 10 cases. It says it was turned down by Workers' 11 Comp. 12 Q Up until now six cases have been recognized. 13 The medical evidence in two further cases 14 indicate that BO is a possible diagnosis, 15 right? 16 MR. MACE: Objection. 17 Q That is eight? 18 A Says possible diagnosis, does not say is 19 bronchiolitis obliterans. 20 Q Says one further claim, you see that, it says 21 one further claim? 22 MR. MACE: Objection. 23 Q That it is the ninth claim, right? 24 MR. MACE: Objection. 25 Q You see that? 0033 1 A I see that. 2 Q Then he clarifies if you look over to 3 understand he's talking about nine total 4 people in the middle of the second page of 5 exhibit -- what did I identify this as? 6 MR. MACE: 4. 7 Q It's Exhibit 4. In the middle of the page, of 8 the seven employees whose medical files 9 mention the diagnosis of bronchiolitis 10 obliterans, six have been recognized as 11 occupational disease cases by Workers' Comp. 12 The seventh employee didn't file a claim 13 within a two year time period after the 14 diagnosis during which such a claim must be 15 filed. A ninth employee with obstructive lung 16 disease filed for recognition as 17 occupationally related BO; do you see that? 18 MR. MACE: Objection. 19 Q There were nine total potential cases? 20 MR. MACE: Same objection, move 21 to strike, rule of completeness, case was 22 turned down by Workers' Comp. 23 Q Do you see he's talking about nine potential 24 cases? 25 A He's talking about nine Workers' Comp cases. 0034 1 Q That he classified earlier as bronchiolitis 2 obliterans, do you see that? 3 MR. MACE: Objection. Misstates 4 the evidence, form. 5 A No, I don't agree that is what he's saying. 6 Q Look at the first paragraph. When the 7 Cincinnati facility of Tastemaker was bought 8 by Givaudan Roure, GR, several current and 9 former employees were affected by a rare 10 occupational lung ideas, bronchiolitis 11 obliterans, BO; do you see that? 12 MR. MACE: Objection. 13 A That is what is written. 14 Q Did you ever then, after -- you did receive 15 this Exhibit 3. I have my numbers right, the 16 2002 FEMA port, right? Did you ever contact 17 FEMA and say oh, no -- do you see 1261? 18 A Sorry. 19 Q -- there were really nine potential cases in 20 our plant, not five? 21 MR. MACE: Objection. 22 Q Did you ever contact FEMA and talk about 23 that? You were looking for dates, this is a 24 2000 memo from Mr. Fluckiger and FEMA who you 25 were closely associated with in 2002, in fact 0035 1 served on several scientific committees, was 2 reporting to its member that there were only 3 five cases in that plant. Did you ever 4 contact FEMA and say oh, no, there were nine 5 potential cases in the plant? 6 MR. MACE: Objection, assumes, 7 misstates the evidence. Objection to form. 8 A I don't think there are nine cases. 9 Q Did you ever contact them, tell them there 10 were at least six confirmed cases according to 11 our consultant of the owner of our company? 12 MR. MACE; Objection. 13 A I don't think there were six cases. 14 Q Did you ever supply them this memo from 15 Mr. Fluckiger, regarding how many cases there 16 actually were at the Givaudan plant when they 17 were referring the entire industry to what had 18 occurred at a plant in 2002? 19 MR. MACE: Objection, form, 20 assumes, mischaracterization. 21 A I did not give FEMA the internal memo dated 22 April 30, 2000. 23 Q Just for the record, Mr. Fluckiger was the 24 medical director of Roche, was he not? 25 A I don't recall his title. 0036 1 Q In fact when you attended the 2002 conference, 2 you never even identified the fact that one of 3 the case clusters that was being referred to 4 was in the Givaudan plant, did you? 5 MR. MACE: Objection. 6 A No, I did not. 7 Q In 2000, you never contacted NIOSH, did you? 8 MR. MACE: Objection, misstates. 9 A I never contacted NIOSH. 10 Q You didn't contact them in 2002, did you? 11 A I never contacted NIOSH. 12 Q You could have contacted NIOSH at any point to 13 ask for a health hazard evaluation within the 14 Givaudan plant; isn't that true? 15 MR. MACE: Objection to form. 16 Objection, argumentative. 17 A Could have been one avenue. We took another 18 avenue, which was to hire experts in the field 19 of occupational health. 20 Q You hired -- let's tell the jury why you did 21 that as opposed to calling NIOSH. If you had 22 called in NIOSH, you couldn't have kept it 23 secret; isn't that true? 24 MR. MACE: Objection. 25 A I don't agree with that. We called in the 0037 1 experts because they were in Cincinnati, 2 University of Cincinnati, they had respiratory 3 experts that we felt we wanted to use. 4 Q But NIOSH was in Cincinnati too? 5 A I told you earlier I don't know that. 6 Q The reality was that you put your experts 7 under confidentiality agreements; isn't that 8 true? 9 A That's correct. 10 MR. MACE: Objection. 11 Q The first one was Stuart Brooks; isn't that 12 right? 13 A I don't know if that is the first one. Yes, 14 we did. 15 Q Stuart Brooks was the first doctor called in 16 to investigate this matter; isn't that right? 17 A That's correct. 18 Q Dr. Brooks said he thought you had 19 bronchiolitis obliterans in the plant; isn't 20 that right? 21 A I don't recall him saying it was bronchiolitis 22 obliterans. 23 Q What he said was you ought to survey all the 24 Givaudan plants worldwide; isn't that true? 25 A I would have to see a document to that effect. 0038 1 Q He also said you ought to warn your customers; 2 isn't that right? 3 MR. MACE: Objection, 4 mischaracterizes. 5 Q Way back in 1994? 6 MR. MACE: Misstate the 7 evidence. Objection to form. Move to 8 strike. 9 A He never told us to contact customers. 10 Q You put him under a confidentiality agreement, 11 didn't you? 12 A I didn't personally. 13 Q You didn't but you know the company did? 14 A Yes. 15 Q Then you fired him, didn't you? 16 MR. MACE: Objection. 17 A No, we did not fire him. 18 Q Do you know why he would claim you fired him? 19 MR. MACE: Objection. 20 A I don't know that he claims that we fired him. 21 Q Didn't you meet with Mr. Mace before this 22 deposition? 23 A Yes. 24 Q Didn't Mr. Mace tell you he attended a 25 deposition -- 0039 1 MR. MACE: Objection. 2 Q -- of Dr. Brooks? 3 MR. MACE: Objection. 4 A No. 5 Q He didn't tell you about that discussion? 6 A No. 7 Q So you've never read Dr. Brooks' deposition 8 about how he was fired after he warned the 9 company that bronchiolitis obliterans was 10 occurring, that you ought to warn your 11 customers? 12 MR. MACE; Objection, misstates 13 the evidence, mischaracterization. Objection 14 to form. Move to strike. 15 A I have not read any depositions. 16 Q Then you hired Dr. Lockey; isn't that true? 17 A That is correct. 18 Q Dr. Lockey was placed under a confidentiality 19 order too; isn't that true? 20 A That's correct. 21 Q In fact, Dr. Lockey never contacted NIOSH to 22 your knowledge about this incident either, did 23 he? 24 A To my knowledge, no. 25 Q In fact, until 2002 Dr. Lockey never published 0040 1 to the medical community anything about what 2 had happened at the Tastemaker plant, had he? 3 MR. MACE: Objection, misstates 4 the evidence. Objection to form. 5 A I don't know Dr. Lockey's reference. 6 Q Look at Exhibit 5. 7 (Exhibit Number 5 8 Marked for identification.) 9 Q Are you familiar with this? 10 A Yes. 11 Q You are familiar this was an abstract that 12 Dr. Lockey submitted to the American Thoracic 13 Society in 2002? 14 A Yes. 15 Q You are aware that Dr. Lockey had to receive 16 permission in order to supply this to the 17 American Thoracic Society because he was under 18 a confidentiality agreement up until that 19 time; isn't that true? 20 MR. MACE: Objection. 21 A I don't know the details of his 22 confidentiality agreement. 23 Q You know he had to ask permission to publish 24 this, do you not? 25 MR. MACE: Objection. 0041 1 A I don't know that. 2 Q Do you not believe that to be true? 3 MR. MACE: Objection. 4 A It would be speculative on my part. 5 Q Weren't you involved in the process of 6 approving him to publish this? 7 A I did not write his confidentiality agreement. 8 Q But you didn't answer my question. Weren't 9 you involved in the process, the discussion of 10 whether or not the company should allow 11 Dr. Lockey to publish this? 12 MR. MACE: Objection, assumes. 13 A I don't recall. 14 Q Do you recall in general that that happened? 15 MR. MACE: Objection. 16 A No, I don't. 17 Q Do you know that Dr. Lockey has testified 18 under oath about his engagement by Tastemaker? 19 A I understand he's been deposed, yes. 20 Q Do you know he testified at first he asked for 21 permission to publish this, was denied 22 permission to publish this -- 23 MR. MACE: Objection. 24 Q -- by Tastemaker? 25 MR. MACE: Objection, 0042 1 foundation. Objection, characterization. 2 Objection, form. 3 A I have not looked at anybody's deposition. 4 Q Are you aware that Tastemaker initially denied 5 him the right to publish this information? 6 MR. MACE: Objection. 7 A No, I'm not. 8 Q Well, let's see what you do know. You do know 9 that there was no other publication of this 10 before 2002, that you are aware of? 11 MR. MACE: Objection. 12 Q That's correct? 13 A I can't answer that. I don't know if there 14 was anything before. 15 Q I asked what you were aware of. Are you aware 16 of anything before this document? 17 A No. 18 Q FEMA published in 2004 another document called 19 Respiratory Health and Safety in the Flavor 20 Manufacturing Workplace, did they not? 21 A May I see it? 22 Q Sure. 23 (Exhibit Number 6 24 Marked for identification.) 25 Q Showing you what we marked as Exhibit 6. 0043 1 A I'm sorry, what was your question? 2 Q Do you recall this? 3 A Yes. 4 Q Would you look over at page 2. Hang on, I 5 want you to look at a different page. Page 7, 6 please. Now, once again in 2004 there is a 7 discussion here regarding the 1996 8 confidentiality report to FEMA; do you see 9 that? 10 A Yes. 11 Q It said in late 1996 a member company reported 12 to FEMA on a confidential basis that a worker 13 developed a respiratory illness identified as 14 bronchiolitis obliterans while working in the 15 manufacture of flavors, goes on from that; do 16 you see that? 17 MR. MACE: Objection. 18 Q Word for word the same, check it, within the 19 2002 report? 20 MR. MACE: Objection, form, 21 foundation, best evidence rule, hearsay. 22 Q You see that, it is the same discussion in 23 2004 occurred in the 2002 report? 24 A They are not identical words. 25 Q They discuss the same issues? 0044 1 A Your question was was it identical words. 2 It's not identical words. 3 Q Miss Higley, is it the same discussion of 4 substance in both documents? Still talking 5 about five workers at a member company plant, 6 right? 7 A They are discussing five workers with 8 respiratory illness. 9 Q That is Dr. Lockey who is discussing it; is 10 that right? 11 A Does not say it's Dr. Lockey. Says a 12 physician. 13 Q Would you look at page 7, the reference is to 14 Dr. Lockey's 2002 American Thoracic Society 15 abstract? 16 A By inference but it doesn't say Dr. Lockey's 17 name. 18 Q It does say Dr. Lockey's name doesn't it, 19 Lockey 2002; do you see that? 20 A No, I don't. Sorry, I do, in parenthesis, 21 yes, excuse me, yes. 22 Q It's not by inference, it's by direct 23 reference, true? 24 A Dr. Lockey has been referenced. 25 Q Do you see that even to FEMA, an organization 0045 1 which you were on the board of in 2004, you 2 still hadn't disclosed that there were more 3 than five cases? 4 MR. MACE: Objection. 5 Q You still hadn't disclosed to the world that 6 Tastemaker/Givaudan was the company, had you? 7 MR. MACE: Objection, compound. 8 Objection to form. Objection, assumes. 9 A I would not conclude that there were five 10 cases. As it states in here, respiratory 11 illness. 12 Q Back up. The question to you is did you ever 13 disclose to your colleagues at FEMA that the 14 reference to the company that reported this on 15 a confidential basis, and the doctor involved, 16 Lockey, was a consultant to Givaudan? 17 MR. MACE: Objection, compound. 18 Objection to form. 19 A It was disclosed to John Hallagan. 20 Q It wasn't disclosed to the rest of the 21 industry, was it? 22 MR. MACE: Objection. 23 A No, it was not. 24 Q It was disclosed to John Hallagan on a 25 confidential basis, in other words you didn't 0046 1 let him tell anybody who it was? 2 MR. MACE: Objection. 3 Q Did you? 4 A That's correct. 5 Q You didn't tell NIOSH who it was? 6 A I made no calls to NIOSH. 7 Q Even in 2004? 8 A I made no calls to NIOSH. 9 Q After NIOSH had published an investigation of 10 microwave popcorn workers that had been 11 diagnosed with bronchiolitis obliterans that 12 were exposed to butter flavor in the State of 13 Missouri; isn't that true? 14 MR. MACE: Objection, 15 characterization. Objection to form, 16 foundation. 17 Q Let me reask the question, so we're clear on 18 it. 19 In the year 2001 there was a report of 20 an outbreak of bronchiolitis obliterans in a 21 microwave popcorn factory in Joplin, Missouri; 22 isn't that true? 23 A I don't believe it's Joplin, Missouri, wasn't 24 it Jasper, Missouri? 25 Q Good, you're well acquainted with the area. 0047 1 It's exactly Jasper, Missouri, and it's a 2 popcorn plant owned by a company called 3 Gilster Mary Lee, you are familiar with that? 4 A Yes. 5 Q There was an outbreak of bronchiolitis 6 obliterans reported in the New England Journal 7 of Medicine? 8 A I believe the New England Journal of Medicine 9 says it is consistent with bronchiolitis 10 obliterans. 11 Q It was reported? 12 A To be consistent with bronchiolitis 13 obliterans. 14 Q When that report came up, did you raise your 15 hand and tell NIOSH, wait a minute, we may 16 have some information that might be helpful to 17 you, we had an experience that is like that? 18 Did you ever contact NIOSH and just tell them 19 what you knew? 20 MR. MACE: Counsel, you don't 21 need to raise your voice. Objection, 22 argumentative. Objection to the form, 23 compound, assumes, mischaracterizes the 24 evidence. 25 A I can't remember the question, please. 0048 1 MR. McCLAIN: Would you read it 2 back. 3 (Question read.) 4 MR. MACE: Objection. 5 A I do not believe our situation is the same. 6 Q We're going to discuss that in just a minute. 7 Did you ever contact NIOSH say to them, we had 8 an outbreak of bronchiolitis obliterans in our 9 flavor plant? 10 MR. MACE: Objection, asked and 11 answered. 12 A I did not contact NIOSH. 13 Q You say that you didn't believe your situation 14 was comparable. Let's take a look at that 15 issue. Look at Exhibit 7. 16 (Exhibit Number 7 17 Marked for identification.) 18 MR. WOODSIDE: You skipped 6. 19 MR. CRICK: 6 was the 2004 FEMA. 20 Q Are you familiar with this article? 21 A Yes. 22 Q It's dated August 1st of 2002; do you see 23 that? 24 A Yes. 25 Q It says in the conclusion section, it's 0049 1 entitled clinical bronchiolitis obliterans in 2 workers at a microwave popcorn plant; do you 3 see that? 4 MR. MACE: Objection to form, 5 hearsay, foundation. 6 A That is what it says. 7 Q The conclusion says the excess rates of lung 8 disease and lung function abnormalities and 9 the relation between exposure and outcomes in 10 this working population indicates that they 11 probably had occupational bronchiolitis 12 obliterans caused by the inhalation of 13 volatile butter flavoring ingredients; do you 14 see that? 15 MR. MACE: Objection, form, 16 foundation, hearsay, best evidence rule, move 17 to strike. 18 A Says that. I don't believe the article 19 supports that conclusion. 20 Q I didn't ask you anything about that. I asked 21 whether or not you read what it says? 22 A What you read is what it says. 23 Q It discusses diacetyl as being a chemical 24 found in butter flavor that they analyzed; 25 isn't that true? 0050 1 MR. MACE: Same objection, move 2 to strike. 3 Q On the last page, 337, first column, 4 inhalation studies, butter flavoring vapors 5 producing diacetyl levels, you see that, on 6 page 337, the last page of text? 7 A Yes. 8 Q The page before that, page 336, says the 9 relation between cumulative diacetyl exposure 10 and changes in pulmonary function; you see 11 that sentence? 12 MR. MACE: Objection, rule of 13 completeness, suggests that diacetyl may be a 14 cause of respiratory disease or a marker of 15 causative exposure. 16 Q Do you see that? 17 A I'm looking for it. 18 Q In the second paragraph. Let's read that 19 whole sentence, so you can see where we are. 20 Do you see in the second column, down near the 21 bottom of the paragraph, before the start of 22 the paragraph which continues on the next 23 page, it says the relation between cumulative 24 diacetyl exposure suggests that diacetyl may 25 be a cause of respiratory disease or a marker 0051 1 of the causative exposure in this population. 2 MR. MACE: Same objection, move 3 to strike. 4 A Yes, I see it. 5 Q You read that at the time; is that right? 6 MR. MACE: Objection. 7 A At what time? 8 Q 2002? 9 A Yes. 10 Q When it was published? 11 A Yes. 12 Q You said that your situation was different. 13 You remember that comment that you made? 14 A Yes. 15 Q One of the workers who was diagnosed with 16 symptoms consistent with bronchiolitis 17 obliterans was Walt Vaske; isn't that true? 18 A Yes, one of the initial suggestions. 19 Q Did you know Mr. Vaske personally? 20 A I probably have met him, yes. 21 (Exhibit Number 8 22 Marked for identification.) 23 Q Exhibit 5 -- 24 MR. CRICK: 8. 25 Q Showing you Exhibit 8. Are you familiar with 0052 1 this document? 2 A No, I'm not. 3 Q Do you see this says original claim, Workers' 4 Comp claim? 5 A I see it says original claim, but I'm not 6 familiar with this document. 7 Q In this document, do you see that it says that 8 he was exposed to inhalation of a variety of 9 chemicals which were put into the flavorings? 10 MR. MACE: Objection, form, 11 foundation, hearsay, best evidence rule, move 12 to strike. Also continued objection on the 13 Workers' Comp. 14 A I'm sorry? 15 MR. MACE: He asked do you see 16 those words there? 17 A I see those words. 18 Q Subsequently Mr. Vaske's -- strike that. Step 19 back for a minute. Mr. Vaske did work around 20 a number of flavoring chemicals, did he not? 21 A We use many flavoring ingredients at our 22 plant. 23 Q Including diacetyl? 24 A That would be one of many. 25 Q Including acetaldehyde? 0053 1 A It would be one of many. 2 Q Mr. Vaske worked with a number of flavoring 3 chemicals; is that right? 4 A There were a number of flavoring chemicals in 5 the plant. I don't know which ones Mr. Vaske 6 would have worked with. 7 Q Let's try to see what his document said. Let 8 me show you Exhibit 6. One of the chemicals 9 he worked with was a chemical called 10 acetaldehyde; isn't that true? 11 MR. WOODSIDE: It's 9, I believe. 12 (Exhibit Nubmer 9 13 Marked for identification.) 14 Q When you try to do the job of a court reporter 15 you demonstrate how incompetent lawyers are. 16 I want to show you what has been 17 marked as Exhibit 9. Do you recall that 18 subsequently Mr. Vaske filed further papers in 19 the Workers' Comp proceeding in which he 20 identified that he worked around a number of 21 flavoring chemicals, including, specifically 22 but not limited to acetaldehyde. 23 MR. MACE: Same objection. 24 A I was not involved with Workers' Comp claims. 25 Q You weren't? 0054 1 A No, I was not. 2 Q Didn't you in fact draft an affidavit which 3 was filed in Mr. Vaske's Workers' Comp 4 proceeding? 5 A I don't recall in relationship to a Workers' 6 Comp claim. 7 Q You don't? 8 A Workers' Comp is not part of my job function. 9 Q Are you telling the jury you didn't file an 10 affidavit in Mr. Vaske's Workers' Comp action? 11 A I don't recall. My job function is not to 12 file Workers' Comp claims. 13 Q I see. 14 (Exhibit Number 10 15 Marked for identification.) 16 Q We will mark Exhibit 10. Do you see your 17 affidavit in this document? 18 A Not yet. 19 Q It's at Bates number 11085. Do you see your 20 affidavit? 21 A Yes, I do. 22 Q This is Exhibit 10, which is a letter from 23 Frost & Jacobs, LLP to the Industrial 24 Commission of Ohio, regarding Walter Vaske's 25 claim, the claim we were just looking at. Do 0055 1 you see that? 2 MR. MACE: Objection, form, 3 foundation, hearsay, best evidence rule. 4 A Yes, I see it. A letter from Frost & Jacobs. 5 Q The number four attachment within this 6 document is the affidavit of Nancy A. Higley 7 with attached curriculum vitae and material 8 safety data sheets; do you see that? 9 A Affidavit of Dr. Nancy Higley, yes. 10 Q That is you? 11 A That is correct. 12 Q That is your affidavit at 11085, is it not? 13 A Yes, it is. 14 Q Does this refresh your recollection that in 15 fact you supplied an affidavit in Mr. Vaske's 16 Workers' Comp action? 17 A No. It refreshes my recollection that I had 18 an affidavit. I did not know -- it does not 19 refresh any recollection that it was 20 specifically for Mr. Walt Vaske. 21 Q It doesn't? 22 A No. 23 Q Look at paragraph five of your own affidavit, 24 just above your signature. 25 A It does. I didn't recall. 0056 1 Q It says I understand that Walter Vaske may 2 attribute his bronchiolitis obliterans 3 condition to exposure to acetaldehyde; do you 4 see that? 5 A I see that. 6 Q When I became aware of this issue, I conducted 7 a comprehensive review of scientific 8 literature on the subject of any relationship 9 between bronchiolitis obliterans and 10 acetaldehyde and didn't find any reported 11 association; do you see that? 12 A That is what it reads, yes. 13 Q In fact you are aware now, and can recall, 14 that Tastemaker -- I'm sorry, Givaudan, denied 15 that acetaldehyde was the cause of 16 bronchiolitis obliterans; isn't that true? 17 MR. MACE: Objection. 18 A I wrote in my affidavit I did not find any 19 scientific literature that would support that. 20 Q Let me show you the answer which we marked as 21 Exhibit 11 to Mr. Vaske's claim. 22 (Exhibit Number 11 23 marked for identification.) 24 Q Just to refresh your recollection again of 25 what position Tastemaker was taking in 0057 1 Mr. Vaske's case about that issue, which you 2 filed the affidavit to support. 3 MR. MACE: Objection, form, 4 foundation. Objection to characterization as 5 refreshing her recollection, which implies she 6 ever had any involvement or recollection. 7 MR. McCLAIN: She has no 8 recollection of anything, even documents she 9 signed. 10 MR. MACE: Objection, move to 11 strike. 12 MR. McCLAIN: I understand you well 13 prepared her to say she doesn't remember 14 anything, Mr. Mace. It is very clear she did 15 have a recollection at one time. I can 16 attempt to refresh it. 17 MR. MACE: Objection, move to 18 strike comments of counsel. Objection to 19 form. 20 Q Look over would you at the answer of Frost & 21 Jacobs, the company that is referred to in the 22 previous document, that is their answer, Frost 23 & Jacobs? 24 A I'm sorry, I have never seen this document 25 before, so I'm not sure what you are referring 0058 1 to. 2 Q Look at page 4. 3 A Of Exhibit 11? 4 Q Yes. Item four says Tastemaker admits 5 applicant has the condition bronchiolitis 6 obliterans, but is without knowledge or 7 information sufficient to form a belief as to 8 the truth of the remaining allegations 9 contained in paragraph four of the 10 application, therefore denies them. 11 MR. MACE; Same objection, move 12 to strike. 13 Q That was the paragraph that referred to 14 acetaldehyde causing bronchiolitis obliterans; 15 do you remember that now? 16 A I've never seen this document. 17 Q How is it you became aware that Mr. Vaske was 18 claiming his bronchiolitis obliterans could 19 have been caused by acetaldehyde then? 20 A I don't recall when I was made aware. 21 Q Now you can recall filing this affidavit to 22 say you did not believe it was acetaldehyde 23 that caused -- 24 MR. MACE: Mischaracterization, 25 objection to form. 0059 1 Q Go ahead. 2 A I recall the affidavit. But again, I had 3 nothing to do with filing Workers' Comp 4 claims. I have never seen this document. 5 Q You were employed to assist the lawyers 6 defending the bronchiolitis obliterans 7 Workers' Comp claim, we see that by this 8 affidavit; isn't that true? 9 MR. MACE: Objection to the 10 characterization. Objection to form. 11 A I was not employed to assist the lawyers. I 12 did sign this affidavit. 13 Q We're mincing words. You were an employee of 14 Tastemaker/Givaudan, right? 15 MR. MACE: Objection. 16 A Yes. 17 Q The lawyers for the company asked you to fill 18 out an affidavit to defend the claim that 19 Mr. Vaske had brought to receive compensation 20 because he had suffered from bronchiolitis 21 obliterans while working at the Givaudan 22 plant, right? 23 MR. MACE: Objection form, 24 compound. 25 A No, that is not what they asked me to do. 0060 1 Q They asked you to file an affidavit, you 2 understood they were defending the claim 3 Mr. Vaske brought; is that true? 4 A No, that is not true. 5 Q They weren't defending the claim that 6 Mr. Vaske had brought? 7 MR. MACE: Objection, compound. 8 Q Didn't you understand that? 9 A No. 10 Q You didn't understand that Frost & Jacobs were 11 defending a Workers' Comp claim that Mr. Vaske 12 brought? 13 A I was asked to sign the affidavit that 14 explains what our processes were for filling 15 out material safety data sheets and to explain 16 what my findings were with regard to 17 acetaldehyde. 18 Q It says here I understand that Walter Vaske 19 may attribute his bronchiolitis obliterans 20 condition to exposure to acetaldehyde. How 21 did you understand that? 22 MR. MACE: Objection, asked and 23 answered. 24 A I was asked to look at the literature search 25 with regard to acetaldehyde. 0061 1 Q Who told you that Walter Vaske attributes his 2 bronchiolitis obliterans to acetaldehyde? 3 A I can't recall. 4 Q Wasn't it the lawyers from Frost & Jacobs? 5 MR. MACE: Objection. 6 A I can't recall. 7 Q Let's make it clear. As of 1998 it was not 8 the position of Givaudan that acetaldehyde 9 caused bronchiolitis obliterans, was it? 10 MR. MACE: Objection. 11 A I need you to repeat that. 12 (Question read.) 13 A We had a suspicion that acetaldehyde was 14 consistent with causing respiratory illnesses. 15 Q You took that position somewhere? 16 A That acetaldehyde -- 17 Q Caused bronchiolitis obliterans? 18 MR. MACE: Objection. 19 A No, I did not take that position. 20 Q No, in fact you took the opposite position, 21 didn't you? 22 MR. MACE: Objection. 23 A Yes. 24 VIDEOGRAPHER: Off the record at 25 10:52. 0062 1 (Recess taken.) 2 VIDEOGRAPHER: Back on the record 3 at 11:13. 4 Q We were talking about Mr. Vaske's Workers' 5 Comp case. I want to take a step back from it 6 before we come around to the issue we were 7 addressing, which was what caused his 8 bronchiolitis obliterans. When we broke we 9 were looking at your affidavit that you filed 10 that said it was not acetaldehyde, so let's 11 look at some of this history and some of these 12 other workers involved, then we will come back 13 to Mr. Vaske, okay? 14 MR. MACE: Objection, 15 mischaracterization, move to strike counsel's 16 comments. 17 Q First of all, let's look at the employees who 18 were diagnosed with bronchiolitis obliterans 19 at the Tastemaker plant. 20 (Exhibit Number 12 21 Marked for identification.) 22 Q Let me hand you what we will mark as Exhibit 23 12. This is a document which was marked 24 Mr. Hochstrasser's deposition, do you know 25 Mr. Hochstrasser? 0063 1 A Yes. 2 Q Addressed to him. John, listed below are the 3 eight current or past employees with the 4 confirmed diagnosis of bronchiolitis 5 obliterans, and the one suspected case. Do 6 you see again referring to the nine cases that 7 were identified in Mr. Fluckiger's memo we 8 looked at a few minutes ago? 9 MR. MACE: Objection form, 10 foundation, hearsay, best evidence rule, 11 mischaracterization, assumes, move to strike. 12 A I can't connect this was Mr. Fluckiger's memo 13 because it doesn't mention Mr. Fluckiger on 14 here. 15 Q Do you remember Mr. Fluckiger said you had 16 eight cases, one possible case, that is nine? 17 MR. MACE: Objection. 18 Q This memo refers to nine bronchiolitis 19 obliterans cases. Were there more than nine? 20 MR. MACE: Objection, 21 mischaracterization. Objection, foundation. 22 Objection, compound. 23 A I recall from Andy's memo nine, yes. 24 Q There weren't like 18 were there? 25 A I recall from Andy's memo the number 9. 0064 1 Q There are nine referred to here too, right? 2 MR. MACE: Objection. 3 A Eight plus one, yes, nine. 4 Q It lists them, Cliff Walker, M.S. McGee, Robin 5 Gaskins, Ron Feldcamp, Gary Shea, Walt Vaske, 6 right? 7 A That's what is written, yes. 8 Q Joey Wallace, right? 9 A Yes, that is what is written. 10 Q Janice Irick, correct? 11 A Yes, that is what is written. 12 Q These are all names that are familiar to you; 13 am I right? 14 A Yes, these names are familiar. 15 Q These were individuals who were looked at as 16 potentially having bronchiolitis obliterans at 17 the Tastemaker plant while you were employed 18 there; is that true? 19 A Yes, that's correct. 20 Q To take us back to the question that I asked 21 you before, about when various things were 22 known, who knew them, let me show you a 23 document that we'll mark as Exhibit 13. 24 (Exhibit Number 13 25 Marked for identification.) 0065 1 Q This is a document which is marked as Exhibit 2 13. The document date is February 18, 1993. 3 It refers to a December 8, 1992 meeting. It 4 says the following personnel met to discuss 5 the concern. The group became the core of a 6 task assigned to resolve this concern. You're 7 listed there; do you see that? 8 A Yes, I see that. 9 Q Along with Mike Davis, who was what, the CEO 10 of the company? 11 A President, yes. 12 Q Pellegrino, another chief executive, right? 13 He ultimately became president. I don't know 14 what his title was at this time. 15 A I don't recall either. 16 Q Duros was a lawyer, right? 17 A That's correct. 18 Q Schmelzel was the plant manager, right? 19 A That's correct. 20 Q Hochstrasser was in charge of environmental 21 and health issues in the plant, right? 22 A That's correct. 23 Q You're listed, then Terri Bonar-Stewart, who 24 is she? 25 A Human resources. 0066 1 Q The concern that is discussed at the top is, 2 two employees working in the Cincinnati 3 facility were diagnosed by a pulmonary 4 physician as having bronchiolitis obliterans. 5 It is important to determine if their disease 6 is or could be related to their occupation; 7 you see that? 8 A Concern was a condition that was defined as 9 bronchiolitis obliterans. 10 Q I didn't ask you that question. I asked did 11 you see what I read? 12 A No, I didn't see what you read. Excuse me. 13 Q Two employees working in the Cincinnati 14 facility were diagnosed by a pulmonary 15 physician as having bronchiolitis obliterans; 16 do you see that listed under concern? 17 A That is what is written, yes. 18 Q Reads it is important to determine if their 19 disease is or could be related to their 20 occupation; do you see that? 21 A Yes, that is what is written. 22 Q Now you had two workers in 1993, do you see 23 that, who had been diagnosed with 24 bronchiolitis obliterans? 25 MR. MACE: Objection, 0067 1 foundation. 2 A Two employees were diagnosed as having 3 bronchiolitis obliterans. 4 Q Right. I want you to go back to Exhibit 3, 5 which is the FEMA report, look with me at page 6 1261 if you could. You were aware, were you 7 not, that NIOSH would do investigations of 8 exposures resulting from bronchiolitis 9 obliterans on as little as two people, were 10 you not? 11 MR. MACE: Objection. 12 A No, I was not. 13 Q You weren't? 14 A No, I'm not. 15 Q First of all, let's read what FEMA, your 16 organization, says NIOSH did in a case where 17 two workers in a baking facility were 18 diagnosed with bronchiolitis obliterans. 19 MR. WOODSIDE: Can I interrupt? 20 Would you speak up just a little, if you don't 21 mind. I realize you have a small voice. It's 22 difficult for me to hear. Sorry. 23 A Sure, excuse me. 24 Q It says the possibility that exposure to 25 flavors in the workplace may result in 0068 1 respiratory injury was noted in a 1986 health 2 hazard evaluation published by the National 3 Institute of Occupation Safety and Health on 4 two workers at a facility that mixed liquid 5 and powdered flavoring for use in the baking 6 industry. The report concluded that it is 7 probable some agent in the mixing room 8 produced severe mixed obstructive lung 9 disease. Lung tissue samples, lung biopsy 10 information from the two workers were not 11 available but the report concluded that the 12 clinical picture was more compatible with 13 bronchiolitis obliterans than with emphysema; 14 do you see that? 15 A That is what is written, yes. 16 Q By this we know that NIOSH conducted a study 17 when two workers were diagnosed with 18 bronchiolitis obliterans, correct? 19 A From this we know that NIOSH conducted a study 20 of two workers, the clinical picture was 21 compatible with bronchiolitis obliterans. 22 Q You we see from the document that I handed you 23 a second ago which is Exhibit 13, is that the 24 exhibit you have in front of you that 25 discusses the fact you had two workers that 0069 1 were diagnosed with bronchiolitis obliterans 2 in 1993, right? 3 A The document indicates two employees, yes. 4 One of which is deceased, so it's not a 5 current employee at the time of writing of 6 this. 7 Q What difference does that make? 8 A Just wanted to clarify it. 9 Q Handing you what we will mark as Exhibit 14. 10 (Exhibit Number 14 11 Marked for identification.) 12 Q Now you in fact received a copy of this 1986 13 report which was the international baker study 14 in 1995, didn't you? 15 A I received it. I don't know what date I 16 received it. 17 Q So in 1995 you became aware of the 18 international baker study that had been done 19 by NIOSH? 20 A Yes, in 1995 I received the attached abstract, 21 yes. 22 Q So, at least by this date you were aware that 23 NIOSH did investigations of employee health, 24 specifically bronchiolitis obliterans in the 25 food industry; am I right? 0070 1 MR. MACE: Objection. 2 A Yes, that is what this report says. 3 Q You did not ask NIOSH to come in and make a 4 similar investigation of your situation, did 5 you? 6 A No, we went a different route. 7 Q In fact you analyzed the international baker 8 study to determine whether or not the workers 9 who had bronchiolitis obliterans were exposed 10 to the same materials that the workers in your 11 plant that had bronchiolitis obliterans were 12 exposed to; isn't that right? 13 MR. MACE: Objection, 14 foundation. 15 A I analyzed the ingredients, the raw materials 16 in our plant to see if they were consistent 17 with what was found in the NIOSH article. 18 Q Two of the ingredients that you found that 19 were consistent were acetaldehyde, and also 20 diacetyl; am I right? 21 MR. WOODSIDE: Objection, 22 foundation. 23 MR. MACE: Objection. 24 A No, you are not right. 25 (Exhibit Number 15 0071 1 Marked for identification.) 2 Q Look at Exhibit 15. This is a project team 3 meeting dated 14th of September 1995, which is 4 a few months after you received the 5 International Bakers study; am I right? 6 A The dates are, yes. 7 Q You were on this project team, you are shown 8 here Nancy Higley, regulatory/toxicology? 9 A That's correct. 10 Q With John Hochstrasser and Jim Lockey, right? 11 A Yes. 12 Q Janice Dees who was in medical management who 13 was the one that sent around the abstract from 14 the International Bakers study; am I right? 15 A Yes. 16 Q Look at the -- look back at the document which 17 is attached here, called raw material 18 sensitivity list. You list all the chemicals 19 that were found in the flavorings in the 20 International Bakers study that your employees 21 had been tested to be sensitive to. The 22 concerns that EH&S, that is Mr. Hochstrasser's 23 function had, about the chemicals being used 24 in your plant; am I right? 25 MR. MACE: Objection, form, 0072 1 characterization, foundation, hearsay, best 2 evidence rule. 3 A No, you are not correct. What you are not 4 correct about, it was not tested for 5 sensitivity. Sensitivity is a scientific 6 term. That column is more reflective of what 7 I would say the workers experienced annoyance 8 with. They were not tested. 9 Q With that clarification, I'm correct? 10 MR. MACE: Objection. Same 11 objection. 12 Q You compared the bakers list, that is the 13 International Bakers study, employee 14 sensitivity as you defined it, and the 15 concerns that Mr. Hochstrasser had regarding 16 the chemicals being used in your plant; am I 17 right? 18 MR. WOODSIDE: Objection, form. 19 MR. MACE: Objection, 20 foundation, form. 21 A I personally did not make this list, no. 22 Q You were on the team that analyzed it, right? 23 MR. MACE: Objection, 24 assumption. 25 Q Weren't you on the team that analyzed this 0073 1 list? 2 MR. MACE: Objection. 3 A I was on the team that received this list. I 4 did not make this list. 5 Q On the first page, the only chemicals that 6 were on all three lists; the baker list, the 7 employee sensitivity, the EH&S concern, were 8 acetaldehyde, correct? 9 MR. MACE: Objection, form, 10 foundation, hearsay. 11 Q Benzaldehyde, the next page, diacetyl, 12 correct? 13 MR. WOODSIDE: Objection, form. 14 MR. MACE: Objection. 15 A That appears to be correct. 16 Q Now, let's go back to Mr. Vaske who you filed 17 an affidavit that said you didn't believe his 18 bronchiolitis obliterans was caused by 19 acetaldehyde. 20 MR. MACE: Objection, 21 mischaracterization. 22 Q Let's look at what we will mark as Exhibit 23 16. 24 (Exhibit Number 16 25 Marked for identification.) 0074 1 Q When Mr. Vaske was examined by Dr. Lockey, he 2 filled out a questionnaire, did he not? 3 MR. MACE: Objection, 4 mischaracterization, assumption, foundation, 5 form. 6 Q The employees that were diagnosed with 7 bronchiolitis obliterans -- let's start again. 8 When you were analyzing this issue, 9 the employees of Tastemaker went through PFT 10 testing, did they not? 11 A Yes, they did. 12 Q The employees that received that PFT testing 13 were asked to fill out the questionnaire; am I 14 right? 15 A The employees were asked to fill out a 16 questionnaire. I'm not -- I do not recollect 17 where the completion of the questionnaire was 18 with relation to the PFT. I'm not sure about 19 the frequency or staging of it. 20 Q You are aware that there was a questionnaire 21 that they filled out? 22 A Yes. 23 Q This was Mr. Vaske's questionnaire. Question 24 18 asks, at Tastemaker are there any chemicals 25 or substances that you worked with that seem 0075 1 to result in tingling, burning or stinging of 2 your eyes, nose or throat or frequent sneezing 3 or difficulty breathing; do you see that? 4 MR. MACE: Objection, form, 5 foundation and hearsay and best evidence. 6 A Yes, that is what is written. 7 Q He checks yes, right? 8 A Yes. 9 Q He lists a series of chemicals and lists all 10 three of the once that your analysis told you 11 were on the Bakers list, on the sensitivity 12 list, and on the E&H concern list of 13 Mr. Hochstrasser, right? 14 MR. MACE: Objection to form, 15 assumes, characterization, foundation, 16 hearsay, completeness. 17 Q That is he lists acetaldehyde, benzaldehyde, 18 and diacetyl, does he not? 19 MR. MACE: Objection. 20 A In addition to mustard seed oil, capsaicin, 21 metholsolithalate, and some others that I 22 can't read. 23 Q Sure. The three I mentioned are there, are 24 they not? 25 MR. MACE: Same objection. 0076 1 A Yes, they are there. 2 Q Here is the question. Did at any time that 3 you were at Givaudan or Tastemaker, anyone say 4 you know what, there is a real easy way to 5 figure this out. Let's look at these three 6 chemicals and see whether any of them will 7 cause lung injury in laboratory animals; did 8 you ever say that? 9 MR. MACE: Objection, 10 characterization and object to form. 11 A No, that would be scientifically an improper 12 way to approach it. 13 Q That is the way NIOSH approached it; isn't 14 that true? 15 MR. MACE: Objection. 16 Q They did laboratory tests to confirm whether 17 or not any of the chemicals in the butter 18 flavor would cause the same change that they 19 were seeing in the workers; isn't that right? 20 MR. MACE: Objection. 21 A No, that is not right. They did laboratory 22 testing, it did not confirm. 23 Q They said it confirmed, didn't they? 24 MR. MACE: Objection. 25 MR. WOODSIDE: Objection. 0077 1 Q Wasn't that NIOSH's conclusion? 2 A No. 3 Q It wasn't? 4 A I don't believe it is. 5 Q Let's look at the report again. Look over 6 with me, would you please, would you look at 7 page 337 of the article. It says inhalation 8 studies, butter flavoring vapors produce 9 diacetyl levels of 352 parts per million, 10 damage respiratory epithelium in the airway of 11 rats; do you see that? 12 MR. MACE: Objection, form, 13 foundation, hearsay, best evidence rule, move 14 to strike. 15 A Yes, it is referencing another paper. 16 Q By Hubbs? 17 A Yes. 18 Q Employed by NIOSH to do the study on the 19 butter flavor from the Jasper, Missouri plant; 20 is that right? 21 MR. WOODSIDE: Object, foundation. 22 A Yes, she works for NIOSH. 23 Q It says NIOSH scientists chose this exposure 24 level as one similar to that of possible peak 25 levels in the space above the heated oil 0078 1 within the mixing or holding tanks in the 2 popcorn plant. A peak diacetyl level of 1230 3 parts per million was later measured in this 4 space, in a tank holding the same butter 5 flavoring tested in the animal studies. 6 Damage in the rats extended below the basement 7 membrane of sloughed respiratory epithelium 8 suggesting that repair would probably involve 9 airway fibrosis. 10 These preliminary findings in animals 11 suggest that a volatile ingredient in the 12 butter flavoring is a biologically plausible 13 cause of the respiratory effects seen in the 14 workers in the popcorn plant. Support for 15 this hypothesis comes from the findings of a 16 health hazard investigation at the company 17 that mixed flavorings in corn starch for the 18 baking industry. It refers to the 19 International Bakers study; do you see that? 20 MR. MACE: Objection, form, 21 foundation, hearsay, best evidence rule, move 22 to strike. 23 A That is what it says. I don't think it 24 properly characterizes Hubbs. 25 Q The question I had is, that is how NIOSH 0079 1 characterized it. You said no, you didn't 2 think so. I'm right about that, aren't I? 3 MR. MACE: Objection. 4 A I don't believe that is what you stated. 5 Q I stayed that NIOSH said the animal studies 6 supported their finding; that is true, isn't 7 it? 8 MR. MACE: Objection, form, 9 foundation, best evidence rule, hearsay. 10 A NIOSH is saying that the animal studies 11 suggest a volatile ingredient in butter 12 flavoring is biologically plausible. 13 Q Supporting their conclusion, that is what they 14 said? 15 MR. MACE: Objection. 16 A It says it is biologically plausible, doesn't 17 say it supports their conclusion. 18 Q Did you see support for this hypothesis, do 19 you see that? 20 MR. MACE: Objection. 21 A That support is coming from reference 18. 22 Q Which is the International Bakers study, which 23 you also had. 24 A Right. 25 Q Did you ever do any animal studies regarding 0080 1 any of these three suspected chemicals in your 2 plant, benzaldehyde, acetaldehyde or 3 diacetyl? 4 MR. MACE: Objection, form, 5 characterization, assumption. 6 A No, we did not. 7 Q Let me show you what we will mark as 8 exhibit -- are we at 17? 9 (Exhibit Number 17 10 Marked for identification.) 11 Q Let me show you what we will mark as Exhibit 12 17. This is another questionnaire that 13 Mr. Vaske filled out, right, it's after the 14 first one, right? 15 A That is correct. 16 Q About a month later, question 3E says, if yes 17 to part 3D are there any chemicals, 18 substances, job activities or particular areas 19 of the plant that seem to result in chest 20 tightness or breathing difficulty; do you see 21 that? 22 MR. MACE: Objection, form, 23 foundation, hearsay, best evidence rule. 24 Q Again he lists diacetyl, benzaldehyde, 25 acetaldehyde as three chemicals among others 0081 1 that cause his problems, right? 2 MR. MACE: Objection, 3 characterization. Same objections, move to 4 strike, completeness, capsaicin, punch oil, 5 mustard seed oil. 6 Q Confirm for Mr. Mace because apparently he's 7 not listening, those three were not on your 8 list in terms of all three chemicals lining up 9 between the Bakers study, your sensitivity 10 list and EH&S concerns, were they? 11 MR. MACE: Objection, 12 characterization. 13 Q The only three that meet that criteria are 14 diacetyl, benzaldehyde and acetaldehyde, 15 true? 16 MR. MACE: Objection. 17 A Those three were on the list you referenced, 18 which is not my list. 19 Q Your group's list? 20 MR. MACE: Objection. 21 Q Right? 22 A The list that is attached. There are other 23 things in this document. 24 Q Right. The document I showed you was sent to 25 you, true? 0082 1 MR. MACE: Objection. 2 A It was provided to me in a meeting, yes. 3 Q The three chemicals that were highlighted on 4 that list, diacetyl, benzaldehyde and 5 acetaldehyde were identified by Mr. Vaske in 6 this questionnaire dated 10-10-95, true? 7 MR. MACE: Objection. 8 A Actually the other ingredients are on the 9 list. 10 Q They are not on each of the lists, are they? 11 A No, they are not. 12 Q The only ones on each of the lists are the 13 three I mentioned; that is benzaldehyde, 14 diacetyl and acetaldehyde, true? 15 A Those three are on the list that was attached, 16 yes. 17 Q One of the other people we saw in a previous 18 exhibit was Mr. Feldcamp. He was another 19 individual who was identified as having 20 bronchiolitis obliterans? 21 MR. MACE: Objection. 22 Q Right? 23 A He was identified on a list. I don't see a 24 clinical report that he had bronchiolitis 25 obliterans. 0083 1 Q Do you want to see one? I'll be happy to 2 provide those to you. We have them on each 3 one of these people. I'm going from your 4 company's list. You remember that list, don't 5 you? 6 MR. MACE: Objection. Move to 7 strike the comments. 8 A It's on this list, this one you referred to 9 that is not dated, Exhibit 12. 10 Q Do you want to see a date on something; what 11 is your question? 12 A At some point I think we need to put this into 13 context. 14 Q Great. In 1997 do you remember that 15 Mr. Feldcamp was seen at the University of 16 Cincinnati, diagnosed with bronchiolitis 17 obliterans associated with his work 18 environment? 19 MR. MACE: Objection, compound, 20 form, foundation, hearsay. 21 A I would not know the date without my memory 22 being refreshed. 23 Q Let me refresh your memory. This is Exhibit 24 18 25 (Exhibit Number 18 0084 1 Marked for identification.) 2 Q Dr. Baughman, however you pronounce it, an 3 associate of Dr. Lockey; do you see that? 4 A Dr. Baughman is an associate of the University 5 of Cincinnati. 6 Q It says as you know Mr. Feldcamp has been 7 diagnosed by myself as having bronchiolitis 8 obliterans associated with his work 9 environment; do you see that? 10 MR. MACE: Objection, form 11 foundation, hearsay, best evidence rule, rule 12 of completeness, goes on to talk about 13 consistent with, may be an infective process, 14 based on epidemiology. 15 Q Right? 16 A That is one of the sentences in here, yes. 17 Q I'm only showing it to you because you wanted 18 to see a doctor's diagnosis, so I'm giving you 19 one; do you see that? 20 MR. MACE: Objection. 21 Q You see the doctor's diagnosis? 22 A I also see further on clarification. 23 Q I didn't ask you anything about clarification. 24 You asked for a doctor's diagnosis, and he 25 says as having bronchiolitis obliterans 0085 1 associated with his work environment, right? 2 MR. MACE: Same objection, rule 3 of completeness, goes on to state consistent 4 with, an infective process and other 5 epidemiology. 6 A You are only reading one part of the 7 sentence. It does go on to qualify it. 8 Q So are you saying that he did or didn't have 9 bronchiolitis obliterans? 10 A I do not believe that this is conclusive that 11 he had bronchiolitis obliterans. 12 Q Look back at your other exhibit. That is 13 Exhibit 12 in front of you, that lists it. Is 14 Mr. Feldcamp listed by your company as having 15 bronchiolitis obliterans? 16 MR. MACE: Objection, 17 characterization. Objection, asked and 18 answered, compound. 19 A I can't answer because this document has no 20 date. 21 Q I don't care what the date is. 22 A This could have been prior to this, which 23 indicates it's inconclusive. 24 Q What difference does it make? The answer is 25 your company said it was bronchiolitis 0086 1 obliterans, didn't it? It doesn't say consist 2 with, doesn't say anything like that. It says 3 they have been diagnosed as having 4 bronchiolitis obliterans, don't they, in 5 Exhibit 12? 6 MR. MACE: Objection, same 7 objection, move to strike. 8 Q Isn't that what it says? 9 A I still believe it needs to be put into 10 context. This was made prior to this. 11 Q Let me stop you for a minute. I'll let you 12 say whatever you want after you answer the 13 question. 14 The document 12 says that, doesn't it, 15 that they have been diagnosed with 16 bronchiolitis obliterans? 17 MR. MACE: Objection. 18 Q Isn't that what it says? 19 A The undated document says -- includes Ron 20 Feldcamp in the list with a current employee 21 with a confirmed diagnosis. 22 Q Of bronchiolitis obliterans? 23 A The header says confirmed diagnosis. 24 Q The diagnosis in Exhibit 18 is bronchiolitis 25 obliterans? 0087 1 MR. MACE: Objection. 2 A With qualifications. 3 Q Dr. Baughman was one of the co-authors with 4 Dr. Lockey, we saw in Exhibit 5 in his 5 abstract, true? 6 MR. MACE: Objection, foundation 7 hearsay. 8 Q You see that? 9 A I see R. Baughman as a co-author in the 10 abstract, 2002. 11 Q Let's go to Mr. Feldcamp and his documents, if 12 we can. Since we clarified the questions that 13 you raised, let's look at Exhibit 19. 14 (Exhibit Number 19 15 Marked for identification.) 16 MR. MACE: Objection, move to 17 strike comments. 18 Q I direct your attention to page 9. You see in 19 answer to question 18 he answers yes to the 20 question, are the results of any chemicals or 21 substance that you work with that seem to 22 result in tingling, burning or stinging or 23 your eyes, nose or throat, or frequent 24 sneezing with difficulty breathing; you see 25 that? 0088 1 MR. MACE: Objection, form, 2 foundation, hearsay. 3 A Yes, I see that. 4 Q He lists diacetyl, does he not? 5 MR. MACE: Objection, 6 completeness, form, foundation, hearsay, best 7 evidence rule. 8 A Diacetyl is listed in addition to 9 acetaldehyde, benzaldehyde, dimethyl sulfide, 10 onion, garlic oils and apple oils. 11 Q We see that diacetyl is listed, acetaldehyde, 12 benzaldehyde, the three chemicals which you 13 had listed in the previous summary that we saw 14 that was consistent between the Bakers study, 15 your employee sensitivity evaluation, and 16 EH&S's concern list, true? 17 MR. MACE: Objection, 18 characterization. Objection, compound. 19 A Yes, it's on the list. The list that -- 20 Q Once again, even though Mr. Feldcamp was 21 diagnosed with bronchiolitis obliterans, 22 identified those same three chemicals, no 23 tests was ordered on the three chemicals to 24 determine whether or not they would cause 25 respiratory injury in animals, were they? 0089 1 MR. MACE: Objection, assumes, 2 compound, characterization, foundation, 3 hearsay, argumentative. 4 A I don't believe the letter of 1997 confirms 5 that he had bronchiolitis obliterans. I 6 further do not believe that listing on this 7 question 18 is indicative of a respiratory 8 situation. It could be stinging of eyes, nose 9 or throat. 10 Q Miss Higley, I understand you want to explain 11 away this whole thing. My question is 12 simple. Did you ask for any tests to be done 13 on the three chemicals that he identified that 14 were consistent with your suspect chemical 15 list? 16 MR. MACE: Objection, move to 17 strike comments. 18 A No, I believe that would have been too narrow 19 of an approach. 20 Q Let's talk about the results of your less 21 narrow approach. Even today it is your 22 contention you don't know what caused 23 bronchiolitis obliterans in your plant, do 24 you? 25 MR. MACE: Objection. 0090 1 A I think that medical records are not 2 indicative that there are cases of 3 bronchiolitis obliterans. I think our more 4 narrow approach was to go after total worker 5 protection, a more comprehensive program. 6 Q You still don't know today what caused the 7 bronchiolitis obliterans in your plant, do 8 you? 9 A I still do not believe that the medical record 10 that you are showing me is telling me Ron 11 Feldcamp has bronchiolitis obliterans. It 12 says it is consistent with. 13 Q Even -- you are not even willing to concede 14 that any of your workers got bronchiolitis 15 obliterans; is that right? 16 A Not this document that I'm looking at here, on 17 Ron Feldcamp. 18 Q What other tests did you do, what other 19 medical evaluations did you make? Dr. Lockey 20 concluded that it caused bronchiolitis 21 obliterans. 22 MR. MACE: Objection. 23 Q He was your consultant. 24 MR. MACE: Objection, 25 mischaracterization. 0091 1 Q If you didn't believe him, what other tests 2 were necessary that you didn't do? 3 MR. MACE: Objection, compound, 4 move to strike, misstates the evidence, 5 foundation. 6 A I don't have a letter from Dr. Lockey that 7 indicates Ron Feldcamp has bronchiolitis 8 obliterans. 9 Q You have his co-author on the paper that they 10 submitted to the ATS that said you had five 11 confirmed cases of bronchiolitis obliterans, 12 don't you? 13 MR. MACE: Objection, 14 mischaracterizes the very document he's 15 handing. 16 A Says clinical findings consistent with 17 bronchiolitis obliterans. 18 Q What do you think that means? 19 A It means that they are not sure. It is 20 consistent with it. Respiratory illness has a 21 whole variety of manifestations. It's 22 consistent with. 23 Q If they didn't have bronchiolitis obliterans, 24 what did they have? 25 MR. MACE: Objection, 0092 1 foundation. 2 A I'm not a medical doctor. 3 MR. McCLAIN: Let's go off the 4 record. 5 VIDEOGRAPHER: We're off the record 6 at 11:57. 7 (Luncheon recess taken.) 8 VIDEOGRAPHER: We're on the record 9 at 1:18. 10 By Mr. McClain: 11 Q Would you look at Exhibit 13 that was in front 12 of you, Miss Higley, Dr. Higley. 13 In the letter marked as Exhibit 13 or 14 the occupational health concern that we looked 15 at earlier that talked about two employees 16 working in the Cincinnati facility were 17 diagnosed by pulmonary physicians as having 18 bronchiolitis obliterans. The two individuals 19 that they were talking about at the time were 20 Janice Irick, who is deceased, and Joey 21 Wallace, correct? 22 MR. MACE: Objection, form, 23 foundation. 24 A That is what is listed is those two 25 individuals with that listed cause of death. 0093 1 Q There is a third individual that is identified 2 as having a respiratory problem, Mr. Cliff 3 Walker; is that not right? 4 A He's identified as having restricted pulmonary 5 function. 6 Q He was subsequently diagnosed as having 7 bronchiolitis obliterans, was he not? 8 MR. MACE: Objection. 9 A I don't have a document to support that. 10 Q You had the previous one that listed him; am I 11 right? 12 MR. MACE: Objection, 13 foundation. 14 A Previous unsigned, undated document. 15 Q Sure, okay. Here is Dr. Lockey's report. 16 (Exhibit Number 20 17 Marked for identification.) 18 Q Here is Dr. Lockey's diagnosis of Mr. Cliff 19 Walker. It was faxed to Frost & Jacobs, the 20 legal counsel for Tastemaker, or faxed by 21 them. It's from corporate legal, from 22 Tastemaker to Frost & Jacobs. If you look 23 over to the last page, discussion, 24 Mr. Clifford Walker is a 48 year old gentleman 25 who has clinical findings as well as 0094 1 laboratory results consistent with 2 bronchiolitis obliterans; do you see that? 3 MR. MACE: Objection to form, 4 foundation, hearsay, best evidence rule, move 5 to strike. 6 A That is what the document says. 7 Q In Dr. Lockey's evaluation of Mr. Walker, he 8 identified that he worked in the process 9 flavors area; do you see that? 10 A Yes. 11 Q He says he noted the following chemical agents 12 that would cause him to have breathing 13 problems. The first one listed is diacetyl; 14 am I right? 15 MR. MACE: Objection to form, 16 foundation, hearsay, best evidence rule. 17 A Number one lists diacetyl. 18 Q The next two, garlics and toasted that were 19 giving him problems were not chemicals 20 identified on all three lists, that is the 21 International Bakers study, the sensitivity 22 list, and the EH&S concern list; am I right? 23 MR. MACE: Objection. 24 A Not one of the ones that was listed on all 25 three. 0095 1 Q Correct? 2 A Yes, it's not one of the ones that was listed 3 on all three lists. 4 Q The only one that is listed is the diacetyl, 5 correct? 6 MR. MACE: Objection. 7 A Yes, diacetyl is the only one listed. 8 Q What it says in this report that went from 9 Tastemaker's legal department to Frost & 10 Jacobs is diacetyl, this could be added to 11 butter. It would reach a certain temperature 12 and flash. He would subsequently awaken at 13 night with chest tightness and cough and 14 frequently breathing. This would last 15 approximately four to five days and resolve. 16 There is no associated fever, chills, muscle 17 aches or pains. This occurred two or three 18 times a week until this butter operation was 19 transferred to the spray dry area 20 approximately two years prior to this 21 evaluation; do you see that? 22 MR. MACE: Objection, form, 23 foundation, hearsay, best evidence rule, move 24 to strike. Also rule of completeness, talks 25 about the occupational exposure at Procter & 0096 1 Gamble, Grace Chemical for one year filling 2 hoppers with an unknown powdered chemical. 3 Frequent chest colds during this one year, did 4 not wear a respirator. 5 Q Do you see that? 6 A The words that you wrote are listed here, or 7 the words that you said. 8 Q If you look at Exhibit 21 with me. 9 (Exhibit Number 21 10 Marked for identification.) 11 Q This is employee confidential medical and 12 employment information, known medical 13 maladies. You see under asthma where it lists 14 Mr. Walker? 15 A Yes, I see that. 16 Q Originally that is what they thought he had 17 because it was a restrictive disease; is that 18 right? 19 MR. MACE: Objection. 20 A I cannot comment. 21 Q You saw that originally at least in Exhibit 13 22 that I showed you that he was not listed as an 23 individual with bronchiolitis obliterans, but 24 subsequently Dr. Lockey made that diagnosis in 25 Exhibit 20? 0097 1 MR. MACE: Objection, 2 mischaracterization, foundation, form, 3 compound. 4 A I don't believe Dr. Lockey made that 5 conclusion. He said consistent with. 6 Q You think that is somehow different than 7 bronchiolitis obliterans? 8 A Yes, I do. 9 Q What is the basis for your belief in that 10 regard? 11 A Respiratory illnesses can range, have a wide 12 range of maladies. If it were bronchiolitis 13 obliterans, I would expect a medical physician 14 to say bronchiolitis obliterans, not 15 consistent with. 16 Q You don't know that there is any difference? 17 MR. MACE: Objection. 18 Q Bronchiolitis obliterans is consistent with 19 bronchiolitis obliterans, isn't it? 20 MR. MACE: Objection. 21 A Not being a medical physician, I can't answer 22 that. 23 Q Would you disagree that Dr. Lockey is in the 24 best position to tell you what he meant by 25 that and if he says Cliff Walker has 0098 1 bronchiolitis obliterans, that that is what he 2 meant, right? 3 MR. MACE: Objection. 4 A I would want to see it was also confirmed by 5 other physicians. 6 Q If we lined up a 100 physicians, tell the jury 7 the truth, no matter what we do, Miss Higley, 8 you are going to say you haven't proven that 9 they had bronchiolitis obliterans, you haven't 10 proven that it was caused by anything in our 11 plant; isn't that true? 12 MR. MACE: Objection, 13 argumentative. Objection to form. Objection, 14 move to strike. 15 Q You did nothing to try to confirm or to 16 dispute the findings of Dr. Lockey, did you? 17 MR. MACE: Objection. 18 A We had Dr. Lockey on retainer as our expert, 19 we depended on him to give us the information. 20 Q You are not willing to accept his judgment. 21 MR. MACE: Objection. 22 A I'm reading and accepting his judgment as 23 written here, which says consistent with 24 bronchiolitis obliterans. 25 Q Look over at the next exhibit that I handed 0099 1 you, which is Exhibit 21. Exposure location, 2 do you see that. This the document that 3 specifically lists out Mr. Walker; do you see 4 that? 5 A On the first page? 6 Q No, on Bates 489 at the bottom. 7 A I don't see Mr. Walker's name on here. 8 Q On the first page? 9 A Yes, I see it on the first page. 10 Q Did you see in Dr. Lockey's history, 11 occupational history, he notes that he worked 12 in process flavors, correct, Mr. Walker? 13 A That's correct. 14 Q In process flavors from this document we see 15 limited exposure to liquid chemicals, 16 diacetyl, sodium hydroxide, hydrochloric acid, 17 dimethyl sulfide, and garlic and meats, dust 18 exposure, right? 19 MR. MACE: Objection, 20 foundation, hearsay. 21 A Yes, that is what is written. 22 Q There is no mention that he was exposed to 23 acetaldehyde, correct? 24 A That's correct, not on this list. 25 Q There is no mention made that he was exposed 0100 1 to benzaldehyde? 2 A No, there is no listing. 3 Q When you did these pulmonary function tests in 4 the Tastemaker plant, there were a number of 5 employees that were found to have decreases in 6 pulmonary function tests, in addition to these 7 eight individuals who had diagnosed 8 bronchiolitis obliterans; am I right? 9 MR. MACE: Objection, compound, 10 form, foundation, assumption, 11 characterization. 12 A I did not conduct these studies. 13 Q No, but you are aware of them, are you not? 14 This is cc'd to you. 15 (Exhibit Number 22 16 Marked for identification.) 17 Q Let's start again. I'm handing you what we 18 marked as Exhibit 22. You are cc'd on this 19 document; is that correct? 20 A That's correct. 21 Q This is pulmonary medical surveillance 22 participants; is that right, that is the 23 subject of this document? 24 A That's correct. 25 Q It says here under results, 424 employees have 0101 1 had more than one pulmonary function test 2 since 1995. 26 employees, or 16 percent have 3 met the criteria, will be administered 4 pulmonary function tests on a quarterly basis; 5 do you see that? 6 MR. MACE: Objection, 7 assumption, characterization. 8 A Yes, I see that written. 9 Q Those 26 people that were identified had 10 deficits on pulmonary function tests, 11 correct? 12 MR. MACE: Objection, 13 foundation. 14 A Says that there is a summary of the people. I 15 don't see where the attached says that the 16 summary is of people with deficits. I have to 17 read this. I don't consider myself qualified 18 to make a conclusion of what the deficit would 19 be. 20 Q Do you recall that more than the eight 21 individuals were found to have deficits of 22 some pulmonary function testing? 23 A I don't recall that number. 24 Q You don't recall the number. Do you recall 25 any of them that were? 0102 1 A I recall there were individuals that were 2 administered the pulmonary function tests, 3 subsequently monitored with increased 4 frequency and referred to Dr. Roy McKay and 5 Dr. James Lockey. 6 Q You will note that on this chart in the back 7 there are 26 individuals listed which 8 corresponds with the numbers in the 9 accompanying memo, correct? 10 A There are 26 job titles listed. 11 Q Then it has a code which says that the A 12 workers were workers with a greater than a 10 13 percent drop in FCV or FEV1, correct? 14 MR. MACE: Objection, hearsay, 15 foundation. 16 A That is what the footnote says. 17 Q The B workers drop in FVC or FEV1, less than 5 18 percent, between 5 and limited detection, 19 correct? 20 MR. MACE: Objection, 21 characterization, hearsay, foundation. 22 A It reads drop in FVC or FEV1 greater than or 23 equal to 5 percent and less than LLN. 24 MR. WOODSIDE: Could you speak up. 25 A Sorry, yes. 0103 1 Q The C, was that FVC was less than 65 of the 2 predicted value? 3 MR. MACE: Same objection. 4 A FEV1/FVC percent less than 71 percent of 5 predicted. 6 Q Right. Now, that study, those numbers have 7 never been even published in the format that 8 we saw in the FEMA document, that is that 9 anonymous number -- or strike that. 10 This information has never been 11 published anywhere, has it? 12 MR. MACE: Objection. 13 Q Not by FEMA, not in abstract form, not 14 anonymously, nowhere has this data been given 15 to Dr. Lockey or someone else for 16 publication? 17 MR. MACE: Objection to form, 18 compound, characterization, foundation. 19 A It's been given to Dr. Lockey. 20 Q As far as you know has this ever been 21 published? 22 A To the best of my knowledge, no, it has not. 23 Q Diacetyl had been a chemical of concern within 24 Tastemaker even before there were documented 25 cases of injury within the plant; isn't that 0104 1 true? 2 MR. MACE: Objection. 3 A Diacetyl had been one of the many chemicals 4 that we looked at to consider for hazard 5 determination. 6 Q There were special precautions to be used 7 around diacetyl; isn't that true? 8 A Special precautions during dispensing. 9 Q Also during spray drying? 10 A When the predominant material was diacetyl. 11 Q As an example, whenever liquid diacetyl was 12 present, a respirator with chemical resistant 13 gloves had to be worn in the plant; isn't that 14 right? 15 MR. MACE: Objection, 16 characterization. 17 A Was to be worn while they were dispensing the 18 diacetyl. 19 Q Whenever the material was in a tank the lid 20 had to be closed? 21 MR. MACE: Objection, form. 22 A Is that a question? 23 Q Isn't that true? 24 MR. MACE: Objection. 25 A Can I see the document. 0105 1 Q I'm asking you for your memory first. I'm 2 happy to show you the document if you don't 3 recall. 4 A I don't recall. 5 (Exhibit Number 23 6 Marked for identification.) 7 A I didn't write this document. I don't know 8 the details of. 9 Q You see 7, whatever material is in any tank 10 the lid must be closed. If ventilation 11 (mechanical) is not connected to the tank or 12 is unavailable, a respirator must be worn at 13 all times while in the room; do you see that? 14 A I see that. My recollection is that it's 15 referring to when the material in the tank is 16 predominantly diacetyl, as it would be if it 17 was dispensing meat concentrate material. 18 Q The point that -- the only point I'm making is 19 that diacetyl was known even before you had 20 cases of bronchiolitis obliterans to be a 21 dangerous material? 22 MR. MACE: Objection. 23 Q True? 24 MR. MACE: Vague and ambiguous. 25 A I wouldn't classify it as dangerous. It's 0106 1 known to be an irritant to skin and eyes. 2 Q Not just an irritant, it will cause severe eye 3 burns, won't it? 4 A It can cause severe -- cause eye burns and 5 irritation to skin, eyes, nose, throat. 6 Q Not just eye burns, severe eye burns? 7 A I believe that the flavor fragrance data sheet 8 does not use the term severe. 9 Q Look at your own. Safety concerns for each 10 step of the procedure, on the first page, 11 vapors will cause severe eye burns, right, 12 burns to eyes? 13 A I didn't write this. 14 Q I didn't ask you if you wrote it. I asked if 15 it said it? 16 A It says that. But that statement is not 17 consistent with the flavor fragrance 18 ingredient data sheet for diacetyl. 19 Q Do you know why someone within Tastemaker 20 wrote up this inaccurate document? 21 MR. MACE: Objection, compound, 22 form, foundation, characterization. 23 A It would be speculation on my part. 24 Q You were there at the time. 25 A I did not write this document. 0107 1 Q I didn't ask you that. You were there, 2 weren't you? 3 A I was at Tastemaker, yes. 4 Q Do you remember Mr. Hochstrasser was asked to 5 review -- Mr. Hochstrasser asked you to send 6 him copies of the literature you received on 7 diacetyl in 1993? 8 MR. MACE: Objection. 9 A Yes, I recall. 10 Q Do you recall that at that point in time, in 11 '93, just after the diagnosis of the employees 12 who were having respiratory problems, those 13 that had been diagnosed with bronchiolitis 14 obliterans, that diacetyl appeared to be a 15 viable candidate as the possible cause or one 16 of the causes? 17 MR. MACE: Objection, 18 characterization, assumption. 19 A I recall diacetyl being one of the list of 20 ingredients, raw materials for which we wanted 21 to look into with regard to respiratory 22 maladies. 23 Q I'll show you what we marked as Exhibit 24. 24 (Exhibit Number 24 25 Marked for identification.) 0108 1 Q Does this refresh your recollection that as of 2 September 13, 1993, Mr. Hochstrasser, who was 3 in charge of environmental health and safety, 4 and had a Ph.D. as you did, believed that 5 diacetyl still appears to be a viable 6 candidate as a possible etiologic agent, or at 7 least one of the agents? 8 MR. MACE: Objection, form, 9 compound. 10 A Yes, Mr. Hochstrasser did say in this memo 11 that diacetyl does still appear to be a viable 12 candidate as a possible etiologic agent or one 13 of the agents. 14 Q It is the only chemical that is called out by 15 name; isn't that true? 16 A In this specific memo, yes. 17 Q Who is Fritzsche, Dodge and Olcott? 18 A It is a flavor company from years ago. 19 Q Tastemaker bought them, right? 20 A No, we did not. 21 Q Tastemaker owns them? 22 A No. 23 Q Or Givaudan does? 24 MR. MACE: Objection. 25 Q Which one? 0109 1 MR. MACE: Objection. 2 A Neither actually. They parallel path to the 3 Fries & Fries, Tastemaker. Givaudan prior to 4 any of us purchased Fritzsche, Dodge & 5 Olcott. Prior to Givaudan purchasing 6 Tastemaker they had purchased Fritzsche, Dodge 7 & Olcott. The two are unrelated. 8 Q Fritzsche, Dodge & Olcott was owned by BASF 9 Chemicals, were they not? 10 MR. MACE: Objection, 11 foundation. 12 A Many years ago. 13 Q BASF Chemicals supplied diacetyl, did they 14 not? 15 MR. MACE: Objection, 16 ambiguous. 17 A BASF didn't supply diacetyl to Tastemaker. 18 Q Did they supply it to Givaudan? 19 A No, they do not supply to Givaudan. 20 Q They were a supplier of diacetyl, were they 21 not? 22 MR. MACE: Objection. 23 A I believe they were, yes. 24 Q They were a member of RIFM, were they not? 25 MR. MACE: Objection, 0110 1 foundation, assumption. 2 A I don't know. I don't know all the members of 3 RIFM. 4 Q IFF was a member of RIFM, were they not, when 5 you were employed there? 6 A Yes, when I was employed there they were a 7 member of RIFM. 8 Q Givaudan was a member of RIFM, were they not? 9 MR. MACE: Objection, misstates 10 the evidence. 11 A The fragrance division of Givaudan was a 12 member of RIFM. 13 Q You are familiar that in 1993 BASF had 14 conducted a study of the respiratory effects 15 on rats of exposure to diacetyl; am I right? 16 MR. MACE: Objection, form of 17 the question. 18 MR. WOODSIDE: Foundation. 19 Q You are aware of that, aren't you? 20 A I'm aware BASF -- 21 MR. MACE: You are asking her 22 today if she is aware? 23 MR. McCLAIN: Don't help her. You 24 coached her well enough. She is doing just 25 fine. 0111 1 MR. MACE: Objection, move to 2 strike comments of counsel. Objection to the 3 ambiguous question. 4 MR. McCLAIN: Read the question 5 back. 6 (Question read.) 7 MR. MACE: Objection, 8 mischaracterization, foundation, and form, 9 compound, assumptions. 10 A I have seen the report from BASF. 11 Q Let me hand you what we marked as Exhibit 25. 12 (Exhibit Number 25 13 Marked for identification.) 14 Q You're familiar with this study, it has come 15 to your attention in recent years; is that 16 correct? 17 A That's correct. 18 Q So you are aware that in 1993 BASF had done a 19 study regarding the respiratory effect of 20 diacetyl exposure on laboratory animals; am I 21 right? 22 MR. MACE: Objection, 23 characterization, form. 24 A That is the date of the study. It was not 25 received until 2001. 0112 1 Q Not received by RIFM until 2001? 2 A That's correct. 3 Q But the study was done in 1993? 4 A That's what the report says. 5 Q Would you look down at the study, on the 6 summary. During the necropsy, do you see 7 that? 8 MR. MACE: What page? 9 Q Page 1 of the summary. First of all, do you 10 see what the aim of the study was on the 11 second page? The one after you are on, to 12 obtain quantitative animal data in order to 13 assess a possible hazard by inhalation of the 14 product; do you see that? 15 A Yes, this appears to be an acute LC50 study. 16 Q Going back to the summary, during the necropsy 17 all animals that died showed general 18 congestion, focal hyperemia of the lungs, and 19 empty gastrointestinal tracts were seen 20 additionally in animals of the mid 21 concentration group. Exposure to the high 22 concentration led to atelectasis and bloody 23 edema of the lungs, bronchial edema and 24 intensified hydrothorax; do you see that? 25 MR. MACE: Objection, form, 0113 1 foundation, hearsay, best evidence rule, move 2 to strike. 3 A That is what is written. 4 Q Up further in the paragraph, in the low 5 concentration clinical examination revealed 6 eyelid closure, restlessness, later apathy, 7 squatty posture, rumpled fur in all animals; 8 do you see that? 9 MR. MACE: Same objection, move 10 to strike. Also rule of completeness. No 11 macroscopic pathologic findings were noted in 12 the animals of the low concentration. 13 MR. McCLAIN: You are not reading 14 from the paragraph I'm reading from. 15 MR. MACE: It's the one you just 16 read from. 17 MR. McCLAIN: I'm reading from a 18 different paragraph now. 19 Q Abdominal and respiratory and dragging 20 respirations as well as respiratory sounds and 21 reduced general state was seen in a single 22 animal; did you see that? 23 MR. MACE: Same objection, move 24 to strike. 25 A That is what is written. 0114 1 Q The mid as well as the high concentration 2 resulted in an abundance of symptoms 3 indicative for respiratory tract injury; do 4 you see that? 5 MR. MACE: Objection. Same 6 objection, move to strike. 7 A That is what is written. 8 Q Last paragraph, histopathology in selected 9 organs of single animals from the mid and high 10 concentration groups revealed extensive 11 hyperemia of the lungs, necrosis in the 12 proximal tubules of the kidneys, and 13 centrilobular swelling of the hepatocytes in 14 the high concentration as well as moderate 15 emphysema and focal hyperemia of the lungs 16 and peripheral swelling of the hepatocytes in 17 the mid concentration; do you see that? 18 MR. MACE: Same objection, move 19 to strike. 20 MR. WOODSIDE: Move to strike all as 21 hearsay. 22 Q Do you see that? 23 A That is what is written. 24 Q When Mr. Hochstrasser asked you to obtain 25 studies, did you attempt to go to BASF to find 0115 1 out whether or not they had done any studies 2 regarding the affect of diacetyl on animals? 3 A No, BASF was not a supplier of ours. 4 Q BASF was a well known company that 5 manufactured diacetyl; isn't that true? 6 MR. MACE: Objection. 7 A At that time I would not have known BASF as a 8 supplier of diacetyl. 9 Q You were a member a RIFM, were you not? 10 MR. MACE: Objection. 11 A No, I was not. 12 Q The company was, were they not? 13 MR. MACE: Objection. 14 Q In 1993? 15 A The fragrance division was, the flavor 16 division was not. I am solely with the 17 flavors division. 18 Q So you would have just had to make a call over 19 to the fragrance division to find out whether 20 or not RIFM had information about the health 21 effects of diacetyl; did you do that? 22 MR. MACE: Objection, 23 mischaracterization. 24 A I would not have done that. 25 Q Meaning you didn't do it? 0116 1 A Correct. 2 Q Nor did you sponsor a study of your own, 3 correct? 4 A Correct. 5 Q They do these studies over at NIOSH, don't 6 they? 7 MR. MACE: Objection. 8 Q In Cincinnati? 9 MR. MACE: Objection. 10 A I don't know where NIOSH would do the study. 11 Q Your CV indicates you did an animal study on 12 acetaldehyde; isn't that true? 13 A I did a study on acetaldehyde bisulphite. 14 MR. WOODSIDE: What was the last 15 word? 16 THE WITNESS: Bisulphite. 17 Q You are familiar with animal studies? 18 A Yes. 19 Q You could have found a laboratory to do them 20 if you wanted to, or if you had been directed 21 to? 22 MR. MACE: Objection, assumes. 23 A I would have found a laboratory to do it if we 24 felt there was a need to do it. 25 Q Subsequently NIOSH did feel a need to do it 0117 1 and did one? 2 MR. MACE: Objection. 3 Q Right? 4 A They have published an abstract. 5 Q Because what they were trying to do is find 6 out what was causing illness among workers, 7 not cover it up? 8 MR. MACE: Objection, move to 9 strike, form. 10 MR. McCLAIN: We need to take a 11 break for this. 12 VIDEOGRAPHER: Off the record at 13 1:53. 14 (Recess taken.) 15 VIDEOGRAPHER: We're back on the 16 record at 2:03. 17 Q What is the FFIDS? 18 A Flavor Fragrance Ingredient Data Sheet. 19 Q Those were something that were available to 20 you; am I right? 21 A That's correct. 22 Q In fact, in 1999 you told Dr. Fluckiger you 23 relied on those; am I right? 24 A That is correct. 25 Q Let's look at the FFIDS for diacetyl. 0118 1 (Exhibit Number 26 2 Marked for identification.) 3 Q Exhibit 26. Do you recognize this as being 4 the FFIDS for diacetyl? 5 A Yes, I do. 6 Q Who is this produced by? 7 A These documents were produced in the late '80s 8 when the OSHA standard came in for flavor and 9 fragrances and they were produced by an 10 outside toxicological firm called Environ. 11 MR. WOODSIDE: Called what? 12 THE WITNESS: Environ. 13 Q There was nine volumes of data provided, 14 statements relevant to making a health hazard 15 determination; is that right? 16 A That is correct. 17 Q In this document, which it's dated I think 18 this is either it's the 9th of February or 19 it's the 2nd of September '85, right, by the 20 date on the bottom? 21 MR. MACE: Objection, assumes, 22 foundation. 23 A I don't know the code. 24 Q You know that it's an '85 because you said so 25 in 1999, right? 0119 1 MR. MACE: Objection. 2 A I don't recall. 3 Q Let's refresh your recollection. 4 (Exhibit Number 27 5 Marked for identification.) 6 Q Exhibit 27 is your letter to Dr. Fluckiger, 7 second page, says with regard to the process 8 of determining hazard classifications, I take 9 full advantage of the RIFM/FEMA flavor 10 fragrance ingredient data sheet program, 11 FFIDS; you see that? 12 A That is what it states, yes. 13 Q In 1985 RIFM and FEMA commissioned a 14 toxicology consulting firm to review the 15 existing data for flavor and fragrance 16 ingredients; do you see that? 17 A That's correct. 18 Q Does that help you remember that the date 19 shown here on the document is in fact when 20 these were produced? 21 MR. MACE: Objection, 22 assumption, foundation. 23 A The letter supports my previous statement that 24 said in the '80s RIFM and FEMA did commission 25 someone. Some documents have different dates, 0120 1 I can't say that is the date. 2 Q Well, you say it happened in 1985 in this 3 document. 4 MR. MACE: Objection. 5 Q That is not the late '80s, that is 1985, 6 right? 7 MR. MACE: Objection, vague and 8 ambiguous. Objection to form. 9 Q Am I right? 10 A 1985 could be construed to be mid '80s. 11 Q Not late '80s, right? 12 MR. MACE: Objection. 13 A That's fine, I agree. 14 Q There is an '85 on the document I gave you, 15 exhibit 20 what? 16 A 26. 17 MR. MACE: Right. Objection, 18 characterization. 19 Q Right? 20 MR. MACE: Objection. 21 A There are numbers on the bottom, of which '85 22 is one of them. 23 Q Under the health effects data, this is for 24 diacetyl, inhalation it says it's harmful, 25 correct? 0121 1 MR. WOODSIDE: Objection as to 2 hearsay. 3 A The word harmful is written there. 4 Q It lists symptoms, sore throat and coughing, 5 right? 6 MR. MACE: Same objection. 7 A That is what is written there. 8 Q It may be absorbed. 9 MR. MACE: Same. 10 Q Then says high concentrations cause irritation 11 of the respiratory tract, correct? 12 A That is what is written there. 13 Q Capable of producing systemic toxicity, true? 14 A That is what is written there. 15 MR. MACE: Objection. 16 Q Then, if you look over on the next page, it 17 says laboratory animal toxicological data. 18 Under LD50 oral; ataxia, gasping and coma, 19 with death occurring within a few days to -- a 20 few minutes to four days; do you see that? 21 MR. MACE: Objection. 22 A That is what is written there, yes. 23 Q Then under inhalation under it, other acute 24 toxicity data, dose duration and pathology, by 25 inhalation, rats died. 0122 1 MR. MACE: Objection. 2 Q Is that right? 3 A Lists death. I don't know if it was one rat 4 or more than one rat. 5 Q Labored breathing and gasping; am I right? 6 MR. MACE: Objection. 7 A That is what is written here. 8 Q At part of this process, when Mr. Hochstrasser 9 sent you the notification in 1993 that 10 diacetyl had to be considered as one of the 11 causes of the bronchiolitis obliterans, what 12 steps did you take to obtain copies of these 13 studies that were referenced in the FFIDS 14 document which you reviewed? 15 MR. MACE: Objection, form, 16 assumes, compound, mischaracterization, 17 misstates the evidence, foundation. 18 A I would have reviewed the references that were 19 available to me. Some of these are 20 proprietary. I would have done a literature 21 search. I would have looked at the scientific 22 literature review for these materials, I would 23 have looked at the MSDSs for the suppliers 24 from which we purchased the material. 25 Q You told me what you would have done. Did you 0123 1 obtain the studies that were referenced here? 2 MR. MACE: Objection. 3 A No, I did not need to get the studies. 4 Q We will let a jury decide whether you needed 5 to get them, Dr. Higley. You didn't get them, 6 did you? 7 MR. MACE: Objection, move to 8 strike. 9 A No, I did not get them. 10 (Exhibit Number 28 11 Marked for identification.) 12 Q Let me show you what we will mark as Exhibit 13 28. Do you recognize the handwriting? 14 A No, I do not. 15 Q Says John Hochstrasser, 1993, 10-20-93; do you 16 see that? 17 MR. MACE: Objection, form, 18 foundation, assumes. 19 A Yeah, I see 10-20-93 on page 1. 20 Q Look over at the page at the word diacetyl may 21 need a risk assessment. 22 MR. MACE: What page number? 23 MR. McCLAIN: 347. 24 MR. MACE: Objection, form 25 foundation, hearsay. 0124 1 A This is a different grouping of documents with 2 a different date. 3 Q 9-28-93, that's correct. This is the way they 4 were produced to us. I don't care whether 5 it's a week or two earlier; do you recognize 6 the handwriting? 7 A No, I do not. 8 Q It says diacetyl may need a risk assessment; 9 do you see that? 10 MR. MACE: Objection, form, 11 foundation, hearsay, also rule of completeness 12 but why not get it from supplier. 13 Q That is exactly right. 14 A That is what is written at the bottom, yes. 15 Q Here is the question. Why didn't you get it 16 from your suppliers? 17 MR. MACE: Objection, assumes. 18 Objection, foundation. 19 A Risk assessment is inappropriate at this 20 point. Under the hazard communication the 21 first thing you need to do is hazard 22 identification. That is different than doing 23 a risk assessment. We would have gotten 24 hazard identification information from our 25 suppliers. It is up to us to do the risk 0125 1 assessment, given the plant conditions. You 2 don't get a risk assessment from suppliers. 3 Q When Mr. Mace asked you to read that, the 4 suggestion was inappropriate? 5 MR. MACE: Objection, move to 6 strike. 7 Q So the question is, did you ever do a risk 8 assessment? 9 MR. MACE: Objection. 10 A We did a hazard assessment. 11 Q Is that different than a risk assessment? 12 A Yes, it is. 13 Q You didn't do a risk assessment, did you? 14 MR. MACE: Objection, vague and 15 ambiguous. 16 A Not a formal risk assessment. 17 Q Let's talk about all the things you didn't do. 18 You didn't do your own animal studies, 19 right? 20 A We did not do animal studies. It was not 21 necessary. 22 Q Once again, Miss Higley, the jury will decide 23 whether it was necessary or not. People's 24 lives are at stake here. It will be their 25 determination. 0126 1 MR. MACE: Objection. Move to 2 strike counsel's comments. 3 Q You didn't do it, did you? 4 A We didn't do animal studies on diacetyl. 5 Q Likewise you didn't request the animal studies 6 that were identified in the FFIDS, did you? 7 MR. MACE: Objection. 8 A No. 9 Q You didn't do a risk assessment on diacetyl 10 either, did you? 11 A We did not do a formal risk assessment. 12 Q Even though diacetyl, by 1993, had been 13 identified as a possible cause of 14 bronchiolitis obliterans in your plant? 15 MR. MACE: Objection. 16 A I don't agree that diacetyl was identified as 17 a possible cause of bronchiolitis obliterans. 18 In the literature searches I did, it's not 19 linked to bronchiolitis obliterans. Nor is it 20 in the structural class of anything that is 21 linked to bronchiolitis obliterans. 22 Q Dr. Hochstrasser said it's a possible 23 etiologic, didn't he? 24 MR. MACE: Objection. 25 A For respiratory. 0127 1 Q For respiratory injury? 2 MR. MACE: Objection. 3 A Yes. 4 Q The respiratory injury you were examining at 5 the time was two employees who had been 6 diagnosed with bronchiolitis obliterans isn't 7 that true? 8 MR. MACE: Objection. 9 A That is only part of what we were 10 investigating. We were investigating whole 11 health hazard identification by any route of 12 exposure. 13 Q Nonetheless, the trigger was two cases of 14 bronchiolitis obliterans am I right? 15 MR. MACE: Objection. 16 A No, you are not correct. 17 Q That is not -- 18 A The trigger was people who were having 19 respiratory issues, not necessarily 20 bronchiolitis obliterans. 21 Q Fine. Call it whatever you want to. Did you 22 ever do animal studies to determine whether 23 diacetyl caused respiratory injury? 24 MR. MACE: Objection. 25 A No, we conducted literature searches. 0128 1 Q Did you obtain the studies referred to in the 2 FFIDSon respiratory injury and diacetyl 3 exposure? 4 MR. MACE: Objection. 5 A No, we did not. 6 Q Did you ever do your own -- did you ever do a 7 risk assessment on that issue, on diacetyl? 8 MR. MACE: Objection. 9 A We did not do a formal risk assessment on 10 diacetyl. 11 Q By 1995 at the Tastemakerplant full face 12 respirators had to be worn when working with 13 diacetyl; isn't that true? 14 MR. MACE: Objection. 15 A Full face respirators were to be worn when 16 they were dispensing diacetyl. 17 Q Well, the requirement within the plant was 18 that the full face respirators should be worn 19 if there are any potential harmful vapors; 20 isn't that true? 21 MR. MACE: Objection. 22 A I would have to see the document. 23 (Exhibit Number 29 24 Marked for identification.) 25 Q Let me show you what is marked as Exhibit 29. 0129 1 You see that, full face respirators should be 2 worn if there is any potential harmful vapors, 3 i.e., diacetyl, acetaldehyde, DMS? 4 MR. MACE: Objection, form, 5 foundation, hearsay. 6 A Yes, that is what is written there. 7 Q When Dr. Lockey first began analyzing this 8 issue, do you remember meeting with him? 9 A Yes, I do. 10 Q Do you remember discussing diacetyl with him? 11 A I remember discussing an approach to look at 12 all chemicals. 13 Q Do you remember telling him this material is 14 very irritating, the use of a respirator is 15 required with this material? 16 MR. MACE: Objection. 17 A I don't recall. 18 Q Were you Dr. Lockey's principal scientific 19 consultant within the company? 20 A No, I was not. 21 Q Who was? 22 A John Hochstrasser. 23 (Exhibit Number 30 24 Marked for identification.) 25 Q Exhibit 30 is Dr. Lockey's notes. 0130 1 MR. MACE: Copy, counsel. 2 Q On the second page, this is the reference to 3 diacetyl. You see where it says diacetyl, 4 this material is very irritating, use 5 respirators with this material, do you see 6 that note? 7 MR. MACE: Objection. 8 Q Under diacetyl, second page? 9 A Yes, it's written. It's not attributed to me 10 saying it. 11 Q That is not the question. 12 MR. MACE: Same objection. 13 Q Do you recall having a discussion with 14 Dr. Lockey about that subject? 15 MR. MACE: Same objection. 16 Objection, completeness, also guam arabi, 17 mustard seed oil -- 18 Q It doesn't say anything about those in the 19 paragraph I just read. I'm asking a 20 question. Do you remember this statement 21 being made? 22 MR. MACE: Acetaldehyde, 23 glutaraldehyde, buteraldehyde, aleraldehyde, 24 benzaldehyde. 25 A I don't recall the statement. Our discussion 0131 1 was on an approach for looking at all of the 2 chemicals in the plant. 3 Q Do you look at -- do you see double production 4 in 19 -- in year 1993; do you see that? 5 MR. MACE: Objection. Same 6 objection. 7 A Double production -- I don't know that means 8 production. Double prod in liquids 1993, yes. 9 Q Is that consistent, had you doubled the 10 production of liquid in 1993? 11 A I can't answer that. 12 MR. MACE: Completeness, same 13 sentence, the Middletown plant site closed the 14 same year. 15 Q About 15 came down, meaning that the 16 production from the Middletown plant came over 17 to the Carthage plant; isn't that right, don't 18 you recall that happening? 19 A I recall yes, the Middletown plant came to the 20 Cincinnati facilities. 21 Q So, they increased production in the 22 Cincinnati facilities, right? 23 A They took on more formulations, yes. 24 Q Isn't it true what you were looking at, what 25 you were postulating was this increased 0132 1 production, particularly of the liquid 2 flavors, had caused this outbreak of 3 bronchiolitis obliterans in the Carthage plant 4 because the ventilation system was not 5 equipped to handle that increased production? 6 A No, that is not an accurate statement. 7 Q In fact isn't that true? 8 A No, I don't think that is an accurate 9 statement. 10 Q We've taken deposition after deposition of 11 your people that tell us your ventilation at 12 this plant was inadequate to handle the level 13 of production you were producing there. 14 MR. MACE: Objection. 15 A I don't think it's accurate with regard to you 16 said liquids department. Most of -- my 17 recollection is most of the formulations that 18 came were processed flavors, not liquids. 19 Q There was an increased use of liquid flavors 20 in the facility beginning in 1993; isn't that 21 true? 22 A That is what is written here. I don't know. 23 Q There was no change in the ventilation in '93, 24 was there? 25 A I don't know when there were changes in 0133 1 ventilation. 2 Q Tell me as a matter of common sense, if you 3 brought in a large amount of increased 4 production of liquid flavors, with no change 5 in production, if there were hazards 6 associated with those liquid flavors, that 7 would have increased the risk to the 8 production employees at your plant; isn't that 9 true, as an abstract principle? 10 MR. MACE: Objection, assumes, 11 compound, incomplete hypothetical, 12 mischaracterization, foundation. 13 A Not necessarily. 14 Q But it's possible? 15 MR. MACE: Objection, same 16 objection, move to strike. 17 Q True? 18 A One would have to do a risk analysis. 19 Q You didn't do one. 20 MR. MACE: Objection. 21 Q How convenient. 22 MR. MACE: Objection. 23 MR. McCLAIN: I withdraw the 24 question. 25 Q Let's talk about your meeting with FEMA. What 0134 1 was becoming clear by 1996 is that you were 2 not going to be able to keep this secret 3 forever; isn't that true? 4 MR. MACE: Objection, move to 5 strike. 6 A That is not correct. 7 Q You thought you would be able to keep it a 8 secret forever? 9 MR. MACE: Objection, move to 10 strike. 11 A Never crossed my mind. 12 Q That it would come out? 13 A It never crossed my mind to approach it in the 14 way you are formulating the question. 15 Q You went to FEMA, said you've got to keep this 16 confidential, what do you mean it never 17 crossed your mind? 18 MR. MACE: Objection to form. 19 Objection, mischaracterization. 20 Q Of course it crossed your mind. 21 MR. MACE: Objection, 22 mischaracterization. 23 A Went to FEMA, asked it to be confidential in 24 order to protect our trade secrets. 25 Q That is not what your other witnesses have 0135 1 said. 2 MR. MACE: Objection. 3 Q You went and asked for confidentiality because 4 you didn't want anyone to use this against you 5 because your competitors would use it against 6 you to take sales from your company. That was 7 truly the reason, wasn't it? 8 MR. MACE: Objection, 9 characterization. 10 A It was not my reason. 11 Q What trade secret was there to protect that 12 you were giving bronchiolitis obliterans to 13 your employees? How was that a trade secret? 14 MR. MACE: Objection, move to 15 strike. 16 A I'm not saying we gave bronchiolitis 17 obliterans to our people. 18 Q Who did it then? 19 MR. MACE: Objection. 20 Q Somebody sneak in your plant at night? 21 MR. MACE: Objection. 22 A I'm not going to answer that. 23 Q I know you don't admit to anything. I know 24 you deny everything. That has never been an 25 effective strategy. I understand that that is 0136 1 your strategy. 2 Let's ask the question without any 3 qualifiers. What trade secrets were there to 4 protect in identifying for FEMA that workers 5 in your plant had a deadly lung disease? 6 MR. MACE: Objection, 7 argumentative. Objection, the preamble move 8 to strike. Objection, mischaracterization. 9 A The purpose to go to FEMA was to find out if 10 there was any other cases of respiratory 11 illnesses. 12 Q Well, actually the reason that you went to 13 FEMA was to try to get FEMA to find other 14 cases so when this came out, they could not 15 use it against Tastemaker? 16 MR. MACE: Objection. 17 Q That is truly the reason? 18 A That is absolutely false. 19 Q It is true, isn't it, that Dr. Lockey 20 suggested to FEMA they do an industry-wide 21 study? 22 MR. MACE: Objection. 23 A That's not true. Dr. Lockey felt that they 24 should go survey the other flavor companies to 25 see if they've had a similar situation. 0137 1 Q FEMA never did that? 2 A Yes, they did. 3 Q When did they do that? 4 A They made phone calls, they investigated. 5 Q Is that a survey? 6 A Yes. 7 Q Is that an epidemiologic survey to make a few 8 phone calls? 9 MR. MACE: Objection. 10 A Dr. Lockey did not request that we do an 11 epidemiological survey. Dr. Lockey felt we 12 should survey the industry to find out if 13 anyone else is having similar issues. 14 Q In fact FEMA has found out that other 15 companies have had similar issues; isn't that 16 true? 17 MR. MACE: Objection. 18 A I don't know that. 19 Q What do you mean you don't know that. You're 20 on the board of governors, aren't you? 21 MR. MACE: Objection. 22 A I'm not on the board of governors. 23 Q You were in 2004? 24 A I was for eight months. The subject of other 25 people's proprietary information did not come 0138 1 up. 2 Q It is not a question of proprietary 3 information. Look at the 2004 report we gave 4 you from FEMA. What number did we mark this 5 one? The flavor industry respiratory safety 6 program 8. 7 MR. WOODSIDE: What exhibit? 8 MR. CRICK: 6. 9 Q Dr. Lockey -- first of all let's get our 10 timing straight. Dr. Lockey suggested FEMA do 11 this in 1996, correct? 12 MR. MACE: Objection, ambiguous, 13 characterization, assumption. 14 Q Isn't that when that suggestion was made? 15 A Dr. Lockey in 1996 suggested that FEMA contact 16 other flavor companies. 17 Q Here is what FEMA says they did. As part of 18 its ongoing respiratory safety program FEMA 19 initiated a confidential incident reporting 20 program in 2002; do you see that? 21 MR. MACE: Objection, form, 22 foundation, hearsay. 23 A That is what is written there, yes. 24 Q Provides flavor manufacturers with the 25 opportunity to report respiratory safety 0139 1 concerns to FEMA in a confidential manner and 2 to obtain assistance if needed to maintain a 3 safe workplace; do you see that? 4 A Yes, it's written there. 5 Q 2002 is six years after 1996s, isn't it? 6 A Yes, but they did contact people in 1996. 7 Q Somehow or another they missed these other 8 reports that other companies had back in 1996, 9 didn't they? 10 MR. MACE: Objection. 11 MR. WOODSIDE: Objection, foundation 12 form. 13 A I can't comment on that. 14 Q Company one, the available information 15 suggests that one employee had severe fixed 16 airway obstruction; do you see that? 17 MR. MACE: Objection, form, 18 foundation, hearsay. 19 A That is what is written. 20 Q Which is similar to the disease seen in some 21 microwave popcorn workers; do you see that? 22 MR. MACE: Objection, form, 23 foundation, hearsay, best evidence rule. 24 A That is what is written. 25 Q Do you see that the flavor that the employee 0140 1 was working with was -- had lactones, acetic 2 and lactic acids and low concentrations of 3 diacetyl? 4 MR. MACE: Objection. So states 5 here irritating to their eyes and nasal 6 passages. 7 Q That helps you. Go ahead. 8 A That is what that sentence says. 9 Q At company two one employee was identified as 10 having signs of exposure related constrictive 11 bronchiolitis after lung biopsy; do you see 12 that? 13 MR. MACE: Same objection. 14 A That is what is written. 15 Q Company 3 -- 16 MR. MACE: Rule of completeness, 17 biopsy also showed several signs inconsistent 18 with exposure related bronchiolitis. 19 Q At company 3 one employee's physician 20 concluded that the employee had bronchiolitis 21 obliterans based on a lung biopsy that 22 according to the physician showed changes 23 consistent with the disease; do you see that? 24 MR. MACE: Same objection, move 25 to strike. 0141 1 A That is what is written. Although they did 2 comment his symptoms were not work related. 3 Q No, they said that about a different 4 employee. A second employee. You see, you 5 have to read carefully. 6 MR. MACE: Objection, move to 7 strike. 8 Q See they are talking about a different 9 employee there. 10 You don't know what happened in 1996 in 11 terms of FEMA's "telephone survey" right? 12 MR. MACE: Objection. 13 A Yes, I do. They contacted flavor companies. 14 Q After they instituted the same confidential 15 procedure that you were allowed, other 16 companies came forward in 2002 and said yeah, 17 we've got cases, true? 18 MR. MACE: Objection, 19 mischaracterizes, compound, form, foundation, 20 assumes. 21 A According to this there were other companies 22 in 2002. Perhaps there were none in 1996. 23 Q You don't know because you were trying to keep 24 it a big secret? 25 MR. MACE: Objection, move to 0142 1 strike. 2 Q You never called up IFF, right? 3 MR. MACE: Objection. 4 A No. 5 Q Didn't call up BBA, right? 6 MR. MACE: Objection. 7 A No. 8 Q Didn't call around to any of your customers 9 either, did you? 10 A No. I went through the trade association 11 which is our normal way to approach situations 12 like this. 13 Q This was not a normal situation, was it? 14 A Not normal but a situation similar to this we 15 go through the association. 16 Q Did you have other outbreaks of lung disease? 17 A No. 18 Q There is something else about Dr. Lockey's 19 note which is exhibit -- yes. On the first 20 page, under the board of governors, this is 21 where he was being briefed about FEMA. It 22 says the board of governors, these people can 23 commit monies for projects; do you see that? 24 A No, I don't. 25 MR. WOODSIDE: Can you point out 0143 1 where you are talking? Exhibit 30? 2 MR. McCLAIN: Did you mark this or 3 not? 4 5 MR. MACE: I don't believe you 6 did. 7 MR. CRICK: Mark it. 8 MR. McCLAIN: If I can find the 9 other copies of it, I will. 10 (Exhibit Number 31 11 Marked for identification.) 12 MR. McCLAIN: Exhibit 31, is that what 13 we are on? 14 MR. MACE: I believe so. 15 MR. CRICK: Yes. 16 Q This is another set of Dr. Lockey's notes. Do 17 you see under board of governors? 18 MR. MACE: Object to form, 19 foundation, hearsay. Continuing objection. 20 Q Board of governors, these people can commit 21 money for projects; do you see that? 22 MR. WOODSIDE: Join whatever 23 objection Mr. Mace made, hearsay. 24 A I see that written. 25 Q Was that in fact true? Did the board of 0144 1 governors have the ability to commit money for 2 projects that affected the industry? 3 A Ultimately, yes. 4 Q Back in this time period in 1996? 5 A Yes, if there was a need to conduct a project, 6 yes. 7 Q Look over at the last page of Dr. Lockey's 8 notes. Conclusion, this is not unique to 9 Tastemaker; do you see that? 10 MR. MACE: Same objections, move 11 to strike. 12 A Appears to be what is written here. 13 Q Did FEMA commission any animal studies or any 14 risk assessments regarding diacetyl? 15 MR. MACE: Objection, assumes. 16 Objection, compound. Objection to form, 17 foundation, mischaracterization. 18 A No, and Dr. Lockey did not recommend any. 19 Q I didn't ask you anything about that. I asked 20 did they do it. 21 MR. MACE: Same objection, move 22 to strike. 23 A No, and Dr. Lockey did not recommend any. 24 MR. McCLAIN: I move to strike your 25 answer. 0145 1 Q Would you answer the question as I phrased it, 2 did FEMA do it? 3 MR. MACE: Objection, vague and 4 ambiguous. Objection, same objections, move 5 to strike. 6 A No. 7 Q Did they do it on acetaldehyde? 8 MR. MACE: Objection. 9 A No, no experts suggested that had we should do 10 it. 11 Q Do you just not listen to my questions, 12 Dr. Higley? I didn't ask you anything about 13 that. If you answer my question, Mr. Mace 14 says he's going to ask you questions. He'll 15 get his chance. If you will be fair and answer 16 my questions, that would be appreciated. 17 MR. MACE: Objection, move to 18 strike. 19 Q Did FEMA do any tests, animal studies, or risk 20 assessments on acetaldehyde? 21 MR. MACE: Objection, compound. 22 Objection, foundation, form. 23 A FEMA would have done risk assessments on 24 acetaldehyde for the purposes of grass. 25 Q Were there any inhalation studies in that 0146 1 group? 2 A I can't recall if there would be in the 3 scientific literature review. 4 Q There may be some for acetaldehyde? 5 A Right. 6 Q There aren't any for diacetyl? 7 A I can't speculate. I would have to see the 8 report. 9 Q As you point out, in the acetaldehyde studies 10 there were no reports of respiratory problems 11 from acetaldehyde, were there? 12 MR. MACE: Objection. 13 A Not that were correlated with bronchiolitis 14 obliterans. 15 Q Or with other respiratory diseases? 16 A There were other respiratory studies on 17 acetaldehyde. 18 Q What did they show? 19 A Without them in front of me, I can't comment. 20 Q Did you have them at the time? 21 A Yes. 22 Q Where are they? 23 A I expect they are with Givaudan or at the FEMA 24 office. 25 Q Did you know they didn't produce them to us? 0147 1 MR. MACE: Mischaracterization, 2 they have been produced. 3 MR. McCLAIN: They have been? What 4 are they? Tell me, because we don't recognize 5 the description of them, what are they? 6 MR. MACE: I didn't memorize 7 them? 8 MR. McCLAIN: Do they exist? 9 You've seen them, you are representing that 10 you've seen them, because I haven't seen 11 them. 12 MR. MACE: Acetaldehyde has been 13 produced, yes. 14 MR. McCLAIN: The studies that 15 Dr. Higley reviewed on acetaldehyde at the 16 time, were they produced to us? 17 MR. MACE: We sent them. 18 MR. McCLAIN: Can you go back and 19 confirm and identify those for us 20 specifically? Because if I would have been 21 aware of that I would have asked her about 22 that. I'm not aware of them. I would like to 23 see them. Can you do that for me? 24 MR. MACE: Probably confirm in a 25 letter or something. 0148 1 MR. McCLAIN: That would be fine. 2 That is satisfactory. I'm not trying to be 3 cute, I'm asking. 4 Q Let's go back. Now, do you recall when you 5 went to Dr. Lockey, or went with Dr. Lockey to 6 FEMA that Karen Duros drafted a talking points 7 memo for him? 8 A Yes. 9 Q Mark this Exhibit 32. 10 (Exhibit Number 32 11 Marked for identification.) 12 Q Do you see that she told Dr. Lockey to talk 13 about the definitions of occupational disease 14 and process factors relied upon to conclude 15 that it was an occupational disease? 16 A To conclude that an occupational disease 17 exists, yes. 18 Q Do you see down here, his conclusion with 19 reasonable degree of medical certainty that 20 the disease is work-related; do you see that? 21 MR. MACE: Objection, best 22 evidence rule, hearsay. 23 Q She told him to talk about that? 24 MR. MACE: Objection, hearsay, 25 foundation, assumes. 0149 1 A That is what is written, yes. 2 Q Based on his understanding of information from 3 the company Dr. Lockey believes that the 4 workplace exposure is probably not unique to 5 Tastemaker; do you see that? 6 A Yes, that is what is written. 7 Q You were to support with knowledge of 8 chemicals used, products manufactured and 9 processes utilized? 10 A That is correct. 11 Q Were you trying to get FEMA to conclude that 12 this was an industry-wide problem, in order to 13 take the pressure off yourself, for the 14 disease being caused in your plant? 15 MR. MACE: Objection, 16 mischaracterization. Object to form, 17 compound, characterization. 18 Q True? 19 A It's false. The objective was request FEMA to 20 take steps to investigate whether 21 bronchiolitis obliterans in a flavor industry 22 issues -- is a flavor industry issue. That 23 was our whole purpose for going, to ask them 24 to call up other flavor companies, to says are 25 you having similar respiratory situations. 0150 1 Q But, here is the point. You didn't want 2 anyone to know that you had the problem? 3 A Correct. 4 Q You didn't want them to know precisely how 5 many people actually were involved? 6 MR. MACE: Objection. 7 A I don't think that is a fair characterization. 8 Q Is there any FEMA document that you have seen 9 that identifies nine employees -- 10 MR. MACE: Objection, 11 mischaracterization. 12 Q -- from your company as potentially having 13 bronchiolitis obliterans? 14 MR. MACE: Objection, form, 15 assumes, foundation, mischaracterization, 16 misstates the evidence. 17 A I don't think there is a document. I don't 18 think the number is nine. 19 Q You know that FEMA thinks the number is five. 20 MR. MACE: Objection. 21 A I don't know that. 22 Q That is what they publish; isn't that true? 23 A I would have to look again. 24 Q You don't recall that was in the document? We 25 went over it several times. I'm happy to go 0151 1 over it again. 2 A I recall company one, two, three, I don't 3 recall the numbers. 4 Q Look back at the 2002 report, see how many 5 they claim Dr. Lockey reported. One initial 6 case then four additional cases. 7 MR. MACE: Consistent with. 8 Q 2261 page, I believe. You are looking at the 9 2004 report, not the 2002 report. 10 A Excuse me. 11 Q The same information is in both. You can use 12 the one you were on. 2261 we looked at 13 before. 14 MR. MACE: You mean 1261? 15 MR. McCLAIN: Is that what it was? 16 You are right. 17 Q You see at that symposium a physician reported 18 five workers of a flavor manufacturing 19 facility, bottom of the page, five? 20 MR. MACE: Referring to what 21 Lockey said? 22 MR. McCLAIN: Right. 23 A Reported an index case four additional workers 24 with clinical findings consistent with 25 bronchiolitis obliterans. 0152 1 Q That is five? 2 A Consistent with. 3 Q We're talking about numbers here, that is 4 five, isn't it? 5 A Yes. 6 Q Have you ever seen a FEMA document which says 7 that you had eight, maybe nine cases? 8 MR. MACE: Objection, assumes, 9 foundation, compound. 10 A No. 11 Q In 2002 NIOSH had meetings on this entire 12 issue, bronchiolitis obliterans in the 13 flavoring and popcorn industry; isn't that 14 right? 15 MR. MACE: Objection, 16 characterization. You can answer. 17 A I believe so. 18 Q You received a fax from Eric Barns regarding 19 the meeting, you remember that? 20 A No, I don't. 21 Q Do you remember John Hallagan was in a meeting 22 with NIOSH? 23 A Yes. 24 Q Do you remember that NIOSH as of 2002 was 25 still unaware that Givaudan was the company 0153 1 that Dr. Lockey had studied? 2 MR. MACE: Objection, 3 foundation, assumes. 4 A I can't conclude that. 5 Q You can't conclude that or you can't remember 6 that? 7 A I can't remember that. 8 (Exhibit Number 33 9 Marked for identification.) 10 Q Do you see this note here in this document, 11 Dr. Higley, where it says they don't know 12 we're company X? 13 A I see that set of documents is incomplete. 14 Q What is it? 15 A There is a missing attachment from the NIOSH 16 correspondence which frames up this fax. 17 NIOSH was requesting us to disclose two 18 formulations. That is what Eric was 19 forwarding to me. There is a piece missing. 20 Q But is this your notes? 21 A Yes. 22 Q Company X referred to the company that had an 23 outbreak of bronchiolitis obliterans in their 24 plant; is that correct? 25 A Company X refers to Tastemaker. 0154 1 Q Company X within the documents that NIOSH had 2 were the disclosure from FEMA that a member 3 company had had an outbreak of bronchiolitis 4 obliterans; am I right? 5 A I don't know what documents FEMA supplied to 6 NIOSH. 7 Q You know that is what the issue is, am I 8 right? FEMA was notifying NIOSH that there 9 had been an outbreak of bronchiolitis 10 obliterans in a member company, they identify 11 the company as company X? 12 A No, I can't conclude that. This is referring 13 to me asking John if as an industry I can 14 submit my formulations to NIOSH through FEMA. 15 Q Why is the designation company X used? 16 A In my discussions with John on 2-28, that is 17 what came up. John indicated to me that they 18 don't know we are company X. I don't know how 19 we were described as company X, by whom. John 20 said they don't know we are company X. 21 Q You don't know that Mr. Hallagan identified 22 for NIOSH that company X had had at least one 23 case of bronchiolitis obliterans that was 24 reported to FEMA before that time; you are not 25 aware of that? 0155 1 A I don't know if it was John or perhaps 2 Dr. Lockey, I don't know who. 3 Q You are aware that someone reported that an 4 unidentified company, company X in the 5 flavoring industry had had a case of 6 bronchiolitis obliterans; am I right? 7 A I'm aware that someone had discussions with 8 NIOSH. I don't know what they said to them. 9 Q You know in fact that Dr. Lockey's abstract 10 was reported in the NIOSH report? 11 A That's correct. 12 Q So, they knew that some flavoring company had 13 had an outbreak of bronchiolitis obliterans; 14 am I right? 15 A They knew some company was investigating 16 respiratory. 17 Q As of 2002 you had not come forward to NIOSH 18 and said hey, we're that company, had you? 19 MR. MACE: Objection. 20 A No. 21 MR. McCLAIN: Let's take a break. 22 VIDEOGRAPHER: Off the record at 23 2:58. 24 (Recess taken.) 25 VIDEOGRAPHER: We're back on the 0156 1 record at 3:16. 2 Q Dr. Higley, it's fair to say, is it not, that 3 no one from Tastemaker or Givaudan to your 4 knowledge ever contacted anyone at the Marion, 5 Ohio plant, informed them about your 6 experience with bronchiolitis obliterans? 7 MR. MACE: Objection, 8 foundation. 9 A That would be correct. 10 Q That would be including ConAgra as a company 11 was not contacted outside of the Marion, Ohio 12 plant, were they? 13 A I would not know that definitively. 14 Q You think someone did contact ConAgra and tell 15 them about your bronchiolitis obliterans 16 problem? 17 A I don't know. 18 Q Do you know of anyone that did? 19 A No, I don't know of anyone that did. 20 Q For heaven sake you didn't even tell the other 21 members of FEMA? 22 MR. MACE: Objection. 23 Q Right? 24 MR. MACE: Objection, move to 25 strike. 0157 1 A That's correct. 2 Q Were you responsible for creating the material 3 safety data sheets, is that part of your 4 function? 5 A Yes, I was responsible for doing hazard 6 identification for them, yes. 7 Q Do you recall that back in 1994 the butter 8 flavors were rated at 3 in terms of hazard 9 ratings? 10 MR. MACE: Objection, over 11 broad. Objection, assumes. Objection to 12 form. 13 A I'm sorry, could you repeat. 14 Q Were you responsible for the MSDSs or weren't 15 you? 16 A I was responsible for the hazards on the 17 MSDSs. 18 Q Were you also responsible for the hazard 19 ratings? 20 A The program would roll up the hazard ratings, 21 depending on the hazard statements. 22 Q Are you aware that in 1994 the butter flavor 23 contained a hazard rating of 3? 24 MR. MACE: Objection to form. 25 MR. WOODSIDE: Object. Here is my 0158 1 objection. I don't know what you are talking 2 about. Butter flavor in general or are you 3 talking about butter flavor from Givaudan? 4 Q Let's look at an exhibit. 5 (Exhibit Number 34 6 Marked for identification.) 7 Q Here is Exhibit 34. This is the natural and 8 artificial butter flavor type 258884. 9 MR. CRICK: Dated February 3rd of 10 '94. 11 MR. McCLAIN: Thank you. 12 Q Do you see that this contains a hazard rating 13 of 3? 14 A This particular MSDS, yes. 15 Q Do you know why it contains a hazard rating of 16 3? 17 A Yes. 18 Q Why? 19 A Butyric acid. 20 Q Huh? 21 A Butyric acid. 22 Q Butyric acid, what are the health effects of 23 butyric acid? 24 A Corrosive to skin and eyes, inhalation is 25 irritating to nose, throat and lungs. 0159 1 Q Did butyric acid remain a component of the 2 butter flavor in the year 2000? 3 MR. MACE: This butter flavor? 4 Q Yes. 5 A I don't know without looking at formulation 6 history. 7 Q Let's look at Exhibit 35. 8 (Exhibit Number 35 9 Marked for identification.) 10 Q This butter type natural and artificial butter 11 flavor carries a health hazard rating of 2, 12 does it not? 13 A Yes. 14 Q Do you know why the butter flavor sold to 15 ConAgra got safer between 1994 and 2000? 16 MR. MACE: Objection form, 17 characterization, assumes. 18 A Without looking to see if there was a formula 19 revision, no, I cannot. 20 Q Let me be clear. There is nothing on either 21 of these about bronchiolitis obliterans; am I 22 right? 23 A That's correct. 24 Q There is no identification within this 25 document of potential irreversible lung injury 0160 1 either, is there? 2 MR. MACE: Objection, assumes. 3 A That's correct. 4 Q By the way, how were these prepared, were they 5 prepared -- tell me how they were prepared. 6 A The hazard statements, each individual 7 ingredient is given a series of hazard 8 statements, using the FFIDS sheets. Each 9 statement is given a ranking of health. So 10 that when the -- whether you do it manually or 11 otherwise, anything in the formula greater 12 than 1 percent, with the exception of 13 carcinogens, which is .1 percent, anything 14 greater than 1 percent is represented by its 15 hazards as if it were a whole. There is a 16 hierarchy to say for example you have a 17 statement that is corrosive, that would 18 supercede a statement of may be irritating to 19 skin and eyes because one is more severe than 20 another. It would roll up to be the most 21 severe statements, and the more severe health 22 rating that would come from those statements. 23 Q We saw in the FFIDS that diacetyl can cause 24 systemic toxicity, you recall that? 25 MR. MACE: Objection. 0161 1 A I recall that is one of the literature 2 references they refer to. That is in the body 3 of the evidence, not in the conclusion of that 4 FFIDS sheet. 5 Q Is that statement at all contained within the 6 material safety data sheets we're looking at? 7 A No, it would be inappropriate. 8 Q Is also there no reference to this being 9 harmful? 10 MR. MACE: Objection. 11 A That is correct. 12 Q By inhalation? 13 A That's correct. 14 Q There is more than 1 percent diacetyl in this 15 material, is there not? 16 A Yes. 17 Q So there is no reference to being harmful by 18 inhalation, as well as no reference to 19 systemic toxicity, right? 20 A Irritation is a systemic effect. 21 Q But not a systemic toxicity, irritation is not 22 a systemic toxicity? 23 MR. MACE: Objection. 24 A You're confusing your terms. Systemic and 25 toxicity are two different terms. 0162 1 Q Why don't you look back at the FFIDS and see 2 if it doesn't say can cause systemic toxicity. 3 A Should probably say systemic effects. 4 Q It's exhibit -- 5 MR. CRICK: 26. 6 Q Capable of producing systemic toxicity is the 7 statement. You can look at mine. 8 A That's fine, I have it here. 9 Q Human health effects data, capable of 10 producing systemic toxicity, do you see that? 11 A Yes, but I don't know what kind of systemic 12 toxicity. 13 Q No, apparently not. 14 A Doesn't say. Doesn't specify here. 15 Q You didn't specify either, or even alert the 16 customer that that was a possibility? 17 MR. MACE: Objection, assumes, 18 foundation. 19 A There was no need to. 20 Q You say that. We have a group of people with 21 bronchiolitis obliterans that would disagree 22 with you. 23 MR. MACE: Objection, assumes. 24 Objection, characterization. Move to strike. 25 Q The real question is, that is not included on 0163 1 any MSDS sheet, is it? 2 MR. MACE: Objection. 3 A It's not included on these two MSDS sheets 4 we're looking at. 5 Q Likewise since we're looking at this document, 6 in regard to the MSDS sheets, animal acute 7 toxicity data, you don't list anything for the 8 oral data, even though there is oral data 9 available for diacetyl, correct? 10 MR. MACE: Objection. 11 A There is not oral data available for this 12 mixture. It's not tested as a whole. 13 Q It's greater than 3 percent of the whole, 14 there was data available for that ingredient, 15 correct? 16 MR. MACE: Objection. 17 A This is referring to whether or not there was 18 animal acute toxicity on the finished flavor 19 formulation. 20 Q You don't say that at all. 21 MR. MACE: Objection. 22 Q You say this material contains no ingredients 23 present at .1 -- .4 or greater, which is 24 listed as a carcinogen or potential carcinogen 25 by IARC, NTP or OSHA, do you? 0164 1 A That's correct. 2 Q There was oral data available, inhalation data 3 available on diacetyl, wasn't there? 4 MR. MACE: Objection. 5 A There is LD50 data on oral. 6 Q Which document, on the 2000? 7 A No, on diacetyl there is oral LD 50 data but 8 that is not what goes in here. What goes in 9 here is if there is oral LD50 for the mixture 10 of the flavoring. 11 Q Since you didn't test the mixture -- 12 A So it says not determined. 13 Q You don't list the ingredient data, or even 14 inform the customer that the ingredient data 15 exists, do you? 16 A There is no need to. 17 Q You keep saying that. I'm asking you did you 18 include it? 19 A No. 20 Q Look back in Exhibit 23. It says whenever 21 liquid diacetyl, or a product where liquid 22 diacetyl is present is to be used, a 23 respirator with chemical resistant gloves must 24 be worn; do you see that? 25 A Yes, it's written there. 0165 1 Q Is there any such information given on the 2 material safety data sheets that were provided 3 ConAgra? 4 MR. MACE: Objection, assumes. 5 Objection, foundation. Objection, form. 6 A No. 7 Q It says any room containing diacetyl in a 8 liquid state must be labeled respirator 9 required; do you see that? 10 A Yes, that is what is written there. 11 Q Is that information anywhere on the material 12 safety data sheets? 13 MR. MACE: Objection. 14 A No, this is not an MSDS for diacetyl. 15 Q That is entirely correct. The user of the 16 butter flavor doesn't even know diacetyl is in 17 it, do they? 18 MR. MACE: Objection. 19 MR. WOODSIDE: Objection, 20 foundation. 21 MR. MACE: Assumption, 22 characterization and form. 23 A I don't know if they know it's in there or 24 not. 25 Q You certainly don't tell them. 0166 1 MR. MACE: Objection. 2 Q Am I right? 3 A On this document it doesn't appear. It might 4 have appeared elsewhere. 5 Q Tell me where? 6 A Confidential disclosures. 7 Q Did you make any such to ConAgra? 8 A I would have to -- I don't know. 9 Q Everything was confidential with you, wasn't 10 it, Miss Higley? 11 MR. MACE: Objection. 12 Q Whenever material is in any tank the lid must 13 be closed, is that information anywhere on the 14 material safety data sheet? 15 MR. MACE: Objection, assumes. 16 Objection to form. 17 A No, it's not on the MSDS. 18 Q If ventilation mechanical is not connected to 19 the tank or is unavailable, a respirator must 20 be worn at all times while in the room, is 21 that anywhere on the material safety data 22 sheet? 23 A No, but I believe previously when we discussed 24 this document I didn't understand, wasn't 25 privy to this 7. 0167 1 Q Following the publication of the NIOSH report, 2 you came up with worker protection solutions 3 for flavors for microwave popcorn; isn't that 4 true? 5 MR. MACE: Objection. 6 Q You prepared the document? 7 (Exhibit Number 36 8 Marked for identification.) 9 Q Exhibit 36. Do you recall that? 10 A No. 11 Q Did you author this? 12 A Yes. 13 Q It says data suggests an increased prevalence 14 of respiratory and dermal symptoms in workers 15 in the microwave popcorn production areas, 16 specifically the mixing room; do you see that? 17 A Yes, that is what is written there. 18 Q That is what you wrote. It says the 19 respiratory symptoms of the case studies in 20 the microwave popcorn plants indicate an 21 effect on the small airways, the bronchials. 22 This suggests that the causative agents are 23 transported deep into the lung. The case 24 studies demonstrate that heated soybean oil, 25 salt and flavoring poured from open buckets 0168 1 into mixing tanks can carry the causative 2 agents deep into the lungs; do you see that? 3 MR. MACE: Objection. 4 A That is what is written, yes. 5 Q Flavor exposure control opportunities, the 6 first thing you list is use of closed 7 processes; you see that, one? 8 A Yes. 9 Q Substitution, two? 10 A Yes. 11 Q Minimize temperature needed to dispense the 12 flavor? 13 A Yes. 14 Q Use of negative pressure to control the 15 volatility? 16 A Correct. 17 Q You see all that? 18 A Um-hum. 19 Q Then use diacetyl as a benchmark to validate 20 exposure control opportunities, do you see 21 that? 22 A Correct. 23 Q None of this information ever made it onto a 24 material safety data sheet, did it, that went 25 to ConAgra? 0169 1 A No. 2 Q Mr. Davis, Mike Davis, I deposed him a couple 3 weeks ago, and he said you had no obligation 4 to warn your customers. Do you believe that 5 too? 6 MR. MACE: Objection, 7 characterization, assumption, form. Move to 8 strike. 9 A I can't say what Mike Davis said. Our 10 obligation is to warn but I don't recall 11 diacetyl has been proven to be the causative 12 agent of bronchiolitis obliterans. I don't 13 believe the data supports that. 14 Q Why didn't you give ConAgra this set of 15 instructions you came up with about how to 16 minimize exposures to workers, are you just 17 that callous? 18 MR. MACE: Objection. Move to 19 strike. 20 A That is not a fair assumption. 21 Q Why not? Why isn't it a fair assumption -- 22 MR. MACE: Objection, 23 argumentative -- 24 MR. McCLAIN: Let me finish my 25 statement and I'll let her say whatever she 0170 1 wants. 2 MR. MACE: Objection, move to 3 strike. 4 Q Why is it true that if you knew workers in 5 your plant could be, I'll give you the benefit 6 of doubt, could be the victims of 7 bronchiolitis obliterans from flavors, why you 8 didn't feel like it was at least appropriate 9 to warn somebody so they could take 10 precautions to prevent the possibility of 11 getting that same disease? 12 MR. MACE: Objection, move to 13 strike. Objection, argumentative, form, 14 foundation, assumptions. 15 A I think you are mixing up worker exposure from 16 the meat material from worker exposure from 17 the flavor ingredient. Our focus with this 18 information was using 100 percent material. 19 Does not translate to the finished flavor. 20 Q That is false. That document was drafted for 21 microwave popcorn workers. That pat answer 22 you just gave me that you practiced with 23 Mr. Mace for two days is false. This document 24 was about microwave popcorn workers. 25 MR. MACE: Objection, move to 0171 1 strike. 2 Q Why didn't you give that to ConAgra or any of 3 your other customers other than you just 4 didn't care what happened to their employees? 5 MR. MACE: Objection, compound. 6 Objection, form. Objection, argumentative. 7 Objection to counsel's comments, move to 8 strike. 9 A It's absolutely not true that those were my 10 intentions. 11 Q Your statement was false, you agree with 12 that? 13 MR. MACE: Objection. 14 Q This document is addressed to microwave 15 popcorn workers, not to the workers in your 16 plant. Your answer to me was absolutely a 17 false reason not to give this to the microwave 18 popcorn workers. 19 MR. MACE: Objection, move to 20 strike. Objection, to characterization. 21 Q Tell the jury that, that you just told them 22 something that was false. 23 A No, it is not false. My intent on this was 24 not as written -- my intent was not for 25 microwave popcorn plant. It was taking the 0172 1 information and trying to direct our people as 2 to how when they are handling the meat 3 material they could minimize their exposure. 4 Q Would you read the title of the document? 5 A Worker protection solutions for flavors for 6 microwave popcorn. 7 MR. McCLAIN: Thank you. No 8 further questions. Take a break. 9 VIDEOGRAPHER: Off the record at 10 3:39. 11 (Recess taken.) 12 VIDEOGRAPHER: Back on the record 13 at 3:44. 14 Q As a former employee of IFF, don't you think 15 this is all IFF's fault? 16 MR. WOODSIDE: Object. 17 Q Tell me, don't you think it's all their 18 fault? 19 MR. MACE: Objection, move to 20 strike. 21 Q You don't have to answer. 22 Here is the question that will be 23 easy. Tell me the process by which the MSDS 24 sheets were prepared physically, how would 25 they be generated and would you or some other 0173 1 person with a toxicology background review 2 them before they went out to the customer? 3 A The way our program works, all raw materials 4 are reviewed by myself, given the hazard 5 statements, with that the associated codes. 6 The system would do the math, in terms of the 7 cut off levels for -- this in the later 8 years. In earlier years we physically had the 9 formulation in front of us, we would draw a 10 line at 1 percent or higher or .1 percent or 11 higher for carcinogens. Take the hazards and 12 their codes, apply the logic to what 13 supercedes what statement by route of 14 exposure. 15 Once those statements are generated, 16 then the rest of the information could come 17 from you've got the physical chemical 18 characteristics, whether or not it is a powder 19 or not. Those kind of statements. Then those 20 would be generated automatically. 21 Q Generated automatically what, by computer? 22 MR. MACE: Objection, time. 23 A In the later years, yes. 24 Q Who created the computer program? 25 A I don't know. 0174 1 Q Was it something that somebody within 2 Tastemaker/Givaudan prepared, or a commercial 3 product? 4 A I don't know. Our early years I don't know. 5 Early years it was manual, was a Word 6 document. Then later on it became a 7 computerized program, but I don't know. 8 Q Following the generation of the MSDS sheets, 9 would a person read them before they went to 10 the customer? 11 A No. 12 Q So they would be generated and sent out 13 manually -- sent out automatically with no 14 further review? 15 MR. MACE: Objection, over 16 broad. 17 A Yes. 18 Q Who would be in a better position than you to 19 determine how MSDS sheets were generated? 20 MR. MACE: Objection. 21 A No one. I know how they were generated. 22 Q No one would have more knowledge than you 23 about MSDS sheets? 24 A No. 25 MR. McCLAIN: No further 0175 1 questions. 2 MR. WOODSIDE: At this time no 3 questions. 4 REDIRECT EXAMINATION 5 By Mr. Mace: 6 Q Miss Higley, what years did you work at 7 Tastemaker/Givaudan? 8 A I need to look at my resume. 9 MR. McCLAIN: '91 through 2004. 10 A '91 through 2004. 11 Q What was your position at Tastemaker? 12 A First I was the director of scientific and 13 regulatory affairs. Then I became a vice 14 president of product safety and regulatory. 15 Q What was your education and training? 16 A Master's in biology, Ph.D. in biochemistry and 17 post doc in toxicology. 18 Q Were you part of the team that was looking 19 into the respiratory issues at the Tastemaker 20 plant in the mid '90s? 21 A Yes. 22 Q What was your role? 23 A My primary role was regulatory and 24 biochemistry, science. 25 Q Dr. Higley, did you ever form a belief that 0176 1 diacetyl was causing any lung disease in 2 employees at the Tastemaker plant? 3 A I did not come to the conclusion that diacetyl 4 was causing lung disease in the Tastemaker 5 plant. 6 Q Did you ever conclude that butter flavoring 7 was causing any lung disease in employees at 8 the Tastemaker plant? 9 A I didn't come to any conclusion that butter 10 flavoring was causing lung disease in the 11 Tastemaker plant. 12 Q During the investigation in the 1990's did you 13 have direct discussion with Dr. Lockey? 14 A Yes, I did. 15 Q Did you have direct discussions with 16 Dr. Lockey regarding potential causative 17 agents? 18 A Yes, I did. 19 Q What did Dr. Lockey tell you about that? 20 MR. McCLAIN: Object to the form of 21 the question, calls for hearsay. 22 A Dr. Lockey and I discussed looking at Talmadge 23 King's paper, identifying the agents that are 24 in Talmadge King's paper, and reviewing them 25 in relationship to other things in our company 0177 1 that were structurally related to those. 2 Q Did any of the discussions -- at that point 3 did Dr. Lockey ever suggest diacetyl as the 4 cause of lung disease at Tastemaker? 5 A No, he did not. 6 Q Did Dr. Lockey ever suggest butter flavor as 7 the cause of lung disease at Tastemaker? 8 MR. McCLAIN: Object to the form of 9 the question as leading. Also calls for 10 hearsay. 11 A In my meetings with Dr. Lockey, he did not 12 suggest that butter flavors were a causative 13 agent. 14 Q Did Dr. Lockey ever suggest that it was a 15 product that was going out the door to a 16 customer that was causing any lung disease? 17 MR. McCLAIN: Object to the form of 18 the question, leading, suggestive, calls for 19 hearsay, and assumes facts not in evidence. 20 Q The answer to my question? 21 A In my meetings with Dr. Lockey he did not 22 indicate there was any ingredients in butter 23 flavors that would cause respiratory disease. 24 Q Did Dr. Lockey ever suggest it was a product 25 going out the door to a customer that was 0178 1 causing any lung disease? 2 MR. McCLAIN: Objection, 3 argumentative. 4 A No, Dr. Lockey did not suggest it was any 5 product going out the door to a customer. 6 Q Did any of the outside experts ever suggest, 7 Dr. Brooks or anybody else ever suggest to you 8 diacetyl was causing any lung disease in 9 employees at the Tastemaker plant? 10 A No, no experts advised us that diacetyl was 11 causing lung disease in the Tastemaker plant. 12 Q Did any of the experts, whether it was 13 Dr. Brooks or anyone, suggest to you that 14 butter flavoring was causing lung disease in 15 employees at the Tastemaker plant? 16 A No, none of our experts indicated that. 17 Q Did you ever think it was a product that 18 Tastemaker or Givaudan was shipping out the 19 door that was causing bronchiolitis obliterans 20 or lung disease? 21 A No, I did not believe it was a product that 22 was causing bronchiolitis obliterans. 23 Q Throughout the period of this investigation in 24 the 1990's did you ever hear anybody even 25 suggest that a product Tastemaker was shipping 0179 1 out the door was causing bronchiolitis 2 obliterans or lung disease? 3 MR. McCLAIN: Object to the form of 4 the question. The question is argumentative. 5 It's leading and suggestive. 6 Q You can answer. 7 A Can you repeat the question? 8 Q Yes. Throughout this period in the 1990s when 9 this investigation was going on, did you ever 10 hear anybody even suggest that a product that 11 Tastemaker was shipping out the door was 12 causing bronchiolitis obliterans or lung 13 disease? 14 MR. McCLAIN: Same objection. 15 A No, I did not. 16 Q Did you ever feel any of your customers had a 17 risk of a similar issue? 18 A Absolutely not. 19 MR. McCLAIN: Objection to the form 20 of the question. 21 Q Since counsel was talking over you, did you 22 ever -- 23 MR. McCLAIN: You have to allow me 24 a chance to object. That is how the procedure 25 works. 0180 1 MR. MACE: Give him a second to 2 object. 3 A I apologize. 4 Q Dr. Higley, did you ever feel any of your 5 customers had a risk of similar issues? 6 MR. McCLAIN: Object to the form of 7 the question. 8 A No, I did not. 9 Q Did Dr. Brooks or Dr. Lockey, or any of the 10 outside consultants ever recommend that 11 Tastemaker notify any customer about any 12 respiratory issues? 13 MR. McCLAIN: Object to the form of 14 the question. 15 A None of our consultants advised us on that. 16 Q Did Dr. Brooks or Dr. Lockey or any of the 17 outside consultants ever recommend that 18 Tastemaker notify any customers about any 19 preventative measures? 20 MR. McCLAIN: Same objection. 21 A No, they did not. 22 Q At the end of the day, what is your 23 understanding regarding the cause of 24 respiratory issues? 25 A My conclusion was we could not come up with 0181 1 one causative, single causative agent that was 2 causing the respiratory illness. 3 Q What were the most likely candidates in your 4 mind? 5 A When you look at Talmadge King's article, 6 talking things that are in the classes of 7 ammonia, sulphurs. Then external to that 8 would be chlorines perhaps. There is viral 9 and there is idiopathic conditions. 10 Q In the data there remains some uncertainty in 11 terms of exactly what medical condition 12 various individuals had? 13 A Yes. 14 Q In the data there remains some uncertainty 15 whether it was caused by working at the 16 Tastemaker plant? 17 A Absolutely, yes. 18 Q Were there other employees doing the same job 19 as the person with respiratory issues who did 20 not have any problems? 21 A Yes. 22 Q What did you conclude about that? 23 MR. McCLAIN: Object to the form of 24 the question. 25 A It supported our conclusion that one could not 0182 1 come up with one single causative agent. 2 Q Was there any discussion about individual 3 susceptibility or genetic predisposition? 4 A There was discussion about prior employment, 5 some of that would lead to predisposition, as 6 well as smoking. 7 Q Did some of these individuals have exposure at 8 jobs before they came to Tastemaker? 9 A Yes, they did. 10 Q Was there any discussion about general 11 environmental factors in the Cincinnati area? 12 A Dr. Lockey and I at one point discussed that 13 in the Cincinnati area there is in general a 14 higher prevalence of asthma. 15 Q Counsel implied you should have contacted 16 customers about respiratory issues at 17 Tastemaker. Why didn't you contact customers? 18 A None of our external experts advised us we 19 needed to do that. We did not feel that this 20 was a finished flavor formulation issue. 21 Q Did you ever feel it was something you were 22 sending out the door that was causing any of 23 these issues? 24 MR. McCLAIN: Object to the form of 25 the question, argumentative. 0183 1 A No, we did not. 2 Q There has been mention about the number of 3 outside experts, Dr. Lockey, and others. Did 4 Tastemaker have the in-house expertise to look 5 at these issues? 6 A We didn't have complete in-house expertise. 7 We needed to go to the outside, toxicologists, 8 Dr. McKay with PFTs and Dr. Lockey, and Susan 9 Hubbs in epidemiology. 10 Q In terms of outside toxicology help who did 11 you have? 12 A We went to TRS, Toxicology Regulatory 13 Services, Dr. Andrea Nicaporoff. 14 Q In terms of industrial hygiene did you get 15 outside industrial hygiene help as well? 16 A John Hochstrasser obtained that, yes. 17 Q Can you estimate for us even in a rough 18 ballpark how much money Tastemaker spent 19 looking into these issues? 20 MR. McCLAIN: Object to the form of 21 the question. 22 A Approximately half a million dollars. 23 Q Did you and others at Tastemaker follow up on 24 recommendations that the outside consultants 25 made? 0184 1 A Yes. 2 Q Can you think of a single example of anything 3 that Dr. Lockey recommended that Tastemaker 4 did not do? 5 A No. 6 Q Did any of the outside consultants suggest 7 that any animal testing be done? 8 A No. 9 Q Counsel asked you about the fact that in the 10 early '90s when these issues came up there was 11 some work brought in from the Middletown, 12 plant. What kind of work did they do in 13 Middletown, what was being moved to 14 Cincinnati? 15 MR. WOODSIDE: Just for the record, 16 the correct pronunciation is Middletown. 17 MR. MACE: No, it's not Ohio, 18 it's New York. I am not sure you are right. 19 Maybe you are right. 20 A It is Middletown. We brought in for the most 21 part, my recollection, process flavors. 22 Q What do you mean by that, what type of raw 23 material? 24 A Those raw materials would be the nitrogen 25 containing enzymes, then they are heated to 0185 1 make like a soup base. 2 Q There was reference to the word sensitive. 3 What do you mean when you use that term? 4 A Scientifically sensitive to me is an 5 irreversible irritation. Sensitive in the 6 context of some of the documents we discussed 7 today is more of an annoyance. 8 Q You were asked about confidentiality 9 agreements. Was it unusual for Tastemaker to 10 have third parties sign confidentiality 11 agreements when they were given access to 12 Tastemaker processes using trade secrets? 13 A It was common practice for us to have 14 confidentiality agreements. 15 Q Not just with the consultants helping you on 16 this, but with other third parties? 17 A Absolutely. 18 Q Are you aware of Dr. Lockey ever requesting to 19 publish anything and Tastemaker not allowing 20 it? 21 A No. 22 Q Did Dr. Lockey ever recommend that you go to 23 NIOSH? 24 A No. 25 Q Did any of the outside consultants ever 0186 1 recommend you go to NIOSH? 2 A No, they did not. 3 (Exhibit Number 37 4 Marked for identification.) 5 Q Showing you what we're marking for 6 identification as Exhibit 37. Do you 7 recognize that? 8 A Yes. 9 Q What is it? 10 A It is an abstract literature search from -- 11 that accesses the NIOSH technical information 12 database of worker exposure articles. 13 Q Why was this done? 14 A This was done to review what would be in the 15 NIOSH literature with regard to bronchiolitis 16 obliterans and to see what causative agents 17 NIOSH publications had indicated could be 18 potentially causative agents. 19 Q Did you review these search results back in 20 the mid '90s? 21 A Yes, we did. 22 Q In terms of the type of things you were 23 finding in terms of causative agents for 24 bronchiolitis obliterans, what were you 25 finding? 0187 1 A Asbestos, vinyl chlorides, chlorine gas, 2 ammonia, phosgene, halogen gases. 3 Q Is there any reference in the searches to 4 diacetyl being a potential cause of 5 bronchiolitis obliterans? 6 A No. 7 (Exhibit Number 38 8 Marked for identification.) 9 Q Handing you what we are marking as Exhibit 10 38. Do you recognize that? 11 A Yes, I do. 12 Q What is that? 13 A NERAC is a literature search service that 14 goes -- has a different set of databases 15 behind it. 16 Q That is also part of your literature search 17 back in the mid '90s looking for potential 18 causes of bronchiolitis obliterans? 19 A Yes, it was. 20 Q What did you find with this search? 21 A This one indicated in animal feed workers 22 proteolytic enzymes, ammonia, chlorine, 23 phosgene, fire smoke, cocaine, pesticides. 24 Q Did you find any reference to diacetyl as 25 being a potential cause of bronchiolitis 0188 1 obliterans? 2 A No, we did not. 3 (Exhibit Number 39 4 Marked for identification.) 5 Q Showing you what we will mark as Exhibit 39. 6 Do you recognize that? 7 A Yes, I do. 8 Q What is it? 9 A This is what is called the base list. As part 10 of the hazard determination program, first 11 thing that is required is you come up with a 12 list of chemicals. This is the list of 13 chemicals that we began our investigation on. 14 There is approximately 16, more than 1600 15 ingredients. 16 Q You referred to a base list. Is this the 17 listing of all the raw materials at 18 Tastemaker? 19 A No, there was approximately at the time 20 approximately 5,000 to 6,000 raw materials. 21 This is a subset of the list. We were trying 22 to pare our list down of ingredients. 23 Q There is, in terms of the information you 24 gathered on each one of these substances, what 25 did you gather? 0189 1 A The approach I used, which would be in the 2 second step of the hazard identification, is 3 to gather the data. Since many of these 4 chemicals have neither an OSHA PEL, or they 5 have any data on them, the approach I used was 6 to use structural activity relationships. 7 What you see in here are the class number for 8 the material, the structural class, molecular 9 formula, in the margin to the left you see the 10 chemical class. There are approximately 31 to 11 34 classes. 12 (Exhibit Number 40 13 Marked for identification.) 14 Q Showing you what we're going to mark as 15 Exhibit 40; do you recognize that? 16 A Yes, I do. 17 Q What is it? 18 MR. McCLAIN: Can you wait until I 19 have it in front of me? 20 MR. MACE: Sure. 21 Q What is that, ma'am? 22 A Reference list for the ingredients that are in 23 the FFIDS sheets. 24 Q Counsel referred to like a nine volume set, is 25 that what you are referring to? 0190 1 A Yes, at the time. Now it's electronic. 2 Q Approximately how many different flavors were 3 listed on this sheet? 4 A Probably 1200, more than 1200 flavor 5 ingredients on here. 6 Q These are all thing presents at the Tastemaker 7 plant? 8 A Not all of them would be present. 9 Q What about the base list, Exhibit 39, were 10 those all things present at the Tastemaker 11 plant? 12 A They were all materials that had the potential 13 to be there, yes. 14 Q You said what, the total number of raw 15 materials that Tastemaker was using back in 16 the mid '90s? 17 A 5,000 to 6,000. 18 Q What did you do -- go back to Exhibit 39 a 19 minute. What did you do once you came up with 20 this list of the base, gather some information 21 on each of the chemicals? 22 A Group the chemicals according to their class. 23 Then began the next phase, which is to gather 24 the data. So we would go to MSDSs, FFIDS 25 sheets. I also employed a consultant 0191 1 toxicologist to do a complete literature 2 search on the chemical classes, the 3 ingredients inside these chemical classes. 4 Q In terms of this approach of grouping the 5 chemicals into structural classes or chemical 6 classes, was that something you discussed with 7 Dr. Lockey? 8 A Yes, I did. 9 Q What kind of feedback did you get back from 10 him? 11 A Dr. Lockey felt this -- 12 MR. McCLAIN: Objection, calls for 13 hearsay. 14 Q You can answer. 15 A In my meetings with Dr. Lockey we discussed 16 this approach. He felt it was a prudent 17 approach given we couldn't identify the 18 causative agent. 19 (Exhibit Number 41 20 Marked for identification.) 21 Q Showing you what was marked as Exhibit 41. Do 22 you recognize that? 23 A Yes, I do. 24 Q What is it? 25 A It is an e-mail, copy of an e-mail from myself 0192 1 to Janice Dees. 2 Q What date is it? 3 MR. McCLAIN: What is the Exhibit 4 number? 5 MR. MACE: 41. 6 Q What is the date, ma'am? 7 A August 2, 1995. 8 Q What did you say in your e-mail? 9 A I'm summarized my conversation with 10 Dr. Lockey, in which case we felt that, in 11 summarizing, it's our professional opinion 12 that a risk assessment on all the chemicals 13 would be work intensive and not necessary. 14 That we are developing another approach that 15 gets at the plant issues on a broad basis 16 rather than on an unmanagable chemical by 17 chemical basis. 18 Q In terms of a broad basis, is that what you 19 just described to us with these categories? 20 A That's correct. 21 Q Refer you to a document marked earlier today. 22 Let me ask a more general question. In terms 23 of these you said there were 31 to 34 24 different chemical groups. In terms of -- did 25 you do any work to try to compare those to the 0193 1 agents you saw listed in the literature as 2 potential causative agents to bronchiolitis 3 obliterans? 4 A Yes, I did. 5 Q What did you find on that? 6 A I found the ones that were of similar 7 structural class would have been, you look at 8 the Talmadge King paper, would be the nitrogen 9 containing and sulfur containing. 10 Q In terms of those class numbers, do you happen 11 to remember what those class numbers were? 12 A Probably 27, sulfur containing compounds are 13 class 27. Heterocylic nitrogen compounds are 14 class 24. 15 Q What class would diacetyl fall in? 16 A Ketone, aliphatic ketone. 17 Q Was that either 27 or 24? 18 A No, it was not. 19 Q Let's step back from diacetyl for a minute. 20 Any of the research you did on potential 21 causative agents for bronchiolitis obliterans, 22 did you see any ketones that are listed as 23 potential causative agents? 24 A No, I did not. 25 (Exhibit Number 42 0194 1 Marked for identification.) 2 Q Showing you what we marked for identification 3 as Exhibit 42. Do you recognize that? 4 A Yes, I do. 5 Q What is it? 6 A It is a toxicological assessment of the 7 aromatic aldehydes, which is one of the 8 groups. 9 Q The company referenced at the top, TRS, who is 10 that? 11 A The consultant, a toxicology consultant that 12 was working with us. 13 Q The type of reports that you described to us? 14 A Yes. This is in essence the third part of 15 hazard identification, which is you accumulate 16 the data, you analyze it, document it. 17 Q In terms of how long it took TRS to do one of 18 these reports for a structural group, how long 19 ballpark did it take? 20 A Approximately six months. 21 Q Counsel asked you about Exhibit 26, the flavor 22 fragrance ingredient data sheet for diacetyl. 23 Can you get that out, please. 24 There is a reference on the first page 25 to Environ, who is that? 0195 1 A Environ is the toxicological consulting agency 2 that was utilized in 1985 to accumulate the 3 data, and review the data for its 4 applicability and come to the conclusion as to 5 the appropriate health hazard statements. 6 Q Are those listed in here somewhere, the 7 appropriate health hazard statements? 8 A Very last page. Number 8, statements relevant 9 to making health hazard determination. 10 Q What did it say for diacetyl? 11 A Liquid and vapor may be irritating to skin and 12 eyes, vapor is irritating to throat and lungs. 13 Q Were those statements used in all the MSDS 14 preparation that you were involved with in 15 regard to diacetyl? 16 A Yes, they were. 17 Q Back to that in a minute. 18 Another resource you mentioned was MSDS 19 sheets from your suppliers. Showing you what 20 we are going mark as Exhibit 43. 21 (Exhibit Number 43 22 Marked for identification.) 23 Q Do you recognize that? 24 A Yes, I do. 25 Q What is it? 0196 1 A MSDS sheet from Polarome for diacetyl. 2 Q What is the date on it? 3 A 8-1-92. 4 Q In terms of the health hazard rating you were 5 being told by your supplier? 6 A One. 7 Q What were you being told about respiratory 8 protection? 9 A Not usually required. 10 Q In terms of the health hazard warnings you 11 were given? 12 A Liquid and vapor is irritating to the skin and 13 eyes. Vapor is irritating to throat and 14 lungs. 15 Q Look over at Exhibit 34, are similar warning 16 statements given in your MSDS sheet for the 17 butter flavor Mr. McClain asked you about? 18 A Similar to what? 19 Q Similar to what appeared in the FFIDS? 20 A These statements are -- these MSDS are a 21 compilation of all the ingredients that are 22 greater than 1 percent. The statement is 23 mostly reflective of butyric acid, which is 24 more severe than diacetyl. 25 Q Let me focus on the lungs. In terms of the 0197 1 FFIDS for diacetyl, what was the summary 2 statement given to you in terms of the 3 respiratory? 4 A Vapor is irritating to throat and lungs. 5 Q In terms of the MSDS sheets for the butter 6 flavoring that counsel showed you, inhalation 7 what does it say? 8 A Inhalation is irritating to nose, throat and 9 lungs. 10 Q While we are on Exhibit 34, you were asked 11 about this particular butter flavor. You were 12 read from a document with some questions about 13 liquids, is this product a liquid, the one 14 referenced in Exhibit 34? 15 A No, this is a powder. 16 Q You were asked questions about going to FEMA. 17 Let me show you document we will mark Exhibit 18 44. 19 (Exhibit Number 44 20 Marked for identification.) 21 Q Exhibit 44, Dr. Higley, do you recognize that? 22 A Yes, I do. 23 Q What is it? 24 A It's our July meeting, the briefing bullets 25 for our meeting with FEMA. 0198 1 Q What year was that? 2 A 1996. 3 Q These are your discussion points. What were 4 your second and third discussion points? 5 A I was summarizing, I wanted us to be able to 6 summarize when we went to FEMA that in our 7 review of the literature, my review of the 8 literature, the causative agents of 9 bronchiolitis obliterans that show up in the 10 literature are not associated with the 11 Tastemaker cases. 12 Third bullet is that our determination 13 at that point has been that there has been no 14 specific chemical, not even in the literature, 15 that has been linked, and any specific 16 chemical at this point would be circumstance. 17 Q What was the next point? 18 A We had to -- we were informing FEMA we had two 19 cases that occurred following acetaldehyde 20 exposure as it was reported by the employees. 21 Q The attachments on here, there is an appendix 22 A, appendix B, who prepared those? 23 A I did. 24 Q The basis for appendix B, where did you get 25 that information? 0199 1 A Majority of this was out of Talmadge King's 2 article. In addition, looking at the 3 literature searches that we previously looked 4 at some of them, with regard to a search on 5 bronchiolitis obliterans and causative agents. 6 Q What was the summary you provided in terms of 7 the potential causative agents of 8 bronchiolitis obliterans are? 9 A A few things I was trying to bring to the 10 attention of FEMA, this was something new for 11 them, was how bronchiolitis obliterans 12 syndrome could be distinguished from other 13 respiratory diseases. Very rare and in 14 general when it has been associated with it in 15 the literature we found it was toxic fume 16 exposure, sometimes transplants. Sometimes 17 it's very difficult to accurately diagnose 18 bronchiolitis obliterans, it can be confused 19 with other chronic obstructive disease. 20 Q In terms of what was the characteristic of 21 bronchiolitis obliterans, what did you 22 conclude on that? 23 MR. McCLAIN: Object to the form of 24 the question, she stated repeatedly she is not 25 a medical doctor. 0200 1 Q You can answer. 2 A The characteristic is it is characterized by 3 dilation and destruction of the small 4 airways. Concentric fibrous obliteration of 5 the small airways. 6 Q In terms of the potential causative agents, 7 you mentioned some earlier. Do you have any 8 research that indicated viral or infectious 9 agents can cause it? 10 A Yes, I believe that is in Talmadge King's 11 article, yes. 12 Q In terms of the types of gases, fumes, mist, 13 vapors you had seen reported, what did you 14 conclude on that? 15 A That is also in Talmadge King's article. None 16 of these ingredients, none of these materials 17 are used in Tastemaker facilities. 18 Q What were the ones you listed? 19 A Ammonia, chlorine, hydrogen fluoride, hydrogen 20 sulfide, nitrogen dioxide, ozone, phosgene, 21 sulfur dioxide, chloropicrin, 22 trichloroethylene, cadmium oxide, 23 methylsulfate, talcum powder and oxygen 24 toxicity. 25 Q A document counsel showed you, Exhibit 32, was 0201 1 with regard to another meeting you had with 2 FEMA. In terms of the objective as counsel 3 read to you on the second page there, words 4 about not unique to Tastemaker but something 5 that could be more generally present in 6 workplaces of other flavor manufacturers; what 7 did you mean by that? 8 A It was still our investigation was leading us 9 to that we didn't feel at the time that there 10 was anything that we were doing differently in 11 our plant that would make this situation 12 unique to Tastemaker. 13 Again, to follow up and to discuss this 14 with other flavor manufacturers, to see if 15 they were having similar experiences. 16 Q You distinguish in your mind between a flavor 17 manufacturer and a flavor user? 18 A Absolutely, yes. 19 MR. McCLAIN: Object to the form of 20 the question. 21 Q What did you refer to? 22 A Flavor manufacturers are those people that use 23 the meat material, are exposed to it at higher 24 concentrations because it's 100 percent 25 concentrated ingredients, those are flavor 0202 1 manufacturers. 2 Q That is the phrase you used in this memorandum 3 back at the time, contemporaneous? 4 MR. McCLAIN: Object to the form of 5 the question. 6 Q Is it? 7 MR. McCLAIN: The document is its 8 own best evidence. 9 Q Is that the term you used, ma'am, in the 10 contemporaneous document back in '96, flavor 11 manufacturers? 12 A Yes, it is. 13 Q You were asked some questions in regards to 14 some work that Dr. Hubbs did. Let me show you 15 what we will mark as Exhibit 45. 16 (Exhibit Number 45 17 Marked for identification.) 18 Q Do you recognize that? 19 A Yes, I do. 20 Q What is it? 21 A This is an abstract of Hubbs, et al. from a 22 presentation they gave in 2004 at the SOT, 23 Society of Toxicology annual meeting. 24 Q In terms of what material was being tested by 25 Dr. Hubbs? 0203 1 MR. McCLAIN: I object to the 2 question, she is not a toxicologist. She said 3 so. 4 Q What material was being tested by Dr. Hubbs? 5 A Diacetyl. 6 Q What were the exposure concentrations? 7 A 99.3, 198.4, 294.6 parts per million. 8 Q At any of those concentration levels was it 9 reported that there were any significant 10 changes in the lung? 11 A No, there were not any significant changes in 12 the lung under those exposure conditions. 13 Q What was the conclusion as you understood it 14 reported in the diacetyl? 15 MR. McCLAIN: Object to the form of 16 the question. It states its conclusion. 17 Q You can answer. 18 A The conclusion, the last sentence, findings 19 suggest that acute exposure to diacetyl alone 20 is sufficient to cause upper respiratory tract 21 epithelial necrosis in rats at a 22 concentrations of 198.4. 23 Q What were your -- 24 A Parts per million. Indicates at the lower 25 dose they did not see any upper respiratory 0204 1 tract effects. 2 Q Lower dose being what? 3 A 99.3 part per million. 4 Q So it was the first dose at which -- what was 5 the lowest dose at which Dr. Hubbs found an 6 effect? 7 A 198.4 parts per million that is effecting the 8 upper respiratory tract. 9 Q Even at the highest concentration were there 10 any effects in the lung? 11 A No, no effects in the lower respiratory tract. 12 Q Showing you what 46 we will marked as Exhibit 13 46. 14 (Exhibit Number 46 15 Marked for identification.) 16 Q Do you recognize that? 17 A Yes, I do. 18 Q What is it? 19 A NIOSH health hazard evaluation report, 20 December 2004 of the Marion, Ohio plant. 21 Q If you go back to page 23, table 9, personal 22 ketone exposures for diacetyl. 23 MR. WOODSIDE: What page? 24 MR. MACE: Page 23. 25 Q Did you see anything even approaching the 198 0205 1 at which NIOSH found upper airway effects? 2 MR. McCLAIN: This is just 3 ridiculous. I object to the form of the 4 question. That question mixes apples and 5 oranges and gets a fruit salad. I object. 6 Q You can answer, ma'am. 7 A The highest level I see is 1.97 parts per 8 million -- 9 MR. McCLAIN: I hope you go down 10 this road at trial. This is just foolish. 11 A -- significantly lower than -- 12 MR. McCLAIN: I object. 13 Q You can answer again, since counsel was 14 interrupting. 15 MR. McCLAIN: This calls for an 16 expert opinion, this is not an expert 17 deposition. I object to it. I object to her 18 offering an opinion which she is not qualified 19 to offer at any event on this issue. Lacks 20 foundation. 21 Q You can answer, ma'am. 22 A The highest level I see on this table is 1.97 23 parts per million which is significantly lower 24 than the lowest dose against which they found 25 an effect, which was 198.4 parts per million. 0206 1 Q Look over at Exhibit 7 -- look at the New 2 England Journal article. Referring to the 3 discussion on page 337, refers to 352 parts 4 per million. 5 A Um-hum. 6 MR. McCLAIN: I object. 7 Q Did you see anything approaching 352 parts per 8 million at the ConAgra test results? 9 MR. McCLAIN: Objection. 10 A No, I did not. 11 Q In terms of the document counsel showed you in 12 The New England Journal of Medicine, is it 13 your understanding that related to the ConAgra 14 Marion plant? 15 A No. 16 Q What did that relate to? 17 A I believe it relates to the Jasper, Missouri 18 plant. 19 Q In terms of the butter flavoring that was 20 being tested at the Jasper, Missouri plant, 21 was that a butter flavoring that Givaudan or 22 Tastemaker had sent to the ConAgra Marion 23 plant? 24 A No. 25 Q Was it even a butter flavoring that Tastemaker 0207 1 or Givaudan had produced? 2 A No, it was not. 3 Q Have you reviewed the reports of Dr. Hubbs 4 work, both the '02 work that she did and the 5 '04 work she did? 6 A Yes, I have. 7 Q Were there any findings of bronchiolitis 8 obliterans in either of those studies? 9 A No, there were not. 10 MR. McCLAIN: Can I hear that 11 question back. 12 (Question read.) 13 MR. McCLAIN: Objection to the form 14 of the question. Rats don't get bronchiolitis 15 obliterans, your question doesn't make any 16 sense. Your question proposes a nullity. 17 Q You were asked about the BASF study. Do you 18 know when that study first became available in 19 the United States? 20 A 2001, the date stamp. 21 Q What type of study was that? 22 A Acute LC50. Do you know what exhibit that is? 23 Q I believe Exhibit 25. 24 A Yes, an LC50 study. 25 Q Was there any finding in that study of any 0208 1 bronchiolitis obliterans lesions, any 2 granulation of the small airways 3 characteristic of bronchiolitis obliterans? 4 MR. McCLAIN: Objection, rats don't 5 get bronchiolitis obliterans. The question is 6 a nullity, I object. 7 Q You can answer, Doctor. 8 A I don't see any references to effects of the 9 distal airways. 10 Q You were asked some questions about the Bakers 11 study. If you can go to the Exhibit 14, 12 please. 13 Exhibit 14 was an exhibit counsel used 14 with you, '95 with an attached article 15 abstract on the International Bakers services, 16 do you remember that? 17 A Yes, I do. 18 Q Plaintiff made the comment you should call 19 NIOSH because they can figure things out. At 20 the International Bakers plant did NIOSH 21 figure out what was causing respiratory 22 injuries in that plant? 23 A No, they did not. 24 Q Is that referenced in the abstract that you 25 received on this? 0209 1 A Yes, it reads no specific etiology of the 2 illness was identified. 3 Q What did the next sentence read in abstracts 4 you received? 5 A The authors conclude that a short-term 6 exposure to a specific mix may have triggered 7 the reaction and initiated the disease in 8 these individuals. 9 Q Did it refer right above that to other workers 10 in the mixing room? 11 A Yes. 12 Q What does it say about that? 13 A Demonstrated symptoms of the disease within 14 five to six months of beginning employment. 15 Q What did it say about the other workers? 16 A Two other workers in the mixing room were not 17 effected. 18 Q In addition to looking at the abstract of it, 19 did you actually look at the report back in 20 the mid '90s? 21 A Yes, I did. 22 Q Show you what we marked as Exhibit 47. 23 (Exhibit Number 47 24 Marked for identification.) 25 Q Recognize that? 0210 1 A Yes, I do. 2 Q What is that? 3 A The NIOSH health hazard evaluation report, the 4 International Bakers report. 5 Q In terms of what medical conditions these two 6 individuals have, was there any information 7 you learned on that, on the bottom of page 4 8 with regard to case one? 9 MR. McCLAIN: Can I hear the 10 question back. 11 (Question read.) 12 MR. McCLAIN: That is leading, I 13 object. 14 A Statement reads although bronchiolitis has 15 been reported in as a compilation of extrinsic 16 allergic alveolitis, the clinical picture in 17 these cases was not suggestive, either of 18 asthma or hypersensitivity. Suggestive of 19 emphysema. 20 Q Was there a discussion in the report when you 21 went to the actual report, in terms of what 22 some of the possible environmental causes were 23 according to NIOSH? 24 A Yes. They discussed nuisance particulates 25 grain dust, amorphous silica, proteolytic 0211 1 enzymes, bacterial endotoxins and bakery 2 flour. 3 Q Was there any mention by NIOSH of diacetyl 4 being a potential causative agent? 5 A No, there was not. 6 Q Any mention of benzaldehyde being a potential 7 causative agent? 8 A No. 9 Q Any reference to acetaldehyde being a 10 potential causative agent? 11 A No, there was not. 12 Q Turn to Exhibit 15, please, Exhibit 15 counsel 13 handed to you and representation was made 14 these documents were all part of a meeting. 15 Were all the documents here part of a project 16 team meeting in September of '95? 17 A I can't verify that. In looking at that 18 agenda, my documentation as to the evaluation 19 based on structurtivity relationship is in 20 there, would be in there. That would be 21 brainstorming and categorization, the 22 attachments, I cannot see how they are related 23 to this. 24 MR. MACE: Counsel, these don't 25 have any Bates numbers. Do you know where 0212 1 these came from? 2 MR. CRICK: They were exhibits 3 from Lockey's deposition. He produced them 4 like that. 5 Q You can't say one way or another, ma'am, 6 whether those attachments go with the cover 7 page? 8 A No, I can't. 9 Q The categorization sheets you referred to, is 10 that the listing of the 31 categories you 11 referred to earlier? 12 A Yes. 13 Q When you were referring to category 27 and 24, 14 those would be the ones listed on here? 15 A That's correct. 16 Q The back of this document was a table called 17 raw material sensitivity list. Is that your 18 document, did you prepare that document? 19 A No, that is not my document. 20 Q In terms of the Bakers list there are a number 21 of stars down the pages, approximately how 22 many stars are there under the Bakers list? 23 A Over 130. 24 Q Listing of chemicals, were those all chemicals 25 present at the Tastemaker plant? 0213 1 A Yes. 2 Q In terms of the employee sensitivity, what did 3 you understand that to be? 4 MR. McCLAIN: Objection, asked and 5 answered. 6 A This is not the scientific definition. This 7 is what the employee indicates that they might 8 have an annoyance reaction with using. 9 Q In terms of the stars in the Bakers list, was 10 it your understanding these were all things 11 that the two individuals with potential 12 respiratory problems at international baker 13 services plant had actually been exposed to? 14 A No. If you read the tables. The tables refer 15 to ingredients that -- what was the 16 terminology -- are occasionally used in bakery 17 mixes or another one is ingredients commonly 18 used. It is just a composit list. 19 Q Was there any reference when you went back to 20 the actual International Bakers NIOSH report 21 that any of these substances was the actual 22 cause of the respiratory issues in the 23 international bakers? 24 A No, they are not listed in the summary as 25 being the cause. 0214 1 Q You were asked about Exhibit 16. Exhibit 16 2 was one of the questionnaires, counsel read to 3 you question 18? 4 A Yes. 5 Q At Tastemaker are there any chemicals or 6 substances that you work with that seem to 7 result in tingling, burning or stinging of 8 your eyes, nose or throat or frequent 9 sneezing, or difficulty breathing. 10 When you would get reports back of 11 various substances to that, did you assume 12 these were all difficulty breathing 13 responses? 14 MR. McCLAIN: Object to the form of 15 the question. 16 A No, this is quite a broad list. Without them 17 specifically saying it was in regards to 18 difficulty breathing it could be in 19 relationship to any of the symptoms that are 20 listed there. 21 Q Tingling in the eyes would be enough? 22 A Yes, any one of those. It says or. 23 Q Go to Exhibit 13, please. You were asked some 24 questions about Exhibit 13, a document from 25 April of '93. As part of these meetings, look 0215 1 at the top of page 3, you were asked about 2 Mr. Wallace. Did you get information 3 regarding Mr. Wallace? 4 A Yes. There was a report that the patient's 5 asthma, if it did occur, was probably not work 6 related. 7 Q Middle of page 4 you are asked about 8 Mr. Walker. Did you give additional 9 information about Mr. Walker, February 4 of 10 '93? 11 A Yes, Dr. Baughman reported there really is no 12 evidence to suggest the diagnosis of 13 bronchiolitis obliterans with obstructive 14 pneumonia. 15 Q In terms of the conclusions that were reached 16 in the document, what was the first 17 conclusion? 18 A That Miss Irick's bronchiolitis obliterans was 19 caused or aggravated by her exposure to 20 chemicals in the workplace, but no causative 21 factor could be identified. 22 Q What was the first part of that? 23 A There was no indication that -- true, there is 24 no indication that Miss Irick's bronchiolitis 25 obliterans was caused or aggravated -- 0216 1 Q By her exposure to chemicals in the workplace? 2 A -- by her exposure to chemicals in the 3 workplace. 4 Q What was the conclusion in regard to Wallace 5 and Walker? 6 A Mr. Wallace and Walker both had asthma that 7 could be exacerbated by a workplace exposure 8 to chemical substances. 9 MR. CRICK: Was that from '93? 10 MR. MACE: Right. 11 Q You were shown Exhibit 22. 12 A Yes. 13 Q Exhibit 22 counsel read you some numbers, 26 14 employees out of 424; is that 16 percent? 15 A No, that is closer to 6 percent. 16 Q Attached to this was a table you were asked 17 about. 18 MR. McCLAIN: You only injured 6 19 percent, is that the point? 20 Q In terms of the sensitivity there, what did 21 you understand the sensitivity to be? 22 A Again sensitivity is not the scientific 23 definition of sensitivity. What the worker 24 would indicate as being an annoying substance. 25 MR. MACE: I guess we better 0217 1 change the tape. 2 VIDEOGRAPHER: Off the record at 3 4:44. 4 (Recess taken.) 5 VIDEOGRAPHER: Back on the record at 6 4:53. 7 Q You were asked some questions about Janice 8 Irick. Was there additional information 9 Tastemaker had in its file on Miss Irick other 10 than what Mr. McClain showed you? 11 MR. McCLAIN: Objection to the form 12 of the question. In what year? 1993 again? 13 MR. MACE: 1990. 14 MR. McCLAIN: 1990? What year are 15 you referring to, counsel? 16 Q 1995? 17 A Yes, there are. 18 Q Let me show you what has been marked as 19 Exhibit 48. 20 (Exhibit Number 48 21 Marked for identification.) 22 Q Do you recognize that? 23 A Yes, I do. 24 Q What is it? 25 A Letter from Dr. Colby to Janice Dees, medical 0218 1 service coordinator at Tastemaker. Indicates 2 looking at the slides he was unable to see 3 good histological evidence of bronchiolitis 4 obliterans. He also noted that from a letter 5 he received from Dr. Baughman that she had 6 first noted the symptoms after being under 7 general anesthesia for the repair of a 8 fistula. 9 Q Showing you what we are going to mark as 10 Exhibit 49. 11 (Exhibit Number 49 12 Marked for identification.) 13 Q Do you recognize that? 14 A Yes, I do. 15 Q What is it? 16 A It's the letter from Dr. Baughman to Michael 17 Dohn, with regard to Janice Meenach Irick. 18 Q What information was there? 19 A In 1976 he indicated that in talking with Miss 20 Meenach Irick, that she had symptoms back when 21 she had a fistula repaired. She was under 22 general anesthesia, she woke up having 23 coughs. She has been having intermittent 24 episodes of coughing, bronchitis since that 25 time. 0219 1 Q Other any other information Tastemaker had on 2 that? 3 A There is a history in her family of a sister 4 and a niece having similar respiratory 5 problems. 6 MR. McCLAIN: It's all a 7 coincidence. 8 Q One of the names mentioned was Miss Gaskins. 9 Let me show you Exhibit 50. 10 (Exhibit Number 50 11 Marked for identification.) 12 Q Do you recognize that? 13 A Letter from Dr. Baughman to Dr. Jim Lockey 14 with regard the Robin Gaskins, 1996. 15 Q Was a copy of that sent to Tastemaker? 16 A Yes, it was, Janet Dees. 17 Q What information did Tastemaker get on Miss 18 Gaskins? 19 A She was exposed to acetaldehyde at very high 20 concentrations. She coughed, gasped for air. 21 Since that day she has had continued 22 symptoms. Shortness of breath. 23 Q A name mentioned to you was Mary Sue McGee. 24 Showing you Exhibit 51. 25 (Exhibit Number 51 0220 1 Marked for identification.) 2 Q Do you recognize that? 3 A It's a letter from Dr. James Lockey, to S.S. 4 Phelps of the Bureau of Workers' Compensation 5 dated March 21, 1996. 6 Q What information about Miss McGee was in 7 there? 8 A That one talks about intense exposure to 9 acetaldehyde, she was leaning over the top of 10 a tank and experienced sudden intense 11 coughing, dyspnea. 12 Q Another name mentioned was Mr. Wallace, Joey 13 Wallace. I will show you what we are going to 14 mark as Exhibit 52. 15 (Exhibit Number 52 16 Marked for identification.) 17 Q Do you recognize that? 18 A Yes, that is a surgical pathology report for 19 Joey Wallace. 20 Q What information did Tastemaker get on that? 21 A The pathology microscopic description showed 22 no evidence of bronchiolitis obliterans. 23 MR. McCLAIN: I do not need to 24 object every time this is not a medical 25 doctor, she doesn't have the information to 0221 1 interpret these reports? Do I need to do 2 that? 3 MR. MACE: Do whatever you need 4 to do. Same response you give me. 5 MR. McCLAIN: She is not a medical 6 expert. I object to any of this. 7 (Exhibit Number 53 8 Marked for identification.) 9 Q Exhibit 35, ma'am, do you recognize this? 10 A Yes, I am reading from a letter from Dr. Ann 11 Middaugh, to Esly Caldwell, University of 12 Cincinnati. 13 MR. McCLAIN: Object to the form of 14 the question. She is not a medical doctor. 15 She didn't see this at the time. She is not 16 being offered as an expert witness. 17 Q What information did you get on that? 18 MR. McCLAIN: When? Today when you 19 handed it to her? 20 Q You can answer, ma'am. 21 MR. McCLAIN: She didn't have it 22 back then and you know it. 23 MR. MACE: Move to strike 24 counsel's comments. 25 MR. McCLAIN: Did she? Lacks 0222 1 foundation. 2 Q You can answer, ma'am. 3 A In reading the letter, it reads that they had 4 located his preplacement spirometry, which 5 demonstrates the presence of a mild 6 obstructive process occurring even at the 7 time, his preplacement -- last paragraph 8 states overall we do not find evidence of an 9 occupational etiology. 10 Q Is this something you learned back in the mid 11 '90s, that several of these individuals had 12 prior exposures that were confounding factors? 13 MR. McCLAIN: Object to the form of 14 the question. Lacks specificity, doesn't 15 relate to this one. She clearly didn't have 16 this document, and you know it. 17 Q You can answer, ma'am. 18 A Yes, we did. 19 Q Another name mentioned to you was Mr. Shea. 20 Let me how you what we're going to mark as 21 Exhibit 54. 22 (Exhibit Number 54 23 Marked for identification.) 24 Q Do you recognize that? 25 A Yes, this is the surgical pathology report for 0223 1 Gary Shea. 2 Q What information did Tastemaker get from that? 3 A Document reads it's negative for histological 4 features of bronchiolitis obliterans. 5 MR. McCLAIN: Object to the 6 document. That is one sentence out of the 7 document. This witness is not -- the clinical 8 diagnosis on the document is bronchiolitis 9 obliterans. 10 MR. MACE: Objection. 11 MR. McCLAIN: Misrepresentation, 12 orchestrated by counsel, with a witness who is 13 only willing to comply with a 14 misrepresentation of the records. I object to 15 it. She is not an expert. This is all 16 leading. 17 MR. MACE: Misstatement, move to 18 strike counsel's comments. 19 MR. McCLAIN: It is not a 20 misstatement. The diagnosis on the very 21 document that this witness read negative for 22 histologic features for bronchiolitis 23 obliterans says the diagnosis was 24 bronchiolitis obliterans. It's a 25 misrepresentation. To say when you ask her 0224 1 what does the document say, she reads the only 2 sentence in the whole thing that supports your 3 ridiculous position. To suggest that this is 4 a witness other than just your mouthpiece, I 5 object to it. It's not proper. 6 MR. MACE: You are the one who 7 is mischaracterizing the document, counsel. 8 Q Could you turn to Exhibit 20. Exhibit 20 was 9 a document that Mr. McClain showed you with 10 regard to Dr. Lockey and Mr. Walker. For 11 completeness, right above what he read to you 12 regarding the occupational history is there 13 also reference in the document to his work at 14 Proctor and Gamble, his work at Grace Chemical 15 for one year filling hoppers with an unknown 16 powdered chemical, had frequent chest colds 17 during the one year employment, did not wear a 18 respirator? 19 A That's correct, it reads that. 20 Q In addition to diacetyl there is also 21 reference to garlics, toasted and enzymes as 22 substances that caused Mr. Walker some issues? 23 A That's true. 24 Q Is there anywhere in this document that 25 Mr. McClain showed to you that Dr. Lockey 0225 1 concludes that Mr. Walker has any lung disease 2 caused by diacetyl? 3 A No, I don't see any reference to that. 4 Q At any point, any of your discussions with 5 Dr. Lockey, did he ever suggest diacetyl as a 6 cause of bronchiolitis obliterans or any lung 7 disease? 8 A No, he did not. 9 Q A comment was made about surveying other 10 plants at Tastemaker, regardless if it was 11 suggested by Dr. Brooks or anyone, did 12 Tastemaker look at other plants besides the 13 Cincinnati plant? 14 A Yes, we do. 15 Q What did you find? 16 A We didn't find any incidences of elevated 17 respiratory illnesses. 18 Q You made the comment you didn't believe the 19 New England Journal of Medicine article 20 supported the conclusion that Mr. McClain 21 stated. What did you mean by that? 22 MR. McCLAIN: Object to the form of 23 the question. 24 A If you read into the article, it states that 25 there is not a causative -- you can conclude 0226 1 it's not a causative agent just because it is 2 predominantly in the flavor. It also stated 3 there is over 100 volatile chemicals, as well 4 as dust in particular, nuisance dust from 5 salt. 6 MR. McCLAIN: Objection, it doesn't 7 say that at all, it is a misrepresentation. 8 Read it to us. 9 MR. MACE: Move to strike 10 counsel's comments. 11 MR. McCLAIN: Another falsehood by 12 this witness. 13 Q Was there reference in the International 14 Bakers study to dust, nuisance particulates? 15 A Yes, definitely. 16 Q In terms of the process flavors department 17 that was referenced, what were the substances 18 of concern in the processed flavors? 19 A Ones I pick out, again building off Talmadge 20 King's factors were things like the nitrogen 21 containing and sulfur containing compounds, 22 and enzymes. 23 Q Counsel showed you a document from 1993 early 24 on that referenced diacetyl. You reference 25 that diacetyl was on a list of raw materials 0227 1 you wanted to look into at the time. Did you 2 look into it? 3 A Yes, I did a literature search. 4 Q What did you determine regarding diacetyl? 5 A Found that there was no relationship in the 6 literature between diacetyl and bronchiolitis 7 obliterans. 8 Q Counsel was asking you some questions about 9 going to FEMA, to use a phrase you asked for 10 it to be kept secret. What was it you asked 11 FEMA not to further communicate? 12 A We asked them not to disclose our company 13 name. 14 Q In terms of the fact there had been some 15 respiratory issues at the Tastemaker plant, 16 was that something -- did you disclose that to 17 FEMA? 18 A Yes, we did. 19 Q Did you restrict them in any way from further 20 disclosing that? 21 A No. 22 Q In terms of the number of individuals that 23 were being looked at, was that anything that 24 you asked FEMA not to further disclose? 25 A No, it was not. 0228 1 Q In terms of the number of individuals, if you 2 look back at Higley Exhibit 5 -- back up a 3 step. 4 Did Dr. Lockey have full information on 5 all the individuals that were being looked at 6 Tastemaker? 7 MR. McCLAIN: Objection. 8 Q What is your answer, ma'am? 9 A Yes, he did. 10 Q In this article that counsel showed you which 11 was Dr. Lockey's abstract, does he refer to 12 nine or eight individuals? 13 A No, he refers to five. 14 Q You were asked some questions, go back to the 15 FFIDS, Exhibit 26. 16 A I can't find it. Does somebody have a copy? 17 Q I have another copy. I think this is the 18 copy. 19 A Thank you. 20 Q You were asked some questions about the FFIDS 21 from Mr. McClain. Over on page 2, is there a 22 difference between target organs and systemic 23 toxicity? 24 A Yes. OSHA hazard guidance document talks 25 about systemic toxicity in things such as 0229 1 irritation, corrosion, sensitization. As 2 opposed to target organ which would be things 3 like respiratory, liver, etcetera. 4 Q This reference to systemic toxicity, is that a 5 reference to the lungs or the respiratory 6 system? 7 A No, this was reference to a systemic toxic 8 event. 9 Q On the next page, page 3, Mr. McClain asked 10 you about the inhalation study, acute toxicity 11 data. 27 milligrams per liter, do you know 12 what type of parts per million exposure that 13 would be? 14 A In the range of 8,000 parts per million. 15 Q Was there any reference in this information to 16 the type of lung disease? 17 A No, there was not. 18 Q In the mid 1990's, you were shown an MSDS 19 sheet from in 1994 I think it was, with regard 20 to a butter flavor. In that time period was 21 this process done manually that you were 22 referring to? 23 A Yes. 24 Q If you go to Exhibit 36. You were asked some 25 questions about Exhibit 36, these exposure 0230 1 control opportunities listed at the bottom of 2 the page. First of all, what year was this 3 document, the date of this document? 4 A Approximately 2003. 5 Q These various exposure control opportunities 6 that are listed, are those something unique 7 that Tastemaker or Givaudan came up with? 8 MR. McCLAIN: Object to the form of 9 the question. 10 A No, these are more of brainstorming of some of 11 these exposure control opportunities that are 12 actually in the NIOSH type documents. 13 MR. MACE: Nothing further for 14 you at this time. Thank you. 15 MR. McCLAIN: Give us 10 minutes. 16 I don't want to go through all this crap. 17 VIDEOGRAPHER: Off the record at 18 5:12. 19 (Recess taken.) 20 VIDEOGRAPHER: Back on the record 21 at 5:26. 22 RECROSS EXAMINATION 23 By Mr. McClain: 24 Q You were talking to Mr. Mace regarding your 25 workers and evidence regarding their health 0231 1 condition. Are you aware that the Ohio Bureau 2 of Comp already entered judgment that Joey 3 Wallace had bronchiolitis obliterans caused by 4 his work environment at Givaudan? 5 MR. MACE: Objection, move to 6 strike. 7 A No, I did not know that. 8 Q Did you know that Robin Gaskins was awarded 9 money for bronchiolitis obliterans by the Ohio 10 Bureau of Workers' Comp? 11 MR. MACE: Objection, move to 12 strike. 13 A No, I didn't know that. 14 Q Or Walt Vaske was adjudged to have 15 bronchiolitis obliterans caused by his 16 employment at Givaudan? 17 MR. MACE: Objection, move to 18 strike. 19 A No, I don't know that. 20 Q Mary Sue McGee was awarded money because the 21 Ohio Bureau of Workers' Comp found she had 22 bronchiolitis obliterans caused by work at 23 Givaudan? 24 MR. MACE: Objection, move to 25 strike. 0232 1 A No, I don't know that. 2 Q When you told Mr. Mace that the Exhibit 47 3 health hazard evaluation report doesn't say 4 anything about diacetyl, that is just really 5 not true, is it? 6 MR. MACE: Objection, 7 mischaracterization of her testimony. 8 A I said it didn't mention it in summary. 9 Q Oh, I see. Again one of these parts of words 10 deals. It's in the tables, isn't it, of the 11 chemicals that are used in the plant? 12 A I acknowledge that in fact I pointed out it is 13 in the table is a list of ingredients that 14 were commonly used in the plant. 15 Q Although you did a toxicological assessment of 16 aromatic aldehydes, you did not do one for 17 diacetyl, did you? 18 A No, I have not done that group yet. 19 Q In regard to the evaluation of the very plant 20 we're discussing -- 21 MR. McCLAIN: Counsel, what was the 22 number of the NIOSH health hazard evaluation 23 of ConAgra? 24 MR. MACE: I believe 46, 25 counsel. 0233 1 MR. McCLAIN: Thank you. 2 Q Would you go over to what NIOSH found in that 3 document. You see where I am? 4 A Page III. 5 Q Yes. Air concentrations of diacetyl, a butter 6 flavoring chemical known to cause injury to 7 airways in animals studies were highest in the 8 slurry room. Other areas in the plant had 9 very low levels; do you see that? 10 MR. MACE: Objection, move to 11 strike, form, foundation, hearsay, best 12 evidence rule. 13 MR. WOODSIDE: Excuse me, could you 14 tell me what page you are on? 15 MR. McCLAIN: III. 16 A Doesn't read that. 17 Q Air concentrations of diacetyl, a butter 18 flavoring chemical known to cause injury to 19 airways in animal studies were highest in the 20 slurry room; do you see that? 21 MR. MACE; Same objection. Move 22 to strike. 23 A Yes, I see that. That is as it's written 24 here, yes. 25 Q The air concentration of diacetyl in the 0234 1 slurry room were similar to those of other 2 plants where mixers had developed lung 3 disease; do you see that? 4 MR. MACE: Objection, move to 5 strike. 6 A It is written that way, yes. 7 Q Some workers in the slurry room had abnormal 8 lung functions on NIOSH tests indicating that 9 some of them probably had been affected by 10 breathing the butter flavor; do you see that? 11 MR. MACE: Objection, assumes, 12 foundation, hearsay, compound, move to 13 strike. 14 A It's written that way, yes. 15 Q It says abnormal lung function in some 16 packaging area workers may mean that they were 17 affected by flavoring chemicals from the 18 slurry room; do you see that? 19 MR. MACE: Objection, form, 20 speculation, assumes, foundation, move to 21 strike. 22 A Yes, it reads that way. 23 Q Look over at the next page. There is a 24 summary in a black box which is the take away 25 message that NIOSH wants to impart, right? 0235 1 MR. MACE: Objection, move to 2 strike. Objection to form, characterization. 3 A It is a statement inside the box, yes. 4 Q At the ConAgra plant and other microwave 5 popcorn plants the pattern of lung function 6 test abnormalities in workers who regularly 7 mix butter flavorings with heated soybean oil 8 implies a risk for development of fixed airway 9 obstruction from inhalation of flavoring 10 related chemicals. Nearby packaging workers 11 may also be at risk if flavoring chemicals or 12 dust in the area of the slurry room 13 contaminate the air in the packaging area; do 14 you see that? 15 MR. MACE: Objection, form, 16 foundation, compound, speculation, best 17 evidence rule, hearsay, move to strike. 18 A Yes, it reads that way. 19 Q You began looking at the issue of workers in 20 your plant in 1993. Workers in your plant 21 with -- start again. 22 In 1993 you began to investigate the 23 issue of whether or not your workers had 24 bronchiolitis obliterans, what if anything was 25 causing that disease; am I right? 0236 1 A That would be correct. 2 Q In 1994, 11 years later, when you left you had 3 not determined number one, whether they had 4 bronchiolitis obliterans, correct? 5 A I left in 2004. 6 Q Strike that. 7 When you left in 2004 you had not 8 determined whether or not they had 9 bronchiolitis obliterans; am I right, that has 10 been your testimony? 11 MR. MACE: Objection. 12 A That's correct. 13 Q You didn't know what had caused any lung 14 injury to workers; am I right? 15 A That's correct. 16 Q After you had been studying it for 11 years, 17 correct? 18 A We had been studying the ingredients. As I 19 testified earlier, the approach was to look at 20 an overall health program, look at all the 21 ingredients. 22 Q NIOSH began studying the Jasper plant in 1999; 23 isn't that true? 24 MR. MACE: Objection, 25 foundation. 0237 1 A That's correct. 2 Q Within 18 months they had reached a conclusion 3 that the workers had bronchiolitis obliterans, 4 correct? 5 MR. MACE: Objection. 6 A I don't agree with that. 7 Q They had determined that the disease in the 8 plant was caused by exposure to butter 9 flavoring chemicals, true? 10 MR. MACE: Objection. 11 A I don't agree with that. 12 Q Here is the point. In 18 months they were 13 able to reach a conclusion and you looked at 14 it for 11 years and never were. Wouldn't it 15 have been a better idea to call in NIOSH, ask 16 them to look at the issue in your plant, 17 rather than go about it in this secretive way 18 you went about it? 19 MR. MACE: Objection, form, 20 assumes, foundation, compound, argumentative, 21 characterization. 22 A No. I feel our approach with going to outside 23 consultants who agreed with our approach was 24 equally, if not better. 25 Q Well, let me tell you the practical real world 0238 1 effect of going about it the way you did. 2 MR. MACE: Objection. 3 A Do you know my client, Keith Campbell, didn't 4 go to work at the ConAgra plant until 1999? 5 Are you aware of that? 6 MR. MACE: Objection. 7 A No. 8 Q That if he had just been warned about this 9 possibility, this could have all been 10 prevented? 11 MR. MACE: Objection, move to 12 strike. 13 MR. WOODSIDE: Objection. 14 Q Are you aware of that? 15 MR. MACE: Objection, assumes, 16 form. 17 A I can't speculate on that. 18 MR. McCLAIN: I have no further 19 questions. 20 MR. WOODSIDE: No questions at this 21 time. 22 REDIRECT EXAMINATION 23 By Mr. Mace: 24 Q You were asked again about this International 25 Bakers report, Exhibit 36. Mr. McClain points 0239 1 out that among the hundreds of compounds 2 listed back in the tables, diacetyl appears. 3 Is there anywhere in the report it says either 4 of the workers that had lung issues had been 5 exposed to diacetyl? 6 A No, there was not. 7 Q Any statement by NIOSH that diacetyl caused 8 either of the workers any type of lung injury? 9 A No, there was not. 10 Q You were asked about Exhibit 46. I asked you 11 does it report on the Marion plant. I read 12 you the statement in the bullet point on III, 13 your concentrations known to cause injury to 14 airways. In terms of injury to airways caused 15 by diacetyl, did Hubbs find injury in the 16 upper or lower airways? 17 A Hubbs reported injury in the upper airway. 18 Q In terms of the concentration at which she 19 found injury, do you recall what those 20 concentrations were? 21 A She found injury at concentrations at 22 approximately 198 parts per million. 23 Q Next comment that counsel read to you, air 24 concentrations of diacetyl in the slurry room 25 were similar to those of other plants; is that 0240 1 a true statement with respect to comparing the 2 Jasper plant to the Marion plan? 3 A Not in looking at the tables of data, no. 4 MR. MACE: Nothing further for 5 you at this time. 6 RECROSS EXAMINATION 7 By Mr. McClain: 8 Q Dr. Hubbs was a NIOSH investigator, is that 9 true? 10 A Yes. 11 Q Dr. Canwell and Dr. Coleman who wrote this 12 summary of the investigation of the ConAgra 13 plant were also investigators at the Jasper 14 plant; am I right? 15 MR. MACE: Objection, 16 foundation. 17 A I don't know if they were investigators of the 18 Jasper plant. 19 Q Get out the New England Journal of Medicine 20 article if you have any doubts. 21 A What exhibit number? 22 Q I think 6. 23 MR. WOODSIDE: 7. 24 Q See if Coleman and Canwell are listed. 25 MR. MACE: I'll stipulate they 0241 1 are not. 2 A Only Coleman is on it. 3 Q You think Dr. Coleman doesn't know the results 4 of his own study? 5 MR. MACE: Objection. 6 A Coleman is an article on this paper. 7 Q He's an author on the paper? 8 A Yes. 9 Q He's an author of this report, Exhibit 46? 10 A Yes, he is. 11 Q Who is in a better position to know whether or 12 not the two studies were comparable, you or 13 Coleman? 14 MR. MACE: Objection. 15 A I would speculate. Be speculating to answer 16 that. 17 MR. McCLAIN: No further questions. 18 REDIRECT EXAMINATION 19 By Mr. Mace: 20 Q While you've got the New England Journal 21 article out counsel is referring to, on page 22 337, is there a reference to the peak diacetyl 23 level found in Jasper over 1,000 parts per 24 million? 25 A Yes, 1230 parts per million. 0242 1 Q Looking back at Exhibit 46, the report on the 2 ConAgra Marion plant, looking through all the 3 tables of all the findings of air measurements 4 that were made, was there anything even 5 approaching the 100 parts per million at which 6 Dr. Hubbs found no evidence of any injury? 7 MR. McCLAIN: Objection. That is 8 false, both statements are false. 9 A No, I don't see anything within the range of 10 diacetyl on this table that approaches what is 11 in the New England Journal of Medicine. 12 Q In terms of the data, underlying data, were 13 the exposures that are being reported by NIOSH 14 at the Marion plant similar to the exposures 15 that were found at the Jasper plant? 16 MR. McCLAIN: Objection, lacks 17 foundation. 18 A No, they appear to be a magnitude of 19 differences. 20 Q Several orders of magnitude? 21 A Yes. 22 MR. MACE: Nothing further at 23 this time. 24 RECROSS EXAMINATION 25 By Mr. McClain: 0243 1 Q The New England Journal of Medicine article 2 refers to head space values, isn't that true? 3 What he called peak values, right? 1,000 4 parts per million is head space value? 5 A I would have to look at -- I can't tell if 6 they are using NIOSH 500. Page 337 I don't 7 believe they stipulate head space. 8 Q You just don't know? 9 A Don't know. 10 MR. McCLAIN: No further 11 questions. 12 VIDEOGRAPHER: We're off the record 13 at 5:41. 14 (Deposition concluded at 5:41 p.m.) 15 (Signature not waived.) 16 - - - 17 18 19 20 21 22 23 24 25 0244 1 I have read the foregoing transcript from page 1 2 through page 243 and note the following corrections: 3 PAGE LINE REQUESTED CHANGE 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 _________________ 20 Nancy Higley 21 Subscribed and sworn to before me this ____day 22 of ____________, 2006. 23 ___________________ 24 Notary Public 25 My commission expires:_______________________. 0245 1 State of Ohio, ) ) SS: CERTIFICATE 2 County of Cuyahoga, ) 3 I, Constance Versagi, Court Reporter and 4 Notary Public in and for the State of Ohio, duly 5 commissioned and qualified, do hereby certify that 6 the within named witness, Nancy Higley, was by me 7 first duly sworn to testify the truth, the whole 8 truth, and nothing but the truth in the cause 9 aforesaid; that the testimony then given by her was 10 by me reduced to stenotypy/computer in the presence 11 of said witness, afterward transcribed, and that the 12 foregoing is a true and correct transcript of the 13 testimony so given by her as aforesaid. 14 I do further certify that this deposition was 15 taken at the time and place in the foregoing caption 16 specified, and was completed without adjournment. 17 I do further certify that I am not a relative, 18 counsel, or attorney of either party, or otherwise 19 interested in the event of this action. 20 IN WITNESS WHEREOF, I have hereunto set my 21 hand and affixed my seal of office at Cleveland, 22 Ohio, on this 17th day of April, 2006. 23 __________________________________________ 24 Constance Versagi, Court Reporter and Notary Public in and for the State of Ohio. 25 My Commission expires January 14, 2008. 0246 1 State of Ohio, ) ) SS: CERTIFICATE 2 County of Cuyahoga, ) 3 I, Steven Mengelkamp, Video Technician do 4 hereby certify that I have accurately taken the 5 videotape recording of the deposition of 6 Nancy Higley, in the cause aforesaid. 7 I do further certify that this deposition was 8 taken at the offices of Squire, Sanders, 4900 Key 9 Tower, Cleveland, Ohio, on Thursday, April 6, 2006, 10 commencing at 9:41 a.m. and was completed without 11 adjournment; and further certify that the total 12 recorded time was 5 hours and 22 minutes, and that 13 no alterations, additions and deletions were made 14 thereto. 15 IN WITNESS WHEREOF, I have hereunto set my 16 hand and affixed my seal of office at Cleveland, 17 Ohio, on this 17th day of April, 2006. 18 19 __________________________________________ 20 Steven Mengelkamp, Video Technician and Notary Public in and for the State of Ohio. 21 My Commission expires February 12, 2011. 22 23 24 25