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Daughetee v. CHR. Hansen, Inc.

United States District Court, N.D. Iowa

March 6, 2013

CHR. HANSEN, INC., a Wisconsin Corporation; FIRMENICH, INC., a Delaware Corporation; and SYMRISE, INC., a New Jersey Corporation, Defendants

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[Copyrighted Material Omitted]

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For Deborah Daughetee, Steven Daughetee, Plaintiffs: Dennis M McElwain, LEAD ATTORNEY, Smith & McElwain, Sioux City, IA; Donald H Loudon, Jr, LEAD ATTORNEY, Humphrey Farrington & McClain, P.C., Independence, MO; Kenneth Blair McClain, Michael S Kilgore, Scott A Britton-Mehlisch, Scott B Hall, LEAD ATTORNEY, PRO HAC VICE, Steven Edward Crick, LEAD ATTORNEYS, PRO HAC VICE, Andrew K Smith, PRO HAC VICE, J'Nan C Kimak, PRO HAC VICE, Humphrey, Farrington & McClain, P.C., Independence, MO; Charles M Stinger, II, Humphrey, Farrington & McClain, Independence, MO.

For CHR Hansen, Inc, a Wisconsin Corporation, Defendant: Bradley C Obermeier, LEAD ATTORNEY, Duncan Green Brown & Langeness, Des Moines, IA; Brent B Green, LEAD ATTORNEY, Duncan Green Brown Langness & Eckley, PC, Des Moines, IA; Christopher W Angius, PRO HAC VICE, Holland & Knight, LLP, Portland, OR; Christopher G Kelly, PRO HAC VICE, Katherine Anne Skeele, Holland & Knight, LLP, New York, NY; Thomas J Joensen, Bradshaw, Fowler, Proctor & Fairgrave, P.C., Des Moines, IA.

For Firmenich, Inc, a Delaware Corporation, Defendant: April Marie Byrd, LEAD ATTORNEY, PRO HAC VICE, Sean P Wajert, PRO HAC VICE, Shook, Hardy & Bacon, LLP, Philadelphia, PA; Erick J Roeder, Patrick Nathaniel Fanning, LEAD ATTORNEYS, PRO HAC VICE, Shook, Hardy & Bacon, LLP, Kansas City, MO; J Michael Weston, LEAD ATTORNEY, Brenda K Wallrichs, Lederer, Weston & Craig, PLC, Cedar Rapids, IA; Bruce W Clark, PRO HAC VICE, Clark Law Offices, PA, Princeton, NJ; Thomas J Joensen, Bradshaw, Fowler, Proctor & Fairgrave, P.C., Des Moines, IA.

For Symrise, Inc, a New Jersey Corporation, Defendant: Angela R Karras Neboyskey, David E Kawala, LEAD ATTORNEYS, PRO HAC VICE, Swanson, Martin & Bell, Chicago, IL; Patrick Nathaniel Fanning, LEAD ATTORNEY, Shook, Hardy & Bacon, LLP, Kansas City, MO; Richard A Stefani, Gray, Stefani & Mitvalsky, PLC, Cedar Rapids, IA; Thomas J Joensen, Bradshaw, Fowler, Proctor & Fairgrave, P.C., Des Moines, IA.


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A. Factual Background

1. The parties and principal actors

2. Deborah's consumption of microwave popcorn

3. Activities with the popcorn industry

B. Procedural Background


A. Summary Judgment Standards

B. Failure To Warn Claims

1. Duty to warn

a. Foreseeability of risk

b. Intermediary user defense

c. Bulk-supplier defense

2. Proximate cause

a. Proximate cause requirement

b. Expert evidence of causation

c. Evidence establishing proximate cause for failure to warn

d. Post-February 2000 warnings

C. Breach Of Implied Warranty Claims

1. Are implied warranty claims redundant?

2. Proof of a product defect

a. Defective because of inadequate warnings

b. Defective design

3. Post-February 2000 implied warranty claims

D. Symrise Butter Flavor in ConAgra Microwave Popcorn

E. Punitive Damages

1. Standard for punitive damages under Iowa law

2. Analysis of the standards


This case brings to mind the idiom, " Too much of a good thing can be bad for you." In this diversity action under Iowa products liability law, plaintiffs allege that Deborah Daughetee developed " popcorn lung" by consuming multiple bags of microwave popcorn daily for several years. Presently, I am asked to determine whether the plaintiffs are entitled to present to a jury both their failure to warn and design defects

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claims generally, and as to a specific brand of microwave popcorn. These questions, and others, are presented by the defendants' motions for summary judgment.


A. Factual Background

As is my usual practice, I set out only those facts, disputed and undisputed, sufficient to put in context the parties' arguments concerning the defendants' motions for summary judgment. Unless otherwise indicated, the facts recited here are undisputed, at least for the purposes of summary judgment. I will discuss additional factual allegations, and the extent to which they are or are not disputed or material, if necessary, in my legal analysis.

1. The parties and principal actors

Plaintiffs Deborah Daughetee and Steven Daughetee are married and residing in Albuquerque, New Mexico. Defendant Symrise, Inc. (" Symrise" ) is a New Jersey corporation with its principal place of business outside of Iowa or New Mexico. Symrise was created in 2002 by merging with, and assuming the liabilities of, Dragoco, Inc. (" Dragoco" ). Defendant Firmenich is a Delaware corporation with its principal place of business outside of Iowa or New Mexico. Defendant Chr. Hansen, Inc. (" Hansen" ) is a Wisconsin corporation with its principal place of business outside of Iowa or New Mexico. Symrise, Firmenich, and Hansen (collectively " defendants" ) all produced butter flavorings containing diacetyl.

The Flavor and Extract Manufacturers Association (" FEMA" ) is a trade association for flavor manufacturers. Symrise, Dragoco, and Firmenich were FEMA members. The Popcorn Board is an industry association created to promote, inter alia , research related to popcorn.

Diacetyl is a basic food chemical present in all cheeses and butters. It is an ingredient used to manufacture butter flavorings. Diacetyl is one of a number of potentially volatile organic compounds present in butter flavorings. Butter flavorings are intended to provide " buttery" taste and smell. Upon opening a microwave popcorn bag with butter flavoring, diacetyl vapors are released.

Defendants sold their butter flavorings to microwave popcorn manufacturers, including ConAgra, General Mills, and American Popcorn. General Mills and ConAgra have been aware, since the 1990's, that defendants' butter flavorings contained diacetyl. ConAgra is the largest manufacturer of microwave popcorn in the United States. It operates five microwave popcorn factories and has been in the microwave popcorn business since the 1980's. In addition to defendants, ConAgra also purchased flavorings from Givaudan, and International Flavors and Fragrances. [1]

Hansen flavoring products were used in ConAgra's ACT II Butter and ACT II Movie Theater microwave popcorns. Symrise shipped butter flavorings to the General Mills plant in Iowa City. Symrise's butter flavorings were used in microwave popcorn manufactured by General Mills and ConAgra. Symrise's butter flavorings were used in General Mills's Pop Secret Movie Theater popcorn and Pop Secret Butter popcorn. Firmenich's butter flavoring was used in only one brand of popcorn that Deborah consumed--General Mills' Pop Secret Movie Theater microwave popcorn. Firmenich butter flavorings were never present in any ConAgra

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brand of microwave popcorn consumed by Deborah.

Dragoco sold and shipped butter flavorings to ConAgra in the early 1990's in a liquid form. In approximately September 1994, ConAgra began using Givaudan flavorings in its ACT II Butter Lover's microwave popcorn. Prior to that, for a period of time, ACT II Butter Lover's microwave popcorn contained a flavoring manufactured by Dragoco. The parties dispute the length of time that Dragoco supplied butter flavorings for ACT II Butter Lover's microwave popcorn. ConAgra stopped using Dragoco butter flavorings because Givaudan's flavorings were less expensive.

2. Deborah's consumption of microwave popcorn

Between 1989 and 2004, Deborah regularly ate microwave popcorn. From 1989 to 2004, she prepared and consumed approximately one or two bags of microwave popcorn each day. Deborah prepared a " Product Identification" Sheet (" Product ID Sheet" ) in which she identified the brands of microwave popcorn she has eaten since 1989. Deborah prepared the Product ID Sheet based on her recollection of the various brands she consumed. She identified various brands manufactured by General Mills, ConAgra, and American Popcorn. Specifically, she recalled consuming the following brands and varieties: ACT II Butter; ACT II Butter Lover's; ACT II Movie Theater; Jolly Time Butter; Jolly Time Butterlicious; Jolly Time White and Buttery; Jolly Time Blast O Butter; Pop Secret Butter; Pop Secret Movie Theater; Orville Redenbacher Butter; and, Orville Redenbacher Movie Theater Butter. Her favorite brands, in descending order, were ACT II, Orville Redenbacher, Pop Secret, and Jolly Time. Deborah believes that during between 1989 and 2004, 50 to 60% of the microwave popcorn she consumed was ACT II, 25 to 30% was Orville Redenbacher, 20% was Pop Secret, and 5% was Jolly Time.

After removing a bag of butter flavored microwave popcorn from the microwave, Deborah would open the bag and draw the buttery smell into her nose and lungs. She " liked the smell of opening a bag near my face," and liked the taste of butter flavored, microwave popcorn. Deborah first ate microwave popcorn in 1989 while working as a writer for the television show " Tour of Duty." She prepared and ate two bags of microwave popcorn while she worked on Tour of Duty. Typically, she would eat one bag at the office and then take another bag home with her. Similarly, she ate between one and two bags of microwave popcorn while working on the television show " Renegade." Deborah first ate ACT II microwave popcorn while she was working on " the trials of Rosie O'Neil" but cannot state a precise date when she began eating ACT II Butter Lover's popcorn. Deborah is unable to specify what percentage of her popcorn consumption of ACT II microwave popcorn was made up of ACT II Butter Lover's popcorn. Between 1989 and 1995, Deborah purchased ACT II popcorn from Costco. She also remembers individual bags of ACT II popcorn being available at Blockbuster, but is not sure when. Deborah stopped eating popcorn in 2004 because she grew tired of it.

3. Activities with the popcorn industry

One of FEMA's standing committees is the Safety Evaluation Coordination Committee. The committee's responsibility is:

To direct and oversee all safety evaluation activities of the Association, and to monitor safety evaluation activity, wherever it occurs, related to flavors. To initiate or cooperate in initiating in activities related to, and supporting,

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competent and effective safety evaluation of flavors. To coordinate the safety evaluation activities of the Board of Governors, the Expert Panel, other committees of the Association, and outside organizations include governmental agencies, scientific and academic institutions and other industry groups.

Membership Directory at 26; Plaintiffs' App. at 72. The Flavor and Ingredients Committee gathered information about ingredients through surveys and identified abnormalities. The Flavor and Ingredients Committee did not sponsor any original studies. Information gathered was distributed to other FEMA committees. Prior to 1997, no FEMA committee had examined whether a product could be hazardous when inhaled.

Fred Stults, Firmenich's Vice President and Technical Director for Flavors, was FEMA's president-elect from 1996 to 1997 and became FEMA's president in 1997. He was also on FEMA's board of governors and served on FEMA's Safety Evaluation Committee from approximately 1984 to 2007. Daniel Stebbins worked for Dragoco from 1973 to 2003, and, after the merger, for Symrise through March 2004. At times during the 1990's, Stebbins served as the secretary, vice president, and president of FEMA's board of governors. Stebbins served as Dragoco's representative to FEMA in 1996 and 1997, while Dragoco's North American division president. Klaus Bauer, Dragoco's vice president of product development served as chairman of FEMA's Flavor Ingredients Committee in 1997.

Symrise and Firmenich, as FEMA members, had access to health hazard information published by FEMA. Among the health hazard information FEMA publishes for its members are Flavor and Fragrance Ingredient Data Sheets (" FFIDS" ) and Material Safety Data Sheets (" MSDS" ) for the flavoring chemicals. At various times, Symrise and Firmenich employees were members and/or officers of FEMA, and served on FEMA committees. In 1985, FEMA issued a FFIDS for diacetyl which stated that, upon inhalation, diacetyl was " harmful" and high concentrations were " capable of producing systemic toxicity." FFIDS at 2; Plaintiffs' App. at 76.

In 1986, the National Institute for Occupational Safety and Health (" NIOSH" ) published a study regarding a Health Hazard Evaluation involving bronchiolitis obliterans at an International Bakers plant in Indiana. The NIOSH's report concluded that two workers at the plant had been diagnosed with lung injuries clinically consistent with bronchiolitis obliterans or emphysema. The NIOSH's 1986 International Bakers report stated: " In the absence of specific identified etiology for the two cases of severe obstructive lung disease, every attempt should be made to control airborne dust exposure in the mixing room." 1986 NIOSH Report; Defendants' App. at 706-07. The NIOSH report makes no reference or recommendation regarding exposure to " vapors, mists or fumes" which could arise from evaporating liquid.

In approximately 1991, Fred Stults, Firmenich's Vice President and Technical Director for Flavors prepared a Chemical Hygiene Plan (" CHP" ) for Firmenich. The CHP contained a section called " Working with Chemicals of Potent Inhalation Hazard." Diacetyl was among the chemicals listed in that section. The CHP required a " special label" for the listed chemicals which included a picture of a nose inhaling vapors and the warning: " Inhalation hazard do not inhale." CHP at 10; Plaintiffs' App. at 200. The CHP also cautions: " Use and store these substances only in a well-ventilated area or a hood or other containment device for procedures

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which may result in the generation of aerosols or vapors containing the substances. Id. Firmenich did not use the " special label" on any of the labels of products that it sold to General Mills. In 1992, Givaudan discovered that one or more of its employees had been diagnosed with bronchiolitis obliterans and that one of the employees may have died as a result. Givaudan's discovery led to the creation of an internal task force to investigate the potential for lung injury at the Givaudan plant. Givaudan established safety procedures, including the use of respirators for workers exposed to diacetyl or diacetyl-containing products. In 1993, the Givaudan task force reported that diacetyl could be the cause of bronchiolitis obliterans and that further studies should be conducted. As part of Givaudan's investigation it retained Dr. Stuart Brooks. In 1994, Brooks confirmed the bronchiolitis obliterans diagnosis in two employees and recommended steps in the investigation to determine the cause and prevent further exposures. Also in 1994, Givaudan retained experts from the University of Cincinnati to investigate the level of lung disease among Givaudan employees. The specialist included Roy McKay, a pulmonary toxicologist; Dr. James Lockey, an occupational medicine physician; and Susan Pinney, an epidemiologist.

Some General Mills's employees began experiencing skin irritation problems in the mid 1990's. In investigating this skin irritation problem, General Mills contacted Givaudan for advice on butter flavoring products and industrial hygiene. At the request of General Mills, Givaudan representatives came to its plant in Iowa City. Givaudan advised General Mills on how to protect workers from skin irritation but never told General Mills that Givaudan always required its workers to wear respirators when working with diacetyl. General Mills asked Givaudan if inhaling butter flavoring was hazardous and was told it was not hazardous.

On July 22, 1996, Mike Davis, Givaudan's President, and Givaudan's toxicologist, Nancy Davis, met with John Hallagan, a science advisory and attorney for FEMA to tell FEMA that one or more Givaudan employees had been diagnosed with bronchiolitis obliterans. On September 27, 1996, Givaudan General Counsel Karen Duros and Dr. Lackey met with Hallagan again to educate FEMA on bronchiolitis obliterans and what was happening at the Givaudan plant. Hallagan, in turn, advised FEMA's board of governors that employees of a member flavor company had been diagnosed with possible bronchiolitis obliterans and that FEMA should provide a seminar for its members on occupational lung disease and respiratory protection.

In late, 1996, FEMA's board of governors held a meeting at which Givaudan's disclosure was discussed. FEMA's executive director and Dan Thompson, an attorney, gave an oral report. FEMA decided to hold the 1997 FEMA Seminar after this meeting regarding Givaudan's disclosure. [2] Davis began serving on FEMA's board of governors in 1997 and continued to serve until at least 2007.

In 1997, FEMA sponsored a seminar entitled " Respiratory Safety in the Flavor and Fragrance Workplace" (" the 1997 FEMA Seminar" ). Hansen was not present at the seminar. Dr. Cecille Rose, an occupational medicine physician from the National Jewish Health Center, and John Martyny, a certified industrial hygienist, spoke at the 1997 FEMA Seminar. Rose and Martyny addressed respiratory safety

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in the flavor industry. Stults, William Troy, and Gordon Ruiterman were registered to attend the seminar for Firmenich. Stults reviewed the 1997 FEMA Seminar materials. Klaus Bauer, Mervyn Brown, Salvatore Cascone, Lawrence Dinkinson, Thomas Karnis, Philip Mingle, James Olano, Luis Olano, Jesus Pardon, Mohan Pradhan, Gene Rachelski, and Andrea Swoboda were registered to attend the seminar for Dragoco. Bauer reviewed the 1997 FEMA seminar materials. By the end of the seminar, both Stults and Bauer were aware of a possible case of bronchiolitis obliterans at a FEMA member plant.

In preparation for the 1997 FEMA Seminar, FEMA shared with Rose information regarding a case of bronchiolitis obliterans and NIOSH's 1986 International Baker's plant study. Rose conducted a literature search to familiarize herself with the flavor process, potential exposures, and to determine whether there was a specific chemical commonly used in flavorings that had been associated with bronchiolitis obliterans. Rose did not find a chemical commonly used in flavorings that had previously been associated with bronchiolitis obliterans. One of Rose's objectives for the 1997 FEMA Seminar was to gather information from FEMA members regarding lung hazards that they were working with or had discovered in their plants.

No speaker at the 1997 FEMA Seminar stated that diacetyl exposure caused or was suspected of causing bronchiolitis obliterans. NIOSH's 1986 International Baker's plant study was attached to the seminar materials. The seminar materials included a section that listed the causes of bronchiolitis obliterans. The seminar materials did not discuss diacetyl as a cause or suspected cause of bronchiolitis obliterans.

Following the 1997 FEMA Seminar, Firmenich did not conduct any research to determine if the chemicals it was using in its products could be hazardous to their consumers' health. Prior to June 2000, Firmenich had not conducted any animal study to determine whether flavoring ingredients were hazardous. Also prior to June 2000, Firmenich did not perform or commission any studies concerning human health aspects of inhalation of its butter flavorings or diacetyl.

Following the 1997 Seminar, Dragoco conducted no investigation to determine if any chemicals it was using could cause bronchiolitis obliterans. Dragoco did not employ a toxicologist prior to June 2000. Symrise and/or Dragoco did not sponsor an animal study to determine if any flavoring ingredients were hazardous prior to June 2000. Dragoco did not conduct tests concerning human health aspects of inhalation of its butter flavorings or diacetyl. Symrise has not conducted a study regarding inhalation of diacetyl among its employees.

Dragoco provided information to General Mills about its butter flavorings in October 1997, a few months after the 1997 FEMA Seminar. General Mills asked Dragoco questions about the safety of its products several times between 1988 and 1998. Dragoco did not inform General Mills about the 1997 FEMA Seminar. Dragoco prepared and sent a MSDS to General Mills for Dragoco's butter flavorings, which reflected that the butter flavorings could cause irritation upon inhalation. Dragoco's MSDS did not warn that exposure to its butter flavorings could cause bronchiolitis obliterans. Similarly, Firmenich's MSDS for a butter flavoring it sold to General Mills stated: " Vapor may be irritating to eyes, nose, throat, and respiratory tract. Breathing high concentrations of vapor may cause coughing and sore throat." Firmenich MSDS at 2; Plaintiffs' App. at 163.

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In 1996-1997, no representative from any FEMA member company, other than Givaudan, disclosed to FEMA that they had any workers diagnosed with bronchiolitis obliterans. FEMA took a survey within the industry to determine whether any other company had an experience similar to Givaudan. The survey disclosed no other company. As of June 2000, no documents existed in public literature which attributed inhalation of diacetyl vapor with bronchiolitis obliterans.

Under the National Fire Protection Association (NFPA), a health hazard rating of " 1" represents " [m]aterial that on exposure would cause irritation but only minor residual injury." NFPA 704 Health Hazard Rating System at 2; Plaintiffs' App. at 171. A health hazard rating of " 1" means " slightly hazardous (toxic) material." NFPA 704 Health Hazard Rating System at 3; Plaintiffs' App. at 172. Firmenich's MSDS for its butter flavorings indicated a health hazard rating of 1. Symrise's MSDS for its butter flavorings sold to General Mills stated that its butter flavorings were an inhalation irritant.

A label identifying a product as an " inhalation hazard" indicates that the product is potentially dangerous or harmful. Dragoco did not place respiratory hazard warnings on the drums of butter flavorings sold to General Mills's Iowa City plant. General Mills hired ventilation consultants in 1999 to install exhaust hoods at its Iowa City plant. Subsequently, a General Mills's employee, Vicki Stillmunkes, claimed to have developed a lung condition at General Mills's Iowa City plant.

FEMA's Flavor Ingredients Committee did not conduct health or safety studies. In 1997, no FEMA committee was responsible for determining whether or not chemicals could be hazardous when inhaled. As of 1997, no list existed of flavor and/or fragrance ingredients that could pose respiratory hazards in the workplace.

In August 2000, NIOSH performed a Health Hazard Evaluation of the Gilster-Mary Lee microwave popcorn plant in Jasper, Missouri. NIOSH conducted a medical survey of Gilster-Mary Lee plant workers, quantitative industrial hygiene surveys, respiratory training and fit testing of certain plant workers, and animal exposure studies of butter flavorings. The NIOSH investigation included Gilster-Mary Lee's quality control room. In its interim report, NIOSH found elevated rates of chronic cough, shortness of breath, obstructive spirometry abnormalities, asthma, chronic bronchitis, breathing trouble, and fatigue among plant workers. NIOSH also found " [s]trong exposure-response relationships existed between quartile of estimated cumulative exposure to diacetyl and respiratory dust and frequency and degree of airway obstruction." Interim Report at 2; Plaintiffs' App. at 301.

After conducting follow-up testing at Gilster-Mary Lee, NIOSH considered the quality control room to be " an additional high risk area" in which " 5 of the 6 workers had airways obstruction." Interim Letter Report at 2; Plaintiffs' App. at 348. NIOSH noted that: " [Quality control] workers are repeatedly exposed for intervals of several seconds up to several minutes to elevated organic vapor concentrations by work processes throughout the shift." Id. The NIOSH reported three sources for the vapors: " microwave oven fan exhaust during cooking of the corn" ; " Bursts of steam and flavoring vapors ejected as bags are opened" ; and " Vapors rising from corn while being loaded into graduated cylinders." Id. The NIOSH also noted that the quality control room " ventilation system is not adequate to remove the volatile compounds generated through QC testing." Interim Letter Report at 3; Plaintiffs' App. at 349. NIOSH made safety recommendations specific to

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the quality control room to improve air quality and reduce worker exposures.

On August 2, 2002, NIOSH provided a " Worker Update" concerning its testing at the Gilster-Mary Lee plant. The update states that " [w]e believe butter flavoring in the air caused lung disease in workers at this plant." Worker Update at 2; Plaintiffs' App. at 359. The NIOSH update made the following observation concerning quality control exposures:

Many quality control workers had abnormal breathing tests and have continued risk even after the ventilation changes in the plant. Based on our survey results, we believe that they may receive many peak exposures to flavoring vapors when microwaving the popcorn bags, opening them, and measuring the amount of hot popcorn. When the popcorn/flavorings temperature increased, the vapor increased, although the high exposures only lasted for seconds or a few minutes. We are concerned about these short peak exposures in the quality control room and have provided recommendations for control.

Worker Update at 3; Plaintiffs' App. at 360.

In 2001, the Wall Street Journal published an article about employees who worked with butter flavorings at the Gilster-Mary Lee plant developing lung disease. After that article was published, in 2001, a Firmenich employee was found to have had a decline in his pulmonary function test. The Firmenich employee was referred to Dr. Robert Kruklitis. On March 25, 2002, Dr. Kruklitis noted in a letter to another doctor that the worker had " obstructive airway disease/constrictive bronchiolitis." Letter at 3; Plaintiffs' App. at 153. Dr. Kruklitis also offered the following observation:

However, it is noteworthy that at least eight other individuals have developed an apparently similar condition while working in the Gilster/Marilee Corporation, a plant in which artificial butter flavorings are made. In fact, [the employee] states that artificial butter flavoring is also made at his plant, and he has participated on several occasions in the process. Given these facts and his lack of other obvious etiology, we are very suspicious that the constrictive bronchiolitis is secondary to exposure to one or more chemicals which [the employee] has been exposed.

Letter at 3; Plaintiffs' App. at 153.

ConAgra become aware of any association between exposure to diacetyl in the workplace and certain lung diseases in 2001. It was alerted about the association by newspaper articles about NIOSH's investigation into reported lung disease among workers at the Gilster-Mary Lee microwave popcorn plant in Jasper, Missouri. On October 3, 2001, Jack McKeon, head of ConAgra's snack food division, sent a memo to all ConAgra employees advising them about NIOSH's investigation at the Gilster-Mary Lee microwave popcorn plant. A week after becoming aware of the association between exposure to diacetyl and certain lung diseases, a ConAgra representative attended the October 2001 Popcorn Board meeting. During this meeting, NIOSH representatives discussed their investigation of the Gilster-Mary Lee microwave popcorn plant. Five days after the meeting, ConAgra received from the Popcorn Board a draft of a personal protection equipment " tip sheet" regarding how to protect microwave popcorn factory workers from butter flavoring fumes. A week after receiving the first " tip sheet," ConAgra received a second " tip sheet" from the Popcorn Board. This " tip sheet" addressed how to provide adequate ventilation in microwave popcorn plants. Beginning in 2001, ConAgra implemented a number of safety precautions in its microwave popcorn plants to protect

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workers from butter flavoring vapors. Following the October 2001, Popcorn Board meeting, ConAgra made no changes to its products' packaging.

In May 2002, NIOSH stated in a fact sheet that it was " unclear what role diacetyl may or may not play in the development of respiratory illness in workers exposed to the flavoring." NIOSH Evaluates Worker Exposures at a Popcorn Plant in Missouri, at 2; Firmenich-Symrise App. at 189. NIOSH also noted that it was " not aware of any evidence to suggest danger to consumers in the preparation and consumption of microwavable popcorn." Id.

By 2003, NIOSH started to conduct investigations at several of ConAgra's microwave popcorn plants. In March 2003, NIOSH conducted a medical survey of ConAgra's workers. NIOSH's survey identified workers with evidence of lung disease of the same type seen in workers who mixed oil and flavorings in other microwave popcorn plants. NIOSH made recommendations to ConAgra regarding how to protect workers from exposure to butter flavorings. ConAgra implemented NIOSH's recommendations and began conducting medical monitoring of its employees. In mid-2003, ConAgra assembled a panel of experts to develop a Consumer Exposure Risk Index to address the potential health concerns. The panel included expertise in inhalation toxicology, chemical and structure activity and pulmonology, and occupational medicine. By the end of 2003, a number of ConAgra workers had filed lawsuits alleging that they suffered lung disease as a result of exposure to butter flavorings. Throughout 2003 and 2004, ConAgra increased ventilation and installed fume hoods in the quality assurance labs, and research and development labs of several of its microwave popcorn plants. In 2004, ConAgra hired Aspen Research Corporation (" Aspen" ) to perform a study that measured the amount of diacetyl released when cooking microwave popcorn. The study included ACT II Butter Lover's popcorn. In May 2005, Aspen provided ConAgra with the final report of its 2004 study. Aspen's 2005 report was not released to the public because it contained information ConAgra considered proprietary. As of October 2004, ConAgra's ACT II Butter Lover's popcorn did not contain any warnings to consumers that exposure to the butter fumes could cause serious lung injury. As of 2004, ConAgra had not conducted any studies evaluating diacetyl emissions from ConAgra microwave popcorn in a simulated consumer home environment. ConAgra continued to use diacetyl in its butter flavorings as an ingredient in its microwave popcorn until 2007.

In January 2006, NIOSH released a report on a cluster of bronchiolitis obliterans cases in former workers at the Gilster-Mary Lee microwave popcorn plant in ...

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