Document MJJVk873j7bZKxkDjJNYd08w9

FILE NAME DuPont Remington DRM DATE 2021 Oct 4 DOC DRM028 DOCUMENT DESCRIPTION Legal - Plaintiff's motion to exclude defense expert John Spencer Exposure assessment of Remington shotgun shells IN THE SUPERIOR COURT OF THE STATE OF DELAWARE Gloria Whalen Plaintiff V. E.I. DuPont de Nemours and Company et al Defendants C.A. No. 09-059 ASB Howard B. Altena et al Plaintiffs V. C.A. No. 09-107 ASB E.I. DuPont de Nemours and Company et al Defendants PLAINTIFF'S MOTION TO EXCLUDE DEFENSE EXPERT JOHN SPENCER AND ANY TESTIMONY RELATING TO HIS OCCUPATIONAL EXPOSURE ASSESSMENT OF REMINGTON SHOTGUN SHELLS By s Thomas Crumplar JACOBS & CRUMPLAR P.A. Thomas Crumplar 0942 10 Corporate Circle Suite 10 302 656-5445 Attorneys for Plaintiffs David O. Barrett Esquire Cooney & Conway LLP 120 North LaSalle Street 30th floor Chicago IL 60602 312 236-6166 Admitted Pro Hac Vice Dated October 4 2024 Plaintiffs move this Court for an order to exclude or at least limit the testimony of Defendant's expert Mr. John Spencer CIH CSP on the grounds that 1 he is unqualified to give the opinions he espouses in these cases 2 his methodology does not meet the standards for expert opinion testimony set forth under Daubert and Evid R. 701 and 702 3 his opinions lack foundation and are not the product of reliable scientific principles and methods and 4 his opinions will only confuse and mislead the jury Additionally Plaintiffs move to exclude entirely any reference to Mr. Spencer's occupational exposure assessment of Remington shotgun shells Plaintiff understands it will have the opportunity to make a formal presentation on these issues at a Daubert hearing which has been scheduled for November 25 2024 and November 26 2024 STATEMENT OF FACTS Shooters Exposed to Remington Shotshells Develop Mesothelioma Before this Court are two cases of mesothelioma each with many years of exposure to asbestos fiber from recreational use of Remington shotgun shells The toxic health effects of asbestos exposure have been known for over one hundred years and the unique relationship between asbestos exposure and mesothelioma since at least 1960 Mesothelioma is a rare cancer of the mesothelial cells that line the lungs and abdomen It is considered a signal tumor for asbestos exposure and it is invariably fatal Howard Altena was born in South Dakota and raised on a 2000 grain and cattle farm in Doon Iowa He has spent his life farming In 1963 at the age of ten his father showed him how to hold a shotgun and Howard has been an avid hunter and trap shooter ever since He has used Remington shotgun shells his entire life and did not learn they contained asbestos until after he was diagnosed with mesothelioma Exhibit 1 Altena Complaint at page 2 Exhibit 2 Altena Affidavit Eugene Schoepke has a similar story Raised on a farm in Varna Illinois he spent his adult life farming crops and raising livestock He was an avid hunter and used Remington shotgun shells from the 1960's through the 1980's Exhibit 3 Janet Schoepke Deposition,,at 17-14 and Exhibit 4 Jeffrey Schoepke Deposition at 2-26 17-22 1-155 He too was diagnosed with mesothelioma Exhibit 5 Schoepke Complaint at page 2. It is the opinion of Plaintiffs medical causation experts Drs Arthur Frank and David Zhang that each man's mesothelioma was caused at least in part by his exposure to asbestos from Remington shotshells Exhibit 6 Frank Report Altena Exhibit 7 Frank Report Schoepke Exhibit 8 Frank Affidavit Exhibit 9 Zhang Report Altena Exhibit 10 Zhang Report Schoepke These are not the first individuals to allege exposure to asbestos from Remington shotshells caused them to develop mesothelioma The first was Huntington Eldridge Jr. a bank executive and a passionate outdoorsman who spent his life raising money for Ducks Unlimited a nonprofit organization and leader in wetland and waterfowl conservation Eldridge was diagnosed with mesothelioma at the age of 65 with no exposure to asbestos other than a lifetime of using Remington shotgun shells He quickly succumbed to his cancer and his estate filed suit against E. I. du Pont de Nemours Du Pont and Sporting Good Properties Inc. as Successor in Interest to Remington Arms Company Remington alleging exposure to asbestos from Remington shotshells contributed to cause his death Exhibit 11 Eldridge Complaint Cir Ct of Cook County Ill County Dept. Law Division No. 2017 L 003421. The case was settled prior to trial There are now at least ten other similar cases pending in courts around the country that allege exposure to asbestos from Remington shotshells is causing mesothelioma including a number of cases in Delaware which will be affected by this Court's rulings in Altena and Schoepke The Delaware claimants who have offered affidavits and deposition testimony regarding their exposures to Remington shotgun shells include Dorman Laycox Dale Zick Darrel Buchholz and the late James Chorey Exhibit 12 Laycox Affidavit Exhibit 13 Zick Affidavit Exhibit 14 Buchholz Affidavit Exhibit 15 Chorey Affidavit Despite many years of using Remington shotgun shells none had any idea that they contained asbestos History of Remington and Du Pont's Asbestos Shotshells E. I. du Pont de Nemours & Company was founded in Delaware in 1802 as a manufacturer of gunpowder Remington Arms Company Inc. was founded in New York in 1816 as a manufacturer of firearms In 1933 Du Pont acquired a majority interest in and assumed management responsibility for Remington Exhibit 16 1933 Remington Annual Report at page 10. Du Pont had already been supplying a major part of the powder used in Remington's shotgun shells for many decades and the two companies had been working together to develop and improve their products Exhibit 17 1933 Du Pont Annual Report at pages 24-25 Remington was well known at the time as a leading manufacturers of sporting arms and ammunition Id In the years that followed Du Pont exercised considerable control over Remington Arms engineering manufacturing and marketing activities formally acquiring Remington on February , 1980 An October 1951 edition of Popular Science magazine featured an article entitled How They Make Shotgun Shells which detailed a visit to Remington's manufacturing plant in Bridgeport Connecticut and described the manufacturing process for the various components of a Remington shotgun shell Exhibit 22 Kendall W. Goodwyn How They Make Shotgun Shells POPULAR SCIENCE Oct. 1951. The shot is made in a foot shot tower and is composed of 95 lead % antimony and % arsenic The shot is screened for roundness sorted for size polished and banked In 1951 Remington made approximately 532,000,000 shot and 1,800,000 shotshells per day Id at 172 The shot is housed in the top of shell The rest of the components as detailed in a sectional view sit just beneath the shot Id at 173. Those include a charge of gun powder a battery cup - which contains the volatile priming mixture that when struck by the anvil ignites the gun powder and a base wad - which fills the base of the shell around the battery cup and beneath the gun powder Id The battery cup has been referred to in Remington patent filings as the boiler room of the shell where the explosive gases of combustion are created which propel the shot out of the gun at a rate of approximately 1300 feet per second Exhibit 23 U.S. Patent No. 3,656,434 issued Apr. 18 1972 The purpose of the base wad which is inserted into the head of the shell during the manufacturing process is to help seal in the explosive gases of combustion to keep the power behind the shot and keep it from leaking and to help absorb the shock of the blast Id For decades prior to 1960 the base wad as well as the outer body casing of the shell was made of paper In 1960 Remington redesigned its shells to incorporate a casing made of Du Pont plastic An explanation of the design and benefits of using plastic for shotshell casings is described in a patent filing dated June 21 1960 which relates to seamless tubular articles which are formed of synthetic olefinic polymers and which are subjected in use to forces of great magnitude at high temperatures which forces tend to tear said articles apart Exhibit 24 U.S. Patent No. 3,103,170 issued Sep. 10 1963 A September 1960 issue of Du Pont Magazine boasts that Rugged allweather hunters need no longer worry about shotgun shells that swell in rain snow or sleet Remington Arms has just announced two new premium type shells Remington and Peters brands made with steel heads and polyethylene bodies he weatherproof qualities of the new SP shells which guard against dampness and humidity also result in loads which stay factor fresh for longer periods Exhibit 25 Torture Tests for an Weather Shotgun Shell DU PONT MAGAZINE Sep./Oct 1951. A central component of the new SP shells was as Du Pont put it a new exclusive base wad In 1965 Remington filed for a patent on this exclusive new base wad Exhibit 26 U.S. Patent No. 3,270,671 issued Sep. 6 1966 The patent filing describes a novel wad molded from cost fibrous material with a preferred embodiment containing 40 asbestos fiber by weight A video produced by Remington describes the development and manufacture of its plastic shells Exhibit 27 Remington Arms Company Inc. Plastic Shells How They Were Developed The video illustrates how the shotshell casings are discharged from the side of the shotgun upon firing It demonstrates that the asbestos containing basewad as part of the shotgun shell casing is released not at the end of barrel but at the side of the shotgun much closer to the hunter's breathing zone VIDEO at 50-5 whereas the shot is discharged out the end of the barrel Id at 05-12 It also shows how the shot is kept in pattern by the use of a shot wad which unlike the base wad is designed to leave the barrel with the shot before falling away Id By 1966 its 150th anniversary year and a year of record profit Remington had discontinued paper shells and converted its entire shotshell line to plastic Exhibit 28 1966 Remington Annual Report at SGPI1000139 As a result virtually every shell manufactured by Remington contained an asbestos base wad Exhibit 29 1964 Product Dwg Dry Molded Base Wads As Remington would later report to the Environmental Protection Agency EPA it used approximately 500 tons of asbestos fiber per year to manufacture its shells Exhibit 30 U.S. EPA Background Information on National Emission Standards for Hazardous Air Pollutants - Proposed Amendments to Standards for Asbestos and Mercury Oct. 1974 at page 5. Remington made the shells in different gauges and lengths and with different size shot pellets It made them in brass construction for range hunting and in brass construction for closer hunting Exhibit 31 1966 Remington Catalog at pages 37-41 From the 1960's through 1980 all hunting loads with the exception of the smallest .410 bore shells contained the asbestos base wad Remington was the only shotshell manufacturer that included asbestos in its product Exhibit 49 infra at page 276 Remington Shotshells Were Manufactured with Asbestos from 19601981. The medical consensus as of October 1964 as presented at a Conference on Biological Effects of Asbestos attended by Du Pont doctors and summarized in correspondence to Du Pont's Corporate Medical Director C.A. D'Alonzo D'Alonzo was that the risk of persons not normally thought of as engaged in work with asbestos and certainly not thought of as being in the asbestos industry is greater than was originally thought This fact should be borne in mind and embraces not only the person's occupation but also his hobbies Exhibit 34 Stopps Trip Report Nov. 2 1964 at page 6. Despite this knowledge and despite the increasing regulatory activity and public concern regarding the hazards of asbestos Remington continued to use hundreds of tons of asbestos every year throughout the 1960's and 1970's Between 1960 and 1981 Remington manufactured and sold many hundreds of millions if not billions of containing shotgun shells to consumers for recreational hunting and target shooting all over the world It was not until 1980 and due to increased attention from the Environmental Protection Agency EPA and the Consumer Product Safety Commission CPSC that Remington finally began to remove asbestos from its shells But it never provided any information to the public about the asbestos in the shells and it never issued a recall As a result hunters were unaware that Remington shells ever contained asbestos and many still have them in their possession Given the construction of the shells and their seemingly unlimited shelf life it can fairly be assumed that the asbestos shells are still being fired today thereby further exposing unwitting hunters and their families to toxic asbestos fibers.fibers.,,,, Asbestos Fiber Release from Remington Shotshells During its investigation into the Eldridge case Plaintiff's counsel gathered dozens of unused Remington shotshells from online salers including both paper and plastic bodied shells and sent them for testing to MVA Scientific Consultants MVA is a licensed and accredited service microscopy lab that uses standard microscopy methods published by organizations such as the American Society for Testing and Materials ASTM the National Institute for Occupational Safety and Health NIOSH and the United States Environmental Protection Agency EPA MVA also offers courses in microscopy Dr. Steven Compton Ph.D a physicist with experience in materials science microscopy industrial hygiene and environmental forensics currently serves as MVA's Executive Director Exhibit 35 Curriculum Vitae Steven P. Compton Ph D. In its initial analysis MVA confirmed that all of the Remington plastic shells contained asbestos base wads Exhibit 36 MVA Scientific Consultants Examination of Remington Shotgun Shell Basewads for Asbestos Apr. 26 2019 1 The shells used in the fiber release studies discussed infra were all manufactured prior to 1982 and were fired without any issues MVA prepared a report summarizing its results that contains numerous photographs of the shell components including the unfired base wads Id Following confirmation that the shells contained asbestos a study was developed to investigate whether and to what extent the shells release asbestos fiber when fired which study took place in October 2019 and is summarized in a report dated March 2020. Exhibit 37 MVA Scientific Consultants Investigation of Asbestos Fiber Release During Discharge of Remington Shotgun Shells Mar. 2 2020 Given the study involved potential exposures to airborne asbestos live ammunition and a firearm MVA took measures to ensure the study was conducted in a controlled and safe manner MVA identified a study site in a remote location and hired an abatement contractor to build an isolation chamber in which to perform the experiment Id at 2. MVA also engaged the services of a firearms instructor and forensic science consultant to oversee handling and firing of the shotgun and to help ensure the safety of all involved Id A target of steel and ballistics rubber was custom to catch the shot and a stand was built on which to mount and fire the shotgun Id at 3. A string was run from outside the chamber to the trigger of the shotgun to allow for remote firing which would limit the risk associated with any potential malfunction Id MVA set up air filters in multiple areas around the shotgun including near the muzzle at the end of the gun barrel where the shot is ejected near the discharge 10 chamber where the shells are ejected and in the breathing zone of a hypothetical shooter Id at 3-4 20. MVA conducted four tests air sampling events with the asbestos shotshells Id The first three involved the discharge of 2 shells over the course of 15 minutes and the fourth involved the discharge of 8 shells over 16 minutes Id In each test and at every location MVA's air sampling filters captured asbestos fibers in the air Id at 10-11 To fully characterize the extent and nature of the asbestos fiber release from the shotshells MVA used a variety of methods to analyze the air filters It used the light microscope method specified by the Occupational Safety and Health Administration OSHA for evaluating workplace exposures It also used two methods specified for evaluating asbestos in ambient air including EPA's AHERA method and ISO10312 - a method developed by the International Organization for Standardization Both of the ambient air methods call for the use of a transmission electron microscope TEM given its superior ability to resolve asbestos fibers Limitations of OSHA's PCM Method As explained by NIOSH phase contrast optical microscopy PCM is the method specified for meeting OSHA's standard for asbestos in the workplace Under the PCM method Asbestos fibers are defined as those particles with a length greater than 5 ...mmicrometers and a diameter ratio of 3 or greater This technique by which only fibers longer than 5 mare counted is recognized as only an index of total fiber exposure and does not imply that shorter fibers do not pose a health Despite its limitations phase contrast microscopy represents the only technique 11 available that can reasonably be used for routine asbestos fiber sampling and analysis emphasis added Exhibit 38 NIOSH Revised Recommended Asbestos Standard Dec. 1976 at page 69 After noting that xcessive cancer risks have been demonstrated at allfiber concentrations studied to date and valuation of all available human data provides no evidence for a threshold or for a safe level of asbestos exposure NIOSH recommended that the workplace exposure standard be set at the lowest level detectable by available analytical techniques an approach consistent with NIOSH's most recent recommendations for other carcinogens Id at 92-93 NIOSH defined that lowest detectible level as 100,000 fibers > ...min length per cubic meter of air 0.1 fibers as measured by PCM but cautioned that this standard was designed not to prevent but only to reduce the risk of asbestos related cancers Id NIOSH cautioned further that This standard was not designed for the population and any extrapolation beyond general occupational exposures is not warranted The standard was designed only for the processing manufacturing and use of asbestos and containing products as applicable under the Occupational Safety and Health Act of 1970. Id at 94 In reviewing the available sampling and analysis techniques for asbestos NIOSH discussed optical and electron microscopy and the difficulties in identifying and quantifying occupational and environmental exposures Id at 58. According to 12 NIOSH electron microscopic techniques represent the best available methods for asbestos fiber analysis but application of these techniques to routine samples is not practical because of high analysis costs long analysis times and limited equipment availability Id at 64 As Dr. Richard Lemen retired Assistant Surgeon General of the United States and retired Acting and Deputy Director of NIOSH noted in 2004 he PCM method was chosen based on its ability to count fibers only and not on a health effect basis Exhibit 39 Richard A. Lemen Asbestos in Brakes - Exposure and Risk of Disease American Journal of Industrial Medicine Vol 45 229-237 2004 at 230 While PCM has been the international regulatory method for analysis it counts only fibers greater than 5 ...min length and it is unable to detect thin diameter fibers 0.2 ...min diameter Id There is no debate that thin fibers including those undetectable via PCM are biologically significant And while there is some debate over the relative potency of shorter fibers researchers have not identified a precise fiber length that did not demonstrate biologic activity Id As Dr. Lemen said again in 2011 in his chapter on Epidemiology of AsbestosRelated Diseases and the Knowledge That Led to What Is Known Today he data to date strengthen the role of short fibers in the etiology of asbestos related diseases Exhibit 40 Lemen Richard A. Epidemiology ofAsbestos Diseases and the Knowledge that Led to What Is Known Today Asbestos Risk Assessment 13 Epidemiology and Health Effects 2nd Edition 2011 at page 167. Studies have repeatedly shown that the overwhelming majority of asbestos fibers found in the lungs of asbestos exposed individuals are less than 5 min length Exhibit 39 at 231. In other words the PCM method underestimates exposures and health risks Id at 230. The hazard of thin fibers is established and any assumption that short fibers less than 5 ...mare not hazardous cannot be justified by the science Du Pont has been aware of the limitations of PCM for the quantification and qualification of asbestos fibers since at least 1979. Exhibit 41 Hemingway R.E. Asbestos Fibers - Quantification and Qualification Apr. 24 1979. Du Pont's in- house Haskell Laboratory for Toxicology and Industrial Medicine prepared a memo on the subject describing as two serious problems the fact that only fibers greater than 5 mare counted thus the count is considered only an index of total fiber exposure and 2 asbestos fibers cannot generally be discriminated from other fiber types present in the industrial environment Id By contrast TEM allows better resolution of smaller fibers to get a more complete size distribution and count and the electron diffraction patterns aid in the identification of asbestos Id The author notes that ithin Du Pont there are electron microscopes which are capable of this type of work Id A study prepared for Du Pont to evaluate the effectiveness of Du Pont's Tyvek material as a barrier to asbestos fibers found that optical light microscopy is an 14 especially poor method for airborne concentrations of short fiber asbestos of the type used in Remington shotshells and that electron microscopy is superior Exhibit 42 Arthur D. Little Inc. The Effectiveness of Tyvek 1422A as a Barrier to Asbestos Fibers DUP 1140144-1140157 The study measured the penetration of Quebec Grade 7R chrysotile asbestos when passed through samples of Tyvek Id at 1140144. Grade 7R was chosen because it contains the shortest fiber lengths and provides a significant percentage of fibers within the respirable size range thus representing a worst case condition Id at 1140147. The study report indicates there is general agreement that the NIOSH method for determining the concentration of asbestos in occupational settings is inadequate for detecting a large fraction of the fibers in the size range that is most respirable Id at 1140146 and that was borne out by the results From the TEM results it is concluded that Tyvek 1422A provides an effective barrier to chrysotile asbestos fibers of all lengths and diameters present in a sample of Quebec Grade Less than 1.2 percent of these fibers were sufficiently large to be detected by the NIOSH optical microscopy method Id at 1140149. Grade 7 asbestos fibers were marketed as asbestos shorts Beginning in 1961 Remington used exclusively Grade 7T asbestos fiber which is even finer than Grade 7R acquiring its product from Canadian chrysotile mines operated by Manville and Carey Canadian 15 EPA Emission Standards on Limitations of PCM and Significance of Short Fibers On April 6 1973 acting under authority authorized by the Clean Air Act the EPA promulgated the Asbestos National Emission Standards for Hazardous Air Pollutants NESHAPs to protect the public from exposure to asbestos Exhibit 43 U.S. EPA National Emission Standards for Hazardous Air Pollutants 38 Fed Reg 8820 Apr. 6 1973 To help protect against the human health effects of asbestos exposure EPA set a no visible emissions standard for asbestos Id at 8829. In support of the regulation EPA explained that asbestos is a hazardous air pollutant and that many persons exposed to asbestos dust have developed lung disease including asbestosis a progressive and potentially fatal scarring of the lungs caused by chronic exposure to high levels of asbestos dust Id at 8820. Furthermore asbestos has been identified as a causal factor for lung cancer and mesothelioma and there have been reports of mesotheliomas associated with occupational exposures to asbestos Id Evidence indicated that mesotheliomas occur after much less exposure to asbestos dust than the exposure associated with asbestosis Id EPA also noted that the effects of asbestos inhalation are cumulative that is level and intermittent exposure to asbestos over a long time may be equally as important in the etiology of asbestotic disease as high level and continuous exposure over a shorter period Id 16 A report on the development of the Asbestos NESHAP discussed existing air sampling methods noting that it had been only recently that methods for determining concentration for industrial hygiene purposes had been standardized specifically a method using phase contrast microscopy PCM Exhibit 44 U.S. EPA Background Information on Development ofNESHAPS Asbestos Beryllium and Mercury Mar. 1973 at page 23. However as EPA notes the PCM method accounts for less than % of the total number of fibers present in a sample and there is no evidence that only those fibers visible under the PCM method 5 ...mand longer are significant in the production of adverse health effects in humans Id at 24. Electron microscopic methods give a much more complete indication of the total fiber content of the air Id at 23 In 1974 the EPA proposed amendments to the Asbestos NESHAP that extended the no emissions standard to the manufacture of shotgun shells which the EPA had recently determined to be a major source of asbestos emissions Exhibit 45 U.S. EPA National Emission Standards for Hazardous Air Pollutants 40 Fed Reg 48291 Oct. 14 1975 Exhibit 30 at pages 5-6 A report of background information on the amendment explains the approach to the emissions standards as first identifying ambient concentrations of the regulated pollutants which were judged to provide an ample margin of safety to protect the public health Exhibit 30 at page 2. In the case of asbestos however it is impossible to prescribe and enforce 17 allowable numerical concentrations or mass emission limitations known to provide an ample margin of safety to protect public health since no safe level has been identified Id Accordingly the standard for asbestos was set at no visible emissions In proposing that the manufacture of shotgun shells be covered by the Asbestos NESHAP the EPA conducted an investigation which included a visit to the only shotgun shell manufacturing plant in the United States that is known to use commercial asbestos Id at 4.2 Discussions with the plant operator revealed that the plant was using approximately 500 tons of asbestos annually which was larger than many of the plants already covered by the asbestos standard Id at 5 Although the EPA was initially focused on limiting emissions during manufacturing processes as the 1970's wore on it became increasingly concerned about exposures to consumers during asbestos product use and it found a likeminded regulatory partner in the newfound U.S. Consumer Product Safety Commission CPSC CPSC Actions on Containing Consumer Products The CPSC was established in 1973 by the Consumer Product Safety Act The CPSC's primary purpose is to protect the public from unreasonable risks of injury from consumer 2 The subject plant was Remington's Bridgeport Works Id at p 18. See also Exhibit 48 at p 249 18 products - which are generally defined as any article for sale to a consumer for use in or around a household a school in recreation or otherwise Exhibit 46 Report by the Comptroller General of the United States The CPSC Should Act More Promptly to Protect the Public from Hazardous Products Jun 1 1978 at page ) The CPSC first became aware of asbestos hazards shortly after it began operations in May 1973 but it did not deal with asbestos at that time because its policy was to emphasize immediate or short hazards rather than chronic or term hazards such as those associated with asbestos Id at 24 In March 1976 in response to growing public interest into the hazards associated with the use of asbestos in consumer products the CPSC's Deputy Executive Director directed the Bureau of Biomedical Sciences to Review the background information on asbestos Id at 27. In April 1976 the Bureau recommended that the CPSC ban the use of all form asbestos in consumer products Id Over the next year the CPSC received petitions seeking specific bans on asbestos containing drywall compounds and artificial fireplace ash Id at 28 The petitions were reviewed by various CPSC divisions and bureaus including the Office of the Medical Director which stated It is necessary to point out that because of the wide range of individual susceptibility to carcinogenic substances the threshold or no effect level may not be applicable the best of our knowledge a no effect level has not been demonstratedfor asbestos emphasis added Id at 29-30 19 In December 1977 the CPSC published regulations banning asbestos in patching compounds and artificial ashes Exhibit 47 CPSC Consumer Patching Compounds andArtificial Emberizing Materials 42 Fed Reg 63354 Dec. 15 1977 In deciding to approve the bans the CPSC found that OSHA regulations only apply to workplaces and not to places where consumers would use the products themselves and therefore that any OSHA regulation could not reduce or eliminate to a sufficient extent the unreasonable risk of injury to consumers Id at 63356 In April of 1978 shortly after the ban on patching compounds went into effect the CPSC published a comprehensive review of asbestos use in consumer products with the intent of identifying asbestos products determining the amount of asbestos in them and assessing if and how asbestos might be released during normal consumer use Exhibit 48 CPSC Review of Asbestos Use in Consumer Products Apr. 1978 The Introduction to the review addresses the health risks of asbestos exposure Recent research indicates that much lower levels of exposure over shorter periods of time increase the probability of cancer The most interesting type of cancer from a medical standpoint is mesothelioma which spreads rapidly through the pleural or peritoneal cavity It is interesting because the only identified cause ofthis disease is asbestos emphasis added Iad t I. 20 Appendix A consists of CPSC Asbestos Product Fact Sheets for a variety of products including Ammunition Shell Wadding The Fact Sheet for Ammunition Shell Wadding citing information provided by Remington and two competitors describes the product as A compressed plug of asbestos and cellulose is interference press fitted into the base of shot shells one manufacturer reports the present use of asbestos emphasis added Id at page 32. The Fact Sheet indicates the wadding contained 1 to % asbestos is designed for consumer use and could release asbestos fibers upon discharge Id Concern over the release of asbestos fibers from Remington shotshells arose again a few months later when the EPA's Office of Toxic Substances issued an analysis to assess sources of environmental contamination including asbestos Exhibit 49 U.S. EPA Chemical Market Analysis Aug. 1978 As stated by the EPA the only shotgun shell manufacturing plant known to use asbestos is operated by Remington Arms Company Id at 276. Although the exact need for asbestos in some base wads is not clear manufacturing emissions are assumed to be very small Id at 277-278 However as regards use emissions the EPA notes When a shot gun shell is fired from a gun the base wad is normally expelled from the cartridge and is commonly fragmented into many separate pieces Monitoring data for asbestos fiber release is not available however it may be possible that free fibers 21 are released when a shotgun is discharged with an containing base wad Id at 278 NIOSH Test Hair Dryers for Asbestos Fiber Release In March 1979 newspapers all over the country reported on a private study of new and used hair dryers that found approximately one in five models contained asbestos Exhibit 50 Asbestos Hair Dryers Raise Fears of Cancer Risk The Morning News Wilmington DE Mar. 1979. response the CPSC promptly issued a Special Order compelling the hair dryer manufacturers to provide information on their products including any testing conducted to determine whether respirable asbestos is emitted into the air during use Exhibit 51 CPSC Special Order Portable HandHeld Electric Hair Dryers Mar. 29 1979. The CPSC sent telegrams to the top executives calling for them to come to Washington for a meeting with the CPSC early the next week See Exhibit 50. Additionally the CPSC ordered studies to determine the nature of the fibers that are released and the degree of hazard to consumers in foreseeable use of the product It ordered the studies be done with electron microscopic methods as opposed to the optical light method used by OSHA for assessing workplace exposures Id CPSC engaged NIOSH to perform the fiber release testing on the hair dryers and the testing methodology specified by NIOSH is described in a report published under an Interagency Agreement between NIOSH and the CPSC Exhibit 52 22 Charles L. Geraci Jr. Ph.D. Testing of Hair Dryers for Asbestos Emissions Sept. 1979. NIOSH tested 30 hair dryers for the release of asbestos fibers into the effluent air to evaluate potential consumer exposure Id As described in the report they determined that the identification and quantitation of fibers emitted by the dryers having lengths and diameters of as little as 1 micrometer or less would be necessary which would require analysis by a transmission electron microscope Id at 1. A system to determine asbestos emissions from hair dryers was fabricated and validated by NIOSH Id at 2. The study was conducted in a small test chamber adapted for the tests and measured airborne asbestos concentrations during operation of the dryers that ranged from 0 to 0.11 asbestos structures Id at 11. The results and publicity resulting therefrom prompted a recall of the asbestos containing hair dryers from all major manufacturers CPSC and EPA Target Containing Consumer Products In October 1979 shortly after the hair dryer recall the EPA and CPSC issued a joint statement detailing a coordination of regulatory activities as well as two Advance Notices of Proposed Rulemaking ANPR regarding asbestos Exhibit 54 CPSC and EPA Commercial and Industrial Use ofAsbestos Fiber and Consumer Products Containing Asbestos 44 Fed Reg 60056 Oct. 17 1979. Despite prior regulatory actions taken by each to control human exposures to asbestos both continue to be 23 concerned that human exposure to asbestos from many sources may present an unreasonable health risk Id at 60056 Regarding the health risks related to asbestos exposure the CPSC described increasing evidence since the early 1960's including epidemiologic studies showing an increased incidence mesothelioma among occupationally exposed populations including individuals with only brief or intermittent exposures Id at 60057. Regarding its regulatory policy approach the CPSC concluded that exposure to any respirable asbestos fibers from consumer products presents a health risk because there has not been demonstrated to be a threshold or effect level below which exposure to asbestos fibers would be considered safe Id at 60058 emphasis added Id at 60058. Consequently the CPSC proposed to seek the elimination of all nonessential uses of asbestos in consumer products from which asbestos fibers are released during reasonably foreseeable conditions of use including misuse Id at 60060 The EPA ANPR for its part outlined a broad effort to systematically gather information on asbestos exposure sources and evaluate health risk based on the life cycle concept which EPA defined as the cumulative risk from exposure to asbestos as examined from primary processing through end use and disposal Id at 60056. The EPA explained that ertain exposures to asbestos are controlled under various Federal and State authorities but due to limited mandates i.e. focused on specific populations or exposure sources technical difficulties e.g. available 24 fiber measurement techniques and other analytical constraints these authorities are not able to deal with the total asbestos problem Id at 60061. EPA expressed its intent to gather exposure information and economic information to assess the risk Id at 60062. As support for that action EPA cited as evidence the fact that tudies of exposed populations have shown that asbestosis a progressive deterioration of lung function and various types of cancer are associated with asbestos exposure even at low concentrations or after short exposure periods Id Attached as an Appendix to the EPA ANPR was a list of various asbestos containing products including several of particular concern that may release asbestos fibers during normal use and about which EPA intended to gather additional information Id at 60067. The EPA was interested in determining the necessity of using asbestos in those products and gathering information regarding what exposures are associated with each use including rate of fiber release frequency duration population exposed and conditions of use Id Amongst those products identified was Remington's ammunition shell wadding Id at 60068 The EPA would not publish its Life Cycle Report until 1982 but the information gathering process began soon after issuance of the ANPR in 1979 Exhibit 55 U.S. EPA Life Cycle of Asbestos Report Feb. 1982. As evidenced in Remington's Corporate Minutes EPA approached Remington in early 1980 25 The Chairman said that our Public Relations people have been called by the EPA inquiring about exposure of both factory employees and shooters Exhibit 56 Remington Corporate Minutes Feb. 26 1980 According to EPA's Life Cycle Report the investigation into shotgun shell base wads included a telephone conference with Ted McCawley of Remington Arms Exhibit 55 at pages 249 256. Remington reported that it was phasing out asbestos and replacing it with a asbestos shell which was both more stable and less costly Id at 249. Although manufacturing emissions were judged to be minor it was reported that fiber emissions probably occur when the shotgun shell is firedfrom a gun but there is presently no means of determining the amount of fibers that become airborne as opposed to those that remain encased in the wad mixture Id In May 1980 a few months after the interview with Ted McCawley an inspector with the Air Compliance Section of Connecticut's Department of Environmental Protection visited Remington's Bridgeport plant to perform a premise evaluation of environmental emissions control equipment as required under state law Exhibit 57 Department of Environmental Protection Air Compliance Section Premises Evaluation Report Jun 30 1980 In his report the inspector noted that Asbestos for shell wadding is carefully controlled during mnf - seems irrelevant since it is later fired into the air Id 26 It is unclear what if any testing Remington conducted to assess the hazard associated with use of the asbestos shotshells It is also unclear whether Remington ever released any information to the media or the public although McCawley indicates the company's intent to keep it confidential writing Obviously we do not intend to make any general release of this but rather only to use it to answer questions Exhibit 58 E.S. McCawley Jr. Asbestos basewads Nov. 7 1980 MVA s Fiber Release Study Found Predominantly Short and Thin Asbestos Fibers As indicated above the majority of the asbestos fibers MVA measured during its fiber release experiment were short and thin fibers not visible under OSHA's light microscope The concentration of fibers measured by MVA in the breathing zone of a shooter ranged from 0.04 to 0.08 fibers using OSHA's method and from 1.0 to 1.9 structures using EPA's method To provide a comparison between these levels and those present in clean background air MVA took background samples prior to testing which measured no asbestos structures at a level of detection of 0.006 cc In other words the use of Remington shotgun shells caused the shooter to experience asbestos exposures more than 100 times above background and more than 10 times that found in NIOSH and CPSC's study of fiber release from asbestos containing hair dryers As is customary MVA retained the air filters from its experiment should Defendants desire to validate MVA's fiber counts Instead Defendants decided to 27 conduct an entirely different experiment of their own and they hired John Spencer to help them do that John Spencer's Occupational Exposure Assessment Involving Remington Shotgun Shells John W. Spencer CIH CSP is an industrial hygienist who has consulted for defendants in asbestos litigation for over 25 years He founded Environmental Profiles Inc. EPI in 1992 and served as its President until it was acquired by JS Held in 2021. With EPI he was routinely retained as a consulting expert by defendants in asbestos litigation to conduct work practice studies and then to testify about those studies at deposition and trial Invariably Mr. Spencer's studies were designed to find that the potential worst case exposure from any and all of his client's products was below current and_ historical occupational exposure limits Mr. Spencer started doing litigation consulting work for Crowell & Moring LLP 20 years ago The Crowell firm serves as national counsel for several national asbestos defendants including Du Pont and Caterpillar In 2003 Crowell hired Mr. Spencer to conduct a study to determine the concentration of fibers in the air during maintenance and repair activities involving friction products brake band linings brake disc linings brake shoe linings and clutch linings and gaskets engine head exhaust and intake manifolds etc. from heavy equipment manufactured by Caterpillar Inc. Exhibit 59 Spencer Boelter Caterpillar Equipment Study Oct. 9 28 2003 at page 1. Mr. Spencer's firm carried out the study with that of another industrial hygienist named Fred Boelter who also routinely testifies in asbestos litigation The product of the study is a report now commonly cited by litigation experts hired by Caterpillar and other manufacturers of heavy equipment in defense of asbestos related product liability suits Ultimately Spenter concluded that he airborne asbestos fiber concentration of a person performing these tasks would be significantly less than the current OSHA hour Time Weighted Average TWA Permissible Exposure Limit PEL of 0.1 cc Id at page 38. Mr. Spencer's Caterpillar study was submitted for publication and rejected As it turned out many of the air samples were overloaded and unreadable More concerning is the fact that only 22 of the 62 gaskets that were analyzed for fiber release actually contained asbestos which fact was not clearly disclosed in the report and about which many defense experts now citing to his study are wholly unaware It was casually revealed at a presentation given at an industrial hygiene conference two years later Exhibit 60 AIH Conference Presentation May 2005 at page 16 By the time Mr. Spencer was hired to do the Caterpillar study he had already conducted several other exposure assessments for asbestos defendants including for gasket manufacturers Durabla Garlock and AW Chesterton He has also done studies for manufacturers of asbestos floor tiles asbestos lab equipment and even asbestos containing toaster ovens In each of these studies he has conducted air 29 sampling in what he has described as an isolation chamber purposely designed to eliminate any ventilation and air circulation to create a static environment in which to accurately measure the asbestos fiber release from the product being tested In 2020 after receiving the results of MVA's fiber release experiment the Crowell firm asked Mr. Spencer to conduct a study on Remington shotgun shells But unlike MVA he used a method specifically designed for assessing occupational exposure and he did it outside in a completely uncontrolled environment Spencer's Study was Engineered to Find No Asbestos Spencer conducted his study outdoors On September 15 2020 he and his colleagues fired 16 asbestos shotshells into the air outside Flintstone Maryland Exhibit 61 EPI Exposure Assessment - Evaluation of Airborne Fiber Concentrations during the Discharge of Vintage containing Remington Shotgun Shells Oct. 22 2020 Like MVA they set up air filters around the shotgun to measure for fiber release After testing they sent the samples to a third party for analysis but they requested that the samples be analyzed only via PCM and not via electron microscopic methods According to the microscopy lab that did the fiber counting they did not see any OSHA fibers longer than 5 ...min length Mr. Spencer concluded that he results of this evaluation demonstrated that shooting shotshells with containing base wads did not produce any measurable concentrations of airborne asbestos fibers Id at page 17 30 Mr. Spencer intends to rely on his study to testify in these cases that Remington shotshells are incapable of releasing asbestos fiber and that there is no potential for exposure when shooting them outdoors He also intends to present a dose reconstruction of both Mr. Altena and Mr. Schoepke's exposures based on measurements of OSHA fibers to suggest that any potential exposure was below OSHA Permissible Exposure Limits PEL consistent with ambient air and below a level which would have increased their risk of mesothelioma See Exhibit 62 Spencer Report Altena and Exhibit 63 Spencer Report Schoepke His dose reconstruction opinions rely upon the application of an hour Time Weighted Average TWA workday - derived from OSHA PEL's which methodology is inapplicable here where the Plaintiffs were exposed nonoccupationally through recreational use of a product manufactured and sold for consumer use His dose reconstruction opinions are inadmissible as 1 they are not based on matters reasonably relied upon 2 the methodology he uses is not accepted in the scientific community 3 the data he used to calculate dose is speculative and completely unrelated to the facts of these cases and 4 any speculative result of this unreliable methodology is irrelevant to Defendants liability for Plaintiffs injuries They are also along with his exposure assessment scientifically dishonest and dangerous ARGUMENT 31 Spencer's Methodology and Opinions as to Plaintiffs Exposures to Asbestos from Remington Shotgun Shells are Not Generally Accepted as Reliable in the Scientific Community and Are Not Based on Matters Reasonably Relied Upon In 1999 the Delaware Supreme Court adopted the Daubert test M.G. Bancorporation v Le Beau 737 A.2d 513 522 Del 1999 It has continued to be used ever since Du Pont's Exposure Assessment is Irrelevant Unreliable and Scientifically Dishonest John Spencer is an industrial hygienist and a career expert for defendants in asbestos litigation He is not a medical doctor not a toxicologist not an epidemiologist and not a microscopist As discussed above John Spencer regularly concludes that no asbestos product manufactured by any defendant who has ever retained him increases a plaintiff's risk of developing mesothelioma His opinion regarding increased risk is based on his hypothetical dose reconstruction which in this case is based on a study specifically designed to underestimate the exposure His reconstruction is further based on a TWA which is derived from the OSHA PELS - exposure limits specific for occupational settings These OSHA PELS and TWAs have no application to the subject cases Outside of workplace regulations there is no scientific justification for diluting a based asbestos exposure by dividing it over several hours to create a false average exposure Defendants hired John Spencer to conduct what he repeatedly characterized at his deposition as an occupational exposure assessment Exhibit 64 Spencer 32 Deposition Eldridge 2021 at pages 22-48 12-19 5-16 3-14 111 112 Mr. Spencer has been conducting such occupational exposure assessments for defendants in asbestos litigation since the late 1990's and explains his role in these cases as the industrial hygienist that applies the occupational health standards and the basis for those occupational health standards Exhibit 65 Spencer Deposition Altena and Schoepke 2024 at page 14-24 As here his testimony is rooted in studies he has done to evaluate asbestos fiber release which studies he has often done indoors At deposition he agreed as is evident that indoor studies are more readily reproducible than outdoor studies given the variability in an outdoor environment Id at 7-21 Here however he chose to conduct the study outdoors firing sixteen asbestos shotgun shells into the open air At the time he developed the protocol for his study he had the benefit of MVA's results He was aware that MVA had found numerous short and thin fibers that are undetectable via PCM but he did not set out to challenge or invalidate the MVA results Instead he set out to cast a recreational exposure to an asbestos containing consumer product as something other - as an occupational exposure so that he might then put such exposure in the context of occupational exposure limits which have no relevance here As discussed above NIOSH the scientific arm of OSHA has explicitly cautioned against applying occupational air 33 sampling methods and occupational exposure limits outside of the occupational context Exhibit 38 at page 94 supra Mr. Spencer's study sheds no light on the actual fiber release from Remington shotshells Had he been concerned with measuring actual fiber release he would have analyzed the air samples using electron microscopy which he chose not to do He would have also conducted the study indoors in a controlled environment Instead what Mr. Spencer sought to do was to conduct a study designed to measure no release and then to suggest that any recreational shooter would have no exposure whatsoever His study does not say that so he should not be permitted to Even Du Pont's state of the art witness John Henshaw himself an industrial hygienist testified that environmental conditions need to be taken into account when determining to what extent somebody could be potentially exposed to asbestos fiber including wind conditions humidity temperature conditions that vary from location to location and from day to day Exhibit 66 Henshaw Deposition Altena and Schoepke 2024 at pages 13-49 All of these confounding variables introduce an unacceptable level of uncertainty into the results of the experiment conducted by Mr. Spencer which is by definition incapable of being reproduced As indicated in his report Mr. Spencer retained AMA Analytical Services to count the fibers measured during his outdoor experiment Exhibit 60 at page 8 supra Spencer asked that the air samples be analyzed using only OSHA's method 34 In other words he specified that fibers less than 5 min length and less than 0.25 um in width would not be counted even if the microscopist by chance happened to see them under the light microscope Spencer did not request any photomicrographs be taken so there is no evidence of what the microscopist saw or didn't see It is not by accident that Defendants have not disclosed any microscopist to testify on its behalf in these cases AMA which has also done contract microscopy work for the EPA describes on its website the various methods available for the analysis of asbestos air samples including those requiring an electron microscope AMA indicates that The Transmission Electron Microscope is one of the most powerful tools that we have available for asbestos analysis TEM analysis can be conducted on a variety of matrices and is often times the most definitive and legally defensible technology available As regards Phase Contrast Microscopy PCM AMA writes PCM analysis is typically used to determine exposure during work practices Exhibit 67 Ex 5 to Spencer Dep Eldridge In conclusion the methodology underlying John Spencer's exposure assessment and dose reconstructions is deeply flawed and unreliable His opinions regarding occupational exposures are irrelevant and confusing in a case involving a occupational exposures to an asbestos containing consumer product His exposure assessment study and any testimony relying thereon should not be permitted by this Court 35