In re E.I. Du Pont De Nemours & Co. C-8 Personal Injury Litig.
Docket: Civil Action 2:13-md-2433
Court: District Court, S.D. Ohio; May 26, 2016; Federal District Court
Defendant E. I. du Pont de Nemours and Company (DuPont) filed a Motion to Exclude the Opinions and Testimony of Carrie Redlich, citing concerns over extra-legal standards of care, improper legal conclusions, and the company's state of mind. The Court has granted in part and denied in part this motion. The case involves Plaintiff David Freeman, whose trial is set for May 31, 2016, as the second bellwether in multidistrict litigation concerning claims related to exposure to ammonium perfluorooctanoate (C-8 or PFOA) from DuPont's Washington Works plant. Freeman is part of the Leach Class, consisting of approximately 3,500 individuals who can file claims under the Leach Settlement Agreement for six diseases linked to C-8 exposure.
Freeman contests DuPont's characterization of C-8 releases as 'relatively low,' arguing that evidence shows the compound, known for its bioaccumulation and persistence in the environment and human body, was released into unlined landfills and waterways since the 1950s. He asserts that DuPont, aware of the potential harms, should have ceased using C-8 or disposed of it safely. Diagnosed with testicular cancer in 2000, Freeman's condition is categorized as one of the Linked Diseases. The Leach Settlement Agreement allows him to pursue various claims, including personal injury and punitive damages, related to his exposure to C-8.
In the Leach Settlement Agreement, DuPont acknowledged the "probable" link between C-8 exposure and a Linked Disease for individuals in the Leach Class, specifically conceding that C-8 could cause Mr. Freeman's testicular cancer. Mr. Freeman bears the burden of proving that his cancer was caused by C-8. He has filed claims against DuPont for negligence and punitive damages, requiring him to establish that DuPont owed him a duty of care, breached that duty, and that the breach resulted in his injury. To support his claim of duty, Mr. Freeman must demonstrate that a reasonably prudent person would foresee potential injury from DuPont's actions related to C-8's release into the environment.
DuPont argues it owed no duty to Mr. Freeman, asserting that it was unaware and should not have been aware of any hazards associated with C-8, citing the prevailing medical and scientific knowledge at the time. There is significant contention between the parties regarding the health information available about PFOA, the results of toxicological studies, and whether DuPont engaged in accurate environmental practices or manipulated testing methods to downplay the chemical's dangers. Both sides have enlisted experts to evaluate DuPont's adherence to industry standards regarding C-8.
Dr. Shane A. Snyder, one of DuPont's corporate conduct experts, provided several opinions indicating that DuPont had been proactive in developing analytical methods for measuring PFOA since before the 1980s, that their 1984 water sampling efforts demonstrated a commitment to accuracy and reliability, and that their collaboration with CH2M Hill reflected responsible stewardship in addressing environmental concerns related to PFOA.
DuPont actively sought and implemented advanced methods for analyzing low levels of PFOA across various media, ensuring that these methods were suitable for their respective time periods and provided reasonably accurate results given the available technology. The company frequently changed laboratories to improve accuracy, specificity, and detection limits, while adhering to rigorous quality assurance and quality control standards that exceeded EPA requirements.
Throughout the 1970s to 1990s, DuPont voluntarily engaged in environmental stewardship regarding PFOA, despite lacking regulatory obligations, by communicating with regulatory agencies and implementing measures to reduce workplace and community exposure to PFOA, despite no established causal links to human health issues. DuPont also entered voluntary agreements with regulatory bodies to study PFOA and mitigate exposure risks.
PFOA discharges from DuPont's Washington Works facility were compliant with applicable regulatory permits, and since PFOA was not classified as hazardous waste under the Resource Conservation and Recovery Act (RCRA), no specific regulatory obligations were imposed on DuPont regarding its identification or management. The company proactively collaborated with the EPA under RCRA and provided information about PFOA, showcasing responsible environmental practices.
Based on extensive regulatory experience, it is asserted that DuPont demonstrated greater diligence and proactivity compared to most companies in understanding the implications of PFOA, implementing exposure controls, and fostering scientific research. DuPont's actions, including rapid responses to new PFOA information and leadership in global environmental stewardship, reflected a commitment to reducing community exposure and enhancing scientific understanding of PFOA's environmental impact.
Robert W. Rickard, Ph.D. D.A.B.T. asserts several key points regarding PFOA exposure and DuPont's actions:
1. Prior to 2011, there was no evidence linking PFOA to disease in humans at community exposure levels.
2. DuPont has actively researched potential health effects associated with its chemicals, including PFOA.
3. The company has consistently evaluated new health-related information and established conservative exposure guidance levels with multiple safety factors to mitigate risks.
4. DuPont has regularly updated its guidance based on emerging health data, maintaining science-based communications regarding PFOA studies.
5. Toxicology studies conducted before or during 2000 did not demonstrate that PFOA caused adverse health effects in humans.
The document also addresses the motion to exclude the expert report and testimony of Dr. Carrie Redlich, who was engaged by Mr. Freeman. Dr. Redlich’s expertise covers standards of care related to DuPont’s actions, biopersistence and toxicity of C-8, and compliance with environmental medicine standards. Her deposition highlighted the significance of biopersistence, comparing DuPont’s knowledge and actions to the prevailing standards during relevant periods. Dr. Redlich, with over thirty years in occupational and environmental health, currently serves as a Professor and Program Director at Yale University’s Occupational and Environmental Medicine Program. She holds board certifications in internal, occupational, and preventive medicine and is licensed in Connecticut and Washington.
Dr. Redlich has a robust background in preventive and occupational medicine, completing her post-doctoral work at prestigious institutions such as Yale-New Haven Hospital and Yale School of Medicine. She has authored approximately 90 peer-reviewed articles covering various topics in occupational and environmental medicine, particularly relating to toxic exposure. Her academic roles are numerous, and she has provided consultation to significant national and international agencies, including the CDC, NIH, and FDA, as well as private organizations.
In her deposition, Dr. Redlich emphasized her capability to lead the Yale Occupational and Environmental Medicine Program, addressing comprehensive health effects across various diseases. She has specifically studied C-8 exposure and has extensive knowledge of PFOAs, having maintained independent research files on the subject prior to her involvement in the current case. Her expertise includes understanding the health implications of C-8 exposure, which she has previously encountered in her clinical practice.
Dr. Redlich's report discusses the concepts of biopersistence and biodurability, highlighting their relevance in assessing the long-term toxicity and pathogenicity of particles and organic chemicals. She notes that biopersistent chemicals can significantly affect the actual dose received, linking exposure time and concentration to true dose measurement, which is pivotal for risk assessment.
Dr. Redlich provides expert testimony linking toxicology to human harm, emphasizing the importance of animal studies in predicting the effects of chemical agents on humans due to ethical constraints. Her review of DuPont's C-8 records from the 1960s, published studies, and her expertise led her to conclude that DuPont had clear knowledge—or should have had knowledge—of several critical aspects of C-8: it is biopersistent, does not biodegrade, can bioaccumulate, is toxic, and has been shown to be a carcinogen in animal studies. Furthermore, she asserts that DuPont was aware of its emissions of C-8 contaminating local drinking water and acted with conscious disregard for community safety, thereby breaching environmental medicine standards of care.
In response, DuPont seeks to exclude Dr. Redlich's opinions and testimony under Rule 702 of the Federal Rules of Evidence and the standards set by Daubert v. Merrell Dow Pharmaceuticals. Rule 702 allows expert testimony if it aids in understanding evidence or determining facts, requiring that such testimony be based on sufficient facts, reliable principles, and proper application of those principles. The Daubert decision established trial judges as gatekeepers of expert testimony, ensuring its reliability. The court retains broad discretion in these matters, with appeals only possible in cases of clear error in judgment.
The proffering party bears the burden to prove the admissibility of expert opinions by a preponderance of the evidence, as established in Nelson v. Tenn. Gas Pipeline Co. Rejection of expert testimony is generally uncommon, supported by case law indicating that courts favor admissibility when doubts arise. The admissibility inquiry is flexible, guided by Daubert principles, which encourage a liberal approach to opinion testimony under Fed. R. Evid. 702.
DuPont argues for the exclusion of Dr. Redlich's opinions on several grounds: (1) her testimony relies on a self-defined 'environmental medicine standard of care,' which is merely a reiteration of the 'precautionary principle' and not the applicable legal standard governing DuPont’s conduct; (2) she makes legal conclusions inappropriate for expert testimony; and (3) she speculates on DuPont's corporate intent and employee mindset regarding C-8.
The court categorizes the arguments into extra-legal and subjective opinions. It acknowledges that standards in environmental medicine do not equate to the legal standard applicable to the case. Both parties present experts to assess industry standards to evaluate potential breaches of legal duty, which Mr. Freeman must prove by demonstrating that a reasonably prudent person would have foreseen likely injury from DuPont's actions. DuPont asserts it adhered to industry standards, utilizing available medical and scientific knowledge relevant to the claims involved.
Expert testimony regarding the medical, scientific, and industrial knowledge available to DuPont is deemed essential for the jury to assess DuPont's defense. Courts have consistently allowed expert testimony on standards of care in specialized fields that exceed the comprehension of average jurors. For instance, in Betz v. Highlands Fuel Delivery, the standard of care for propane tank refurbishment was identified as beyond lay understanding. Similar rulings occurred in cases involving pharmaceutical standards (In re Baycol Products Litigation) and nuclear facility practices (Cook v. Rockwell Mem. Corp.), where expert insight was necessary due to the complexity of the subject matter. Conversely, experts may be excluded if deemed unqualified or if their testimony risks confusing the jury, as noted in the context of Dr. Hoffman's ethical principles. Defendants have successfully sought summary judgment in cases where plaintiffs failed to present expert testimony on industry standards, as seen in Betz and In re Yasmin, reinforcing that expert opinions are critical to establishing whether a legal duty was breached. In the current case, the jury needs to examine the relevant knowledge and standards from the 1950s onward to evaluate DuPont's practices.
Understanding the scientific and medical data regarding chemical quantification is essential for evaluating DuPont's practices over the past fifty years, which are supported by extensive litigation involving millions of documents and numerous expert witnesses across various fields such as toxicology and public health. DuPont asserts that it complied with industrial and scientific standards, highlighting its proactive approach and exemplary conduct in managing PFOA, a polyfluoromer chemical. The company contends that expert testimony is necessary to clarify complex issues for the jury, particularly in demonstrating that its stewardship of PFOA was consistent with industry best practices. DuPont emphasizes its commitment to understanding the health impacts of PFOA, stating it has invested more in research and environmental stewardship than many of its peers, thereby establishing a standard of care that exceeds regulatory requirements. Experts’ opinions will aid the court in assessing the appropriateness of DuPont's actions relative to industry standards and practices.
The MDL plaintiffs aim to counter DuPont's claims by introducing Dr. Redlich's testimony, which challenges the conclusions of DuPont's expert, Dr. Rickard, regarding the toxicity of C-8. Dr. Redlich possesses specialized knowledge on the use and management of chemicals, including biopersistence and toxicity, which she believes contradicts Dr. Rickard's assertion that DuPont was unaware of C-8's potential harm to humans.
DuPont contests Dr. Redlich's testimony, arguing it relies on a subjective "environmental medicine standard of care," which they claim is not legally recognized or relevant to DuPont's actions. They assert that this standard, rooted in the "precautionary principle," could lead to excessive liability based on non-mandatory safety measures, referencing a previous court ruling that deemed such ethical standards inadmissible.
The Court rejects DuPont's arguments, finding that Dr. Redlich's standard is not self-created for the case but is part of an established scientific discipline. The Court notes that environmental medicine is recognized by reputable institutions and is not merely fringe science, as suggested by DuPont. Evidence from Dr. Redlich's qualifications and the legitimacy of environmental medicine is cited, including references to programs at Yale University and respected journals in the field.
DuPont challenges the validity of environmental medicine as a recognized standard of care, citing a decade-old deposition from a single defense expert, which it argues fails to demonstrate that environmental medicine lacks acceptance within the medical community. DuPont further asserts that the environmental medicine standard of care is merely a reflection of the precautionary principle, which advises manufacturers to limit chemical use when health effects are uncertain. This principle, developed in the 1990s, suggests that precautionary measures should be taken without waiting for definitive scientific proof of harm.
Dr. Redlich counters DuPont's claims, stating that the standard of care in environmental medicine predates the 1992 emergence of the precautionary principle. She argues that the standard is a comprehensive synthesis of various principles and practices in the field, not solely derived from one document or principle. Dr. Redlich clarifies that while the precautionary principle serves as an example of the overarching standards of care, it does not encompass the entire standard applicable to DuPont. She emphasizes that her conclusions consider the evolution of the standard of care over time and that the precautionary principle serves as a framework rather than the sole basis for environmental health practices. The argument surrounding the precautionary principle's role in environmental medicine does not fully address the inquiry at hand.
The Court is evaluating the relevance of Dr. Redlich's expert testimony under Rule 702 and the Daubert standard. Rule 702 mandates that expert testimony must assist the trier of fact in understanding the evidence, and testimony that does not relate to the case is deemed irrelevant and unhelpful. A crucial aspect is the "fit" between the proposed testimony and the case's questions. Dr. Redlich asserts that the environmental medicine standard of care is recognized in the chemical industry and that she has extensive experience advising chemical companies on this standard. She specifically assesses whether DuPont adhered to industry standards concerning PFOA, drawing on her knowledge of how other companies managed PFOA and health concerns.
DuPont counters that Dr. Redlich lacks knowledge of any companies besides DuPont and 3M that manufactured or used C-8 and is unaware of how C-8 was perceived by regulatory bodies. However, this assertion is challenged by the fact that Dr. Redlich was not required to identify every company involved with C-8 or to have detailed knowledge of industry standards. During her deposition, Dr. Redlich requested access to her records to accurately answer questions but was not allowed to do so. This indicates she was not asked to review all other companies' practices concerning C-8 and highlights that her inquiries were limited by the circumstances of the deposition.
A request was made to a witness to provide a list of companies that produced C-8, but objections were raised regarding the appropriateness of asking the witness to create a document. The witness, Dr. Redlich, indicated she was not prepared to respond to the request and did not have the names of other companies that used C-8 memorized, although she acknowledged being aware of other companies' usage. Dr. Redlich stated that while she had not specifically researched or memorized the names, she could reference her records to find the information. It was clarified that her inability to list other companies did not imply a lack of comparison between DuPont's conduct and that of other companies regarding C-8. The court rejected DuPont's argument that Dr. Redlich was imposing a legal duty based on internal policies, asserting that her expert testimony was aligned with industry standards informed by medical, scientific, and industrial knowledge, rather than aspirational policies.
The jury will utilize the established standards to assess whether DuPont had a legal duty and whether it breached that duty. DuPont argues that prior rulings have rendered certain testimony inadmissible, referencing EMO 2 at page 27, which excluded Dr. Siegel’s vague opinions on a general duty of care and ethical corporate behavior. The court found such opinions unhelpful to the jury. In contrast, Dr. Redlich's testimony is based on specific scientific and medical data, informed by her specialized training and extensive experience. Her opinions will assist the jury in evaluating DuPont's compliance with industry standards in environmental medicine and whether DuPont acted as a reasonably prudent corporation would. DuPont's claim that all of Dr. Redlich's opinions should be excluded due to their basis in the precautionary principle is addressed, emphasizing her reliance on substantive knowledge rather than subjective ethical standards.
Dr. Redlich's opinions on biopersistence, toxicity, and knowledge related to environmental medicine are admissible, despite potential inadmissibility of her opinions on the standard of care. However, her assertion that DuPont exhibited "conscious disregard for the rights and safety" of individuals is deemed an inadmissible legal conclusion, as expert testimony should not apply legal standards to facts. Courts typically exclude expert opinions regarding a corporation's state of mind or intent, viewing them as matters within the jury's purview. DuPont argues that Dr. Redlich speculates on the company's knowledge and motivations without evidence, particularly regarding its awareness of C-8's potential harm and decisions surrounding emissions elimination. Although Dr. Redlich can discuss the financial constraints documented by DuPont that affected the C-8 elimination program, she cannot speculate that these were merely "relatively minor financial concerns."
Testimony from Dr. Redlich does not usurp the jury's role in fact-finding, as it focuses on her assessment of what DuPont knew or should have known, rather than on the company's motives or intent. The Court finds her qualifications sufficient for her opinions regarding biopersistence, toxicity, and environmental medicine, countering DuPont's claims of her unqualification. DuPont's concerns about Dr. Redlich’s methodology, particularly her reliance on historical records and the precautionary principle formulated in 1992, are dismissed. The Court notes that Dr. Redlich's testimony is based on established principles that predate 1992, thus maintaining its reliability. DuPont is entitled to challenge the accuracy of her conclusions, but this does not affect the admissibility of her testimony.
DuPont's challenge to the accuracy of Dr. Redlich's opinion pertains to the weight of her evidence rather than its admissibility. Disputes over the reliability of expert evidence should be resolved through cross-examination and contrary evidence presentation, as established in *Little Hocking Water Ass'n, Inc.* and *Daubert*. The court rejects DuPont's argument that Dr. Redlich's reliance on hand-picked documents by counsel undermines her opinion's reliability, noting that it is common for experts to depend on counsel to identify relevant documents in extensive historical records. Dr. Redlich asserts she reviewed a comprehensive array of documents beyond those selected by the plaintiffs' lawyers. Critiques of her evidence-gathering methods, like alleged cherry-picking, impact the evidence's weight, not admissibility. The court concludes that Dr. Redlich's testimony will provide essential context regarding industry standards for chemical companies and assist the jury in evaluating DuPont's liability concerning the release of C-8. Additionally, regarding DuPont's motion in limine to exclude certain ethical considerations, the court acknowledges its authority to manage trial proceedings and the purpose of such motions to streamline trial efficiency and fairness.
Courts typically resist broad exclusions of evidence in limine, preferring to evaluate evidence during trial for its relevance and impact. A party seeking exclusion must demonstrate that evidence is clearly inadmissible on all grounds. Even relevant evidence can be excluded under Federal Rule of Evidence 403 if its probative value is significantly outweighed by the potential for unfair prejudice, confusion, or other factors. The decision to exclude evidence under this rule is at the trial court's discretion, and appellate courts review such decisions with a favorable view towards the evidence's proponent.
In the context of DuPont's case, the company argues against the admission of testimony from Dr. Redlich regarding environmental medicine standards, claiming it would confuse jurors by mixing moral and ethical considerations with the legal standards they must apply. DuPont's motion asserts that such evidence could mislead the jury into considering non-legal factors, diverting focus from the actual issue of negligence. The company emphasizes that Dr. Redlich's proposed standards could suggest a breach of duty that conflicts with the legal standards provided by the court, thereby impairing the jury's ability to make a proper legal determination.
DuPont was found to have breached a self-defined ethical duty, which the Court ruled is not a suitable subject for expert testimony in this case. The determination of expert testimony related to ethical conduct is fact-dependent, as established in the In re Welding Fumes Product Liability Litigation, which deemed such testimony inadmissible except for rebuttal purposes. The Court emphasized its responsibility to provide clear jury instructions to avoid confusion, similar to the approach taken in the Bartlett trial.
In Mrs. Bartlett's negligence claim, she must establish three elements by a preponderance of the evidence: (1) DuPont owed her a duty of care; (2) DuPont breached that duty; and (3) her injuries resulted from that breach. The Court clarified that establishing a duty involves demonstrating that a reasonable company would foresee potential injury from its actions. The standard for determining reasonable prudence hinges on whether a reasonably prudent corporation would have anticipated that its conduct could likely result in injury, without needing to predict the specific injuries suffered by Mrs. Bartlett. The jury was instructed on the burden of proof and the definitions of negligence and ordinary care, emphasizing that ordinary care is context-dependent and not an absolute measure.
The Court will apply similar jury instructions in both the Bartlett and Freeman trials, emphasizing the expectation that juries will follow these instructions and assess multiple claims accurately. During the Bartlett trial, expert witnesses were questioned about the differences between legal and scientific standards related to DuPont's stewardship of C-8, a practice encouraged for the Freeman trial as well. An exchange with Dr. Siegel highlighted that public health standards, which focus on minimizing risks, differ from legal determinations of causation in individual cases. The Court noted that the introduction of such evidence has not led to mini-trials in the Bartlett case and will not do so in Freeman's trial either. To address DuPont's concerns about potential confusion, the Court reaffirmed its prohibition on the use of specialized legal terms like "breach," "negligence," or "duty" during the trials. Instead, parties may refer to existing medical, environmental, or scientific standards without framing them as a "duty of care." Experts can opine on whether DuPont's actions aligned with these standards but cannot assert that DuPont fulfilled or breached any legal duty. The Court's rulings are flexible and may be modified based on trial developments. Additionally, the Court partially granted and denied DuPont's motion to exclude Carrie Redlich's testimony based on extra-legal standards of care. Dr. Snyder, an expert with extensive background in environmental research and consulting, is introduced, highlighting his qualifications and experience in the field.
Dr. Rickard, a highly experienced federal environmental regulator with over thirty years at the United States Environmental Protection Agency, specializes in compliance, enforcement, hazardous waste remediation, and pollution control. He holds a Ph.D. in toxicology and an M.S. in microbiology and has over thirty-five years of experience in toxicology, including more than thirty years at DuPont in various roles. Mr. Freeman has presented additional corporate conduct experts, though DuPont seeks to limit their testimony regarding extra-legal duties, legal conclusions, and DuPont's motives, with related discussions occurring in separate Daubert motions. Dr. Redlich's opinions are also contested in a motion in limine by DuPont. This case is part of seven multidistrict litigations overseen by Judge Joseph R. Goodwin involving over 60,000 cases related to transvaginal surgical mesh for pelvic organ prolapse and stress urinary incontinence, with over 13,000 cases specifically in the Boston Scientific Corporation MDL.
