Toxic Tort Litigation Blog : Toxic Tort Lawyer & Attorney : Epstein Becker Green Law Firm : Product Liability, Contamination, Pollution

We discussed in an earlier article how the Reference Manual for Scientific Evidence, published by the Federal Judicial Center, has become an indispensable tool for judges in managing cases involving complex scientific and technical evidence. The manual describes key scientific fields from which legal evidence is typically derived, and judges often refer to the manual to help them better understand and evaluate the relevance, reliability and usefulness of the evidence being proffered. It has been suggested by some practitioners that the Third Edition, published in 2011, retreats from the rigorous Daubert standards set forth in the Second Edition, and thus will assist the plaintiff’s bar.

A distinguished panel comprised of members of the International Association of Defense Counsel (“IADC”) will examine this issue at IADC’s upcoming Annual Meeting in a program titled, “Reference Manual on Scientific Evidence: Take 3.” The moderator of the panel will be Bruce R. Parker, a partner at Venable LLP in Baltimore, Maryland. The panel members will include James F. Rogers, a partner with Nelson Mullins Riley & Scarborough LLP in Columbia, South Carolina; James W. Shelson, a partner with Phelps Dunbar LLP in Jackson, Mississippi; and Jessalyn H. Zeigler, a partner with Bass Berry & Sims PLC in Nashville, Tennessee.

The panelists have jointly authored a paper titled, “Changes in the Reference Manual on Scientific Evidence (3rd Ed.)” (“RMSE Third”). The authors discuss some of the changes to RMSE Third that suggest a weakening of the Daubert standard for the admissibility of expert testimony. In particular, there is significant concern that the First Circuit’s decision in Milward v. Acuity Specialty Products Group, Inc., 693 F.3d 11 (1st Cir. 2011) will undermine Supreme Court precedent requiring that expert testimony be admitted only when it is based on sound science.

The Milward case involved a plaintiff who alleged that his Acute Promyelocytic Leukemia (“APL”), an extremely rare disease, was caused by his exposure to benzene. The key issue on appeal was whether the expert opinion of plaintiff’s toxicology expert, Dr. Martyn Smith, was admissible on the issue of general causation.

In reversing the district court, which had excluded Dr. Smith’s testimony, the First Circuit held that the district court had erred in treating the separate evidentiary components to Dr. Smith’s analysis “atomistically” in “reasoning that because no line of evidence supported a reliable inference of causation, an inference of causation based on the totality of evidence was unreliable.” The First Circuit concluded that Dr. Smith’s “weight of the evidence” approach was acceptable because Dr. Smith reasoned, “to the best explanation for all of the available evidence.”

According to the IADC panel authors, Milward is bad law because: (1) its application of the “weight of the evidence” methodology permits an expert’s opinion to be admitted solely on the basis of the ipse dixit of the expert – i.e., a statement that rests solely on the authority of the expert who made the statement. This is expressly contrary to Joiner  which cautioned that the ipse dixit of the expert does not transform the expert’s opinion into a reliable methodology; (2) reasoning to “the best explanation for all of the evidence available” is not alone sufficient because an expert’s opinion must be excluded when the underlying scientific data do not permit a conclusion beyond hypothesis or speculation; and (3) the First Circuit was wrong to criticize the district court for “atomistically” or, separately, reviewing each evidentiary component of Dr. Smith’s analysis.

Rule 702 requires that expert testimony be “based on sufficient facts or data” and a gatekeeping court must inquire into the data and reasoning underlying an expert’s testimony.  For more information concerning the legal discussion, you can look to the Defendants/Appellees' Petition for Rehearing and, best of all,  the Petition for a Writ of Certiorari to the US Supreme Court,  which did not accept cert.  This issue may ultimately be taken up by the Supreme Court, however, because the First Circuit's decision is at odds with the Daubert jurisprudence of all of the other circuit courts of appeal that have considered these issues. 

RMSE Third frames the issue of “atomization” by asking, “When there is a Daubert challenge to an expert, should the court look to all the studies on which the expert relies for their collective effect or should the court examine the reliability of each study independently?” RMSE Third incorrectly suggests that the former approach may be the more appropriate.

Although the “weight of the evidence” approach may be used by regulatory agencies to assess the risk of chemicals, that does not render this approach reliable and relevant under Daubert. It is well known that regulatory agencies will often err on the side of caution without clear scientific evidence, but that Daubert requires that testing and validation occur before evidence is admissible in court.

With little fanfare, the Federal Judicial Center and the National Research Council of the National Academies issued the Reference Manual on Scientific Evidence: Third Edition, in 2011. Soon after the Supreme Court’s historic 1993 holding in Daubert v. Merrill Dow Pharmaceuticals, Inc., in which federal judges were directed to serve as “gatekeepers,” the Federal Judicial Center published the First Edition of the Reference Manual on Scientific Evidence, which became the leading reference source for federal judges seeking an understanding of difficult issues involving scientific testimony. The Second Edition was published by the Federal Judicial Center in 2000.  Considering advances in science, both in terms of how science is treated in the courtroom and in the laboratory, over the last 12 years, a new edition is certainly welcome. 

For the toxic tort practitioner, the Reference Manual on Scientific Evidence is an indispensable reference work. As with previous editions, the Third Edition is organized according to the important scientific and technological disciplines often encountered by federal (or state) judges. It would be difficult to imagine preparing any toxic tort case for trial (or the filing of a Daubert motion) without reviewing, for example, the manual's chapters on exposure science, epidemiology, toxicology, neuroscience and/or engineering. 

In particular, two critical issues germane to the interpretation of scientific evidence, namely issues of causation and conflict of interest, are highlighted in the new edition’s Preface. Judges are in a less favorable position than scientists to make causation assessments. Scientists have the luxury of delaying their decision while they or others gather more data. Judges, on the other hand, must rule on causation based upon existing information presented to the court. In the final analysis, a judge does not have the option of suspending judgment until more information is available, but must fulfill his gatekeeper role after considering the best available science. The Third Edition seeks to make that judicial task more manageable.

The Preface also discusses the problem of conflict of interest, which is an issue that cuts across most, if not all, scientific disciplines. What is the relationship between conflict and bias? According to the Preface, even though financial conflicts can be identified, the existence of a conflict, even one involving huge sums of money, does not necessarily mean that a given individual will be biased. Thus, having a financial relationship with a commercial entity produces a conflict of interest, but does not inevitably evoke bias. As the Third Edition points out, it is critical that judge and juries consider financial conflicts of interest when assessing scientific testimony, and the threshold for pursuing the possibility of such bias must be low.

I would appreciate comments from practitioners concerning how, if at all, the issuance of the Third Edition has impacted toxic tort trial practice or might do so in the future.

Guest Blogger ANDREA J. LAWRENCE is a Senior Counsel at Epstein Becker & Green in New York.  She provides legal advice and counsel to clients in the real estate industry. Andrea has extensive commercial litigation experience, and has provided legal representation to real estate companies, landlords, developers, property management companies, and commercial tenants  In this jointly written post, we discuss a recent Appellate Division, First Department toxic mold case, which was reinstated after dismissal in the trial court.

The adverse health effects of toxic mold are frequently litigated in courts throughout New York, where many apartment dwellers claim to suffer from various medical illnesses resulting from mold and dampness. Just last week, toxic mold again created a stir in the legal community when the Appellate Division, First Department, in Cornell v. 360 West 51st Street Realty, LLC (2012 NY Slip. Op. 01643), reversed a lower court decision dismissing a plaintiff’s mold personal injury claim against her landlord. Despite plaintiff offering scientific and medical evidence in support of her claims, why did the lower court award summary judgment to the landlord? It is noteworthy that plaintiff’s expert, Dr. Eckhard Johanning, has made a career testifying for plaintiffs in mold personal injury actions. This was not the first case in which his expert testimony had been rejected by a trial court due to his off-the-wall methodology.

In Cornell, the plaintiff had resided in her apartment directly above the building’s basement since 1997. After flooding in the basement in 2002 and 2003, the plaintiff observed mold in her bathroom, and began to feel ill every time that she entered this room. In October 2003, the building was sold and the new owner began to remove debris from the basement in preparation for renovations to the building. During the course of the debris removal, plaintiff experienced dizziness, chest tightness, congestion, a shortness of breath, a rash, swollen eyes and a metallic taste in her mouth. In November 2003, the plaintiff was forced to permanently vacate her apartment purportedly as a result of her medical condition. Shortly thereafter, she commenced a personal injury action.

In support of her motion seeking summary judgment (and in opposing the landlord’s motion), the plaintiff presented expert testimony establishing that mold was capable of causing the medical ailments she experienced. Her treating physician opined that her symptoms were caused by exposure to toxic molds.

Notwithstanding the causation evidence presented by plaintiff, the lower court granted defendants’ motion for summary judgment and dismissed the complaint. In doing so, the court relied on Fraser v. 301-52 Townhouse Corp., 57 A.D.3d 416 (1st Dep’t 2008), holding that “the Fraser majority has resolved the issue of the sufficiency of the current epidemiological evidence on which [plaintiff’s physician] relied was not sufficiently strong to permit a finding of general causation, and as the limited supplemental studies that are submitted in this action plainly do not remedy the insufficiency found by the Fraser majority, this court is constrained to hold that plaintiff is unable to prove general causation.”
The trial judge reasonably assumed that if Dr. Johanning's scientific evidence had failed to pass legal muster in Fraser, his testimony should not be given credence in her courtroom either.

In a 3-2 split, the Appellate Division First Department held that the lower court had erred in its dismissal of the plaintiff’s personal injury claims based upon Fraser. The court stated that, “we never disavowed the underlying theory that exposure to mold may, under certain circumstances, give rise to respiratory and other ailments.” The court noted that its holding in Fraser was limited by the facts of that particular case, and reiterated “our holding [in Fraser] does not set forth any general rule that dampness and mold can never be considered the cause of a disease.” So holding, the Appellate Division reinstated the plaintiff’s complaint against the landlord for mold-related personal injuries.

 At first blush, it may appear that the trial court dismissed plaintiff’s mold claim because it had read Fraser as a categorical rejection of all toxic mold personal injury mold cases. However, the trial judge had certainly not done this.  In his dissenting opinion, Judge Catterson faulted plaintiff’s experts in the lower court for failing to rely upon “generally accepted science.” He determined that plaintiff’s submission concerning medical causation failed to meet the test under Frye v. U.S., 293 F.1013 (D.C. 1923)(known as the Frye test), which requires that the reliability of a new test, process or theory, be “generally accepted” within the relevant scientific community. Upon close examination of the studies relied upon by plaintiff’s experts, he determined that plaintiff’s proof fell short of the mark.  We agree with Judge Catterson. 

Unfortunately, Cornell may provide a roadmap to clever toxic tort plaintiff lawyers and their experts on how to beat back a Frye challenge in New York state court.  At the end of the day, the experts are cooking up the same suspect causation opinions that were rejected in Fraser. It is just that they are adding some scientific "gloss" to those opinions to get to the jury. 

A Sixth Circuit case, Moeller v. Garlock Sealing Technologies, LLC, 2011 U.S.App.Lexis 19987 (6^th Cir. Sept. 28, 2011), is the most recent in a series of judicial decisions that have rejected the opinions of plaintiffs’ experts in asbestos cases who espouse the “any exposure” or “any fiber” or “single fiber” theory of causation.  Pursuant to this specious line of reasoning, asbestos disease is a cumulative dose response process. Each and every exposure to asbestos during a person’s lifetime, no matter how small or trivial – even a single fiber – substantially contributes to the disease, whether it be asbestosis, lung cancer or mesothelioma. Using this theory of causation, plaintiffs have initiated a wave of new lawsuits against defendants far removed from the production of asbestos containing products.  As defense practitioners are well aware, successfully challenging weak causation expert opinions is key to winning any toxic exposure case, whether it involves asbestos or some other substance.

In a “must read” column in the New York Law Journal, dated October 19, 2011 titled "Courts Shoot Down Asbestos Causation Theory", Michael Hoenig, whose law firm defends asbestos case litigation, describes how plaintiff experts are promoting the “any fiber” or “any exposure” theory in courtrooms across the country and how a series of notable judicial decisions have begun to reject these theories as the underlying scientific methodology is subjected to scrutiny. In a recent amicus curiae brief filed by eleven distinguished scientists in a Pennsylvania asbestos case, none of whom received funding from or testified as experts for any of the parties in the case, the scientists attacked the methodological errors of the “any exposure” expert for:  (1) failing to consider the dose level of exposure and minimum threshold of asbestos fiber levels; (2) failing to consider the physical chemical and toxicological differences between various types of asbestos; (3) failing to distinguish between general causation and specific causation (and not even establishing general causation for chrysotile asbestos); (4) for suggesting that “every exposure” and “cumulative risk” theories are generally accepted when they are not; and (5) ignoring the large body of toxicological studies demonstrating that chrysotile asbestos is not potent as a cancer-causing agent. 

The Pennsylvania Supreme Court observed in Gregg v. V-J Auto Parts Co., 943 A.2d, 216, 223 (Pa. Sup. Ct. 2007), that although it was “common for plaintiffs to submit expert affidavits attesting that any exposure to asbestos, no matter how minimal, is a substantial contributing factor in asbestos disease,” such opinions are not “not couched within accepted scientific methodology.”  The court called the “willingness on the part of some experts” to offer such opinions “one of the difficulties” courts face in the mass tort cases.

As the plaintiff bar continues to look further and further afield in its “endless search for a solvent bystander,” as one well-known plaintiff’s lawyer described the litigation, successful challenges under Daubert and Frye should only increase.  The author thanks Mr. Hoenig for his thoughtful treatment of this important topic.

From a risk management perspective, peripheral toxic tort defendants often decline to mount  Daubert challenges due to the cost and time involved and the uncertainty of the result, particularly when the plaintiff presents them with seemingly  reasonable settlement demands.  As a result, hundreds of peripheral defendants continue to be named in these cases and often pay their "penny in tribute" just to get out of the case.  Unfortunately, in many jurisdictions, judges responsible for large asbestos dockets are unwilling to give appropriate consideration to motions by "shade tree" defendants who might otherwise challenge plaintiffs' experts'  theories of causation.  Cynically, these judges know that the cases will most likely settle out if this type of motion is given short shrift.  There is little incentive for a peripheral defendant to risk an adverse  judgment at trial merely to earn the right to bring an appeal, no matter how strong the grounds may be.  Hopefully, cases like Moeller will have a trickle down effect and motivate the trial judges responsible for the asbestos dockets to re-think their approach. 

The Consumer Product Safety Improvement Act of 2008 ("CPSIA") provides that the Consumer Product Safety Commission ("CPSC") will establish and maintain an Internet database on the safety of consumer products.  The CPSIA Section 212 requires that the database be: (1) available to the public; (2)  searchable; and (3) accessible on the CPSC's website.  Reports of harm caused by consumer products may be reported by consumers; local, state or federal govenment agencies; health care professionals; child service providers; and public safety entities. Ideally, the database will encourage the sharing of information and direct communications among consumers, consumer advocacy groups and state attorneys general, who have been given an important new role under the CPSIA.  For the first time, consumers will have direct instant access on the Agency's website to potentially important product safety information. 

The CPSIA of 2008 is much needed legislation to upgrade the level of  protection provided to the American consumer by the federal government.  The law represents the Congress' response to a year of multiple, embarrassing consumer product scandal after another during what some commentators have termed the "Year of the Recall".  In the past, information vital to the public welfare concerning defective consumer products has not been promptly provided to the American people.  At times, this delay may have been responsible for what may have been preventable injuries or deaths --  hence, the legislative mandate for the database.   

In light of these public benefits, can there be any dark side to this new era of governmental transparency?  Are consumer product companies justified in fearing that the database has the potential to  spread disinformation and unfairly tarnish reputations? 

The statute requires that a report submitted for inclusion on the database: (1) describe the consumer product; (2) identify the manufacturer or private labeler; (3) describe the harm related to the use of the product; (4) provide contact information; and (5) contain a verification that the report is true and accurate. Based upon informal Commission staffer comments, the CPSC is not required to perform an independent investigation to determine the veracity of a report or whether the incident that is the subject of the report occurred in the manner claimed or occurred at all.  For this reason, there is a risk that the database may morph into a  consumer Wikipedia, but with the imprimatur of United States approval and the gloss that comes from being hosted on a federal regulatory agency website.  What opportunity will  manufacturers have to comment on a report that one of their products may have triggered a fire in a home or caused a child to suffocate before the report is posted?  Unfortunately, not a whole lot!  The statute requires that within five days of receiving a report the Commission shall "to the extent practicable" transmit the report to the manufacturer identified in the report prior to the report being posted on the database.   Because the person making the report need not be identified to the manufacturer unless he or she explicitly consents, there may not be much the manufacturer can do, within the 10 day window provided before the report is posted, to determine whether the report is accurate. Certainly, this narrow window does not permit a manufacturer to obtain the product from a consumer, assuming the consumer can be identified, and inspect it.  The manufacturer can request that proprietary or trade secret information not be posted on the database, but that request, if granted, will result only in the sensitive information being redacted, not in a delay in posting the report on the database.  The statute permits a manufacturer to request that its own comments also be included in the database, but in the absence of a realistic time frame to perform an investigation of the underlying report, what would be an appropriate comment to make?  Moreover, the manufacturer may be at a disadvantage if reporters call seeking comment after the consumer's report is posted by the Commission. 

 On September 19, 2008, President Bush signed S. 2450 into law and new Evidence Rule 502  was added to the Federal Rules of Evidence.  The new rule provides for protections against waiver of the attorney-client privilege and work product immunity. The practical effect of the new legislation should be to reduce the often staggering legal costs corporations often incur in complex litigation, particularly in producing electronic discovery.  In drafting the legislation, the Advisory Committee of Evidence Rules recognized that lawyers spend significant time and effort preserving the attorney-client privilege and work product.  Under the prior rule, if a protected document was produced, even accidentally, there was a risk that a court would find a subject matter waiver that would apply, not only to the instant case and document, but to other cases and documents as well.  Thus, lawyers placed an enormous amount of effort (and expense) into pre-disclosure document review to protect against inadvertent disclosure.  Although waiver issues always have been a concern in document-intensive litigation (and will no doubt continue to be in the future), the increased discovery burden created by e-discovery brought this issue to the boiling point over the past two years.  Under the new rule, the jeopardy to corporations (and their law firms for permitting a waiver) is substantially mitigated.

The new rule does not address the scope of the attorney-client privilege or work product protection.  Rather, the new rule covers issues of scope of waiver, inadvertent disclosure, and the controlling effect of court orders and agreements.