Mass Tort Claims, Product Testing & Causation Issues

Michael J. McCabe, Jr., Ph.D., DABT, ATS

Robson Forensic, Inc.The Bourse Building, Ste 1000111 S. Independence Mall East

Philadelphia, PA 19106(215) 922-1604

www.robsonforensic.com

A.J. de Bartolomeo, Esq.

Gibbs Law Group LLP One Kaiser Plaza, Ste 1125

Oakland, CA 94612(510) 350-9711

www.classlawgroup.com

Stanley Goos, Esq.Daniel I. Jedell, Esq.

Harris Beach PLLC1o0 Wall Street

New York, NY 10005(212) 867-0100

www.harrisbeach.com

The Daubert Standard

Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993)

Two touchstones for admissibility: Relevance and Reliability

Courts undertake “gatekeeping function” regarding expert scientific opinion

testimony, to ensure evidence presented to the jury is reliable and relevant.

Four factors guide courts in assessing reliability of expert’s methodology:

1) Whether the expert’s methodology has been tested;

2) Whether the technique has been subjected to peer review/publication;

3) Whether there is a known or potential error rate of the methodology; and

4) Whether the technique is generally accepted in the relevant scientific community.

Rule 702 of the Federal Rules of Evidence

The Frye Standard

Keystone Analysis: Whether the methodology employed is “generally accepted” in the expert’s particular scientific field

Underlying notion – the scientists, not the judge, should determine whether the methodology applied is generally accepted

Court’s Role as Gatekeeper: to ensure the experts employ the same level of intellectual rigor in the courtroom that characterizes their scientific practice in the field

Goal: exclude junk science – “clearly invalid and unreliable expert opinion”

State Rules of Evidence (examples):

New York CPLR § 3101(d)

California Evidence Code § 801, 802

“While the inquiry is a flexible one, the focus must be solely on principles and methodology, not on the conclusions that they generate.”

- Chapman v. Procter & Gamble Distributing, LLC (11th Cir. 2014)

“Disagreement among experts is to be expected, since causation analysis involves professional judgment in interpreting data and literature. An expert opinion is precluded when it is reached in violation of generally accepted scientific principles.”

- Reeps v. BMW of North America LLC, et al. (N.Y. Sup. Ct. 2013)

It’s All About Principles and Methodology…

Proving Causation: 2-Step Process

General Causation: Whether the substance at issue has the potential to cause plaintiff’s injury

Plaintiff bears the burden of proof

Court as gatekeeper, under Daubert or Frye, must determine:

Does plaintiff’s expert have the requisite qualifications?

Does plaintiff’s expert employ the necessary methodology?

Does plaintiff’s expert rely upon sufficiently sound scientific evidence?

Does plaintiff’s expert comport with the inquiry and factors identified in Daubert or Frye within the respective areas of expertise?

Specific Causation: Whether plaintiff can demonstrate that the substance at issue actually

caused his or her particular injury

Goals Under Daubert and Frye

Plaintiff

To get over the hurdle of establishing general causation, a plaintiff

must present scientifically reliable evidence, not junk science

General and specific causation cannot be conflated; evidence of a dose-response relationship (which pertains to to general causation) is distinct from evidence of the dose the plaintiff was exposed to (which pertains to specific causation)

Key to establishing general causation: estimating a threshold exposure level

Threshold exposure level must be established using sound, reliable methodology, typically via epidemiological studies. However, in the absence of epidemiology (“epi”) studies regarding the substance at issue (i.e. the disease/outcome is rare), a plaintiff must still find a reliable way of demonstrating the requisite dose-response relationship

Goals Under Daubert and Frye

Defendant

Challenge the methodology employed by plaintiff’s expert(s) as

not generally accepted in the scientific community

Motion in limine to attack plaintiff’s expert’s testimony as inadmissible:

Plaintiff’s expert failed to use a reliable (primary) methodology to

establish general causation;

Plaintiff’s expert failed to demonstrate the necessary dose-response

relationship;

Plaintiff’s expert relies on junk science (i.e. speculative, not subjected

to peer-review or publication, etc.), and thus must be excluded.

Expert opinions based on “junk

science”are precluded

by the Court

Expert opinions based on accepted scientific principles and sound methodology are permitted to go to the Jury

The Expert’s Perspective

Causation Challenge: Multifactorial Basis of Disease

Disease/Disorder/OutcomeMechanism of ActionIn reality complex

Environmental Factors (extrinsic) Genetic Factors (intrinsic) Adaptation & Variability = characteristic of biology

Disease/Outcome

Intrinsic FactorsExtrinsic Factors

The Expert’s Perspective

The Scientific Method

1.Define Problem in Form of a Question

2.Gather Information

3.Form a Hypothesis

4.Determine Variables

5.Design Experiment to Test Hypothesis

6.Analyze the Results

7.Draw Conclusions;

Communicate Findings (replication validation, falsification)

The Expert’s Perspective

Bradford Hill criteria for disease causation

Strength of association; coherence epidemiological studies OR, RR, SMR > 2.0 (more probable than not)

Temporal association exposure timing relative to diagnosis

Biological plausibility mechanism of action

Biological gradient dose response

* In addition to these 5 factors, the Bradford Hill criteria also contain the following 4 factors:

•Consistency•Specificity•Experiment•Analogy

The Expert’s Perspective

Epidemiology and Causation

General Causation and Epidemiological Evidence:

Epidemiology is the study of the incidence of disease in human populations

Epidemiology expert opinion is commonly admissible if study design is

strong and assumptions are reasonable (equivalence of exposed group to

unexposed group) because data comes from humans.

Some jurisdictions require an increase in Relative Risk of adverse

effect > 2 (twice as likely as not that the disease is related to exposure)

The Expert’s Perspective

Types of Epidemiology Studies

The Expert’s Perspective

Hierarchy of Epidemiology Studies

The Expert’s Perspective

Are Epidemiology Studies Necessary to Establish Causation?

Adami et al., Toxicological Sciences 2011; 122:223-234

The Expert’s Perspective

Case Reports Alone Are Not Persuasive

“Case reports, which anecdotally describe an occurrence, often on an individual basis, cannot establish general causation ‘because they simply describe reported phenomena without consideration to the rate at which the phenomena occur in the general population or in a defined control group; do not isolate and exclude potentially alternative causes; and do not investigate or explain the mechanism of causation.”

- Burst v. Shell Oil Co., 2015 WL 3755953 at *8 (E.D. La 2015)

“All things are poison and nothing is

without poison, only the dose permits

something not to be poisonous.”

Paracelsus, c. 1520

Disease/Outcome

Extrinsic Factors Intrinsic Factors

General Causation in the Absence of Epi Studies

Chapman v. Procter & Gamble Distributing, LLC (11th Cir. 2014)

Defendant’s motion to exclude testimony of plaintiffs’ causation experts affirmed; experts did not satisfy any of the reliable primary methodologies for establishing general causation.

Neither the experts, nor the scientific support they relied on, determined how much of the toxin one must be exposed to for how long in order to increase the risk of developing a neurological deficit, as plaintiff did.

Court: the secondary methodologies relied upon by plaintiffs’ experts are insufficient proof of general causation.

“… could mislead the jury by causing it to consider testimony that was insufficient by recognized primary methodologies to prove using Fixodent causes myelopathy.”

General Causation in the Absence of Epi Studies

Wendell v. Johnson & Johnson (N.D. Cal. 2014)

Defendants’ motion for summary judgment granted; establishing general causation requires, at minimum, admissible evidence to support an inference of “a reasonable causal connection” between the substance at issue and the development of the disease/outcome the plaintiff sustained.

Plaintiff’s causation experts conceded their opinions would not satisfy the standards required for publication in peer-reviewed medical journals.

Court rejected experts’ contention that they could not identify any epi studies or animal studies demonstrating a causal link between plaintiff’s form of cancer and the drugs prescribed because the particular form of cancer is “exceedingly rare.”

Court: the difficulty of conducting studies “does not relieve plaintiffs of their obligation to present evidence of causation,” particularly since > 70% of observed cases of plaintiff’s form of cancer are idiopathic (no known cause).

Using Only Case Reports When Epi Studies Exist

Yates v. Ford Motor Co. (E.D.N.C. 2015)

Defendants’ motion to exclude expert opinion as reliant on case reports denied; case reports may be used to support other reliable proof

Defendants: epidemiological (“epi”) studies are necessary predicate to support case reports; using case reports alone is prejudicial under Fed. R. Evid. 403.

Case studies are criticized as unreliable evidence of causation because: not controlled studies; not verified through peer review; fail to exclude other potential causes; frequently lack analysis.

However, case reports may provide data that corroborates or supports epi studies; experts may properly rely on case studies as long as doing so would be consistent with sound methodology.

Court: Plaintiffs’ experts did not rely solely on case reports; they referred to epi studies, animal studies, and cellular experiments, among other authorities.

Dealing with Inconsistent Epi Studies

In re Actos (Pioglitazone) Products Liability Litigation (W.D. La. 2014)

Defendants’ motion to exclude plaintiffs’ experts’ causation testimony denied; dispute over whether cancer presenting in ≤ 1 year from first exposure to Actos should be excluded from or included within consideration from case studies:

Plaintiffs: improper to exclude cases of bladder cancer development within 1 year of exposure to Actos, as they demonstrate a statistically significant increase in bladder cancer among those exposed to Actos;

Defendants: the clinical studies cannot demonstrate causation of bladder cancer since that type of cancer requires at least 1 year to develop; thus any cancers presenting within 1 year must be excluded from statistical analysis.

Court: absent any evidence of biological implausibility, the mere fact that plaintiffs’ theory is new, and in conflict with the status quo, does not automatically render such evidence or opinion inadmissible as a threshold inquiry, if otherwise properly supported and the result of reliable methodology.

Junk Science

Sean R. v. BMW of North America, LLC (N.Y. Ct. App. 2016)

Denial of plaintiff’s motion to reargue court’s preclusion of causation experts affirmed; absence of threshold number = failure to establish causation

General Causation: In the absence of an epi study correlating the exposure to the toxin to the disorder, the Bradford Hill criteria is not applicable. Moreover, plaintiff’s experts’ application of Bradford Hill criteria was not sound:

Scientific sources relied upon dealt with toluene (not gasoline vapor);

Measurement of strength of association based on case reports (not epi).

Specific Causation: Methodology rejected; experts concluded the infant was exposed to enough gasoline vapor to cause birth defects based on his mother’s reported “symptoms of acute toxicity during exposure.” The experts’ opinion that the mother inhaled 1,000 ppm of gasoline vapor was extrapolated from studies concluding that ≥ 1,000 ppm of gasoline vapor concentration is required for those symptoms to occur immediately.

Mass Tort Claims, Product Testing & Causation Issues

Michael J. McCabe, Jr., Ph.D., DABT, ATS

Robson Forensic, Inc.The Bourse Building, Ste 1000111 S. Independence Mall East

Philadelphia, PA 19106(215) 922-1604

www.robsonforensic.com

A.J. de Bartolomeo, Esq.

Gibbs Law Group LLP One Kaiser Plaza, Ste 1125

Oakland, CA 94612(510) 350-9711

www.classlawgroup.com

Stanley Goos, Esq.Daniel I. Jedell, Esq.

Harris Beach PLLC1o0 Wall Street

New York, NY 10005(212) 867-0100

www.harrisbeach.com