Health Law Daily Warning concerns not within average juror’s common knowledge, requires expert testimony
Thursday, May 17, 2018

Warning concerns not within average juror’s common knowledge, requires expert testimony

By Jeffrey H. Brochin, J.D.

Whether expert testimony will be necessary is dependent upon the facts, claims, and issues involved in a given case. Where matters and issues are within the common knowledge and experience of the average juror, no expert testimony is necessary; however, when a claim involves highly complex matters of science, medicine, engineering, technology and other matters which are beyond the common knowledge and experience of the average juror, expert testimony will be necessary, the Supreme Court of West Virginia has ruled. The issue of failure to warn via a drug label involves medical judgments, and expert medical testimony was required in such a case (J.C. v. Pfizer, Inc., May 15, 2018, Loughry, J.).

Background. Several mothers filed suit against Pfizer, Inc. Pfizer after taking the anti-depressant drug Zoloft® during pregnancy, and subsequently giving birth to children who suffered from birth defects. Litigation commenced on July 11, 2012, with the filing of a complaint alleging products liability and negligence claims on behalf of the minor children. The petitioners alleged that the birth defects were proximately caused by their ingestion of the drug and their complaint included claims that Pfizer failed to adequately warn of the risks of birth defects, and, that adequate warnings would have prevented the injuries.

After claimants’ initial expert witness became unavailable due to health reasons, the Mass Litigation Panel (Panel) ordered that an affidavit be tendered from his doctor as to the witness’s condition. When various extensions of time did not produce the witness for deposition nor the affidavit, the petitioners sought leave to have a replacement expert witness deposed. However, after the Panel refused to agree to a request limiting the length of a nationally renowned expert witness’ deposition, the petitioners withdrew his name as an expert and sought to rely on Pfizer’s own experts, documents and data to prove their failure to warn claim. The Panel then entered summary judgment in favor of Pfizer, and the claimants appealed.

Importance of an expert witness. The Panel observed that the main question in the case was whether Pfizer acted reasonably when warning of the drug’s risks under the circumstances, and the Panel noted the importance of having an expert witness in failure to warn cases, particularly when there are "complex technical, scientific, and medical issues beyond the common knowledge and experience of the average person." The Panel found that whether Pfizer behaved as a reasonably prudent manufacturer would when warning about the use of Zoloft during pregnancy involved complex issues of science and medicine, and that this was not a case where the label was silent regarding the alleged risk. During the relevant time period, the label carried the Category C pregnancy warning, and the FDA had repeatedly approved Zoloft’s label. Furthermore, numerous independent organizations had concluded that the evidence did not support a causal link between Zoloft and birth defects.

The claimants’ statements regarding the importance of their labeling expert and the prejudice to their case without such an expert, were inconsistent with their later assertion that they did not need an expert because the alleged inadequacy of the Zoloft label was "obvious."

Knowledge and experience of average juror. The Panel further found that the subject matter of the documents cited by the petitioners in opposition to summary judgment—including animal studies, epidemiology, adverse event reports, Core Data Sheets, and FDA regulations—were not within the common knowledge and experience of the average juror, and therefore such evidence could not substitute for expert testimony on the adequacy of the Zoloft label.

Neither the interpretation of Pfizer’s studies nor the appropriate method for distilling such lengthy and complex information, was within the ordinary knowledge and experience of the average juror, and the Panel ruled that under the facts of the case, the adequacy of Zoloft’s label required expert testimony. Because the petitioners had withdrawn their warning and label expert, the Panel concluded they could not meet the burden of proof on an essential element of their claim.

Need for medical judgments. The state Supreme Court ruled that the determination of whether expert testimony is necessary to sustain the burden of proof in complex cases involving matters of science, medicine, engineering, and technology needs to be made on a case-by-case basis. It reiterated the Panel’s finding that when issues are beyond the common knowledge and experience of the average juror, expert testimony is required, and agreed with the Panel on the need for expert testimony is the instant case, noting that such matters generally require expert testimony on the standard of care, given that the development of a drug label involves, in part, medical judgments.

Because the petitioners could not sustain their evidentiary burden using Pfizer’s witnesses, the Panel had ruled correctly, and the appellate court affirmed the grant of summary judgment to Pfizer.

The case is No. 17-0282.

Attorneys: Benjamin L. Bailey (Bailey Glasser LLP) for J. C. Michael J. Farrell (Farrell, White & Legg PLLC) for Pfizer, Inc., Roerig, A Division of Pfizer, Inc. and Greenstone, LLC f/k/a Greenstone, Ltd.

Companies: Pfizer, Inc.; A Division of Pfizer, Inc.; Greenstone, LLC f/k/a Greenstone, Ltd.

MainStory: TopStory MDeviceNews PLDeviceNews SafetyNews WestVirginiaNews

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