September 08, 2015 Practice Points

Guidance Offered Regarding Permissible Expert Testimony in Pharmaceutical Labeling Actions

Be diligent to insulate your experts from challenge by ensuring they remain within the scope of their claimed expertise.

By Lucas Michelin

With the growing number of lawsuits filed against Eli Lilly and Company surrounding its antidepressant Cymbalta, the U.S. District Court for the Central District of California issued an important ruling regarding the expertise needed by witnesses to testify about the adequacy of pharmaceutical labeling. In Hexum v. Eli Lilly & Co., Judge Wilson offers guidance on the limitations placed on experts in pharmaceutical-based products liability actions. No. 2: 13-cv-02701-SVW-MAN2015, U.S. Dist. LEXIS 106153, *1 (C.D. Cal. Aug. 10, 2015).

Erin Hexum and her husband brought suit against Eli Lilly based on its alleged failure to warn about the risks associated with the discontinuation of Cymbalta. Eli Lilly moved to exclude testimony of two experts, Dr. Joseph Glenmullen and Dr. Louis Morris. Judge Wilson struck parts of the experts' reports and limited their testimony to their specific areas of expertise.

Dr. Louis Morris
One of the experts offered by the plaintiffs, Dr. Morris, a social scientist, offered opinions regarding the adequacy of Cymbalta's label. Dr. Morris worked at the FDA for more than twenty years and held prominent positions such as Acting Director of the Division of Drug Advertising and Labeling and Chief of the Drug Research, Education, and Labeling Branch. His primary responsibilities involved evaluating consumer-oriented advertising materials. Dr. Morris sought to testify as to whether the Cymbalta label was inconsistent with FDA guidance, if Eli Lilly could have altered the label to more accurately reflect information published in a 2005 medical journal, and whether the label was misleading to physicians. Dr. Morris described his methodology as the same process he used at the FDA for determining whether promotional materials were misleading.

Judge Wilson held that Dr. Morris was unqualified to opine about the accuracy of Cymbalta's labeling under FDA guidance. Judge Wilson stated, "Plaintiffs still fail to show that Morris's conclusions are the result of reliable methods reliably applied. The FDA relies on analysis of this type performed by experts with significant training and experience. Morris is a social psychologist with substantial regulatory experience. He is not a clinical psychologist and has never prescribed medication to patients." Id. at *20–21 (citation omitted). He continued, "Moreover, Morris does not claim that the FDA typically reviews published articles summarizing and analyzing raw data rather than the raw data itself. Thus, to the extent that Morris seeks to opine regarding whether Cymbalta's label adequately represents the data submitted to the FDA under the FDA's own guidelines, he fails to show that he followed the FDA's process of comparing the data to the label." Id. at *21–22. Therefore, Dr. Morris's experience evaluating promotional materials did not qualify him to testify regarding the adequacy of labeling directed towards physicians. His lack of experience as a prescribing doctor also rendered him incapable of opining whether the risks of potential side effects were adequately disclosed.

Dr. Morris also opined that Cymbalta's label, which stated "the following symptoms occurred," implied that the listed symptoms occurred in the aggregate, and not that each of the symptoms occurred individually. This testimony was also struck because "Morris is not a doctor and has not studied doctors' interpretations of Cymbalta's label." Id. at*24. Judge Wilson limited the scope of Dr. Morris's testimony to opinions regarding the FDA's general procedures and regulations, and only in rebuttal to Eli Lilly's defense-in-chief.

Dr. Joseph Glenmullen
The plaintiffs also offered the testimony of Dr. Glenmullen relating to the label's adequacy, veracity, and tendency to mislead, as well as Eli Lilly's corporate conduct. In his expert report, Dr. Glenmullen discussed the adequacy of Cymbalta's label in light of the prescribing habits of physicians. He specifically opined that "doctors rarely have the time to conduct their own research" and that "treating physicians rely on the label as the ultimate authority on a drug's safety and efficacy." Id. at*8–9. He further opined that Eli Lilly obscured the results of its clinical trials by publishing the results in a medical journal "not widely read in the United States" and that physicians who were aware of the published clinical trials would credit the drug label over the journal article.

Judge Wilson excluded these findings under Federal Rule of Evidence 702, holding that they lacked support; Dr. Glenmullen had not cited any relevant authority or study in support of these opinions. Dr. Glenmullen's experience prescribing antidepressants was insufficient on its own to meet the requirements of Rule 702.

Despite the lack of support for some of Dr. Glenmullen's specific findings, the court denied Eli Lilly's motion to exclude his complete testimony. Judge Wilson concluded that his experience as a clinical psychiatrist and in academic writing about antidepressant withdrawal rendered him a qualified witness. Therefore Dr. Glenmullen could testify about general causation (i.e., whether Cymbalta could cause discontinuation symptoms) and the nature of those symptoms. Furthermore, as a clinical psychiatrist, he could opine as to whether the label adequately reflected the available data. He could not, however, "speculate regarding what would have happened in a given study if a different methodology [] were used." Id. at *11. He was also barred from discussing Lilly's corporate conduct as beyond the scope of his expertise.

Judge Wilson's opinion is an example of a court exercising its role as "gatekeeper" by preventing testimony outside of a witness's specific area of expertise. Judge Wilson makes clear that an expert's qualification to testify about a specific issue in the case does not grant broad discretion to offer opinions that are void of relevant support or methodology. Going forward, counsel should be diligent to insulate their experts from challenge by ensuring their experts remain within the scope of their claimed expertise. Opposing counsel should be cognizant of opposing experts' scope of expertise. In addition, counsel should—as they should for their own submissions—ensure their experts have support for their claims and opinions.

Lucas Michelin is with Drinker Biddle & Reath LLP in Philadelphia, Pennsylvania.

Keywords: expert witnesses, litigation, Cymbalta, Eli Lilly, scope of expertise

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