Hundreds of plaintiffs have filed suit against Bayer in state and federal courts alleging the prescription drug Trasylol®, used to reduce bleeding in coronary artery bypass surgery, caused personal injuries and, in some cases, death. The federal actions involving more than 1800 plaintiffs have been consolidated in a multidistrict litigation (MDL) pending in West Palm Beach, Florida. Plaintiffs’ FDA regulatory expert in the MDL, Dr. Suzanne Parisian, sought to proffer testimony in four general areas: (1) the nature of the FDA’s approval and regulatory process; (2) the duties and obligations of drug manufacturers in relation to FDA regulations and industry standards; (3) Bayer’s actions in relation to FDA regulations, industry standards and the FDA regulatory process; and (4) her opinion as to whether Bayer’s actions were reasonable and appropriate.

Bayer asked the district court to exclude Dr. Parisian’s testimony because her opinions did not pass the gate-keeping standards in Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993). Bayer argued that Dr. Parisian lacked the appropriate expertise; her testimony consisted of factual narratives, legal conclusions and personal opinions; and she planned to offer slanted, irrelevant and speculative opinions about Bayer’s knowledge, state of mind and motives. Bayer also sought to exclude Dr. Parisian’s testimony on the ground that some of her opinions were preempted by federal law and she did not apply a sound methodology to the facts of the case to reach reliable conclusions.

Plaintiffs argued that Dr. Parisian was competent and qualified to offer regulatory opinions and that her opinions were not merely factual narrative or legal conclusions. Plaintiffs also claimed that Dr. Parisian’s opinions regarding Bayer’s conduct were not inadmissible speculation because she was not offering testimony regarding Bayer’s state of mind or personal opinions regarding pharmaceutical companies.

In addition to considering extensive briefing by the parties, the district court held a six-hour Daubert hearing on Bayer’s motion to exclude Dr. Parisian from testifying at trial. On April 27, 2010, the court granted Bayer’s Daubert motion – excluding Dr. Parisian’s testimony in its entirety. In its 41-page order, the court found that most of Dr. Parisian’s testimony would not assist the trier of fact in understanding the evidence because Dr. Parisian made no effort to confine her testimony to her area of expertise: the FDA regulatory scheme. Moreover, while Dr. Parisian’s expert report “cites to some FDA regulations, it mostly consists of a factual narrative of Trasylol®’s regulatory history and summaries of Bayer’s internal documents. Dr. Parisian does not analyze the facts; she . . . regurgitates them and reaches conclusory opinions that are purportedly based on these facts. These facts should be presented to the jury directly.”

The district court also determined that Dr. Parisian made conclusory opinions regarding Bayer’s and the FDA’s motives, state of mind and knowledge based on her reading of internal Bayer documents and FDA correspondence. The court reasoned that Dr. Parisian had no expertise that allowed her to infer Bayer’s and the FDA’s knowledge and intent and present those inferences to the jury. In its order the court concluded that Dr. Parisian’s opinions were also unreliable, primarily because they all suffered from a “fatal flaw: she recounts Trasylol®’s regulatory history, the contents of Bayer’s internal documents and e-mails, and the findings of scientific studies; she then offers a broad opinion, often outside her scope of expertise, that is not connected to the underlying facts in any apparent way and that lacks regulatory expert analysis.”

The court denied a subsequent motion by plaintiffs to certify for interlocutory appeal the court’s order excluding Dr. Parisian’s testimony. The court has also permitted plaintiffs to name another FDA regulatory expert, subject to certain limitations including that the expert’s testimony must be limited to areas deemed permissible by the court’s prior orders.

The court’s order on Bayer’s motion to exclude the testimony of Dr. Parisian is available at In re: Trasylol Prods. Liab. Litig. – MDL-1928, No. 08-MD-01928-Middlebrooks/Johnson, 2010 U.S. Dist. LEXIS 51811 (S.D. Fla. April 27, 2010). Squire Sanders serves as defense liaison counsel and Florida counsel for the Trasylol® MDL, and assisted in Bayer’s efforts to exclude Dr. Parisian’s testimony.