The massive Taxotere multi-district litigation (“MDL”) arises out of a breast cancer chemotherapy drug, which plaintiffs claim has caused the undisclosed side-effect of permanent baldness. As is common in many large-scale pharmaceutical cases, the Taxotere case involves hundreds of claims, as well as highly technical medical issues. As a result, the Taxotere MDL is the latest case in which the Court ordered what has been commonly referred to as a “science day,” during which experts from both sides will be able to present scientific information regarding the drug and its alleged effects in an informative, non-adversarial format. Essentially, these sessions provide somewhat of a tutorial for the Court. Usually cross-examination is forbidden, and the transcript of the proceeding is not shared with the parties. It is intended to be an educational exercise, so that the Court can learn more about the case and the science involved. As such, it has become increasingly regular for science days to be ordered in pharmaceutical MDLs. Although it is intended to be a non-adversarial tutorial session, the science day is the first chance that parties and their experts have to sway the Court. As such, attorneys and their expert witnesses should have a theory of the case developed, and be well-prepared to be as persuasive as possible while sticking within the non-adversarial boundaries set by the Court.
Taxotere
The Taxotere MDL continues to grow in the Eastern District of Louisiana. The central issues in the case arise out of allegations that the chemotherapy drug Taxotere caused permanent hair loss, that defendants were aware of this side effect and failed to warn patients, and that defendants marketed Taxotere as more effective than other chemotherapy drugs when other drugs were equally effective without the risk of permanent hair loss. The manufacturer defendant is Sanofi S.A., but recently lawsuits against generic manufacturers of the drug have been included in the consolidated lawsuit. As of February 15, 2017, the multi-district litigation had 755 separate lawsuits. Pursuant to a pre-trial order, the parties will finance a litigation fund account, which will pay for expert witnesses and other litigation costs.
What are Science Days?
Science days have become increasingly common in large complex pharmaceutical lawsuits. The American Bar Association describes science days as “tutorials that explain the complicated science issues to the judge.” They are designed to educate judicial officers, and typically involve multiple expert witnesses, including physicians and researchers, who will explain “medical and scientific facts behind how the drug works, the studies that have been conducted so far, and the results of those studies and what they mean for patients.” As one commentator describes, a science day is essentially the Court inviting both sides to “come in, lawyers, put on witnesses, no cross-examination,’ more like a classroom, ‘and tell us your view of how the science is supposed to work in this particular case.”
Once the Court permits a science day, it will establish the structure of the presentation, which could include a request for prerecorded or live presentations by experts. Science days have been described as “essentially lectures by experts selected by both sides; question and answer sessions with court participation — in which cross examination may or may not be permitted; or written presentations in which key background texts and analyses are summarized and made available to the court.” They are designed for the free-flow of information and, usually, the Court prohibits cross-examination and disallows the parties from reviewing the transcript. Some Courts have prohibited the recording of science days altogether “in order to facilitate a more candid and informational educational process.”
It should be noted that science days are typically scheduled before Daubert motion practice, and prior to the exchange of expert reports. They are sometimes thought of as a precursor to Daubert hearings that the Court uses to learn about the pharmaceutical product and the various health and medical issues.
Large Pharmaceutical MDLs Schedule Science Days
Science days are a common occurrence in pharmaceutical MDLs. Below are a few examples of some of the nation’s largest pharmaceutical MDLs that have ordered science days:
• In a MDL regarding a diabetes pharmaceutical Invokana and Invokamet, the Court ordered a science day where both sides will be allowed to present expert medical and scientific evidence in non-adversarial, off-the-record presentations. • In a MDL concerning the antibiotics Levaquin, Cipro and Avelox, the Court ordered a Science Day where “presentations will be made by physicians and scientists who will not be sworn in and who will not be cross-examined by opposing counsel.” The Court further directed that “counsel may lead their own expert through a ‘modified direct’ format to focus on the witnesses’ lectures.” The presentations will be off the record and the transcript will only be available to the Court. • In a MDL arising out of the blood-thinner pharmaceutical Xarelto, the court also ordered a science day where both sides will present expert physicians and researchers. • In a MDL arising out of the anti-psychotic pharmaceutical Abilify, a science day was ordered where each side will be able to present all the educational scientific and medical information they deem relevant to the case or that could come up during litigation. • In a talcum powder MDL, science days were ordered to educate the Court about the science and medical evidence that will be presented in the litigation. • A science day was also ordered in a case involving the weed-killer Roundup. In the Roundup case, the defense claimed that the plaintiffs were using “junk science,” prompting the Court to order a science day to seek a more thorough understanding of the research regarding glyphosate’s potential role as a carcinogen. • A science day was also ordered in the Januvia MDL, a case regarding a diabetes drug which is alleged, which is alleged to be linked to causing pancreatic cancer. • In a medical products MDL about a warming system to prevent hyperthermia during surgical procedures, the Court also ordered a science day to teach the Court about the scientific and medical issues at play.
As the Taxotere case has re-confirmed, science days are becoming a necessary part of pharmaceutical MDLs. Attorneys and expert witnesses should be aware of this practice and begin to prepare for these science days early and often. Although many of the science days are structured so that cross-examination is prohibited and the record is not distributed to the parties, the parties should try to use what they learn from their opponent’s expert witnesses to their advantage later in the litigation, even if the statements during the science day cannot technically be used. This sort of tutorial day seems to be increasingly common, and attorneys in major pharmaceutical MDLs would be well-served in maximizing their opportunity to use the science day to begin to sway the Court and to capture as much information as possible about their opponent’s stable of experts and their opinions.
Joseph B. Evans focuses his practice on the defense of Federal and New York State criminal and regulatory inquiries and the prosecution of complex litigation matters. He is an associate at Gage Spencer & Fleming LLP, a trial law firm well known for defending the nation’s most high-profile white-collar criminal cases from inception to verdict.
