Status Update on Federal Yaz-Yasmin Litigation

A hearing was held by Judge Herndon in the Yaz/Yasmin federal court proceedings on September 19, 2011. The hearing resolved disputes that had arisen between plaintiffs’ lawyers and the lawyers for drug maker Bayer over the scheduling of depositions for the expert witnesses that each side intends to present at Yaz-Yasmin trials. The judge ruled in favor of the plaintiffs, allowing more time to schedule the depositions so that the plaintiffs’ lawyers who were the most well-versed on the witnesses’ expertise could participate in the depositions.

Expert witnesses are required in all pharmaceutical cases to establish that the drug in question was capable of causing a particular side effect. In the Yaz and Yasmin cases, the plaintiffs’ experts will rely on epidemiology studies to prove that Yaz and Yasmin cause blood clots, strokes, pulmonary embolisms, deep vein thrombosis, and gallbladder issues. These epidemiology studies compare the experiences of two groups of women — one group that took Yaz or Yasmin, and one group that did not. If a higher percentage of the Yaz/Yasmin group suffered pulmonary embolisms (or deep vein thrombosis, or strokes, etc.) than the other group, the study will support expert testimony that Yaz causes pulmonary embolisms. The larger the discrepancy between the two groups, the stronger the study will be for proving “causation.”

These expert witnesses on Yaz-Yasmin causation can testify at a “general” level, or a “specific” level. At the general level, the experts testify that the drug is capable of causing a side effect — that based on medical science, we understand the mechanism by which Yaz or Yasmin interacts with the body and with particular organs to cause an increase in the formation of blood clots. They also testify that when observed in large groups of the general population, doctors actually diagnose more blood clots and clotting-related issues among Yaz and Yasmin users. This general causation testimony is required before the Yaz/Yasmin litigation can move forward.
The expert witnesses must also testify about “specific causation” — they must be certain to a reasonable degree of medical certainty that a particular woman’s blood clots were caused by Yaz or Yasmin. These experts rule out other causes, like family history or conditions that existed before Yaz was prescribed. Because these factors change in every case, these experts must be familiar with each woman’s medical history. These experts’ opinions are comparable to the plaintiff’s personal physician, who often expresses an opinion at the time of diagnosis that Yaz must have caused the adverse event (like blood clots, pulmonary embolisms, gall bladder, etc.).

Judge Herndon’s ruling cleared the way for the experts’ depositions to move forward during October and November. Following the depositions, Bayer filed motions to have the judge decide that the plaintiffs’ experts are “unreliable,” or that their conclusions are based on junk science. These motions are called Daubert motions, based on a famous Supreme Court case that decided that federal judges could exclude crazy or unsupportable testimony that was generated just for a lawsuit. Interestingly, the experts in the Yaz-Yasmin cases rely upon studies conducted by reputable organizations that are trying to protect women’s health. Bayer’s motions are just another tactic to discredit the mountain of scientific evidence that is stacked up against the company in the Yaz and Yasmin cases.

Even Judge Herndon questioned how Bayer could have known that it would be filing these Daubert motions long before Bayer heard the expert’s testimony in the deposition. Despite Judge Herndon’s admonition that “caution[ed] everyone against simply filing Daubert motions for the sake of filing a Daubert motion,” Bayer filed motions to exclude every expert witness designated by any plaintiff in the case. Apparently, in Bayer’s view, any scientific or medical expert on Yaz and Yasmin that disagrees with the company is not only wrong, they don’t even qualify as legitimate scientists or doctors. The Judge will be holding a hearing on December 8, 2011 to decide — and hopefully deny — Bayer’s motions.

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