It took us more than a week, but we finally put away the last serving pieces from last week’s family Hanukkah celebration. We love Hanukkah, a festive holiday that celebrates victory over a tyrant king, a reclaimed temple, and a small quantity of oil that should have lasted only one night but that miraculously burned for eight nights. In commemoration, we light candles for eight nights. And we use oil. Lots and lots of oil. Like, eight dozen potato latkes-worth of oil. Though the holiday has far less religious significance than does Christmas, it is a time for family and gifts and food and song and celebrating the “miracle” of the bit of oil that improbably shed eight nights of light.
In a similar vein (pun intended), today we celebrate a very short, but surprisingly bountiful, decision out of the inferior vena cava (“IVC”) filter MDL pending in the Southern District of Indiana. We love warnings causation, a potent doctrine too often rendered toothless by passive judges. Not so in In re Cook, Inc. IVC Filters Marketing, Sales Practices, and Prods. Liab. Litig. (Tonya Brand), 2018 WL 6415585 (S.D. Ind. Dec. 5, 2018). In the IVC filter MDL, the plaintiffs allege that the filters are prone to tilting, migrating, fracturing, and perforating the inferior vena cava. In Brand, the defendants’ IVC filter was inserted in the plaintiff’s inferior vena cava to prevent pulmonary embolism during an upcoming spine surgery. Two years later, the plaintiff began to experience pain on the inside of her right thigh. Shortly thereafter, the plaintiff noticed something protruding from her thigh and pulled out a portion of her IVC filter. The plaintiff was required to undergo open surgery to remove the rest of the filter. The plaintiff sued, alleging that the instructions for use (“IFU”) that accompanied her filter did not adequately warn her physician of the risks associated with the filter.
The court explained that, under Georgia’s learned intermediary doctrine, the plaintiff could prevail on her warnings claims only by proving both that the warnings in the IFU were inadequate and that the inadequate warnings proximately caused her injuries. The court emphasized, “Where the learned intermediary has actual knowledge of the substance of the alleged warning and would have taken the same course of action the plaintiff contends should have been provided, . . . the causal link is broken and the plaintiff cannot recover.” 2018 WL 6415585 at *3. The plaintiff’s physician testified that he was aware of all of the relevant risks when he implanted the Plaintiff’s IVC filter. His knowledge of the risks was not based on the IFU; rather, it was based on his “education, training, and experience.” Id. Moreover, the doctor testified that he continued to use the defendant’s filter even after the plaintiff’s filter fractured, and that nothing about the plaintiff’s experience changed his mind about IVC filters in general or about the specific filter he used in the plaintiff. The court held, “In the face of this devastating testimony, Plaintiff fails to raise a genuine issue of material fact on the proximate causation element” of her failure-to-warn claims. Id. at *4.
The plaintiff also argued that the defendants breached Georgia’s continuing post-sale duty to warn because they did not warn her physician, after he implanted her filter, of the filter’s propensity to perforate and fracture. She alleged that, if the defendants had provided such a warning, her doctor “potentially could have removed the filter before it fractured and pieces migrated throughout [her] body.” Id. The court rejected this argument as well, holding that it was based on speculation and that the evidence, including the fact that the plaintiff’s physician continued to use the same filter in patients even after the plaintiff’s filter fractured, suggested that no post-placement warning would have prompted the doctor to retrieve the plaintiff’s filter any earlier. As such, the plaintiff “fail[ed] to raise a genuine issue of material fact that any post-implant failure to warn caused her injuries.” Id. Because the plaintiff failed to sustain her burden of proving the causation element of her warnings claims, the court granted summary judgment for the defendants on those claims and on the claims that were based on them.
We make these same arguments over and over and over again in our medical device cases. We often don’t prevail, even on clear records. We wish that more courts had the clear-eyed approach to warnings causation that this MDL judge employed. We will keep you posted on similar decisions. And we still have a couple dozen potato latkes in the freezer, in case you are in our neighborhood.