A key to many drug or device law cases is the learned intermediary doctrine. It can powerful, and so we generally approach it with great care and from multiple angles. We meticulously develop labeling histories to establish when the label first mentioned the alleged side effect and how and where it was discussed over time. We do scientific research so that we can show the contemporaneous state of the science, when there was a signal to warn and, just as important, when there wasn’t, and we then match that to the contents of the label. We lay out the company’s internal and regulatory history to show that it understood and advanced the science and included it, when appropriate, in the label. And we take testimony of prescribers and treaters to show that they knew the potential side effects, were warned, and/or would’ve made the same decision even today. When we do this well in discovery, we often feel that we should win summary judgment.
But despite a good discovery record on the learned intermediary doctrine courts sometimes seem unwilling to end a case before trial. They gloss over which party has the burden of proof. They can misconstrue the doctrine as an affirmative defense. They can punt the decision on a seemingly adequate warning to the jury, or ask the jury to consider whether it should have been disseminated differently or better. We’re sure that many of you have had similar experiences on summary judgment.
With that background, we want to discuss D’Agnese v. Novartis Pharmaceuticals Corp., 2013 U.S. Dist. LEXIS 92757 (D. Az. July 2,
2013). It involves a plaintiff (and his wife suing for loss of consortium) who claimed to have suffered bisphosphonate-related osteonecrosis of the jaw as a result of using Aredia/Zometa. While he brought a number of claims, they were all, at bottom, based on failure to warn. And the learned intermediary doctrine played a vital role. The defendant, Novartis, established its labeling history during discovery. It had placed osteonecrosis in the Adverse Reactions section in September 2003 and revised the language in February 2004 to say that causality could not be determined but it was prudent to avoid dental surgery while on the drug. In September 2004, Novartis added a three-paragraph discussion of osteonecrosis to the Precautions section. It sent a Dear Doctor Letter to doctors attaching the revised label. Id. at *15-18.As for plaintiff, his original prescriber prescribed him Aredia in 1996. In March 2005 – after all these label changes were put into effect – a second prescriber informed plaintiff of the risk of osteonecrosis, plaintiff signed an informed consent form and, later that year, plaintiff made it clear that he wanted to continue on the drug. Plaintiff’s story was different in litigation. He claimed no memory of the risk discussion or of signing the informed consent. In 2005, Plaintiff was tentatively diagnosed with osteonecrosis of the jaw. Finally, plaintiff’s second prescriber testified that he still prescribes Zometa today and even suggested that plaintiff restart it in 2010. Id. at *18-19.These facts make this is one of those cases that we feel should be a defense win on summary judgment. But, as we mentioned, we’ve seen courts find the smallest of holes through which to push a trial. Maybe the plaintiff’s different recollection about being told of the risk is enough for a jury to consider. . . . Or maybe a court could send it to a jury because there was no testimony from the original prescriber, like there was from the second prescriber, that he still prescribes Zometa and suggested that plaintiff restart it . . . . Or maybe there were some adverse events or animal studies that the doctor didn’t know about … Let a jury decide.
Continue Reading An Aredia/Zometa Win Thanks to the Learned Intermediary Doctrine