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From Products Liability Law Daily, July 29, 2014

 “Armies of expert witnesses” to evaluate Novartis warnings’ adequacy

By Bryant Storm, J.D.

A federal district court in Pennsylvania allowed two of three products liability challenges against Novartis Pharmaceuticals Corporation (NPC) to continue. The claims are premised on allegedly inadequate warnings the manufacturer gave physicians relating to the use of its cancer drug, Zometa®. The court held that although one injured patient could not show a dispute as to whether a change in manufacturer warnings would have altered the course of his treatment, the other two patients’ claims did raise such a dispute. Therefore, the court decided, those two claims would be allowed to continue so that a jury could determine the adequacy of the warnings (Rowland v. Novartis Pharmaceuticals Corp., July 28, 2014, Hornak, M.).

Zometa. The three lawsuits before the court centered on an FDA-approved intravenous bisphosphonate (IV BP) prescription drug used to prevent bone destruction in cancer patients. Zometa, the drug at issue, is an IV BP manufactured by NPC. Each of the three patients developed osteonecrosis of the jaw (ONJ). ONJ causes permanent disfiguration, severe pain, and bone death, which sometimes leads to the loss of the jaw bone. The injured patients contended that they developed a specific kind of ONJ, known as bisphosphonate-induced osteonecrosis of the jaw (BIONJ), as a direct result of using Zometa. Karen Rowland, George Machen, and Michelle Pratt Orr were each prescribed Zometa, and each took the drug for a period time before being taken off the medicine due to ONJ symptoms or diagnosis. Rowland, Machen’s wife, and Orr brought products liability actions against NPC contending that, among other things, NPC had failed to give adequate warnings to prescribing physicians regarding the risk of ONJ presented by IV BPs like Zometa.

Failure to warn. To succeed on their failure to warn negligence claims, the three plaintiffs needed to show: (1) NPC owed them a duty; (2) NPC breached that duty; and (3) the breach was the proximate cause of their BIONJ injuries. Under Pennsylvania law, the warnings that the plaintiffs claimed were negligently given are warnings which a drug manufacturer must give to a physician. To have been lawful, the warnings from NPC to physicians needed to be adequate. In other words, the Zometa warnings or label needed to have accurately conveyed the scope and nature of the ONJ risk posed by the drug.

Adequacy. Despite NPC’s contention that the warnings were factually accurate and sufficient to apprise physicians and patients of the risk of ONJ, the court held that resolution of that question was best made by a jury. The court reasoned that the question was not one that the court was qualified to answer. Rather, it said that the best solution was to allow the “armies of expert witnesses,” enlisted by the parties, the opportunity to clarify the difficult fact question.

Causation. NPC’s most significant objection to the failure to warn claim challenged the plaintiffs’ contention that, but for the negligent warnings, they would not have been injured. The essence of NPC’s argument was that even if the patients had been given full knowledge of the relationship between IV BPs and ONJ, the prescribing physicians still would have prescribed the drugs; and, therefore, NPC’s allegedly inadequate warnings were not to blame for the resulting BIONJ. The court agreed with NPC with respect to the patient, George Machen, because he was not able to make a showing that a warning would have had any impact on his taking Zometa and his subsequent BIONJ. The court reasoned that all the evidence suggested Machen would have been prescribed Zometa, would have taken the drug, and would have had undergone dental procedures which caused or exacerbated his BIONJ regardless of any additional warnings.

However, the court ruled that the claims relating to Orr and Rowland presented more complex factual issues. Specifically, the court found that there was a factual dispute about how much caution Orr’s and Rowland’s physicians would have exercised had they been given additional warnings. The court held that because there was a factual dispute over whether additional warnings would have caused Orr and Rowland to not take Zometa, the issue had to be decided by a jury. The court dismissed Machen’s case in its entirety but allowed Orr’s and Rowland’s failure-to-warn claims to proceed.

The case numbers are 2:12-cv-01474, 2:12-cv-01476, and 2:12-cv-01715.

Attorneys: John J. Vecchione (Valad & Vecchione, PLLC) for Karen Rowland. Constantine J. Passodelis (JonesPassodelis PLLC), Ethan D. Stein (Gibbons PC), and Neil S. Bromberg (Hollingsworth LLP) for Novartis Pharmaceuticals Corp.

Companies: Novartis Pharmaceuticals Corp.

MainStory: TopStory WarningsNews DrugsNews PennsylvaniaNews

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