Products Liability Law Daily Failure-to-warn claims fail without evidence of additional information affecting decision-making
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Thursday, October 6, 2016

Failure-to-warn claims fail without evidence of additional information affecting decision-making

By Kayla R. Bryant, J.D.

A negligent failure to warn claim brought by the estate of a deceased patient could not succeed in a learned intermediary state when there was no evidence that additional warnings would have changed the decision to prescribe the drug, a three-judge panel for the U.S. Court of Appeals for the Third Circuit held in a decision designated as not precedential. The panel ruled that a Pennsylvania federal district court properly dismissed claims alleging that Novartis Pharmaceuticals Corporation (Novartis) failed to warn that its drugs, Aredia® and Zometa®, could contribute to osteonecrosis of the jaw (ONJ). The patient’s death precluded any testimony that his doctors were not aware of the drugs’ risks, and the physicians all testified that they would still use/prescribe the drug in a similar situation (Bock v. Novartis Pharmaceuticals Corp., October 5, 2016, Greenaway, J.).

Drugs and injury. Aredia and Zometa are bisphosphonates and are intended to inhibit bone resorption in patients who have a complication of cancer caused by calcium release into the bloodstream, known as hypercalcemia of malignancy (HCM). After studies indicated a potential link because these therapies and ONJ, Novartis changed their packaging in 2003 and 2004 to provide notice of the ONJ cases and to encourage caution when undergoing dental procedures while using these medications. The drug maker also notified the medical community of changes to the package inserts including precautions about ONJ through "Dear Doctor" letters in 2004 and 2005.

In the fall of 2005, the patient, who had a history of cancer, was diagnosed with HCM and multiple myeloma, and was prescribed Aredia. The oncologist was aware of the possibility of ONJ and stated that it was his practice to discuss this risk with his patients. Around this same time, the patient began to see a hematologist, who also was prescribing these therapies to patients with multiple myeloma. The hematologist was aware of the risks of ONJ, and his records indicated that the patient was to take Zometa indefinitely. Records also stated that the patient and his family were warned, in detail, of the risks associated with any dental surgeries and the need to inform the hematologist right away of any dental problems.

Later, a dental extraction was performed, leading to a lesion. The patient was referred to an oral surgeon who diagnosed the patient with osteonecrosis and proceeded to perform another surgery after reviewing the potential risks. In 2010, the patient filed a complaint against Novartis alleging counts of strict liability and negligence, which were all dismissed. The patient appealed the failure to warn claim.

Elements. The appellate panel analyzed the required elements of duty, breach, and causation and noted that Pennsylvania uses the learned intermediary doctrine in failure to warn cases related to drugs. A manufacturer can be held liable only if it did not use reasonable care in informing a physician of a drug’s danger. Causation can be shown if the doctor would have declined to prescribe the drug or detailed the known risks to a patient who would have then declined the drug if the doctor had been properly warned.

The court agreed with the district court’s reasoning that the evidence in the case precluded a showing of proximate causation. The patient’s death precluded testimony that he would have declined the drugs. Also, the physicians testified that while they were aware of the risks, they would have discussed the risks with the patient, and still would have prescribed the drug if presented with a similar patient because the benefits of the drug outweighed the risks. Thus, the dismissal was affirmed.

The case is No. 15-3696.

Attorneys: Avrum Levicoff (Levicoff Silko & Deemer PC) for William M. Bock. Jeffrey Cohen (JonesPassodelis PLLC) and Katharine R. Latimer (Hollingsworth LLP) for Novartis Pharmaceuticals Corp.

Companies: Novartis Pharmaceuticals Corp.

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