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From Products Liability Law Daily, June 18, 2014

Merck scores win in Fosamax® failure-to-warn decision

By Leah S. Poniatowski, J.D.

A patient who sustained a femur fracture after long-term use of the bisphosphonate drug Fosamax® did not establish that the drug manufacturer failed to warn of the risk, the federal district court in New Jersey ruled in an unpublished opinion (In re: Fosamax Products Liability Litigation (Gaynor v. Merck Sharp & Dohme Corp.), June 17, 2014, Pisano, J.).

Background. Barbara Gaynor had been prescribed Fosamax® for her osteoporosis in 1996 and continued to take the drug until September 2011, when she sustained a right spontaneous atypical femur fracture. Merck Sharp & Dohme Corp. manufactures Fosamax® and was contacted, along with other bisphosphonate manufacturers, in June 2008 by the Federal Drug Administration about occurrences of atypical fractures with bisphosphonate use. The FDA requested investigations conducted by the manufacturers of these types of occurrences after the agency became aware of reports of these fractures in patients using those drugs.

Merck complied with the FDA’s request and submitted a Prior Approval Supplement to add language to the Precautions and Adverse Reactions/Post-Marketing Experience to share that there was an increase in atypical femur fractures associated with Fosamax®. However, the FDA rejected the label change on the ground that the data did not support a clear connection between use of bisphosphonates and atypical fractures.

After an independent research group reported its study in September 2010, the FDA issued two Drug Safety Communications. The communication issued in October 2010 required all bisphosphonate manufacturers to add information on atypical femur fractures to the Precautions section of the drug labels and required a new Limitations of Use statement in the Indications and Usage section because these fractures might be related to long-term use, usually more than three years, of those drugs. In January 2011, Merck incorporated the warning. Multi-district litigation against Merck followed, and cases arising from these injuries had been identified as “pre-label change” and “post-label change.”

The patient in this case filed a lawsuit against Merck in 2012 alleging that her long-term use of the drug caused her femur fracture. She asserted 13 causes of action, namely a failure to warn under New York law and several state-law negligence and related claims. Because her injury occurred after September 14, 2010, her claim was in the “post-label change” category. Specifically, the patient’s failure- to-warn claim was based on the allegation that the drug was not accompanied by appropriate warnings which reflected the risk of use of the drug, and that the manufacturer failed to timely and reasonably warn the patient and her physicians of the safety and efficacy of the drug.

Duty to warn. The court concluded that the patient’s arguments were inconsistent because one focused on proximate cause without addressing breach, and the second addressed breach without addressing proximate cause. The allegation that the manufacturer failed to update its label by the early 2000’s could not form the basis of the failure-to-warn claim because there was clear evidence that the FDA would have rejected a stronger warning label prior to the independent study in 2010. The second theory—that the manufacturer failed to communicate the January 2011 revised warning to the patient’s physician—also failed to support the breach allegation because the patient’s own expert concluded that the patient would have suffered the injury regardless of any warning.

The court also determined that the label was adequate as a matter of law with respect to atypical femur fractures. The label was accurate, the language on the warning label was sufficiently clear, direct, unequivocal, and sufficiently conveyed the risks of taking the drug. The warnings and medication guide were consistent, precise, and without any contradictions. Additionally, the patient failed to establish that there was a material fact at issue on whether the manufacturer communicated these warnings to her physician. The evidence provided by the manufacturer established that the drug label expressly warned of the exact injury the patient sustained, and the label’s content reflected the exact language required by the FDA. Therefore, the manufacturer was entitled to summary judgment on the failure-to-warn claim.

The court also held that because the remaining state-law claims were predicated upon the failure to warn claim, the manufacturer was entitled to summary judgment on all the claims.

The case number is 12-1492, 08-08.

Attorneys: Edward Braniff (Weitz & Luxenberg) for Barbara Gaynor.

Companies: Merck Sharp & Dohme Corp.

MainStory: TopStory WarningsNews DrugsNews NewJerseyNews

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