Summary Judgment Granted in Lawsuit Over Fosamax Fracture Warnings

The federal judge presiding over all Fosamax femur fracture lawsuits has granted summary judgment in favor of Merck in a bellwether case, finding that warnings issued by the drug maker in 2011 were sufficient.

Merck has faced more than 1,000 product liability lawsuits involving allegations that the drug maker failed to adequately warn about the risk of femur fractures associated with long term use of the medication.

All of the plaintiffs claim that they suffered suffered spontaneous femur fractures following long-term use of Fosamax, which typically occurred with little or no trauma at all, such as while taking a step or falling from standing height or less.

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Since May 2011, all cases pending in the federal court system cases have been centralized before U.S. District Judge Joel Pisano in the District of New Jersey, as part of a multidistrict litigation (MDL) for coordinated pretrial proceedings.

Earlier this year, Judge Pisano entered an order dismissing hundreds of Fosamax cases where plaintiffs claimed that they suffered a femur fracture prior to September 14, 2010, finding that any failure to warn claims prior to that date are pre-empted by federal law since there is evidence that the FDA would have rejected any request to strengthen the Fosamax warning label prior to that date.

Remaining cases in the Fosamax fracture MDL all involve claims for injuries that came after a label update issued by Merck and the FDA in late 2010, which was sent to doctors in January 2011. Plaintiffs in those cases have maintained that the label warning remained insufficient and that information about the risk was not properly provided to doctors.

In an order (PDF) issued June 17, Judge Pisano granted summary judgment in favor of merck in a bellwether case involving a post-label update injury. The case involved an injury suffered by Barbara Gaynor, who began using Fosamax in 1996 and suffered a spontaneous atypical femur fracture in September 2011, following the label update.

Judge Pisano found that Gaynor failed to put forth a sufficient argument to support its claim that Merck failed to adequately warn the medical community after September 2010 in a way that could have prevented Gaynor’s injuries.

“As a whole, the label conveys an unmistakable meaning as to the consequences of ingesting Fosamax and instead of simply stating that a side effect may result from use of the drug, it advises physicians of the specific manner in which an AFF may materialize,” Judge Pisano wrote. “Thus, in finding that the label is accurate, clear, consistent and as a whole conveys a meaning that is unmistakable as it relates to AFF’s, the Court is satisfied that the Fosamax label is adequate as a matter of law.”

While this particular judgment only applied to Gaynor’s claim, the decision leaves the hundreds of remaining Fosamax lawsuits involving post-September 2010 injuries in jeopardy. It is likely that Judge Pisano will issue a show cause order, calling for remaining plaintiffs to establish why their cases should not be dismissed in light of this new ruling.


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