On March 22, 2017, the Third Circuit Court of Appeals breathed new life into the Fosamax Multidistrict Litigation (MDL). Hundreds of MDL Plaintiffs allege that they suffered serious femur fractures while taking Fosamax, and that Merck failed to warn patients about that risk.
The Fosamax cases were initially consolidated into an MDL in the District of New Jersey. In 2014, after discovery and a bellwether trial, U.S. District Judge Joel A. Pisano granted Merck’s motion for summary judgment and dismissed all of the MDL Plaintiffs’ claims, finding they were preempted by federal law. Under the Supreme Court’s decision in Wyeth v. Levine, drug companies can’t be sued for failure to warn where there is “clear evidence” that the FDA considered a proposed warning but rejected it for inadequate data.
The Third Circuit reversed Judge Pisano’s ruling because there was a valid argument that Merck could have gotten approval for a fracture warning if it had described the fractures differently. The FDA’s communication to Merck showed that the agency specifically objected to Merck’s use of the term “stress fracture,” since not all fractures related to Fosamax fit that description. Accordingly, the panel found that a reasonable juror could conclude that, had Merck submitted a revised warning, it could have been approved.
This is a very good result on the preemption issue. Lawyers in our firm have handled a good number of Fosamax cases.
Sources: Law360.com and http://ca3blog.com/uncategorized/third-circuit-en-banc-procedure-the-basics-and-beyond/
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