A New Jersey federal judge ruled that the U.S. Food and Drug Administration’s rejection of a proposed warning from Merck means federal law preempts state law claims in multidistrict litigation that the company failed to warn consumers about certain fracture risks of its osteoporosis drug Fosamax.
In what appears to signal the end of the more than decade-long MDL, U.S. District Judge Freda L. Wolfson found that the claims are preempted because the FDA would not have approved a “differently worded warning,” given that the basis for its 2009 decision was its belief that there was insufficient evidence connecting Fosamax to atypical femoral fractures.
The judge rejected the plaintiffs’ argument, which she said they made “for the very first time in this long-pending MDL,” that the FDA’s complete response letter, or CRL, about Merck’s proposed warning is not preemptive since it does not constitute a final agency action.
The MDL includes claims from more than 500 plaintiffs who say they suffered atypical femoral fractures between 1999 and 2010 after using Fosamax.
Tthe FDA signed off on a warning about risk of such fractures in the “adverse reactions” section of Fosamax’s label but not for the “precautions” section.. Between the two sections, the standard for a warning in the adverse reactions section is lower.
After further investigation, the agency in 2010 directed Merck and other drug manufacturers to include a warning about the risk in the precautions sections of their labels.
The judge’s decision is essentially the same conclusion reached in 2013 by U.S. District Judge Joel A. Pisano, who found that federal law preempted the plaintiffs’ state law failure-to-warn claims. About four years later, the Third Circuit overturned that decision, finding that a jury should decide the issue of preemption.
The judge rejected the plaintiffs’ claims that Merck misled the FDA, including by stating in its proposed warning for the precautions section that “stress fractures with similar clinical features also have occurred in patients not treated with bisphosphonates.” The FDA included similar language in the warning it ultimately approved.