A federal judge in New Jersey has dismissed on summary judgment a bellwether case against Merck & Co. in the mass litigation over Fosamax, an osteoporosis treatment that can lead to femur fractures.
U.S. District Judge Joel Pisano on Tuesday found that plaintiff Barbara Gaynor’s claims fail because she took the drug after Merck revised its labeling in 2010 to fully convey the potential for fractures, and she did not set forth sufficient evidence that Merck did not give her doctor adequate notice.
Merck suggested Gaynor’s case for trial as representative of the interests of plaintiffs in the multidistrict litigation who attribute fractured femurs to use of the drug after the label change.
Plaintiff counsel resisted, citing incomplete discovery, which prompted Merck’s motion for summary judgment.
The ruling comes a year after a defense verdict in another Fosamax suit, brought by a user of the drug before the labeling change. Following that decision, in Glynn v. Merck, Pisano dismissed roughly 650 similar cases.
Another 215 cases pending in the MDL were brought by users of the drug after the label change.
Plaintiff counsel Paul Pennock of Weitz & Luxenberg in New York said he expects Pisano to issue an order to show cause why those cases should not be dismissed in light of the Gaynor ruling.
Gaynor, of Hicksville, N.Y., took Fosamax from 1996 until she fractured her right femur in September 2011. She claimed her long-term use of the drug made the relabeling immaterial, saying, “Merck has submitted no evidence that Mrs. Gaynor’s use of Fosamax in 2011 was a substantial factor in causing her femur fracture.”
Pisano said that argument confused the proper analysis of a failure-to-warn claim by expecting that Merck first prove that no issue of fact concerning proximate cause existed.
Pisano called Gaynor’s contention that Merck should be liable for failing to warn of Fosamax’s dangers in the late 1990s and the early 2000s “baffling,” because he had ruled in Glynn that such claims are preempted. Merck maintained that it had sought Food & Drug Administration approval of a stronger warning but it was rejected.
Pisano said Gaynor “re-characterized” her suit’s claim that Merck’s warnings about the side effects of Fosamax were inadequate when she later contended that the court should not decide that claim because it was not a proximate cause of her injury. He said she “cannot have it both ways.”
Her lawyer, Pennock, said the decision was “clearly wrong” because her fractured femur was “a fait accompli” by the time Merck changed the label.
Merck spokeswoman Lainie Keller said Wednesday: “We are pleased with the court’s ruling that the updates to the Fosamax label in 2011 were adequate as a matter of law and that Merck adequately communicated those changes to others. The company provided appropriate and timely information about Fosamax to consumers and to the medical, scientific and regulatory communities. We remain confident in the efficacy and safety profile of Fosamax and will continue to always act in the best interest of patients.”
Merck’s lawyers are from Venable in Baltimore, King & Spalding in Atlanta, Skadden, Arps, Slate, Meagher & Flom in Washington, D.C., and Fox Rothschild in Lawrenceville, N.J.
An appeal of the Glynn ruling on preemption is pending before the U.S. Court of Appeals for the Third Circuit.
All told, Merck has been named in 4,430 suits claiming Fosamax caused femur fractures. Of those, 2,785 are in state court in New Jersey, pending before Superior Court Judge Carol Higbee. Another 525 femur cases were filed in state court in California, and 1,120 went to the MDL.
The company also was named in about 1,150 suits claiming that Fosamax caused necrosis of the jawbone, most of which have settled.
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