New
Jersey U.S. District Judge Joel A. Pisano on Tuesday dismissed a suit brought
against Merck & Co. Inc., in multidistrict litigation accusing the company
of negligence over femur fractures allegedly caused by its osteoporosis
drug Fosamax,
finding the failure to warn claims fail because the drug's label is clear and
accurate.
Judge Pisano granted Merck’s summary judgment motion on grounds 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.
Judge Pisano granted Merck’s summary judgment motion on grounds 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.
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. An appeal of the Glynn ruling on preemption is pending before the U.S.
Court of Appeals for the Third Circuit. For more information on those topics, see
my previous blog posts.
Another
215 cases pending in the MDL were brought by users of the drug after the label
change.
It
is expected that Judge Pisano will issue a show cause order as to why those cases
should not be dismissed in light of the Gaynor ruling.
Gaynor,
of Hicksville, New York, 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.”
Judge
Pisano reasoned that 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 FDA approval of a stronger warning but it was
rejected.
Pisano
wrote that 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 reasoned that she “cannot have it both ways.”
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.
There
are approximately 1,150 suits pending over claims that Fosamax causes osteonecrosis
of the jawbone. Many of those claims have settled.
