(Adds Merck comment, updates share price)
By Jonathan Stempel
March 22 A federal appeals court on Wednesday
revived claims by several hundred plaintiffs who accused Merck &
Co of failing to adequately warn about the risks of
thigh bone fractures associated with its osteoporosis drug
In a 3-0 decision, the 3rd U.S. Circuit Court of Appeals in
Philadelphia said the plaintiffs may proceed to trial on their
failure-to-warn claims, and a lower court judge erred in finding
the claims pre-empted by federal law.
Merck said it is reviewing its options, and that a judge,
not a jury, should decide the pre-emption question. It also said
it remains "confident" in Fosamax's safety and effectiveness.
David Frederick, a lawyer for the plaintiffs, did not
immediately respond to requests for comment.
Fosamax, whose chemical name is alendronate sodium, has been
prescribed to treat or prevent bone loss in post-menopausal
women since 1995.
But the plaintiffs claimed to suffer atypical femur
fractures from long-term use, and said Merck knew about the risk
for more than a decade before adding it to the Fosamax warning
label in January 2011.
The Kenilworth, New Jersey-based company changed the label
four months after an outside task force hired by the U.S. Food
and Drug Administration published a report associating Fosamax
with the fractures.
In March 2014, U.S. District Judge Joel Pisano in Trenton,
New Jersey, dismissed all claims by plaintiffs injured before
Sept. 14, 2010, the date of the task force report, leaving only
about 20 active cases.
The judge, who retired from the bench in 2015, cited a 2009
U.S. Supreme Court decision that state law-based failure-to-warn
claims were pre-empted when there was "clear evidence" that the
FDA would not have approved a warning that plaintiffs requested.
Writing for the appeals court, however, Circuit Judge Julio
Fuentes found enough evidence for a reasonable jury to conclude
that the FDA would have approved "a properly-worded warning"
about Fosamax, "or at the very least, to conclude that the odds
of FDA rejection were less than highly probable."
Fuentes said a jury could also find that some doctors would
not have prescribed Fosamax had Merck discussed the risk of
fractures on a warning label.
Merck's annual sales of Fosamax regularly topped $3 billion
before the company lost patent exclusivity in 2008.
Fosamax is now available as a generic. Sales of Fosamax
totaled $284 million last year, down from $3.05 billion in 2007.
In afternoon trading, Merck shares were down 0.8 percent at
The case is In re: Fosamax (Alendronate Sodium) Products
Liability Litigation, 3rd U.S. Circuit Court of Appeals, No.
(Reporting by Jonathan Stempel in New York; Editing by Bill
Trott and Matthew Lewis)