Court revives more than 500 lawsuits over Fosamax femur fracture risk

Organon & Co.

20/09/2024 22:25

By Brendan Pierson
       Sept 20 (Reuters) - A U.S. appeals court on Friday
revived more than 500 lawsuits alleging that Merck & Co  MRK.N 
failed to warn that its osteoporosis drug Fosamax increased the
risk of thigh bone fractures.
    A unanimous panel of the Philadelphia-based 3rd U.S. Circuit
Court of Appeals ruled that federal law did not block the
plaintiffs' state law claims over the drug. Fosamax was acquired
in 2021 by Organon  OGN.N , which agreed to indemnify Merck
against liability from the lawsuits.
    "We're pleased by the Third Circuit's very careful and
nuanced judgment, which gives Fosamax victims an opportunity to
seek justice from Merck," David Frederick of Kellogg Hansen Todd
Figel & Frederick, a lawyer for the plaintiffs, said in an
email.
    Merck referred a request for comment to Organon, which said
it "remains confident in the efficacy and safety profile of
Fosamax."
    About 3,115 lawsuits over Fosamax were pending against Merck
in both federal and state courts around the country as of June
30, according to Organon's most recent quarterly report. The
cases affected by Friday's ruling are federal cases that have
been centralized in New Jersey.
    The federal litigation stretches back to 2008, and has now
been dismissed and revived twice. All of those decisions have
hinged on the issue of federal preemption - whether the federal
law governing what pharmaceutical companies are required to put
on drug labels overrides, or preempts, state law claims that the
label fails to warn consumers.
    Merck has argued that it does, saying that in 2009 it
proposed adding a warning about femur fractures but was
initially rejected by the FDA. The warning was eventually added
in 2011.
    Now-deceased U.S. District Judge Joel Pisano in Trenton, New
Jersey, ruled in Merck's favor on the preemption issue in 2013,
but the 3rd Circuit overturned that ruling in 2017, concluding
that issue should have been decided by a jury.
    The U.S. Supreme Court in 2019 ordered the issue
reconsidered once again, saying it was a legal issue for a
judge, not a jury.
    In 2022, U.S. District Judge Freda Wolfson, who had taken
over the case, again sided with Merck on preemption.
    The 3rd Circuit on Friday, however, again reversed. It said
that, even though the FDA had not approved the specific warning
proposed by Merck in 2009, it would not necessarily have
rejected any warning about femur fractures.
    It said that Wolfson's decision failed to interpret the
FDA's action "in a manner that disfavors pre-emption and carries
out Congress's intent to permit displacement of state law only
when it is abundantly clear that it is impossible for a
manufacturer to comply with both federal and state law."
    Circuit Judge Kent Jordan wrote the opinion, joined by
Circuit Judges Peter Phipps and Arianna Freeman.
    Wolfson has since retired, and the case is now assigned in
the trial court to U.S. District Judge Karen Williams. The
litigation will return to that court for potential future
trials.
    The case is In re Fosamax (alendronate sodium) Products
Liability Litigation, 3rd U.S. Circuit Court of Appeals, No.
22-3412.
    For plaintiffs: David Frederick of Kellogg Hansen Todd Figel
& Frederick
    For Merck: Yaakov Roth of Jones Day
    
    Read more:
    Merck defeats 500 lawsuits over Fosamax bone-fracture risk
warnings
    Supreme Court gives Merck another shot to avoid Fosamax
lawsuits

 (Reporting By Brendan Pierson in New York)
 ((Brendan.Pierson@thomsonreuters.com; 332-219-1345 (desk);
646-306-0235 (cell);))