Court Rules Judge, not Jury, Should Rule on Merck Fosamax Case
May 20 2019 - 6:51PM
Dow Jones News
By Jess Bravin
WASHINGTON -- Merck & Co. won a partial victory at the
Supreme Court, with the justices unanimously ruling that a judge,
rather than a jury, must determine whether federal regulators took
steps that immunize the company from claims its osteoporosis drug
Fosamax injured patients.
The court agreed with Merck that juries are less suited than
judges to decide often technical questions of whether the Food and
Drug Administration was provided sufficient information and refused
to approve changes to the drug's warning label regarding potential
injuries.
Still, the majority opinion, written by Justice Stephen Breyer,
suggested Merck may have a difficult time proving its position
before a judge. Three conservative justices disputed that
implication in a concurrence that construed the facts more in
sympathy with the Kenilworth, N.J., company.
Fosamax helps treat and prevent osteoporosis, a condition that
can cause bone fractures in postmenopausal women, by adjusting the
process by which the body replaces old bone cells. But evidence
collected after the drug went on sale in 1995 indicated Fosamax
also may increase the risk of a different class of bone damage
known as atypical femoral fractures.
In 2011, Merck and the FDA agreed to revise the Fosamax label to
reflect such risks; more than 500 people who took the drug before
the label change and suffered atypical fractures sued, arguing that
the company should have acted more quickly to warn physicians and
patients of the risk.
Under Supreme Court precedents involving failure-to-warn claims,
drugmakers are can't be sued for injuries if the FDA didn't let
them revise the product's label. While the theoretical possibility
of atypical fractures long had been known by both Merck and the
FDA, the parties dispute whether the FDA was provided with adequate
information to determine if a label update was warranted.
In 2017, the Third U.S. Circuit Court of Appeals, in
Philadelphia, said that was a factual question to be decided at
trial in the Trenton, N.J., federal district court where the claims
were consolidated. Monday's opinion, however, said such issues were
complicated legal matters best untangled by a judge.
"Judges are better suited than are juries to understand and to
interpret agency decisions in light of the governing statutory and
regulatory context," Justice Breyer wrote, joined by Justices
Clarence Thomas, Ruth Bader Ginsburg, Sonia Sotomayor, Elena Kagan
and Neil Gorsuch.
A drugmaker is immune from lawsuits only if it would be
impossible to comply both with federal law regulating the product
label and state law creating liability for failure to warn about
potential injuries. Justice Breyer suggested that would be a high
bar to pass.
"A drug manufacturer will not ordinarily be able to show that
there is an actual conflict between state and federal law such that
it was impossible to comply with both," he wrote.
Justice Thomas went further still, writing separately that
Merck's argument "should fail as a matter of law" because the
drugmaker identified "no statute, regulation, or other agency
action...that would have prohibited it from complying with its
alleged state-law duties."
The court's three other conservatives, while agreeing that a
judge rather than jury should make the legal determination, wrote a
separate concurring opinion accusing the majority of skewing the
dispute in the plaintiffs' favor.
In response to the ruling, Merck said it "remains fully
committed to defending these cases going forward and will continue
to present evidence that it acted appropriately at all times in
regard to the potential risk of atypical femur fractures."
Plaintiffs' lawyer David Frederick said Monday's "opinion makes
clear that pre-emption can be established only by a formal FDA
action prohibiting the manufacturer from changing its warning
label."
Write to Jess Bravin at jess.bravin@wsj.com
(END) Dow Jones Newswires
May 20, 2019 18:36 ET (22:36 GMT)
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