By Lawrence Hurley and Bill Berkrot
WASHINGTON/NEW YORK, June 24 The U.S. Supreme
Court ruled on Monday that generic drugmakers cannot be sued
under state law for adverse reactions to their products, a
decision that consumer advocates called a blow to patient
In a 5-4 vote, the court ruled for Mutual Pharmaceutical Co,
owned by Sun Pharmaceutical Industries Ltd,
overturning a multimillion-dollar jury award to a badly injured
patient in New Hampshire who alleged a generic drug she had
taken was unsafe based on its chemical design.
The majority opinion, written by Justice Samuel Alito, said
the state's law could not run against federal laws on
prescription medicines whose design has been approved by the
U.S. Food and Drug Administration.
A Supreme Court ruling in 2011 found that pharmaceutical
companies that make branded drugs are liable for inadequacies in
safety warnings of a medicine's label, but not the makers of
cheaper copies of those medicines.
Consumer watchdog group Public Citizen said the Supreme
Court decision on Monday undermines patient safety at a time
when about 80 percent of U.S. prescriptions are filled with
"Today's court decision provides a disincentive for generic
makers of drugs to monitor safety of their products and to make
sure that they have a surveillance system in place to detect
adverse events that pose a threat to patients," Michael Carome,
director of Public Citizen's Health Research Group, said in an
He pointed out that, in many cases, the potentially
dangerous side effects of medicines have not come to light until
decades after they were approved and often after there was no
longer a branded version on the market.
With the threat of litigation removed, "groups that think
this undermines patient safety could be onto something," said
David Maris, an industry analyst with BMO Capital Markets. "The
blanket protection that they are under now is that if the FDA
says you are approved, as long as they (generic company) don't
introduce new problems into the drug then they're fine."
UMBRELLA PROTECTION FOR GENERIC DRUGMAKERS
Mutual Pharmaceutical had asked the court to overturn a $21
million jury award to Karen Bartlett, a New Hampshire woman who
took Mutual's generic non-steroidal anti-inflammatory drug,
sulindac, in 2004 after her doctor prescribed it for shoulder
pain. Sulindac is a generic version of Merck & Co Inc's
Bartlett suffered a rare hypersensitivity reaction three
weeks after she started taking it. Her skin began to peel off,
leaving her severely disfigured with burn-like lesions over
two-thirds of her body and nearly blind.
Mutual, backed by the Obama administration, said federal law
trumped state law claims such as those Bartlett had made,
pointing to the fact that the drug had already won FDA approval
with an agency-approved label carrying safety warnings.
Federal law requires generic drugs to have the same design
and warning labels as their brand-name equivalents, Mutual
The high court agreed.
"Because it is impossible for Mutual and other similarly
situated manufacturers to comply with both state and federal
law, New Hampshire's warning-based design-defect cause of action
is pre-empted with respect to FDA-approved drugs sold in
interstate commerce," the majority decision said.
In the ruling, the justices said Bartlett's situation was
"tragic and evokes deep sympathy," but added a straightforward
application of pre-emption law requires that the judgment of the
lower court be reversed.
At the time Bartlett filled her prescription, sulindac's
label did not specifically refer to the serious skin reaction
known as toxic epidermal necrolysis, although the FDA later
added the warning for drugs in that class of medicines.
Because the high court had previously ruled that generic
companies could not be sued based on safety warnings in the
label, Bartlett's lawyers brought their suit under New
Hampshire's design-defect cause of action that says
manufacturers have a duty to design products reasonably safely
for the uses which they can foresee.
They had successfully argued before the lower court that
generic manufacturers facing design-defect claims could comply
with both federal and state law by choosing not to make the drug
at all. The high court said the District court's rationale that
Mutual could escape the impossibility of complying with both
state and federal laws by ceasing to sell sulindac was not a
viable option and incompatible with prior rulings.
Anthony Nguyen, a legal analyst for Wolters Kluwer, said
Monday's ruling further protects generic drugmakers on top of
the 2011 decision.
"Now they've got that umbrella protection of 'We can't make
any changes to our drugs. We can't preemptively make any changes
without having to come up with a new drug ourselves and that's
not the business that we're in,'" Nguyen said.
"The generic industry dodged a bullet on this one," BMO's
Maris said. "Had it gone against them it would have put a big
cloud over the industry."
The case is Mutual Pharmaceutical v. Bartlett, U.S. Supreme
Court, No. 12-142.