* Generic drugs total 70 percent of all prescriptions
* Obama administration said the companies can be sued
* Follow-up to related Supreme Court ruling in 2009
(Adds reaction by generic drug industry including lawyer and
By James Vicini
WASHINGTON, June 23 The U.S. Supreme Court
ruled on Thursday that generic drug companies cannot be sued
under state law over allegations that they failed to provide
adequate label warnings about potential side effects.
By a 5-4 vote, the justices gave a victory to Israel's Teva
Pharmaceutical Industries Ltd (TEVA.TA), Mylan Inc's (MYL.O)
UDL Laboratories and Iceland-based Actavis Inc by overturning
U.S. appeals court rulings that allowed such lawsuits.
The companies argued that federal law barred such lawsuits
because the drug had been approved by the U.S. Food and Drug
Administration (FDA). Federal law requires generic drugs to
have the same labels as their brand name equivalents.
Justice Clarence Thomas in the court's majority opinion
agreed. He said federal drug regulations applicable to generic
drug manufacturers directly conflicted with and thus pre-empted
The Supreme Court decided a related issue in 2009 when it
ruled FDA drug regulations do not protect pharmaceutical
companies from being sued under state law over drug labeling, a
case involving Pfizer Inc's (PFE.N) Wyeth unit and its
antinausea drug Phenergan.
But in the generic drug cases, the justices reversed
separate U.S. appeals court rulings that the lawsuits against
the companies could go forward.
The high court agreed with the arguments of the generic
drug makers that they had no choice but to use the same drug
labels as the brand manufacturer.
Teva, Actavis and the Generic Pharmaceutical Association
hailed the ruling.
COURT 'HIT NAIL ON THE HEAD'
Attorney Jay Lefkowitz, who represented Teva, said, "The
Supreme Court hit the nail on the head today by making clear
that federal law does not permit states to hold generic drug
manufacturers liable for using the very warnings federal law
required them to use."
Actavis CEO Doug Boothe called the ruling "an important and
necessary step by the Supreme Court to clarify the proper
interpretation of regulations governing pharmaceutical
Bob Billings, the trade group's executive director, said
assessing liability would have placed "the generic manufacturer
in the impossible position of defending the content of a label
that they are required by law to use but prevented by law from
One case involved Julie Demahy, who sued Actavis and said
it should have warned her of the risks of developing a
neurological movement disorder from metoclopramide, a generic
drug for heartburn, nausea and vomiting.
The drug's brand name equivalent is Reglan.
In another case, Gladys Mensing sued the three generic drug
makers in federal court in Minnesota after allegedly developing
the same disorder after taking generic versions of Reglan.
When the women first took the drug, the approved labeling
said that "therapy longer than 12 weeks has not been evaluated
and cannot be recommended."
That warning was changed in 2004 to say simply that therapy
should not exceed 12 weeks and in 2009 the FDA ordered that
specific warnings about the movement disorder be added to
Reglan and metoclopramide.
The Obama administration supported the two women. It said
the companies could have sought changes to the drug's label.
Generic drugs account for more than 70 percent of all
prescriptions filled in the United States.
Liberal Justices Sonia Sotomayor, Ruth Bader Ginsburg,
Stephen Breyer and Elena Kagan dissented.
The Supreme Court cases are Pliva v. Mensing, No. 09-993,
Actavis v. Mensing, No. 09-1039 and Actavis v. Demahy, No.
(Reporting by James Vicini, Editing by Gerald E. McCormick,
Dave Zimmerman and Matthew Lewis)