US top court to decide generic drug labeling issue

* Drug at issue had been approved by federal regulators

* Ruling expected before the end of June

* Generic drug companies had appealed to high court

By James Vicini

WASHINGTON, Dec 10 (BestGrowthStock) – The U.S. Supreme Court said
on Friday that it would decide whether generic drug companies
could be sued under state law over allegations they failed to
provide adequate label warnings about potential side effects.

The nation’s highest court will consider whether federal
law preempted such lawsuits because the drug had been approved
by the U.S. Food and Drug Administration (FDA).

The high court agreed to hear appeals by Teva
Pharmaceutical Industries Ltd, (TEVA.TA: ) Mylan Inc’s (MYL.O: )
UDL Laboratories and Actavis Inc, based in Reykjavik, Iceland.

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.

The justices are expected to hear arguments in the generic
drug cases in March or April, with a decision likely by the end
of June.

In one case, a U.S. appeals court ruled that Actavis could
face claims by a woman who said it should have warned her to
risks of metoclopramide, a drug that treats symptoms such as
heartburn, nausea and vomiting. The drug’s name brand is
Reglan.

Julie Demahy sued Actavis under Louisiana law, claiming she
developed a neurological disorder after the company failed to
alert her to literature about the risks of using metoclopramide
and failed to change the drug’s label.

In another case, a woman, Gladys Mensing, sued the three
generic drug makers in federal court in Minnesota after
allegedly developing a severe neurological movement disorder
after taking generic versions of Reglan. A U.S. appeals court
ruled her lawsuit could go forward.

The Obama administration supported the two women and said
the appeals court in their cases correctly ruled their claims
were not categorically preempted.
(Reporting by James Vicini)

US top court to decide generic drug labeling issue