Generic Drug Firms Shielded from State Suits: Supreme Court

By | June 23, 2011

The Supreme Court ruled 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., Mylan Inc.’s 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 state lawsuits.

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 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.

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.

The Obama administration supported the two women. It said the companies could have sought changes to the drug’s label.

The FDA ordered warnings about the movement disorder be added to Reglan and metoclopramide in February 2009.

Generic drugs account for more than 70 percent of all prescriptions filled in the United States.

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. 09-1501.

(Reporting by James Vicini, Editing by Gerald E. McCormick, Dave Zimmerman)

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