Healthy Skepticism Library item: 19176

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Publication type: news

Vicini J
US top court to decide generic drug labeling issue
Reuters 2010 Dec 10
http://www.reuters.com/article/2010/12/10/genericdrugs-labeling-warning-idUSN1012728820101210

Abstract:

• Drug at issue had been approved by federal regulators

• Ruling expected before the end of June

• Generic drug companies had appealed to high court

Full text:

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.