Generic Preemption?

  • by: |
  • 05/25/2010

WASHINGTON -(Dow Jones)- The U.S. Supreme Court on Monday asked the Obama administration for its views on whether generic drug companies can be sued over allegations that they inadequately labeled their products.

Generic drug makers are seeking to preempt a product liability lawsuit by a woman who allegedly developed a severe neurological movement disorder after taking generic versions of the heartburn drug Reglan.

The woman alleged the drug posed more serious risks than drug makers indicated on their labels.

A trial judge had dismissed the woman's lawsuit but an appeals court reinstated it last year.

The generic drug companies, including Teva Pharmaceutical Industries Ltd. ( TEVA) and Mylan Inc.'s (MYL) UDL Laboratories, said the lawsuit should be preempted by federal law because it would require them to write labels that deviate from the brand-name drug's label.

In ruling against the generic drug makers, the St. Louis-based 8th U.S. Circuit Court of Appeals cited a 2009 Supreme Court decision against Pfizer Inc.'s (PFE) Wyeth unit that said Food and Drug Administration drug regulations do no protect a drug company from being sued under state law over drug labeling.

The 8th Circuit said Congress could have crafted a provision that preempted drug-labeling lawsuits against generic drug companies but chose not to do so.

In a short written order, the Supreme Court asked the U.S. Solicitor General's office to express the Obama administration's views on whether the court should consider the drug makers' appeal.

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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