Generic Drugmakers Lose Preemption Argument

A generic drug may be bioequivalent with a brand-name med and approved by the FDA, but that doesn’t mean a generic drugmaker is shielded from a product-liability lawsuit. That’s what a federal judge ruled in refusing to dismiss a lawsuit by consumers who allege two generic drugmakers failed to warn about side effects caused by differences in their versions of the Wellbutrin XL antidepressant.

In a 29-page decision, US District Judge Berle Schiller cited the US Supreme Court’s decision in Wyeth vs. Levine, which determined FDA approval does not shield drugmakers from state lawsuits, and concluded that generic drugmakers also have a duty to warn about any new side effects that may occur after the FDA has approved their medicines. Several generic drugmakers recently petitioned the US Supreme Court to review their liability .

The lawsuit alleges that Teva Pharmaceuticals and Impax Laboratories became aware of the side effect issue, but failed to warn the public about differences that affected the release rate of the active ingredient. “A generic drug manufacturer is not absolved of liability because the FDA has approved its generic product,” Schiller wrote.

Some background: In 2003, GlaxoSmithKline released Wellbutrin XL, an extended-release form of the pill that could be taken just once daily and used a membrane-release technology, which meant the drug would seep at a controlled rate through a membrane that passed through the entire body intact, The Legal Intelligencer writes.

Since the membrane technology was patented, generic manufacturers who wanted to release a version of Wellbutrin XL were forced to devise their own methods of delayed release. Impax and Teva used a different matrix technology and their drugs achieved peak concentrations in two hours. Wellbutrin XL and generic versions made by other companies achieved this in five hours.

For patients who switched, the faster release made the drug less effective in combating depression, according to the lawsuit, which alleges neither Impax nor Teva took steps to warn doctors or patients that their versions worked differently or disclosed side effect complaints.

“Levine teaches that the ultimate responsibility rests with the drug maker, not the FDA, to either adequately inform the public or remove the drug from the market,” Schiller wrote. “Defendants have offered no compelling reason why Congress would have given generic drug makers favored status.”

Original News Source:
http://www.pharmalot.com/2010/05/generic-drugmakers-lose-preemption-argument/