FDA Certification No Shield to Suit Against Generic Drug Makers

A federal judge has ruled that manufacturers of generic drugs are not shielded from lawsuits by an FDA process that certifies generic versions as the “bioequivalent” of their brand name counterparts.

U.S. District Judge Berle M. Schiller refused to dismiss a suit brought by plaintiffs who were previously taking brand-name antidepressant drug Wellbutrin and later experienced side effects when they switched to the generic version of the drug, buproprion.

According to the lawsuit, Impax Laboratories and Teva Pharmaceuticals were aware of the problem, but chose not to warn the public about the differences between the two versions of the drug, which affected the rate of release of the active ingredient in the body.

The defendants’ representation have argued for a lawsuit dismissal because of the FDA’s determination that the generic drugs were determined “as safe and effective” as their brand name equivalents. Applying the recent U.S. Supreme Court’s recent decision in Wyeth v. Levine, Judge Schiller determined that the manufacturers of the generic drugs have a duty to issue warnings about any potential dangers that arise after a drug has received FDA approval. Citing the Hatch-Waxman Act, he saidthat just because the drug has been approved does not mean that the manufacturer is absolved of liability. He said that litigation of this kind serves a vital role in ensuring that only safe drugs reach the consumer.

The plaintiffs’ lawyers celebrating this victory include fourteen firms, led by Allan Kanner, Conlee S. Whiteley and M. Ryan Casey of Kanner & Whiteley in New Orleans and Richard M. Golomb of Golomb Legal in Philadelphia.

Court papers have revealed that the generic drug buproprion had more than 20 million retail prescriptions annually, making it the fourth most prescribed antidepressant in the country in 2007.

In 2003, drugmaker GlaxoSmithKline released Wellbutrin XL, an extended-release form of the drug that could be taken only once daily. The extended release was achieved using a membrane-release technology, which allowed medicine to seep through the walls of the pill at a controlled rate as it moved through the body intact. Since this technology was patented by GlaxoSmithKline, generic manufacturers had to find other ways to achieve the same results to release their own version of the drug. Teva and Impax formulated a matrix technology, but it did not achieve the same results, with peak concentrations of medication occurring after two hours, versus five hours for Wellbutrin XL and the generic versions manufactured by competitors Waston Pharmaceuticals and Anchen Pharmaceuticals. Patients who switched to the Teva and Impax versions stated that the faster release made the drug less effective in treating their depression. Despite the numerous complaints these companies received from patients, neither company took the appropriate steps to warn patients or doctors of the differences between their drug and the brand name drug.

While the defendants’ lawyers sought a dismissal of the suit under the argument that the Levine decision should not apply, Judge Schiller concluded that the ultimate responsibility rests with the drug manufacturer, not the FDA. “Defendants have offered no compelling reason why Congress would have given generic drug makers favored status,” he said.

Judge Schiller also concluded that the defense’s attempt to argue that the plaintiffs cannot recover without contradicting the FDA’s finding was logic that could be taken to absurd extremes. Defendants could use an approval of this logic to effectively bar all lawsuits over bad drugs, removing the incentive for any drug manufacturers to monitor the safety of their products and update their labels accordingly.

Teva was represented by attorneys C. Robert Boldt and R.C. Harlan of the Los Angeles office of Kirkland & Ellis. Boldt did not immediately return a call seeking comment.

Impax was represented by attorneys Asim Bhansali and Paula L. Blizzard of Keker & Van Nest in San Francisco. Impax spokesman Mark Donohue said the company stands by the drug as a safe and effective product and will continue to defend it in the litigation.