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,
Ruben Honik and
Kenneth Grunfeld of
Golomb & Honik 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.