Will Withdrawal Of Generic Bupropion XL Resurrect Product Liability Litigation?
Personal injury firms began looking for clients after FDA announced that Impax/Teva’s generic product was not equivalent to GSK’s Wellbutrin XL, but Supreme Court’s Mensing decision may keep cases from getting off the ground.
You may also be interested in...
In what appears to the first downgrade of a generic equivalency based on patient complaints, FDA changes the high dose of the Teva/Impax product from AB to BX. The four other generic manufacturers of 300 mg bupropion extended-release must conduct their own bioequivalence tests, but FDA does not expect problems because they are differently formulated than the Teva/Impax version.
Sen. Leahy plans to introduce legislation to overturn the Supreme Court’s ruling in Pliva v. Mensing; the attorney who represented generic manufacturers in that case says the legislation is unlikely to pass.
While the Supreme Court’s ruling last year found that failure-to-warn claims against generic manufacturers are preempted by federal law, some courts have refused to dismiss all claims.