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FDA Proposes Rule That Would Once Again Permit Generic Drug Injury Lawsuits

By July 9, 2013July 17th, 2019Dangerous Drugs

Last month, the U.S. Supreme Court ruled that generic drug injury lawsuits are federally preempted even when they are not making failure to warn claims. I’ve written a lot about this issue as a pharmaceutical liability attorney since the Supreme Court decided PLIVA v. Mensing, which held that generic drug makers cannot be sued for failure to warn in state court because FDA rules require them to have exactly the same labels as name-brand drug manufacturers. That was reaffirmed in last month’s Mutual Pharmaceutical Co. v. Bartlett. The decision left many people outraged, because it left the severely disabled Karen Bartlett, and people like her, with no recourse when they are injured by generic drug makers’ negligence.
Now, according to the New York Times, the FDA is planning a new rule that would solve the problem by allowing generics to change their labels unilaterally. The FDA quietly published the proposal in a list of proposed new rules on July 3. It said the agency wishes to “create parity” between generic and name-brand manufacturers by allowing generic manufacturers to change their labels when they receive important new information about their drugs. Name-brand manufacturers may also do this, and generics are required to follow suit if the FDA agrees to the name-brand label change. A spokesperson told the newspaper that it’s too soon to say exactly how the rule would be worded, but the newspaper said the new rule might be in place by September.
As the Times noted, many lawsuits against generic drug manufacturers have been dismissed since the Supreme Court decided Mensing in 2011. Consumer advocates pointed out that the situation created by Mensing is absurd: two consumers injured in the same way by the same chemical formulation have radically different legal rights if only one took the name brand. Mensing held that state-court lawsuits alleging failure to warn claims against generic manufacturers are preempted by federal law, meaning they cannot be brought, because generics are required by law to carry the same labels as their name-brand counterparts. Bartlett extended that ruling to design-defect claims that turn on the label’s adequacy. The FDA’s new rule would take away the conflict found by the Supreme Court by giving both kinds of manufacturers the right to change their labels.
As a defective drug lawyer, I’m delighted that the FDA has finally taken this step. Indeed, it’s surprising that it didn’t act earlier, considering that there has been no change in the political leadership of the country that might change the FDA’s preferences. In the two years between Mensing and Bartlett, I’ve written about numerous lawsuits that were dismissed or allowed only because of an unusual circumstance like failure to comply with an FDA order. As a result, many people have been left unable to pursue their claims, and denied justice for permanent disabilities inflicted by dangerous drugs. Most will still be unable to sue even if the rule changes, because of statutes of limitations (deadlines to sue). As a dangerous drug attorney, I do not believe generic drug makers should be protected from the consequences of their own negligence in this way.

If you were injured by a prescription or over-the-counter drug you thought would help you, don’t wait to contact Carey, Danis & Lowe to discuss your legal rights. You can reach us through our website or call toll-free at 1-877-678-3400.
Similar blog posts:
Supreme Court Rules Design Defect Claims That Turn on Warnings Are Preempted – Mutual Pharmaceutical Co. v. Bartlett
Supreme Court Rules State Drug Tort Claims Preempted by Federal Drug Regulations – PLIVA Inc. v. Mensing
First Circuit Upholds Design Defect Verdict for Woman Burned and Blinded by NSAID – Bartlett v. Mutual Pharmaceutical Co.