Generic drug manufacturer liability has been a hot button issue for many months now, and the issue recently reached a fever pitch when the Alabama Supreme Court endorsed a theory of innovator liability that would allow plaintiffs to sue brand name manufacturers over generic products they didn’t make.
The court’s endorsement for innovator liability came earlier this month via a ruling in a case in which the plaintiff sued pharmaceutical company Wyeth for fraud over side effects he allegedly suffered from taking the generic version of the acid reflux drug Reglan. AlthoughWyeth didn’t produce the generic drug that the plaintiff took, the court ruled 8-1 that Wyeth was liable for Mr. Weeks’s complaints because federal law requires generic manufacturers to use the same warning labels as brand-name drugs.
The debate surrounding generic drug manufacturer liability began in earnest in 2011 when the Supreme Court ruled in Pliva v. Mensing that because generic makers didn’t control their warning labels, they couldn’t be sued for any problems that transpired.
The Pliva decision was upheld this summer when the Supreme Court in Mutual Pharmaceuticals v. Bartlett overturned a $21 million state court award for a plaintiff who had lost 60% of her skin, suffered lung and esophageal damage, and became legally blind after taking a generic painkiller, holding that the generic drug maker wasn’t liable for the painkiller’s content or warning label because federal law requires it to mimic the brand-name drug.
As a result of the Court’s decisions in Pliva and Mutual Pharmaceuticals, consumers have been left without an adequate remedy when they are injured by unsafe pharmaceuticals. Legislative initiatives have made little headway at addressing the problem, however. In July, several lawmakers reiterated their previous call for regulatory action on the part of the FDA to revise drug regulations so that generic manufacturers can improve the warning labels on their products when they receive new information, and can be held accountable if they fail to do so. Although the FDA indicated that it planned to do so, no such action has yet taken effect.
Several other courts have rejected the innovator liability theory, including the Fourth, Fifth, Sixth, Eighth, Tenth, and Eleventh Circuits, but some speculate that the Alabama Supreme Court’s decision could draw further attention to the need for legislation that holds generic drug manufacturers liable for their unsafe products.
As Burton LeBlanc, President of American Association for Justice, wrote to the Wall Street Journal, “Over 80% of prescription drugs dispensed in America are generics. If manufacturers cannot be held accountable when their drugs harm and kill patients, safety is at risk. Safety is an issue that cannot wait.”
At Ankin Law Office, LLC, our Chicago product liability lawyers are dedicated to protecting consumers from dangerous and defective products and helping the victims of unsafe products obtain full and fair financial recovery from any and all responsible parties. Because we have significant experience handling class action lawsuits regarding unsafe pharmaceuticals and defective medical devices, we are familiar with the complex legal issues that these kinds of lawsuits generally involve. Contact us at (312) 600-0000 for more information on unsafe pharmaceuticals and generic drug liability.