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FDA Proposes Holding Generic Drug Makers Accountable

Written by Ankin Law Office

Earlier this month, the U.S. Food and Drug Administration (FDA) proposed a new rule that would allow generic drug makers to update labels with new information in the same way that brand name drug makers can update their labels, thereby opening them up for liability when their drugs injure patients.

According to Today News, the proposed rule came more than after the watchdog group Public Citizen first asked the FDA to close what it called a “dangerous safety gap.” 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.

As we have reported, 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 don’t control their warning labels, they cannot be sued for any injuries that are caused by their drugs.

Most recently, 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 Supreme Court’s rulings in Pliva and Mutual Pharmaceuticals, and because federal law currently requires generic labels to mimic brand name drugs, consumers are without left without an adequate remedy when they are injured by unsafe generic drugs.

With more than 80 percent of prescriptions in the U.S. filled with generic drugs, it is imperative that generic drug makers be responsible for ensuring that their labels are accurate and up-to-date, and that they be held accountable when they fail to adequately warn consumers about risks associated with the medication.

According to Janet Woodcock, M.D., director of the FDA’S Center for Drug Evaluation and Research, “This proposal will help ensure that health-care professionals and consumers have access to the latest safety information for medications they use.”

The FDA’s proposed rule change must first undergo a 60-day public comment period before it can be finalized.

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.

Categories: Product Liability