Generic Drug Label Rules May Be Changed, Eliminating Preemption

Federal regulators are considering new rules regarding generic drug warning labels, which could reverse the effects of a recent Supreme Court ruling that has essentially provided manufacturers immunity from lawsuits over the failure to warn about potential side effects associated with generic medications they manufacture and sell. 

In 2011, a split Supreme Court decision in Pliva v. Mensing ruled that generic drug makers can not be held liable for failing to provide proper safety warnings, as long as the labels on medications they sell match the original brand name drug.

Known as preemption, the Supreme Court found that federal rules requiring generic drug warnings to match brand name labels made it impossible for manufacturers to provide updated warnings, even if they knew the labels did not adequately disclose the risks associated with the medication.

As a result of the decision, consumers have been left without a source of recovery, as they could not bring a claim against the name-brand manufacturer since they never used their product and the generic drug maker could avoid all liability by arguing that they had to match the branded version. Over past two years, courts across the country have dismissed cases involving injuries caused by generic equivalents of Reglan, Accutane, Fosamax and other drugs that have been linked to serious side effects that were not adequately disclosed on the warning label.

The majority opinion in Mensing noted that the Supreme Court’s ruling appeared unfair and perhaps even nonsensical, indicating that the FDA or Congress could change the generic label requirements to solve the issue.

In a January 2013 amicus brief (PDF) filed by the government in another drug case being reviewed by the Supreme Court, Mutual Pharmaceutical v. Bartlett, a footnote indicates that the FDA is considering the creation of new rules that would make generic drug makers responsible for providing adequate warnings. The footnote reads:

“This Office has been informed that FDA is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances. If such a regulatory change is adopted, it could eliminate preemption of failure-to-warn claims against generic-drug manufacturers.”

The change may allow consumers to once again hold generic drug makers responsible for damages caused when they provide misleading or inaccurate information about potential risks that are caused by medications. However, there is no indication as to what the FDA’s final rules will look like, and concerns have been raised in the industry that it could result in different warning labels for the same generic drug when made by different manufacturers, which could confuse doctors and patients.

The Barlett case, where the rule consideration was mentioned, involves the ability of plaintiffs to file personal injury lawsuits against generic drug makers. Generic pharmaceutical companies argue that the Mensing ruling should be a large umbrella precedent, shields the companies them from personal injury claims as well as failure to warn lawsuits, hoping to reverse a following a $21 million personal injury jury award issued to Karen Bartlett of New Hampshire.

Barlett suffered Stevens-Johnson Syndrome and toxic epidermal necrolysis after taking Sulindac, a generic version of the anti-inflammatory drug Clinoril. She was blinded and permanently injured by the severe skin reactions.