Supreme Court Makes Second Landmark Ruling on the Liability of Generic Drug Manufacturers

Over the last year, I have written about the evolving law on an issue at the center of much controversy: the ability to bring product liability lawsuits against generic drug manufacturers.  While the Supreme Court determined that state law failure to warn claims cannot be pursued against generic drug manufacturers in PLIVA v. Mensing in 2011, the decisions in several lower court rulings seemed to provide plaintiffs the ability—although limited—to bring product liability lawsuits alleging other state law claims.  However, lower courts were divided on this issue and the primary question remained:  Can design defect claims be pursued against generic manufacturers in the wake of Mensing?

Amidst a series of historic decisions handed down this summer, the Supreme Court answered this question when they decided Mutual Pharmaceutical Co., Inc. v. Bartlett on June 24, 2013.  In that opinion (reversing the First Circuit), the Court found that design defect claims based on the adequacy of the drug’s warnings are pre-empted by federal law under Mensing, and accordingly, cannot be brought against generic drug manufacturers.  This decision extends the holding in Mensing and essentially extinguishes the ability for a plaintiff to pursue any claim for injuries against a manufacturer of a generic drug.

The Court’s rationale in Bartlett directly mirrors that used in deciding Mensing.  In these cases, the Court reasoned that because the Federal Food, Drug and Cosmetic Act (FDCA) requires a generic drug to have the same ingredients, route of administration, dosage form, strength and labeling as its brand name equivalent, a generic manufacturer is prohibited by law from either strengthening the warnings (Mensing) or altering the composition of the drug (Bartlett).  As a result, state law product liability claims that place a duty on manufacturers to render a drug safer by either altering its composition or label are pre-empted.

The ramifications and seeming injustice that results from this decision did not go unnoticed by the Court when issuing the opinion:

This case arises out of tragic circumstances.  A combination of factors combined to produce the rare and devastating injuries that respondent suffered;  the FDA’s decision to approve the sale of sulindac and the warnings that accompanied the drug at the time it was prescribed, the decision by respondent’s physician to prescribe sulindac despite its known risks, and Congress’ decision to regulate the manufacture and sale of generic drugs in a way that reduces their cost to patients but leaves generic drug manufacturers incapable of modifying either the drugs’ compositions or their warnings.  Respondent’s situation is tragic and evokes deep sympathy, but a straightforward application of pre-emption law requires that the judgment below be reversed.

In light of Mensing and Bartlett, it is clear that a generic manufacturer’s inability to alter a drug or update the labeling—even when relevant safety information becomes available—unfairly shields them from all responsibility and liability, and ultimately leaves a substantial amount of consumers without any legal recourse when injury occurs. 

In response to this issue, the FDA has recently announced plans to issue a rule that would allow generic drug makers to change their labeling if they become aware of safety concerns or new information.  While it is unclear if and when this will become effective, this proposed rule is both an acknowledgement of the serious problem at hand and a significant step to address it.  If this rule should be implemented, it could eliminate pre-emption of failure to warn claims against generic drug manufacturers.

This ever-changing area of law will only continue to evolve.  The Supreme Court’s decision in Bartlett made it almost impossible to pursue a claim against a generic drug manufacturer, but also highlighted the significant problems resulting from this holding.  The FDA’s response was both immediate and on point, and in the coming months may have a dramatic impact on the Supreme Court rulings.