Generic Drug Companies Held to Lower Standard Than Name Brand Counterparts – U.S. Supreme Court Rules in Pliva v. Mensing

Federal preemption has long been a hot button issue in pharmaceutical drug cases, with consumer advocates arguing that drug companies should be held to the sometimes higher state standards. However, the U.S. Supreme Court appears to have reversed the federal preemption stance it took in Wyeth v. Levine. In Wyeth, the Court held that the negligence claim against the pharmaceutical company was not preempted by federal regulations and that the drug company was liable for its failure to provide adequate warning of its drug’s dangers.

However, in Pliva v. Mensing, No. 09-993, the Supreme Court ruled that a pharmaceutical manufacturer could not be sued under state law for failing to warn consumers about its drug’s risks. This decision seems to go against the Court’s ruling in Wyeth just two years ago; both lawsuits deal with federal preemption issues and involve states setting higher safety regulations than the Food and Drug Administration (FDA). Yet in Wyeth, the Court held the drug company responsible, while in Pliva, the Court ruled the pharmaceutical lawsuit was barred under federal preemption.

Yet on closer inspection, there appear to be some key differences between the facts surrounding the drug warning labels in Wyeth and Pliva. The main issue in both the Wyeth and the Pliva pharmaceutical cases involved an FDA regulation referred to as “changes being effected” (CBE). Under the CBE regulation, a drug manufacturer may modify its warning label without prior FDA approval if the modifications will improve the drug’s safety. Under CBE regulations, the FDA approval comes after the warning changes, not before; however, the assumption is that the warning changes in such matters are so important to consumer safety that the FDA will eventually approve those changes.

In Wyeth, the U.S. Supreme Court ruled that the pharmaceutical company could and should have strengthened its warnings in order to protect consumers and that there was no reason to believe the FDA would have rejected Wyeth’s changes. However, in Pliva, the Supreme Court found that there was enough evidence to suggest that the FDA might not have approved the proposed drug warning changes.

The primary basis for the Court’s uncertainty regarding FDA label approval hinged on the fact that the medication at issue in Pliva was generic and was therefore subject to using the same warning label as its name brand counterpart, Reglan. The CBE regulation has typically applied to name brand manufacturers, not the generic drugs that later piggy-back on the FDA approval of the brand name medications.

Therefore, if a generic drug carries the same warning label as its name brand equivalent, then in theory it is complying with federal regulations. And under preemption rulings, federal regulations take precedence over state regulations, even if the state regulations impose a higher standard. Justice Thomas commented on this dilemma when writing the majority opinion, stating that

makers of generic drugs are caught in an impossible bind: They can comply with the state law requiring them to change their labels or the federal law prohibiting changes, but not both. Given that impossibility, federal law pre-empts state law under the Constitution’s Supremacy Clause.

However, the Supreme Court ruling was nowhere near unanimous, but was a 5 to 4 split along ideological lines. Justice Sotomayor wrote a passionate dissenting opinion in which she accused her colleagues of inventing “new principles of preemption law out of the air” and that would lead to “absurd consequences”. While she agreed with the majority that generic drug manufacturers cannot unilaterally change their warning labels, Justice Sotomayor argued that this did not mean that they could remain idle after discovering drug safety issues.

And if a drug company fails to take action after learning of its drug’s dangers, then a “drug consumer’s right to compensation for inadequate warnings now turns on the happenstance of whether her pharmacist filled her prescription with a brand-named drug or generic.” So while the plaintiff in Wyeth was able to bring a successful claim against the brand name drug manufacturer because of its failure to warn consumers, the plaintiffs in Pliva were barred from pursuing a similar claim solely because they prescribed a generic drug.

This distinction seems problematic in a time when the U.S. consumers are becoming increasingly reliant on generic medications; currently generic drugs account for almost 75% of all prescriptions sold in the U.S. Yet while consumers see little difference between brand name drugs and their generic counterparts, the law holds generic drug manufacturers to a much lower standard. The Pliva decision places severe limits on the types of pharmaceutical litigation claims injured consumers can bring against generic drug manufacturers.

Chicago’s Kreisman Law Offices has been handling Illinois pharmaceutical litigation matters for more than 35 years in and around Chicago, Cook County and its surrounding areas, including Harwood Heights, Chicago’s Beverly neighborhood, Morton Grove, Highland Park, and Elmhurst.