PharmExec Blog

Supreme Court Ruling Makes Generics More Dangerous

Today’s Supreme Court ruling on Pliva v. Mensing, which held that generic drug companies are not responsible for updating drug labels in light of new safety concerns, makes taking generic drugs a riskier proposition for consumers, Justice Sonia Sotomayor wrote in her dissenting opinion. Justices Stephen Breyer, Elena Kagan and Ruth Bader Ginsburg also dissented in the 5-4 split.

“Today’s decision introduces a critical distinction between brand-name and generic drugs. Consumers of brand-name drugs can sue manufacturers for inadequate warnings; consumers of generic drugs cannot,” writes Sotomayor. “These divergent liability rules threaten to reduce consumer demand for generics, at least among consumers who can afford brand-name drugs.”

In an article published in Pharmaceutical Executive’s May issue, John Brenner, a partner at Pepper Hamilton, suggested that it’s not inconceivable for plaintiffs seeking “failure to warn” protection to take up their grievances with the brand drug manufacturer, the originator of a given drug label. Generics companies must, by law, use a verbatim copy of the original brand drug label, regardless of new risk information or adverse events reports.

Commenting today on the Supreme Court’s decision, Brenner noted that two state courts, an appellate court in California (Conte v. Wyeth, November 2008), and a Vermont District Court (Kellogg v. Wyeth, October 2010), have ruled that brand drug companies could be held liable for the labeling on a generic drug, and therefore be subject to claims. While the California and Vermont decisions don’t necessarily constitute a consensus, Brenner said that “there are 50 states out there, and a lot of them have a great penchant for saying, ‘We really don’t like to leave our injured citizens without a remedy.’”

Writing for the majority, Justice Clarence Thomas acknowledges “the unfortunate hand that federal drug regulation has dealt [the plaintiffs],” leading Brenner to surmise that “there can’t be any question about the fact that the majority knew exactly what it was doing.” In her dissenting opinion, Sotomayor writes that “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-name drug or a generic…if she takes a generic drug, as occurs 75% of the time, she now has no right to sue.” Brenner says Sotomayor may want to check with the plaintiff’s bar about that one. “[Sotomayor] doesn’t know how clever these folks are,” said Brenner.

UPDATE: Brenner points to a statement released yesterday by metoclopramide (the generic form of Wyeth’s Reglan) claimants, including Elizabeth Conte of Conte v. Wyeth, announcing plans to take their cases to the brand manufacturer, in this case, Wyeth (now Pfizer). If generics companies can’t be held liable for what Reglan users consider an insufficient warning label, then Wyeth/Pfizer itself must be liable, according to the statement. “This ruling puts the responsibility back in the lap of brand name manufacturers,” said Michelle Schwartz, a metoclopramide victim who is also a spokesperson for the Reglan Metoclopramide Victims Organization, in the statement.

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One Comment

  1. Alex G
    Posted June 24, 2011 at 4:24 pm | Permalink

    Looks like generics will be limited-tort while branded will be full-tort. What about REMS? It does appear that conservative judge are conspiring against consumers perhaps in favor of “small government and regulation”. That along with class action suits being squelched.

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