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SCOTUS Drug Label

Jun 23, 2011 - Industry News by Jason G. Wehrle




On June 23, 2011, the Supreme Court of the United States held in Pliva v. Mensing131 S.Ct. 2567 (June 23, 2011) that State Law failure-to-warn labeling claims against generic drug manufacturers are preempted by Federal Law. 

            The Court’s decision was based upon impossibility of performance—“it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same” because under the Hatch-Waxman Amendments to the Federal, Drug and Cosmetic Act (“FDCA”) the labeling for a generic drug must be the same as the labeling which the FDA approved for the name-brand drug. 

            The plaintiffs in Mensing and its companion case alleged that they developed tardive dyskinesia as a result of ingestion of generic metoclopramide.  They sued the generic drug manufacturers under Minnesota and Louisiana law, claiming that the generic drug manufacturers failed to warn that long term use of the drug could cause this neurological disorder.  The generic drug manufacturers claimed that plaintiffs’ claims were preempted by the FDCA.  Justice Thomas, who delivered all but one part of the opinion, concluded that the federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus preempt, state law failure to warn claims.  In its decision, the Court also rejected the plaintiffs’ argument (1) that generic drug manufacturers could have send additional warnings to physicians in “Dear Doctor letters,” finding that this would qualify as prohibited labeling under federal law and (2) that generic drug manufacturers should have asked the FDA for permission to change their labeling because “when a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for preemption purposes.” 

            Justice Sotomayor, dissenting, recognized that the majority’s decision “strips generic-drug consumers of compensation when they are injured by inadequate warnings.”  She noted 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 a consumer’s prescription is filled with a generic drug, “as occurs 75 percent of the time, she now has no right to sue.” 

            Federal and state courts across the country have since dismissed failure to warn claims against generic drug manufacturers.  For example, Judge Carol Higbee, Presiding Judge of the Superior Court of New Jersey, Atlantic County dismissed all failure to warn claims against generic drug manufacturers in the In Re: Reglan/metoclopramide litigation, with the exception of those claims based upon failure to change the label to match the brand-name label.    Notably, Judge Sandra Mazer Moss in Philadelphia County, Pennsylvania and Judge Richard Kramer in San Francisco County, California both denied generic drug manufacturers’ demurrers to plaintiffs’ complaints in Reglan/metoclopramide litigation.  There are thousands of cases pending in both jurisdictions.  In Philadelphia, the generic drug manufacturers have sought permission to file a collateral appeal.  In San Francisco, the generic drug manufacturers have filed a Petition for Writ of Mandamus.