A sharply divided Supreme Court ruled today (5-4) in PLIVA, Inc. v. Mensing that federal prescription drug laws preempted the plaintiffs' state claims against generic drug manufacturers for failure to warn of harms associated with a drug.  The case means that individuals harmed by generic drugs with inadequate warning labels cannot sue the manufacturers in state court.  Given the ubiquity of generics "“  which made up seventy-five percent of the prescription drug market in 2009 "“ this is no small hitch for those harmed by prescription drugs.  The case also means that the Court has taken a sharp turn in favor of federal preemption, in effect turning the traditional presumption against so-called impossibility preemption toward a presumption in favor of federal preemption, at least under schemes that operate like the federal prescription drug laws here.

 

          The plaintiffs in the case, Gladys Mensing and Julie Demahy, sued the manufacturers of the generic drug metoclopramide in state court, alleging that the drug companies had failed to warn them about the harms associated with long-term use of the drug.  (Metoclopramide is designed to speed the movement of food through the digestive system.  But long-term use can lead to tardive dyskinesia, a serious and often irreversible movement disorder.  Mensing and Demahy both alleged that they acquired the disease from their use of generic metoclopramide.)  The manufacturers argued that because federal law prohibited them from unilaterally updating their labels to reflect the harms, they therefore could not comply with both federal law and a state failure-to-warn standard, which would have required them to update their labels.  They argued that federal law thus preempted the plaintiffs' claims under "impossibility" preemption.

 

          If this sounds familiar, that's because it is.  Just two years ago, the Court ruled (by a vote of six to three) in Wyeth v. Levine that federal prescription drug laws did not preempt a plaintiff's state failure-to-warn claim against a brand-name manufacturer.  Mensing thus tested whether federal law was different for generics than for brand names for the purpose of federal preemption.  In particular: Did generic manufacturers have the same flexibility under federal law to change their own labels that brand-name manufacturers had, such that generic manufacturers could comply with both federal drug labeling laws and state failure-to-warn requirements, as in Wyeth?

 

          The Court ruled that they did not.  In an opinion by Justice Thomas (writing for a majority that also included the Chief Justice and Justices Scalia, Kennedy, and Alito), the Court held that federal law only allowed generic manufacturers to petition the FDA to change their labels; unlike brand-name manufacturers, generic manufacturers cannot change their labels themselves.  But that does not say whether the FDA would have implemented the changes: it might have, or it might not have.  If the manufacturers petitioned (which they did not), and if the FDA approved a label change, the manufacturers could have complied with both federal law and a state failure-to-warn standard that required them to change their labels.  But this possibility was not enough for the majority, which explained that "[t]he question for [impossibility preemption] is whether the private party could independently do under federal law what state law requires of it."  Because of the uncertain intervention of the FDA, the manufacturers here could not.

 

          This new standard chips away at "“ or even shifts "“ the traditional presumption against impossibility preemption.  To see this, consider the facts in Wyeth.  In that case, brand-name manufacturers could unilaterally strengthen their label warnings before receiving FDA approval "“ a privilege that, all parties agreed, did not extend to generic manufacturers.  But the FDA retained authority to reject brand-name manufacturers' changes. 

 

          In short, the FDA played a similarly uncertain intervening role in Wyeth as it played here.  But we have a different result.  The Court told us that the FDA's uncertain intervention in Wyeth represented a "possibility of impossibility" (because the FDA might reject the change).  This was not enough to sustain preemption.  But, by contrast, the Court told us that the FDA's uncertain intervention here represented a "possibility of possibility" (because the FDA might grant a petition for a change).  This was not enough to avoid preemption.

 

          But if the Court's standard shifts the traditional presumption against impossibility preemption, four Justices "“ the majority, with the exception of Justice Kennedy "“ would have gone even further.  Justice Thomas wrote that a segment of the Supremacy Clause "“ referring to "any Thing in the Constitution or Laws of any State to the Contrary notwithstanding" "“ is a non obstante provision by the customary use of such language in the eighteenth century.  As such, it "suggests that federal law should be understood to impliedly repeal conflicting state law."  By Justice Thomas's reckoning, this would substantially simplify preemption analysis and put an even heavier thumb on the scale in favor of preemption.

 

          Justice Sotomayor wrote a spirited and lengthy dissent, which was joined by Justices Ginsburg, Breyer, and Kagan.  In it, she emphasized congressional purpose as "the ultimate touchstone in every pre-emption case" and thus looked to language, structure, and legislative history to conclude that federal law did not preempt the plaintiffs' state claims.  Justice Sotomayor's analysis was probably exactly the kind of "strain" in reconciling federal law with state law that Justice Thomas railed against in his plurality opinion on the non obstante clause, even if it also looked a lot like the Court's analysis in Wyeth.

 

          In the end, only two Justices "“ Kennedy and Thomas "“ switched positions between Wyeth and Mensing.  But these are two key Justices on preemption doctrine "“ ones to watch.  Justice Thomas previewed his narrow, text-based approach to preemption doctrine in his Wyeth concurrence and brought it into full bloom here, gaining a majority for all but the strongest version of it.  Justice Kennedy less explicably changed positions, but notably declined to join the strongest part of Justice Thomas's opinion.  If this case presages anything, look for the Court to move toward Justice Thomas's narrow, text-based approach "“ but not his stronger non obstante approach "“ in future preemption cases.

 

          And a final note: As with any preemption case, Congress will have the last word.  This case does not and cannot restrict Congress from changing federal law not to preempt state law and to allow state cases like Mensing's and Denahy's to move forward. 

Posted in Analysis, Featured, Merits Cases

Recommended Citation: Steven Schwinn, Commentary: Court charts new course in preemption analysis, SCOTUSblog (Jun. 24, 2011, 1:42 PM), http://www.scotusblog.com/2011/06/commentary-court-charts-new-course-in-preemption-analysis/