Saturday, June 25, 2011
Mensing v. Pliva - SCOTUS Opinion Affirming Preemption as to Generic Drugs
Drew Britcher has written this synopsis of Mensing and its effect that is worth a read:
The U.S. Supreme Court released its opinion in Pliva v. Mensing today. In a 5-4 decision, the Supreme Court narrowed its previous holding in Wyeth v. Levine (2009) and exempted generic drug manufacturers from lawsuits arising from inadequate warning labels. At first blush, it is a peculiar decision in light of the recent 2009 Wyeth holding, where the Court found brand-name drug manufacturers liable for any deficiency on the warning label regardless of the federal regulations. However, upon serious reflection, the decision reflects a strict interpretation of the Supremacy Clause and the role of the Supreme Court in federal preemption cases. Although frustrating to admit, it appears that Justice Thomas, the author of the majority opinion and a member of the Majority in Wyeth, is consistent in his legal theories concerning the Supremacy Clause and federal preemption.
The question presented was "whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, these state-claims". The parties in Pliva disputed whether the generic manufacturers were permitted to change their warning labels after they have received approval from the FDA. The Court held that federal law does pre-empt state law because the FDA advised them that "it interprets its regulations to require that the warning labels of a brand-name drug and its generic copy must always be the same--thus, generic manufacturers have an ongoing federal duty of 'sameness.'" As such, the Court determined that the "FDA's views are controlling unless plainly erroneous or inconsistent with the regulation[s] or there is any other reason to doubt that they reflect the FDA's fair and considered judgment." (citation and internal quotation marks omitted) (emphasis added). In respect of Mensing and Demahy's arguments concerning the "changes-being-effected" (CBE) processes and "Dear Doctors" letters, the Court deferred to the FDA's interpretation of its CBE and its generic labeling regulations as well as deferring to the FDA's interpretation that Dear Doctor letters qualify as "labeling." The Court declined to resolve the FDA's proposed different avenue for changing generic drug labels: "According to the FDA, the manufacturers could have proposed --indeed, were required to propose--stronger warning labels to the agency if they believed such warnings were needed. If the FDA had agreed that a label change was necessary, it would have worked with the brand-name manufacturers to create a new label for both the brand-name and generic drug."
The majority held that generic manufacturers need not comply with the same regulations and duties under state tort law because there is a federal law -- that was designed to encourage and speed up the process of introducing generic drugs into the marketplace -- requires the manufacturers to maintain the same warning labels as the corresponding brand-name drug labels. As such, the Court found federal preemption because it was impossible for generic drug manufacturers to comply with both state and federal requirements. "If the [generic manufacturers] had independently changed their labels to satisfy their state-law duty, they would have violated federal law." Rejecting Mensing and Demahy's argument that the generic drug manufacturers "cannot bear their burden of proving impossibility because they did not even try to start the process that might ultimately have allowed them to use a safer label," the Court clarifies that "[t]he question for 'impossibility' is whether the private party could independently do under federal law what state law requires of it." According to the majority, acceptance of Mensing and Demahy's argument would cause most conflicts between federal and state law to be illusory.
However, the dissent emphasizes that "impossibility preemption" is a demanding affirmative defense; the defendant must prove that "compliance with both federal and state laws is a physical possibility," or more plainly, an "inevitable collision." The dissent provides that the generic drug manufacturers could have raised the issue of inadequate warning labels with the FDA and asked the FDA to initiate a label change. Thus, if the FDA agreed that a label change was necessary, it could require the brand-name to change its label; thereby allowing the generic drug manufacturer to change its label to conform with the corresponding brand-name label. The dissent would find that the generic drug manufacturer's failure to initiate the aforementioned proposal to the FDA means they cannot sustain their burden of proving the affirmative defense of impossibility preemption. However, the defense questions whether the generic drug manufacturers had the duty to invoke this potential mechanism for initiating label changes.
In respect of Wyeth v. Levine, the
Pliva Court stated that, although "Wyeth is not to the contrary," the majority recognized that "from the perspective of Mensing and Demahy, finding preemption here [in Pliva] but not in Wyeth makes little sense." Brand-name manufacturers are not held to the same requirements as generic manufacturers -- they are permitted to change their warning labels whereas generic drug manufactures must ensure that their warnings conform to that of the brand-name drug. The Court recognized the dissonance between plaintiffs injured by brand-name drugs and those injured by generic drugs, stating that the federal drug regulations has dealt an unfortunate hand to Mensing, Demahy and others similarly situated. Regardless, the Court maintained that it was not the role of the Court to "decide whether the statutory scheme established by Congress is unusual or even bizarre." More plainly speaking, the Court passed the ball to Congress (and the FDA) to rectify the situation. It will be the efforts of Congress that determine whether plaintiffs injured by brand-name or generic drugs are treated equally in a court of law. Ultimately, the Court refused to distort the Supremacy Clause to achieve a particular outcome that would, in their words, "create similar preemption across a dissimilar statutory scheme."
The dissenting opinion, authored by Justice Sotomayor, focuses on the fact that whether "consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug." It is an outcome that entire Court agrees makes very little sense. However, one could argue whether it is the role of the Court to "correct" the outcome, or leave the issue for Congress to tackle. This case raises two important questions to be addressed in the near future: (1) Will Congress act to rectify this dissonance between consumers injured by inadequate warning labels on brand-name drugs and those injured by inadequate warning labels on generic drugs and (2) Is there truly no possible legal relief for those injured in the generic drug context? Could plaintiffs sue the brand-name manufacturers for their failure to maintain adequate warning labels, in turn causing generic drugs to have corresponding inadequate warning labels? Such questions are likely to arise in the future and the Court's response shall be interesting.
The inescapable travesty of this case is that the statutory scheme leaves open the idea that this result can be justified