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In Wyeth v. Levine, PLIVA, Inc. v. Mensing and Mutual Pharmaceutical Co. v. Barlett, the United States Supreme Court stated federal law prohibits generic drug manufacturers from being sued for state law failure to warn claims. A brand-name manufacturer seeking new drug approval is responsible for the accuracy of its label. A manufacturer seeking generic drug approval is responsible for ensuring that its warning label is the same as the brand name. If the generic drug is the chemical equivalent of the approved brand name drug, has the same active ingredients, route of administration, strength, dosage form, is the bioequivalent, and has the same rate and extent of absorption, and has the same labeling as the approved brand-name generic manufacturers are shielded. Consequently, plaintiffs have commonly pursued a theory of liability referred to as innovator liability. Innovator liability attempts to hold brand-name manufacturers liable for injuries allegedly caused by the consumption of generic drugs on a failure to warn theory. For instance, in the March 2018 case Rafferty v. Merck & Co., the Massachusetts Supreme Court held a plaintiff may not bring a negligence claim against the generic manufacturer for failure to warn, but may bring a failure to warn claim against the brand name manufacturer if they intentionally failed to update the label on its drug, knowing or having reason to know of an unreasonable risk of death or grave bodily injury associated with its use.
The Seventh Circuit explained that federal preemption takes three forms: (1) Express (where Congress clearly states an intention to override state law); (2) Implied (which occurs when the structure and purpose of a Congressional act shows an unexpressed intent by Congress to preempt state law); and (3) Conflict or Impossibility (where conflict between state law and federal law makes it impossible for a person to obey both federal and state law). When a conflict exists between federal and state law, the federal law will control, and any state law claims must be dismissed. In this case, Mrs. Dolin sought to hold GSK liable under a state law theory of negligent failure to warn. GSK responded that Mrs. Dolin’s claims were preempted by federal law since the FDA controls the content of drug warning labels and prevented GSK from adding the warning that Mrs. Dolin suggested should have been included on Paxil. The inclusion of the warning on Paxil, in turn would have mandated that Mylan acting pursuant to FDA regulations update their warning label on paroxetine.
In December 1992, the FDA granted GSK approval to manufacture and market paroxetine under the brand-name Paxil. Prior to this approval, the FDA required GSK to submit, and subsequently supplement, an analysis of the risk of suicide associated with the drug. The initial review of the data submitted by GSK and independent investigation by the FDA into Paxil and other related antidepressants led to a unanimous finding of no credible evidence of a causal link between antidepressant drugs and suicidal behavior. Thus, Paxil was approved for sale without any warning regarding suicide on the original label. Throughout the 1990s and early 2000s, GSK continued to submit additional data on Paxil, but the FDA continued to reject any findings linking Paxil and suicidal behavior. In 2004, the FDA approved the addition of language warning of an increased risk of suicide with the use of antidepressants in patients under the age of 18 but continued to deny any addition of language regarding potential risks for adult patients. A final revision to Paxil and other antidepressant warning labels came in 2007 when the FDA ordered that all antidepressant warning labels be amended to reflect “an elevated risk for suicidality and suicidal behavior among adults younger than 25,” but no increased risk for patients between 25 and 64.
GSK had two options for amending the label for Paxil: (1) asking FDA permission; or (2) unilaterally changing the label under a “changes being effected” or “CBE” regulation. A CBE regulation is an exception allowing drug manufacturers to change warning labels to “reflect newly acquired information” if the changes will “add or strengthen a warning.” The FDA reviews all CBE submissions and can reject label changes. In 2006, GSK conducted a re-analysis of its data on potential links between Paxil and suicide and submitted the findings to the FDA requesting a change in the drug’s label to reflect a potential increased risk. GSK also unilaterally changed the Paxil labelling under a CBE regulation to add the warning. However, in 2007, when the FDA issued their new warning for all antidepressants, they also required that the warnings be uniform class wide and struck GSK’s label change. GSK followed up with four requests to reconsider and allow the warning, but each request was denied.
The Seventh Circuit held that Mrs. Dolin’s state-law claims against GSK were preempted by federal law since GSK could not have added the adult suicide warning using a CBE regulation. To amend the warning, GSK would have needed newly acquired information about the potential risks but no evidence was presented that such information existed. Further, the court found that even if the information did exist, GSK provided clear evidence that the FDA would have rejected any proposed CBE regulation warning. Thus, it was impossible for GSK to abide by both federal law’s labeling requirements and satisfy state law at the same time.
The Seventh Circuit ruling will significantly impact pharmaceutical litigation. First, it provides drug manufacturers with a strong defense against liability in failure to warn cases, so long as they can show their warnings followed FDA regulations and they did not have new information that would warrant revision to a drug’s warning label.
Second, despite acknowledging that in prior cases they had analyzed preemption under Levine as a legal question, the Seventh Circuit in this case found that it was not necessary to determine whether preemption involves factual question for the jury. In this case, the Seventh Circuit concluded that no reasonable jury applying the clear-evidence standard could find that the FDA would have approved an adult-suicidality warning for Paxil under the CBE regulation between 2007 and Mr. Dolin’s death in 2010.
Third, the Seventh Circuit noted that the United States Supreme Court had recently granted certiorari to review the Third Circuit’s decision on preemption being a question of fact in Merck Sharp & Dohme Corp. v. Albrecht. By not directly ruling on this issue, the Seventh Circuit seems to signal on the potential monumental consequences of the Third’s Circuit’s opinion being adopted by the majority of circuits.