Courts tend to overreact to Supreme Court decisions. The Supreme Court rules for a plaintiff on a specific ground and suddenly lower courts overwhelmingly rule for plaintiffs who bring even remotely similar claims. Eventually the right case works its way back to the Court, which holds that plaintiffs don’t always win, as anyone reading the first opinion should have understood. That ruling then sends the pendulum swinging back the other way, and the whole cycle is repeated.
The lower courts’ reaction to Wyeth v. Levine is a good example of this phenomenon. The Levine decision, although unfortunate for defendants in many ways, recognized that the doctrine of preemption is alive and well (okay, maybe a little sickly, but still viable) and that certain claims still could be preempted. But the lower courts seem to have missed that last part, as the court did in In re Budeprion XL Marketing & Sales Litigation, MDL No. 2017 (E.D. Pa. May 26, 2010).
The Budeprion plaintiffs brought consumer fraud claims alleging that the defendants failed to warn them about the differences between Budeprion XL, a generic drug, and Wellbutrin, the name brand version. In response to defendants’ motion to dismiss on preemption grounds, the court joined the recent chorus of decisions applying Levine to generic drug manufacturers. Id. at 14-21. No news there.
But this case presented a different twist. Defendants said that the FDA had repeatedly found that their generic is bioequivalent to the name brand drug and that those findings contradict and preempt plaintiffs’ particular theory that the generic was not the equivalent of the name brand drug. This interesting argument has a strong basis in Levine’s recognition that preemption is still possible if the FDA affirmatively decides an issue, as we have discussed.
Rather than squarely confront this interesting issue, the court knocked down a bunch of straw men. First, the court said that FDA approval did not absolve generic drug makers of liability, id. at 22 – but defendants were not arguing that. Second, the court said that preemption would leave plaintiffs without a remedy, id. – but Levine left intact the doctrine of preemption, which does leave plaintiffs without remedies if their claims are preempted. Third, the court said that the drug’s maker is responsible for the label, id. – but defendants were not contesting that, either.
In its fourth point, the court again recited the defense argument – “Defendants repeatedly assert that this is a case in which the FDA has already spoke and therefore a jury may not reassess the position taken by the FDA” – but continued to dance around it, by saying (a) FDA approval of a drug as safe and effective does not equate to a finding of preemption; (b) generic drug makers may add or strengthen warning labels without FDA approval; and (c) the FDA did not rejected the additional warnings proposed by plaintiffs. Id. at 22-23. The court never directly addressed the question whether the FDA’s finding of bioequivalence preempts a claim that the drug maker should have warned that the generic is not equivalent. Instead, the court concluded with more non-responsive anti-preemption shibboleths (“Defendants would turn [FDA] approval into a lock that would forever shut the courthouse door and would remove any incentive for generic drug makers to monitor the safety of their medications and update their labels accordingly”) and rejected the preemption claim. Id. at 24.
With rulings like this, it is hard for a blog once labeled “all preemption, all the time” to avoid being all pessimistic all the time about preemption in drug cases. But we have faith that eventually, if the lower courts keep failing to recognize the preemption possibility left open by Levine, the Supreme Court will make a correction by ruling in favor of a defendant, and the pendulum will swing back the other way. We’re ready.