Post-BMS, Are Clinical-Trial Sites the New Hook for Hailing Out-of-State Pharmaceutical Defendants into Court?
The ink has only recently dried on the U.S. Supreme Court’s June 19 personal jurisdiction decision in Bristol-Meyers Squibb Co. v. Superior Court of California, and already, we’re seeing courts and litigants grapple with the reach of the court’s holding. The U.S. District Court for the Northern District of California’s recent decision in Dubose v. Bristol-Myers-Squibb Co. et al.—another case in California brought by an out-of-state plaintiff—suggests that the results may be all over the map.
In Dubose, the plaintiff alleged that defendants failed to warn about the cardiovascular risks associated with its diabetes medication, and also engaged in inadequate clinical testing and inadequate reporting of risks to the FDA. Following service, the drug manufacturer defendants moved to dismiss, arguing there was no specific jurisdiction over the claims against them because the plaintiff—a resident of South Carolina—could not show her injuries resulted from their activities in California. The defendants relied in part on the U.S. Supreme Court’s recent decision in the BMS case, which held there was no personal jurisdiction against BMS in a Plavix suit by a non-resident plaintiff in California state court because BMS’s sale of Plavix to other California patients was not sufficient to meet the threshold for finding specific jurisdiction. The decision has been hailed as a significant victory for pharmaceutical defendants, who have been struggling with forum shopping in magnet jurisdictions like California for ages.
Given the similarities between the Plavix suit and Dubose, one might have expected the same result. The Dubose court, however, denied the motion and found specific jurisdiction over the claims.
Although the court briefly considered the Plavix decision, it found that the Supreme Court’s reasoning was distinguishable because, in Dubose, the defendant’s contacts with California were sufficient to support a finding of specific jurisdiction over the plaintiff’s claims. Specifically, the court noted that a number of the Phase III clinical trials for the drug were conducted—at least in part—at trial sites in California. Citing those facts and relying on the U.S. Court of Appeals for the Ninth Circuit’s preexisting “but for” test, the court held that specific jurisdiction existed because plaintiff’s injuries “would not have occurred but for [defendants] contacts with California,” since the pre-approval clinical trials were “part of an unbroken chain of events leading to Plaintiff’s alleged injury.” After all, “if the drug at issue had never been developed, tested or approved, Plaintiff would not have been harmed by it.” Having found personal jurisdiction, the court nevertheless transferred the case back to South Carolina.
The Dubose decision is noteworthy in several respects, chiefly because of the importance the court placed on the plaintiff’s allegations regarding the adequacy of the clinical trials in California.
First, Dubose didn’t allege that she’d participated in any of the California-based trials. Instead, the court relied on the defendant’s conduct vis-à-vis other clinical trial participants who were wholly uninvolved in the case. That seems squarely in conflict with the Supreme Court’s reasoning in the Plavix decision, which essentially held that other plaintiffs’ experiences with the drug, no matter how similar, are not sufficient to confer specific jurisdiction.
Second, as the opinion acknowledges, clinical trials for the drug were conducted all over the country—not just in California. Under the court’s reasoning, any one of those states would be an appropriate place for any non-resident plaintiff to bring suit. That seems like the opposite of what the Supreme Court majority intended with the BMS Plavix decision.
Third, the focus on clinical trials highlights the interesting preemption issue lurking in the background. Setting aside personal jurisdiction, a claim that relies on a clinical-studies theory of liability is prime target for a preemption motion. After all, the Supreme Court’s 2001 decision in Buckman established that state-law fraud-on-the-FDA claims are preempted. It’s unclear what else plaintiffs could mean by alleging “inadequate” reporting to FDA (and notably, even the plaintiff’s own complaint in Dubose acknowledges the FDA was aware of the risk of cardiac issues in newly developed anti-diabetic medications before it reviewed defendants’ clinical study data and approved the new drug application for the defendants’ drugs.
And if we’re not talking about fraud-on-the-FDA claims, there is also good reason to think that claims relying on allegations about inadequately designed or insufficient Phase III trials should also be preempted. The Supreme Court’s decisions in Bartlett and Mensing instruct that plaintiffs—and courts—don’t get to rely on hypotheticals or counterfactuals to question the FDA’s decision-making when it comes to approving a drug. Moreover, a series of fairly recent decisions from other federal courts—most recently, the Utts decision from the U.S. District Court for the Southern District of New York—signals that claims challenging the strength of warnings about risks that FDA did know about when it approved the drug are likely preempted, too.
Admittedly, personal jurisdiction and preemption are two separate inquiries, and a preemption motion won’t help defendants avoid claims by nonresident plaintiffs in magnet jurisdictions altogether. It’s also possible that the Dubose decision is an outlier and that future courts will be less persuaded by the “clinical studies” line of reasoning. If not, pharmaceutical defendants likely can expect to see a heightened interest in allegations regarding the adequacy of their clinical studies and clinical data in plaintiffs’ complaints. And if that’s the case, it may be worth considering whether a 12(b)(6) preemption motion is the next best option for making a swift exit.