We suspect most readers of this blog are living the same lives we are: We've now submitted either the Supreme Court's decision in Riegel or the Third Circuit's decision in Colacicco as supplemental authority in our pending cases, and we're seeing the plaintiffs' responses. Those responses may give us a clear view of our future (Bexis had a Ouija board, after all) if, knock on wood, the Supreme Court rules in favor of preemption in Wyeth v. Levine.
In Riegel, the Supreme Court noted that express preemption in the medical device context "does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case 'parallel,' rather than add to, federal requirements." Riegel v. Medtronic, No. 06-179, slip op. at 17 (U.S. Feb. 20, 2008). So plaintiffs are now insisting in every case that manufacturers violated FDA regulations, and the lawsuits should proceed unabated.
(That's no surprise. We could see that argument coming, and we've previously suggested answers to it.)
Plaintiffs' argument can take many forms: The drug company engaged in off-label promotion, supposedly dissolving the preemption defense; the manufacturer did not report all required data to the FDA, supposedly dissolving the preemption defense; the manufacturer failed to change its package insert as allegedly required (according to plaintiffs' counsel, not the FDA ) by CBE or other regulations, supposedly dissolving the preemption defense, and so on.
We have no idea whether the Supreme Court will repeat in Wyeth v. Levine the language about parallel state law claims. If it does, however, we've seen the future, and it is now: Plaintiffs' counsel will be drawn to that supposed loophole as moths are drawn to light, and we'll spend our lives fighting over three huge issues:
First, what does it mean for a state to have "provided a damage remedy for claims premised on a violation of FDA regulations"? That can't simply mean that every plaintiff can add a paragraph to every complaint pleading that "the defendant violated FDA regulations" and then go on to pursue run-of-the-mill strict liability, negligence, and warranty claims. Nor can it mean that plaintiffs can re-cast all of their run-of-the-mill claims as "negligence per se" and so avoid preemption. Rather, the Supreme Court's language means that a state must have passed a statute with the express intent to create a damages remedy for a violation of federal law. That's battleground number one.
Second, where's the line between privately actionable "parallel state law requirements" and non-actionable "fraud on the FDA"? Buckman tells us that private plaintiffs cannot pursue claims for fraud on the FDA. Isn't a claim that a manufacturer failed to disclose required data to the FDA effectively a claim of fraud on the FDA? And isn't every other claim that a manufacturer violated an FDA regulation really an effort by a private plaintiff to enforce rules that are meant to be enforced only by the FDA, in the exercise of its reasonable prosecutorial discretion? Perhaps, as we've suggested before, the issue will turn on whether the FDA's regulation was meant to govern the FDA's interaction with a drug manufacturer (which would not be enforceable by a private plaintiff) or the manufacturer's interaction with the public (which is arguably different).
Finally, what proof is required that a manufacturer in fact violated an FDA regulation? We saw this coming, too, and we stand by what we wrote. In the rare situation when a plaintiff finds a state law that authorizes a damages remedy and a duty that runs from the manufacturer to the public, the plaintiff must then plead and prove the existence of a regulation that in fact declares illegal particular conduct that is causally related to the plaintiff's alleged injury. Proof of the violation should ordinarily be proven through fact witnesses, rather than purported experts on the FDA regulations who will give their interpretations of what the FDA's regulations supposedly mean.
We saw that The American Lawyer [free registration required] was concerned about what the pharmaceutical product liability defense bar would do if Riegel and Levine wiped out our practice area.
Would that it were so.
We'd be delighted to see America's system of regulating drugs become a little more rational (although we'd really miss you guys, because we'd have to shut down our little experiment in blogging).
But we fear that we've seen the future, and we'll spend the years from now to retirement fighting about what the Supreme Court meant when it wrote the words "parallel state law claims."
One "can live greatly in the law."