One of our correspondents just alerted us to an important decision from the EDNY in Bowdrie v. Sun Pharma. Indus., No. 12-CV-853(WFK)(MDG) (E.D.N.Y, Nov. 9, 2012) (Slip Op.). The court denied plaintiffs’ motion to remand a generic drug case that involved state law claims but that had been removed by the defendant on federal question grounds. Generally, you can’t remove a case on federal question grounds if the claims weren’t created by federal law. But not always. Sometimes even state law claims are removable if they are based on embedded federal issues that are so substantial that they warrant federal question jurisdiction. Here’s the Supreme Court in Grable & Sons Metal Prods. v. Darue Eng’g & Mfg., 545 U.S. 308, 312 (2005), addressing that notion:
The doctrine captures the commonsense notion that a federal court ought to be able to hear claims recognized under state law that nonetheless turn on substantial questions of federal law, and thus justify resort to the experience, solicitude, and hope of uniformity that a federal forum offers on federal issues.
We thought that we’d eventually see federal question removal allowed in parallel violation medical device cases because they involve allegations based on specific FDA requirements set out in a PMA. We blogged about that here. And we may still see that. But lo and behold we first get it in a generic drug case.
The Bowdrie plaintiffs claimed that they were injured from the use of the antiepileptic drug Phenytoin Sodium, the generic of Dilantin. (Slip Op. at 2.) Plaintiffs alleged that the generic manufacturers had failed to warn because they didn’t use the FDA’s CBE process to update their labels so that they would match Dilantin’s label. In other words, plaintiffs alleged that the generic manufacturers failed to use an FDA-created mechanism to satisfy a federal obligation.
There’s the embedded federal issue. Plaintiffs argued that the federal issue wasn’t substantial enough to warrant removal, citing Merrell Dow Pharmas. v. Thompson, 478 U.S. 804, 813-14 (1986), for the proposition that importing a standard from the FDCA is not, by itself, substantial enough to confer federal question jurisdiction. But the Bowdrie court saw it differently. There was more involved here. Plaintiffs did more than just incorporate a federal standard – though we think that this alone may have been enough given the particulars of this case. They implicated federal labeling requirements nationwide for this particular drug:
In this case, the federal issue involved goes far beyond simply incorporating a federal standard into a state law cause of action. To the extent they invoke the “federal duty of sameness,” Plaintiffs’ causes of action implicate the labeling requirements for generic drug manufacturers nationwide. The federal question present in this case involves a responsibility that is in the first instance, and primarily, federal: regulation of the manufacturer, marketing, and distribution of drugs?
(Slip op. at 7)
This decision seems like a pretty big deal. In essence, plaintiffs who sought to avoid Mensing preemption by stating claims that incorporated federal standards, by doing so, brought themselves into federal court. That’s where we want them.
And for good reason. Read the rest of the opinion. The court determined that plaintiffs’ claims were preempted because they wanted the generic manufacturers to match a label that the brand-name manufacturer had submitted via CBE but that had not yet been approved by the FDA. According to the court, that’s still Mensing preempted:
That either FDA approval of [the brand manufacturer’s CBE label], or a specific FDA directive, is a necessary predicate to generic drug manufacturers’ ability to update labeling, including any medication guide, is consistent with the process by which FDA approval of an ANDA is secured in the first instance.
(Slip op. at 10.)The court then invoked TwIqbal to dismiss other insufficiently pleaded claims and dismissed the complaint. Congratulations to defense counsel on a terrific victory.