This morning we posted about just how strong the preemption defense can be for pharmaceutical and device manufacturers. And not to hide the light of preemption under a bushel, but there is the flip side. It’s sort of like an elementary school science project. You put a nice red, ripe tomato on the counter and wait to see how long it takes to spoil. It starts off aromatic, sweet, juicy. Very appealing. After a short time, it starts to shrivel, turn green, grow mold. And finally, it just really stinks. Well, that’s what Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) did for preemption in the Seventh Circuit. Smelled it up. (see posts here and here).
We get that courts in that circuit are bound by the decision and we lament new decisions that essentially reach the same conclusion as Bausch. But even applying its extraordinarily broad concept of a parallel violation claim, warning related claims in Bausch didn’t survive. So, we were more than a bit taken back by the recent decision in Comella v. Smith & Nephew, Inc., No. 13 C 1850, slip op. (N.D. Ill. Dec. 11, 2013) in which the court tumbles all the way down the Bausch slippery slope and allows what is effectively a fraud on the FDA claim to be a non-preempted parallel failure to warn claim.
This is going to leave a nasty taste in our mouth, but we’ll plow through it anyway. First, like Bausch, Comella is a hip replacement case. Following her hip replacement surgery, the plaintiff began experiencing hip pain and began hearing “squeaking” noises. Ultimately, the hip replacement device failed, resulting in another hip replacement surgery.
Plaintiff’s complaint alleges negligence and strict liability causes of action both of which she premised on alleged violations of FDA’s current good manufacturing practices (“CGMPs”). That’s the Bausch hook. We’ve made it clear that we don't think a CGMP violation is ever enough for a parallel violation. The CGMPs are simply too generic. But certainly, in light of Buckman we don’t understand how a claim for violating FDA reporting requirements survives preemption.
Let’s start with the “parallel” portion of the court’s reasoning. The court found that plaintiff’s common law failure to warn claim was “sufficiently parallel to the requirement to make disclosures under the federal regulations so as not to be preempted.” Comella, slip op. at 3-4. What? Plaintiff’s common law duty to warn is a duty owed to the plaintiff to provide appropriate warnings to her doctor. We don’t see the FDA in that equation anywhere. In fact, this decision gets even stranger because the court held that “to the extent the complaint alleges a breach of a duty to advise or warn the public and medical community, it creates an additional requirement and is preempted.” Id. at 4. What other duty is there in a state tort failure to warn claim? Certainly, a traditional failure to warn claim doesn’t include failure to warn the FDA. So, our first problem with Comella is that there is no state law duty to warn that is parallel to FDA’s reporting requirements. Plaintiff is bringing a direct claim for violation of FDA regulations – which is expressly preempted.
As if that wasn’t enough, in Buckman the Supreme Court made clear that claims for “fraud-on-the-agency or noncompliance with the FDA” are preempted. Id. at 4-5. With that acknowledgement, one would think the Comella court would have to conclude that plaintiff’s claims that defendant failed properly to submit adverse event report and post-marketing reports to the FDA are preempted. They are indeed claims for violating reporting requirements that create every one of the practical problems that led to preemption in Buckman.
So, how did the court sidestep Buckman? By calling a spade a club. The court found that Buckman preempts “fraud” claims. But, plaintiff Comella’s claim is
not based on fraud, but a breach of a state common law duty to warn based on failure to comply with disclosure and reporting requirements. . . . Although plaintiff’s claims are premised on alleged violations of federal regulations, they are also capable of existing independent of these regulations as failure of the duty to warn.
Id. at 5. Again, we say: What? The court has already thrown out the only real failure to warn claim – failure to warn the doctors. All that is left is failure to warn the FDA – a claim which is not based in state common law but which is inextricably and undeniably tied directly to FDA regulations. The suggestion that failure to warn the FDA is an independent tort had us reeling as it is. The suggestion that calling it failure to warn rather than fraud somehow changes the underlying basis of the action has us just about knocked over.
As if that wasn’t enough, the court also followed Bausch on the sufficiency of plaintiff’s pleadings. Because product-specific information “is kept confidential as a matter of federal law,” plaintiff may need formal discovery before she “can fairly be expected to identify specific defects.” Id. at 6-7.
Simply a rotten tomato of a case.