We have another “parallel violation” decision from the Northern District of Illinois and another head scratcher. See Tillman v. Smith & Nephew, Inc., 2013 U.S. Dist. LEXIS 100299 (N.D. Ill. July 18, 2013). That said, it isn’t too surprising since it comes from a court bound by the 7th Circuit’s decision in Bausch v. Stryker Corp., 630 F.3d 546, 549 (7th Cir. 2010). We’ve laid bare the problems we find in Bausch so many times before that it would be too cumbersome to provide all the links. This one should be enough, as Bexis really gets going.
The Tillman court started its preemption analysis by citing Bausch. That’s what we call foreshadowing. Tillman is a hip replacement case in which the plaintiff had post-surgery problems and sued. After having his initial defect claims dismissed as preempted, the plaintiff filed an amended complaint recasting them as parallel violation claims, the nomenclature for state-law claims that enforce requirements parallel to, not different from or in addition to, FDA requirements. There were two problems with these claims. One, plaintiff never identified an independent state-law claim that actually enforces these parallel requirements. Two, the complaint doesn’t seem to allege facts about the actual problems with the device. The court saw it differently.
On the state-law claim, the court was satisfied that plaintiff’s state-law strict liability and negligence claims enforced parallel requirements. How do we know that? Because the plaintiff says they do:
Tillman's negligence and strict liability claims are based on numerous alleged violations of cGMPs by Smith & Nephew, including failure to comply with design controls under 21 C.F.R. § 820.30, failure to inspect and maintain in-process and final device acceptance activities under 21 C.F.R. § 820.80, failure to implement corrective and preventive actions under 21 C.F.R. § 820.100, and failure to investigate complaints and maintain complaint files under 21 C.F.R. § 820.198. . . . Because Tillman's claims are based on alleged violations of cGMPs, they do not impose any additional or different requirements from federal ones and are thus not expressly preempted.
Id. at *8-9.
Nothing in the court’s opinion illustrates a history of (presumably Illinois) state-law negligence and strict liability claims actually enforcing requirements parallel to those enforced by the FDA. In fact, as the above-quotation illustrates, plaintiff wasn’t trying to enforce parallel state-law requirements. He was trying to enforce the actual FDA requirements. But only the United States can sue to enforce FDA requirements. A statutory prohibition against private enforcement of FDA requirements is no prohibition at all if a plaintiff can nonetheless initiate such private enforcement by simply renaming the action as a state-law negligence or strict liability claim. This is particularly so in Illinois where, as we’ve pointed out before, precedent doesn’t seem to even allow negligence per se claims based on violations of FDA requirements.
On plaintiff alleging facts to support his claim, the block quotation we provided above sets out the cGMPs invoked in the complaint. But the opinion provides precious few if any facts from the complaint that suggest that these cGMPs were violated, and even less connecting those alleged violations to plaintiff’s injuries. As laid out in the opinion, the complaint doesn’t appear to have the minimal facts necessary under Twiqbal to suggest that plaintiffs’ claims are plausible. Possible, maybe. But that’s not enough.
Unfortunately, we think we’ll see more of these types of decisions from certain courts in the 7th Circuit. We suspect, however, that discovery will uncover many of the problems that no doubt underlie these claims, and we can later discuss with you opinions on successful summary judgment motions.