A federal judge in Texas recently ruled that Texas law does not allow a claim for negligence per se based solely on alleged violations of the FDCA or FDA regulations. Monk v. Wyeth Pharmaceuticals, Inc., 2017 U.S. Dist. LEXIS 72477, *21-23 (W.D. Tex May 11, 2017). That seems pretty straightforward to us. Plaintiffs typically use negligence per se to try to privately enforce a provision of the FDCA, i.e., by using an alleged violation of a safety-related provision of the FDCA as the basis for their state law claim.  State law does not always allow this, but even when it does, such a claim should not withstand implied preemption under Buckman.  That is because Buckman and section 337(a) of the FDCA make it clear that litigants cannot privately enforce the FDCA, and a negligence per se claim based on a purported violation of the FDCA is an unveiled attempt to accomplish exactly that. Monk doesn’t say all of that explicitly, but it relies on cases that do. That’s good enough for us.

Plaintiff based her negligence per se claim on the defendants’ alleged failure to provide medication guides for distribution with amiodarone prescriptions.  The basis for the claim was the federal regulation requiring manufacturers of some prescription drugs to make medication guides available either by providing a sufficient number of guides to distributors and dispensers or by providing the means to produce guides in sufficient numbers. Id. at *3, *6 (citing 21 C.F.R. § 208.24(b)).

And this is where things get confusing, because while the court dismissed plaintiff’s negligence per se claim based on violation of this regulation, the court reached the opposite conclusion regarding plaintiff’s negligent failure to warn claim based on exactly the same thing.  A state law failure-to-warn claim based on a violation of federal prescription drug regulations? Sounds like implied preemption to us, but the court concluded that this very federal-sounding claim was actually a parallel state law failure to warn claim. But wait. Isn’t plaintiff suing because the defendant allegedly violated the FDCA.  That’s Buckman implied preemption. As many courts have noted, plaintiffs seeking to avoid preemption have to weave their way through a “narrow gap” by alleging they are suing for conduct that violated the FDCA, but not because the conduct violated the FDCA. But the only allegation here is that defendants did not provide the medication guides as required by federal regulations.

The court’s reasoning is based entirely on dicta in the Fifth Circuit’s decision in Eckhardt v. Qualitest Pharmaceuticals, Inc., 751 F.3d 674, 679 (5th Cir. 2014) that “failing to provide FDA-approved warnings would be a violation of both state and federal law, this is a parallel claim that is not preempted.” Id. But the claim that defendants provided no warnings was not alleged in the complaint and so was not allowed by the court. There is no information in Eckhardt regarding the basis for plaintiff’s claim that defendant failed to provide any warnings and so it is unknown if it was “because” defendant’s violated a federal regulation.

In Monk, the court knew precisely the basis for plaintiff’s failure to warn claim – 21 C.F.R. § 208.24(b); the same basis as plaintiff’s negligence per se claim. That the result is different on both claims is really difficult to reconcile. So we won’t try. We’ll instead reiterate – no negligence per se based on FDCA in Texas.