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This breaking news post is from the non-Dechert bloggers, because it discusses a metoclopramide case.

Like the Drager case we told you about earlier, another case has held that, in the context of generic drug preemption, labeling a design defect claim a “risk/utility” or “consumer expectations” is a distinction without a difference – and both are preempted.  This time it’s a federal court in Arkansas on remand from the Eighth Circuit’s Fullington decision.  See Fullington v. Pfizer, Inc., 720 F.3d 739 (8th Cir. 2013).  The new case is Fullington v. Pfizer, Inc., No. 4:10CV00236 JLH, slip op. (E.D. Ark. Feb. 28, 2014).  As you might expect Fullington relied heavily on the Fourth Circuit’s reasoning in Drager.  But more that, Fullington got it right because, right from the start, the court asked the right question:  “[T]he Court directed [plaintiff] to explain what the Generic Defendants could have done to comply with [state] law without violating federal law.”  Slip op. at 5.  The correct answer was – as we’ve been saying since our “bullseye” post – nothing.  Generic manufacturers cannot change their warnings without prior FDA approval.  No drug (or device) manufacturer can change its design without prior FDA approval. Finally, plaintiffs cannot avoid preemption by claiming that the manufacturer of an FDA-approved drug had some state-law duty to take it off the market.  Slip op. at 5.

The only other thing the plaintiff in Fullington could think of was “post-marketing surveillance.”  Id.

[Plaintiff] does not explain how a failure to conduct post-marketing surveillance constitutes a design defect or breaches one of the implied warranties, nor does she explain how the defendants could have avoided liability on her design defect and implied warranty claims by conducting post-marketing surveillance.


We’ve said it before, and we’ll say it again.  For preemption purposes there is no distinction between theories of design defect.  What must the defendant actually do?  As long as any theory would require a change in design, it’s preempted because that requires prior FDA approval.