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This guest post is from Richard Dean at Tucker Ellis. We’re both greatly interested in extending impossibility preemption beyond generic drugs, particularly in the context of design defect claims, so when Dick saw this case, he both sent it to us (he’s very good about that) and was willing to write it up. As always with guest posts, the author deserves all the credit and gets assigned any blame for the contents of what follows.


Courts are starting to “get” the design defect preemption argument. That makes sense because the argument is simple. Any major changes in the design of a drug or a medical device require the prior approval or permission of the FDA. And if FDA approval or permission is required, PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011), requires implied preemption.

Last Friday’s post regarding Batoh v. McNeil-PPC., Inc., No. 3:14-cv-01462 (MPS), 2016 WL 922779 (D. Conn. Mar. 10, 2016), is followed only a few days later by this report on Barcal v. EMD Serono, Inc., No. 5:14-cv-01709-MHH, 2016 WL 1086028 (Mar. 21, N.D. Ala. 2016). Barcal involved alleged heart birth defects from a fertility drug – Serophene. The drug’s labeling included a statement about congenital heart defects being observed in children of mothers whose pregnancies had been induced by the drug, but the plaintiff claimed the risk was higher than indicated. Before discovery commenced, the defendant filed a motion to dismiss. The plaintiff filed a Rule 56(d) request saying she needed to have discovery to respond to the motion. As to some parts of the motion – the failure to warn claim – the court denied the motion and agreed that the plaintiff was entitled to discovery, but the court disagreed as to the design defect claims and entered judgment on behalf of the defendants. The court held that the design claims were both preempted under the Supremacy Clause—the focus of today’s post—and barred by Alabama’s Extended Manufacturer’s Liability Doctrine (AEMLD) under the principles of comment k.

This case is significant procedurally, as well as substantively, because the preemption motion was granted at the preliminary pleading stage – not at the end of years of litigation as in Yates v. Ortho-McNeil Pharm., Inc., 808 F.3d 281 (6th Cir 2015). Yates was this blog’s leading defense decision of 2015.

Barcal is notable for its succinctness and clarity on the preemption issue. It dispenses with preemption in three short paragraphs. The first paragraph repeats the core holding of Mensing: that the question for impossibility “is whether the private party could independently do under federal law what state law requires of it.” 131 S.Ct. at 2579. The reference to a “private party” is key; the court did not refer to a “generic pharmaceutical company.” This is the building block of the design preemption argument. In Barcal, there is not even a discussion of whether Mensing applies beyond generics. It is assumed given the broad language of Mensing.

The second paragraph cites the key sentence from Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013), noting that “once a drug – whether generic or brand name – is approved, the manufacturer is prohibited from making any major changes to the . . . active ingredients.” Id. at 2471. The opinion then notes that under the state tort scheme, a finding for the plaintiff would require a redesign of the product. But having to ask for approval for such a change is at odds with independent action test in in Mensing.

The third and final paragraph simply notes that Wyeth v. Levine, 555 U.S. 555 (2009) “is not to the contrary.” That is of course precisely the language Justice Thomas used to distinguish Wyeth in Mensing. 131 S.Ct at 2581. Wyeth found no preemption on a failure to warn claim against a brand name manufacturer because the CBE process existed. Barcal correctly found that because no such process exists for design changes, Wyeth is inapplicable. (Note that not all parts of the label are subject to the CBE provisions; for example, the Mechanism of Action section of the label requires prior approval. Indeed, the general presumption of the statutory scheme is that prior approval is required for label changes. In re Celexa & Lexapro Marketing & Sales Practices Litig., 779 F.3d 34, 37 (1st Cir. 2015)). [Editorial note: see here for a post about various forms of FDCA “major” changes.]

So that’s it. A short one-two-three punch: Mensing, Bartlett, and Wyeth. When it’s simple, you don’t have to write much.

The other interesting thing about Barcal is that it does not cite Yates, the only Circuit court decision to address this issue. Nor does it cite any of a number of district court opinions on design defect preemption decided before and after Yates. The preemption discussion cites nothing other than Supreme Court cases. [Editorial note: our cheat sheet on drug preemption collects all the relevant cases].

It should be mentioned that only major changes in drugs and medical devices must be approved or permitted by the FDA before taking effect. So one does have to compare the alleged defect against those regulations. Suffice it to say that in regard to a drug, a change in the “molecule” clearly suffices. In a medical device case, plaintiffs do sometimes point to a specific defect which then must be evaluated against the regulations.

The major rationale used by lower courts to reject this argument is a claim that Mensing applies only to generic pharmaceutical companies. See, e.g., In re Tylenol Marketing, 2:12-cv-07263, 2015 WL 7075949 (E.D. Pa. Nov. 13, 2015). That conclusion flies in the face of a straightforward sentence in Mensing, not to mention the Bartlett language also quoted above. It is a claim rejected directly in Yates and implicitly in In re Celexa. This subject is generally discussed at length in Dean & Larimer, “Between a Regulatory Rock and a Hard Place: Does Preemption Provide an Escape?” DRI In House Defense Quarterly (Fall 2014).