This post is not from the Dechert side of our tripartite blog.
We are particularly pleased with the result in Drager v. PLIVA USA, Inc., ___ F.3d ___, 2014 WL 292700 (4th Cir. Jan. 28, 2014), a generic preemption case that – like so many – involves metoclopramide/Reglan. Drager is the first appellate court post-Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), to get it 100% right on the tempest in a teapot plaintiffs have attempted to create regarding the “consumer expectation” approach to design defect. In Bartlett the Court construed New Hampshire law, and New Hampshire follows the majority rule “risk/utility” approach to design defect. Plaintiffs in Bartlett succeeded in the lower courts in converting New Hampshire strict liability into a form of absolute liability by claiming that they didn’t need any alternative design to assert a design defect. The Supreme Court had none of that and properly rejected plaintiffs’ construction of New Hampshire law. 133 S. Ct. at 2473-74. Ever cautious, the Court “save[d] for another day” whether a “true absolute-liability state-law system” (which no state has actually adopted) could escape preemption. Id. at 2474 n.1.
Plaintiffs desperate to escape preemption have tried nitpicking Bartlett to death. They have sought to extend the Court’s hesitation to address legal theories not actually presented to include the minority “consumer expectation” approach to design defect. A couple of decisions have thereby been induced to – not reject preemption – but at least suggest that this issue could be open after Bartlett. See Bell v. Pfizer, 716 F.3d 1087, 1096 (8th Cir. 2013) (remanding issue for consideration by district court) (applying Arkansas law), Fullington v. Pfizer, Inc., 720 F.3d 739, 747 (8th Cir. 2013) (same). Other appellate courts have dodged the issue in one way or another. Strayhorn v. Wyeth Pharmaceuticals, Inc., 737 F.3d 378, 397 (6th Cir. 2013) (Tennessee would not apply consumer expectation test to drugs).
In our prior “bullseye” post we praised In re Fosamax Products Liability Litigation, ___ F. Supp.2d___, 2013 WL 4306434 (S.D.N.Y. Aug. 15, 2013), for getting this issue right. Risk/utility vs. consumer expectation in the context of preemption under Bartlett simply doesn’t matter. The result in either case (should a plaintiff win), would be liability predicated on a defendant’s failure to do the impossible: alter a drug’s (or medical device’s) design without FDA pre-approval. Impossibility preemption doesn’t give a damn about the theory, it looks at whether the common-law outcome can be squared with the defendant’s federal obligations.
That’s where Drager comes in. It’s the first court of appeals to face this false distinction head on and identify this non-issue for what it is. Plaintiff in Drager (which was named Gross in the district court) claimed that Maryland follows the “consumer expectation” test, 2014 WL 292700, at *5, and maybe it does. That doesn’t matter a hill of beans (is “immaterial,” id.), though, where the issue is impossibility preemption:
The Court in Bartlett did not determine that the New Hampshire law was preempted because it applied the risk-utility approach. Instead, it concluded that there was no action that the defendant could take under that approach to increase the safety of its product without violating the restrictions of the FDCA. We have no trouble concluding that the same is true under either the risk-utility or the consumer-expectations approach in Maryland. [Defendant] cannot be required to stop selling its product, but at the same time it is prohibited from making any changes to the product itself or the accompanying warnings. Regardless of the way in which Maryland assesses the unreasonableness of a product’s risks, if [defendant’s drug] is unreasonably unsafe, there is no apparent action that [defendant] can take in compliance with FDCA restrictions to avoid strict liability.
Drager, 2014 WL 292700, at *5 (emphasis added). That’s precisely the point – and the only point. If the result of a verdict is that, to avoid liability under state law, the defendant would have to violate FDA regulations requiring Agency pre-approval of any alteration of the product’s design, then state law is preempted as “impossible” to enforce in the face of supreme federal law.
And once again, we point out that this is true whether the product in question is a generic drug, an innovator drug, a PMA medical device, a §510k medical device, or a vaccine. In every instance FDA pre-approval (and often an entirely new start-to-finish approval process) is required before the product’s design can be altered. There is no “changes being effected” way around FDA pre-approval for design changes.
There’s other stuff in Drager too, but to us it’s not as important as the court’s dispatching of the consumer expectations/risk-utility distinction without a difference. Specifically:
- It was not an abuse of discretion for the court to refuse a motion to amend that was never properly made. Drager, 2014 WL 292700, at *2. The judge can’t be blamed where the plaintiff failed to follow basic rules of civil procedure
- “[C]ourts may not avoid preempting a state law by imposing liability on a generic manufacturer for choosing to continue selling its product.” Id. at *3 (sure, that’s the same as Bartlett, but it’s a quotable quote).
- “[A] generic may not unilaterally change its labeling or change its design or formulation, and cannot be required to exit the market or accept state tort liability. Therefore, if a generic drug manufacturer cannot satisfy a state law duty except by taking one of these four actions, that law is preempted and of no effect.” Id. Another quotable quote.
- There’s no separate claim for negligent failure to test. “Divorced from the context of an eventual sale to the consumer, [defendant] could not owe any duty to that consumer to perform any testing or inspection on its product, and there could therefore be no cause of action for negligence.” Id. at *4. Thus, Drager goes on our duty to test cheat sheet.
- “Maryland law does not recognize causes of action for breach of implied warranties of merchantability or fitness for a particular purpose when the goods at issue are pharmaceuticals.” Id. at *6. Nice to have that said so clearly.
- Where a defendant cannot change its product’s formulation or warnings, warranty claims amount to a choice of liability or stop selling the product, and are therefore preempted. Id.
- “[T]he content of generic drug manufacturers’ product descriptions and other assertions is mandated by federal law,” therefore express warranty claims are preempted. Id.
- It is “frivolous” to argue that fraud and negligent misrepresentation clams based on “promotional and warning materials” are preempted, since these claims “are premised on the content of statements made by the defendant to the plaintiff.” Id. at 7. Hear that? Frivolous.