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Of all the catch phrases that we have coined or popularized (see Twiqbal), one of our favorites is the “one-two punch,” our affectionate label for post-Mensing cases holding that (1) a plaintiff can bring product liability claims only against the maker of the drug that he or she actually took and (2) that claims against generic manufacturers are preempted. We like these cases a lot and write on them every chance we get because they make so much sense. A court should not have to say out loud that a plaintiff cannot bring product liability claims against a defendant that did not make or sell the product. That is why it is called “product” liability. We also agree wholeheartedly with generic preemption, which is the only solution to the “damned if you do, damned if you don’t” position that generic manufacturers would otherwise find themselves in, i.e., unable to comply with state-law claims because federal law prohibits it. We like one-two punch cases also because they give us the opportunity to criticize the wrongly reasoned and wrongly decided Conte case from the California Court of Appeal. (Have we mentioned that we do not think very much of Conte?). The so-called “innovator liability” that Conte attempted to pioneer based on “common sense” and “the general rule of duty” has floated like a lead balloon, probably because it made no “sense” and because “general rule of duty” was code for “based on no body of law that we can specifically identify.” 

The Fifth Circuit has just given us another clear-minded one-two punch in yet another case involving generic metoclopramide. The case is Lashley v. Pfizer, Inc., No. 12-60861, 2014 WL 661058 (5th Cir. Feb. 21, 2014), and our only regret is that it is not published, because the holding and its reasoning are right on the money. The two plaintiffs in this consolidated appeal—one alleging claims under Texas law and the other under Mississippi law—used generic metoclopramide and allegedly developed tardive dyskinesia and akathisia, so they sued not only the manufacturers of the generic drugs they actually took, but also the manufacturers of branded Reglan. Id. at *1. 

The court disposed first of the claims against the generic manufacturers, against whom the plaintiffs alleged the usual laundry list of claims: Negligence, gross negligence, strict liability, breach of numerous warranties, misrepresentation, fraud, suppression of evidence, and deceptive trade practices. In the end, however, the court correctly saw all of the claims for what they were—variations on failure-to-warn—and from there it was a short step to preemption: “At their core, all [of the plaintiffs’] claims against the generic manufacturers turn on the adequacy of the labeling and related information, and can thus be construed as failure-to-warn claims. As such we find them to be preempted under Mensing.” Id. at *2.

The plaintiffs tried to argue their way around Mensing in a few ways. They first argued that generic manufacturers could have made consumers aware of the risks in ways that did not differ from the content in the warnings, but the court through that: As was said in Cool Hand Luke, “what we have here is a failure to communicate.” Thus Lashley held that Mensing forecloses all claims based on allegedly inadequate communication, no matter what means of transmission. Id. at **2-3. The plaintiffs also argued that not all of their claims were based on a failure-to-warn, but the court shot that down, too. To begin with, we can’t really tell from the opinion how the plaintiffs thought that any of their claims were based on anything other than an alleged failure to provide adequate warnings. Maybe the court could not tell either, but regardless, the court held that “non-failure-to-warn claims” were preempted in light of Bartlett because “assuming distribution of the drug was acceptable in the first place, any useful action (of lack thereof) for which the companies could be held responsible would necessarily involve some form of warning.” Id. at *3.

Finally, the plaintiffs argued that some of their state-law claims were “parallel” to federal law and thus not preempted. This is our favorite, because the plaintiffs were so clearly trying to pull a fast one. So-called “parallel claims” can exist only within the express preemption context, where the relevant question is whether state law is imposing a requirement “different from or in addition to” federal requirements. Although we don’t like it, courts have allowed state-law claims to proceed where they “parallel” federal claims, i.e., where the state requirement neither adds to nor is different from federal requirements.

The concept becomes utter nonsense when imported into implied preemption, which is the only kind of preemption that was at issue in Lashley. The Fifth Circuit was not fooled, and it rejected the plaintiffs’ parallel claim argument because:

Medtronic and Hughes [cited by the plaintiffs] concern express preemption; in those cases, “parallel” state law claims against manufacturers of medical equipment were allowed to proceed because there was no express preemption found in the applicable statute. In Mensing, as here, the Supremacy Clause—not a statute—made it impossible for the generic defendant to do what state law required of it and, therefore, the state law claim was preempted. In these types of cases, the inquiry is not whether there is a “parallel” claim where one looks for absence of conflict with the statute; the inquiry is whether the state law claim is impliedly preempted.

Id. at *4 (emphasis added). We like this quote. It is a correct statement of the law (although we still think the parallel claim doctrine does not hold water), and it maintains a conceptual distinction between express preemption and implied preemption that is necessary to prevent confused and unfair results. The opinion thus affirmed the district court’s order dismissing claims against the generic manufactures. This was blow number one.

The court’s second blow affirmed summary judgment in favor of the innovator manufacturers on the basis that they did not make or sell the products that these plaintiffs used.  Id. at **4-5. The court did not cite Conte, but it understood what the Conte court did not—that the innovator manufacturers owed the plaintiffs no duty because the plaintiffs “did not ingest the . . . brand defendants’ products.” Id. at *4. The court applied Mississippi law to one plaintiff and Texas law to the other, but we would have courts come to this conclusion under any state’s law because it is so clearly the correct result. It comforts us to know that we are not the only people who feel that way, including nearly every court  to consider the issue. Add the Fifth Circuit to the list and hope that the next time they file an opinion like Lashley they deem it worthy of publication.