As we try to keep pace with the unusually fast-moving Zantac MDL, today we review In re: Zantac (Ranitidine) Products Liability Litigation, ___ F. Supp. ___, 2021 WL 2865869 (S.D. Fla. July 8, 2021). As we’ve discussed before, the drug under attack allegedly breaks down naturally into N-Nitrosodimethylamine (“NDMA”), an unfortunately ubiquitous carcinogen. Anyone who consumes bacon, beer, or cheese has probably had far greater overall exposure from such other sources than they could ever have been exposed to from tiny pills. But, of course, that didn’t stop plaintiffs from suing everybody they could think of on practically every existing theory (and a number that don’t exist).
In our “Prevalence of Preemption” post we examined generic preemption (the drug has been generic for quite some time, now), but the dismissal that time around was without prejudice. The plaintiffs then let their word processors run even wilder and came up with “amended” complaints so prolix that they’re hard even to describe. The decision recites that the amended master complaint for “personal injury” “contains 17 counts and numerous state-specific sub-counts.” 2021 WL 2865869, at *3. Rather than go over every count, we simply totaled them up. That one complaint has, by our count, 663 “sub-counts.” Id. The other two complaints, for “economic loss” and “medical monitoring,” contain 1,675 and 638 counts, respectively. Id. at *4
These MDL plaintiffs weren’t content with throwing in the kitchen sink – they created an entire sewer system.
This Zantac opinion freed all of the generic manufacturers from this litigation version of the Great Dismal Swamp on motion to dismiss. As we’ve said many times. Preemption is the most powerful defense there is in prescription medical product liability litigation.
Pages *6-10 of the new Zantac opinion are essentially identical to the opinion we already reviewed, so we’ll skip right to the heart of the matter – the preemption analysis.
The first thing to go were failure-to-report claims, but the new decision simply adopted the same implied preemption reasoning, based on Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), and Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017), that it had used to dismiss similar claims against branded manufacturers, a few days earlier. 2021 WL 2865869, at *11 (referencing June 30, 2021 order to dismiss all such claims with prejudice, without regard to any generic-specific argument).
The Eleventh Circuit explained that the plaintiff’s negligence claim based on failure to report to the FDA was a claim for negligent failure to warn. The court held that this claim was pre-empted. The court reasoned that the plaintiff’s theory of liability was based on a duty to file a report with the FDA and was very much like the “fraud-on-the-FDA” claim the Supreme Court held was impliedly preempted in Buckman. In both cases, a plaintiff alleged a manufacturer failed to tell the FDA those things required by federal law. The court concluded that federal law pre-empted the plaintiff’s claim insofar as the manufacturer’s duty was owed to the FDA and the plaintiff’s theory of liability was not one that state tort law has traditionally occupied.
In re Zantac (Ranitidine) Products Liability Litigation, 2021 WL 2685613, at *21 (S.D. Fla. June 30, 2021). After all, “[w]hen analyzing questions of federal law, a transferee court in an MDL applies the law of the Circuit in which it is located.” Id. at *22 (citations omitted).
Frankly, plaintiffs have nobody but themselves to blame, since situating this MDL in the Southern District of Florida – in the Eleventh Circuit – was their own idea. See In re Zantac (Ranitidine) Products Liability Litigation, 437 F. Supp.3d 1368, 1369 (J.P.M.D.L. 2020) (“plaintiffs appeared to have coalesced around the Southern District of Florida as their first choice for transferee district”). Mink had already been the law of the Eleventh Circuit for three years before that.
Plaintiffs’ claims for failure to warn and negligence followed. As detailed in our Generic Preemption Scorecard, scores of courts, from the United States Supreme Court on down, have held that the generic duty of “sameness” precludes all state tort claims for failure to warn. So the plaintiffs tried to make up something new – “sub-duties” that at least had the advantage that not having mounds of adverse precedent directly on point. 2021 WL 2865869, at *15. Plaintiffs advanced three novel sub-duties: “a duty to warn through an accurate expiration date,” a duty “to properly package ranitidine,” and a duty “to properly store and transport ranitidine.” Id.
The Plaintiffs contend that, although they have brought failure-to-warn claims, the relevant state-law duty for pre-emption purposes is not the duty to warn of known risks. They similarly contend that, although they have brought various negligence claims, the relevant state-law duty for pre-emption purposes is not the duty to use reasonable care.
2021 WL 2865869, at *16. No such thing as “sub-duties” existed.
The Plaintiffs provide no authority for the proposition that their proffered “sub-duties” are, in fact, duties. In the Court’s experience, there is no such tort as “Negligent Choosing and Making of Containers” or “Negligent Transporting and Storing of Products.” Instead, a failure to reasonably package a product or a failure to reasonably transport a product are merely fact patterns that would permit a plaintiff to bring the tort of ordinary negligence. In other words, the failure to properly package a product or the failure to properly transport a product are theories of breach, not independent duties.
* * * *
[C]ourts and attorneys alike may commonly refer, in the colloquial sense, to a particular fact pattern underpinning a theory of breach as a “duty”. . . . But the actual duty under state law is the duty to use reasonable care, not the duty to clean up dangerous puddles or to keep sidewalks in good repair. . . . The Court rejects the Plaintiffs’ theory that “sub-duties” are cognizable (and divisible) legal duties, let alone the duties to be used for comparison in federal pre-emption analysis. While “sub-duties” may have their place in a plaintiff’s strategic approach to litigating a case, they do not fit within the required paradigm for pre-emption analysis.
Id. at *16-17 (emphasis original).
In other words, stop making things up.
In the long term, this is by far the most significant part of this Zantac opinion. Plaintiffs inevitably respond to preemption by trying to invent new purported causes of action – the aforementioned failure to report is one such attempt to turn a fact pattern into a separate tort. Duty to test, duty to update, and duty to train are others that come to mind. We now have a great rationale and quote to respond to future attempts to create new variations on the theme of, as here, failure to warn or design defect.
Relying primarily on one of our favorite generic preemption cases, Drager v. PLIVA USA, Inc., 741 F.3d 470 (4th Cir. 2014) (our 5th best case of 2014), Zantac shot down all of the plaintiffs’ purported “sub-duties” as variations on preempted design defect claims. 2021 WL 2865869, at *17.
As in Drager, where there was no specific cause of action for negligent testing, there are no specific causes of action for failure to warn through proper expiration dates, negligent product containers, negligent storage and transportation, or negligent failure to test.
Id. at *18. While various states may “refer” to warning duties “in different ways,” these variations make no difference to generic preemption. Id. Impossible was still impossible, given the federal “sameness” mandate:
[T]he Generic Manufacturer Defendants could not satisfy these legal duties − the duty to warn of the risks associated with the use of ranitidine and the duty to use reasonable care − under federal law. The Generic Manufacturer Defendants could not warn consumers of the alleged risks that ranitidine posed when the labeling on brand-name ranitidine products did not contain such warnings. Furthermore, accepting the Plaintiffs’ allegations about ranitidine as true, no drug manufacturer could satisfy its duty to use reasonable care by releasing ranitidine products into the marketplace as they were designed and labeled.
Id. at *19.
Going on to examine the “breadth” of plaintiffs’ purported “sub-duties,” Zantac recognized that they all stemmed from the most basic impossibility of them all – the chemical formulation of the FDA-approved drug, which plaintiffs claimed “is a defectively designed molecule; it is highly unstable and apt to form a potent carcinogen.” Id. at *20. No matter how many counts plaintiffs might try to split this preempted design defect claim into, it was always going to be preempted:
[E]ven though the Plaintiffs’ claims purport to be based on theories other than design defect, the Plaintiffs’ design-defect theory remains at the center of this case and, by extension, at the center of all of the Plaintiffs’ claims. . . . Plaintiffs’ expiration-date claims seek to impose liability on the Generic Manufacturer Defendants because the expiration dates on ranitidine products should have been shorter. But why should the expiration dates have been shorter? Not because of the loss of any of ranitidine’s potency over time, nor because of any steady decay. Instead, the Plaintiffs’ answer is that ranitidine is dangerous from the moment it is created. . . .
In another example of design defect, the Plaintiffs’ temperature-based claims seek to impose liability on the Generic Manufacturer Defendants because they did not affirmatively chill the ingredients. . . . But why should the Generic Manufacturer Defendants have chilled ingredients? Not because the FDA-approved process for manufacturing ranitidine required chilling, but because ranitidine was a defective molecule that required chilling to counteract its defect.
Behind each of these examples is the Generic Manufacturer Defendants’ alleged knowledge of all of the defects inherent in the design of ranitidine itself.
Id. (citations omitted).
In short, no matter how much they run their word processors – no matter how long and convoluted their complaints – they can’t get away from the fundamental basis for preemption under Bartlett: “the drug is chemically incapable of being redesigned,” so once the FDA has approved it, no design defect claims can survive preemption. Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472, 473 (2013).
After knocking out the key claims, Zantac turned to what little was left. Unjust enrichment, loss of consortium, and wrongful death were all “derivative” and fell with the preemption of all the plaintiffs’ substantive claims against the generic defendants. 2021 WL 2865869, at *22. Then there were claims against “Store-Brand Defendants,” but they added nothing:
The Plaintiffs have not alleged nor argued that the Store-Brand Defendants had any greater authority under federal law to change their store-brand ranitidine products’ design or labeling than did the Generic Manufacturer Defendants with respect to generic ranitidine products.
Id. at *23.
Finally, rather than let plaintiffs kill another forest with still more amendments, Zantac dismissed all these claims with prejudice. Neither verbosity nor complexity was any substitute for merit. “[P]ermitting the Plaintiffs to file a third round of master pleadings against the Generic Manufacturer and Store-Brand Defendants would be futile.” Id. at *24. No matter how large their smokescreen, all plaintiffs’ claims were dependent on their attack on the FDA-approved molecule itself – and as to generic drugs (and we would say all drugs) those design defect claims were preempted.