The first three significant Zantac MDL decisions, which we chronicled here, here, and here, were all issued on December 31, 2020. Today’s installment, In re Zantac (Ranitidine) Products Liability Litigation, ___ F. Supp.3d ___, 2021 WL 76433 (S.D. Fla. Jan. 8, 2021), was issued this year. For those of you who have not read those prior posts, Zantac is a drug that has been around, in branded or generic form, since 1983. After more than 30 years, it was discovered that the active ingredient could break down into an alleged carcinogen – nitrosamines, the same type of substance anyone who consumes bacon, beer, or cheese has already been exposed to for many years (pills being a lot smaller). Litigation ensued, against both branded and generic-affiliated defendants. Id. at *1-2.

We’ve mentioned that, as longtime readers of judicial opinions, the Zantac opinions are well organized with the court’s rulings at the beginning – so we don’t have to waste time searching for through the chaff to find the wheat. The summary here was quite to our liking:

Design-defect claims based on the FDA-approved formulation of [the drug] products are pre-empted, regardless of the Plaintiffs’ allegations that the products were misbranded. . . . [C]laims against Defendants based on allegations of failure to make changes to the FDA-approved design that the Defendants could not have made independently while remaining in compliance with federal law are dismissed with prejudice as pre-empted. . . . The Court grants the Plaintiffs leave to replead design-defect claims that are based on labeling defects and to plead pre-approval design-defect claims. The Plaintiffs’ claims that seek a refund and are not premised upon a personal injury to a plaintiff’s person or property are not saved from express pre-emption under 21 U.S.C. § 379r(e).

2021 WL 76433, at *5.

Once again, PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), control. Changes in drug (and device) design must necessarily affect the safety of the product to be relevant in product liability litigation – but any alteration that does that is a “major” change that requires prior FDA approval. 2021 WL 76433, at *7. However:

The [Mensing] Court stated that the “question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it.” “[W]hen a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for preemption purposes.”

Zantac, 2020 WL 7864585, at *9 (citations to Mensing omitted). Then, in Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), the court explicitly applied this holding to design defects, since “as a matter of both federal law and basic chemistry,” a “drug manufacturer was unable to change the drug’s composition” without such approval. Zantac, 2021 WL 76433, at *9.

Design defect claim are thus “pre-empted because the Defendants could not change the design of [the] products without FDA approval while remaining in compliance with federal law, and therefore it was impossible for them to independently fulfill any duties under state design-defect causes of action.” Id. at *10. “A claim that a brand-name drug manufacturer should have changed a drug’s FDA-approved formulation is a pre-empted claim because the manufacturer cannot make such a change independently and while remaining in compliance with federal law.” Id. at *11 (citations omitted).

Simply calling the drugs “misbranded” does not magically make preemption go away. This decision referenced the extensive discussion of this fallacy in a prior Zantac opinion. Id. at *12. “[A] claim based on an allegation that a brand-name drug’s FDA-approved formulation renders the drug misbranded is a pre-empted claim because the drug’s manufacturer cannot independently and lawfully change a drug formulation that the FDA has approved.” Id.

We call this the “Mensing independence principle,” and as this opinion demonstrates, properly utilized, it is quite powerful.

Displaying the same helter-skelter argument style that we have commented on in prior posts, the Zantac plaintiffs brought up the largely discredited distinction between “pre-approval” and “post-approval” design claims. Id. at *11-12. Once again, despite three different master complaints and over 7,000 paragraphs of allegations, plaintiffs jumped to a theory that they had failed to plead. “Plaintiffs have not pled a pre-approval design-defect claim.” Id. at *13. Thus, the issue was not decided. Cautioning plaintiffs that they “have not identified which, if any, states recognize a pre-approval duty that drug manufacturers owe to consumers,” this Zantac decision left the issue for later, “[s]hould the Plaintiffs raise a pre-approval design-defect claim or claims upon repleading.” Id. at *13.

The second type of preemption that this Zantac opinion recognizes is express preemption under 21 U.S.C. §379r, which is limited to over-the-counter (“OTC”) drugs. We’ve discussed this preemption clause before – it has quite broad language, but is largely ruined by a savings clause, exempting “products liability” actions from preemption. That wasn’t a problem in Zantac – at least as to the economic loss claims. As our posts point out, “product liability” requires either physical harm or property damage. Thus, section 379r wiped out the economic loss claims against all OTC products. – no fewer than “320 state-law claims” alleged in this ridiculously over- (yet under-) pleaded litigation. 2021 WL 76433, at *13.

The Court agrees with the Defendants that, at least as a facial matter, caselaw establishes that all of the Plaintiffs’ state-law claims against the Defendants are pre-empted to the extent those claims are premised upon the adequacy of OTC ranitidine products’ design or label and are limited to injuries stemming from the purchase of [the drug].

Id. at *15. Zantac then once again rejected plaintiffs’ magic word “misbranding” argument. Id.

Plaintiffs’ last ditch attempt to avoid §379r was to claim, contrary to all precedent, that purely economic loss claims were nonetheless “product liability” and thus saved by the statute’s savings clause. That argument was based on hair-splitting – they argued that “because the Defendants have not made a state-by-state argument that the Plaintiffs’ claims fail under state product liability law, the Motion to Dismiss must be denied.” Id. Defendants responded that “product liability” as used in a federal statute, was a term to be defined under federal law. Id.

Only in an MDL….

In any event, there is plenty of general authority that “[f]ederal law generally governs terms used in federal statutes.” Id. (citations omitted). Once again, plaintiffs were simply making things up. “[T]he Plaintiffs provide no authority for the proposition that the Court should consult state law to interpret phrases in federal statutes.” Id. at *16. Instead, they relied on a couple of cases where courts happened to refer to state law in discussing §379r. Id. Thus, plaintiffs lost the argument:

The Defendants have cited a plethora of authority for the proposition that federal law should be consulted to determine the meaning of phrases in federal statutes − authority that the Plaintiffs have not refuted. The caselaw is binding.

Id. at *16 (citations omitted).

Sounding a bit like our post, “What is ‘Product Liability,’” Zantac finished off the plaintiffs’ claims by declaring that, whatever “product liability” may or may not mean in the abstract, Congress did not intend with this limited savings clause to allow purely economic loss claims:

[T]his Court need not define the precise boundaries of product liability law. . . . What is before this Court is whether Congress intended to permit state-law causes of action when no plaintiff suffered a personal injury to their person or to their property − when a plaintiff’s damages are limited solely to the purchase of the product itself. As to this specific boundary, as to this specific question, the Defendants have the more persuasive argument. The Court concludes that Congress did not intend for any state to have the authority, under the §379r(e) savings clause, to classify a claim as a product liability claim when the plaintiff did not suffer a personal injury.

Id. at *17.

Another one – actually, another 320, to be precise − bites the dust.