Another of the recent significant decisions from the In re Zantac MDL, No. 2924, addressed preemption – mostly but not entirely involving defendants who manufactured generic versions of the drug.  In re Zantac (Ranitidine) Products Liability Litigation, ___ F. Supp.3d ___, 2020 WL 7864213 (S.D. Fla. Dec. 31, 2020).  For those who have not read our prior post, the Zantac MDL involves a claimed product defect in the nature of a design defect (an active ingredient that allegedly breaks down over time into a different chemical that “increase[s] the risk of cancer,” id. at *2).

The type of substance involved – nitrosamines − is something anyone who consumes bacon, beer, or cheese has already been exposed to for many years (pills being a lot smaller).  This purported defect was not discovered until well after the relevant patents had expired and generic versions of the product had entered the market.  Id.  The Zantac plaintiffs sued everyone they could think of, including the generic manufacturers and certain repackagers of the drug.

These defendants responded with preemption motions.  The motion filed by the generics was based on the by-now quite familiar PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), decisions, which hold that since generic labels and designs must be “the same” as the original branded drug on which their Abbreviated New Drug Applications rest, it is impossible for them to comply with immediate state tort duties without the FDA first having to take action.  Zantac, 2020 WL 7864213 at *7-8 (describing rationale of Mensing and Bartlett).  Zantac also discusses the three types of drug-related “changes”:

  • Major, which “include[s] certain labeling changes, changes in the qualitative or quantitative formulation of the drug product . . . and changes in the synthesis or manufacture of the drug substance that may affect the impurity profile and/or the physical, chemical, or biological properties of the drug substance. A major change requires a supplement submission and [FDA] approval prior to distribution of the product made using the change.
  • Moderate, which is “any change in the drug substance, drug product, production process, quality controls, equipment, or facilities that has a moderate potential to have an adverse effect on the . . . safety or effectiveness of the drug product.. . . . A moderate change generally requires a “supplement submission at least 30 days prior to distribution of the drug product made using the change.”  However, some “moderate changes that may be made upon the FDA’s receipt of the supplement and need not await the passage of 30 days,” such as the label-strengthening “Changes Being Effected supplement.”
  • Minor, which “is a change in the drug substance, drug product, production process, quality controls, equipment, or facilities that has a minimal potential to have an adverse effect on the . . . safety or effectiveness of the drug product.” Minor changes may simply be “described in an annual report,” and do not require FDA pre-approval

Id. at *5-6 (regulatory citations and quotation marks omitted).

The plaintiffs in Zantac, of course, knew that they would be faced with preemption.  So rather than bring types of product liability claims (design, warning, Dear Doctor letter, testing, fraud, misrepresentation, express and implied warranty) that have already have been held preempted, id. at *9, they alleged novel, FDCA-related claims through which they hoped to make an end run around preemption.

For the most part, it didn’t work.  Plaintiffs’ primary effort to dodge preemption was to sprinkle in “misbranding” allegations to their complaints, and claim that – given the very broad language of the FDCA’s misbranding provision, 21 U.S.C. §352 – Mensing, Bartlett, and all forms of impossibility conflict thereby disappeared.  Since “misbranding” under the FDCA exists when a drug’s “labeling is false or misleading in any particular” or when “it is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof,” every common-law tort claim can be recast in this fashion.

First, a version of that argument had been asserted by the FDA in Mensing itself, and was held insufficient to prevent preemption.  2020 WL 7864213 at *11 (discussing Mensing, 564 U.S. at 616-17).  Second, every other court to consider “misbranding” allegations post-Mensing had nonetheless ruled in favor of preemption.  Id. at *12-13.

Third, the Zantac plaintiffs’ “misbranding” argument proved too much.  “No court has adopted Plaintiffs’ theory that impossibility pre-emption can be avoided by showing that a drug is misbranded.”  Id. at *13.  Nor can plaintiffs enforce the misbranding provisions of the FDCA.

It does not follow that, because a drug manufacturer that introduces a misbranded drug into interstate commerce is subject to criminal liability, a civil remedy must also be available.  There is no private cause of action to enforce the federal misbranding statutes.

Id. (citations omitted).  Finally, “misbranding” is not some form of anti-preemption kryptonite:

A finding that Plaintiffs can avoid pre-emption by alleging that defects in . . . products made the products misbranded . . . would render the vast body of pre-emption caselaw in the drug context, including binding Supreme Court decisions, meaningless.  If Plaintiffs’ position were accepted, a plaintiff could avoid pre-emption simply by asserting, for example, that a drug’s labeling was “false or misleading in any particular” or that the drug was “dangerous to health when used” as prescribed.  The Court cannot adopt a position that would render pre-emption caselaw meaningless.

Id. (citations omitted).

Zantac also held that the repackager defendants were entitled to the same relief as the generic manufacturers:

Plaintiffs do not contend that Repackager Defendants could lawfully make product or labeling changes that Generic Manufacturer Defendants could not lawfully make.  The same pre-empted claims against Generic Manufacturer Defendants are likewise pre-empted as against Repackager Defendants.

Id. at *14.

Besides misbranding, the Zantac plaintiffs had a fallback argument based on the expiration dates and testing.  The purported rationale of these allegations was that, since the deterioration that supposedly created the cancer risk was gradual, a shorter expiration date would reduce the claimed risk.  2020 WL 7864213, at *14.  The testing claim was related – if defendants had done more testing, they would have known to shorten the expiration date.  Id. at *14-15.  This argument was completely novel.  “None of the parties have pointed to any case where a claim based on failure to shorten the expiration date for a drug has been presented to a court.”  Id. at *15.

This time the Zantac plaintiffs’ primary problem was that they were making up things as they went along.  The master complaints ran to over 7,000 paragraphs.  Id. at *14 (7,236, to be exact).  But none of them pleaded claims about either expiration dates or testing.  Id. at *16 (“the Master Complaints do not state claims based on expiration dates and testing upon which relief can be granted”).  While that might be correctable by repleading, they have a serious consistency problem – their new argument that the products become more unsafe over time conflict conflicts with their existing allegations “that the products were dangerous upon being manufactured.”  Id.  Oops.  That’s what happens when you change course on the fly.  “Plaintiffs’ incorporation of inconsistent factual allegations into their counts is improper.”  Id.

And there’s more.  “Plaintiffs have not identified in the Master Complaints the state-law duty or duties for each of the 52 jurisdictions that they maintain Defendants did not fulfill when they did not shorten expiration dates for ranitidine products.”  Id.  Most states do not recognize an independent common-law claim for “negligent testing.”  See our duty to test cheat sheet.  Moreover, the only contrary “authority” cited in Zantac, 2020 WL 7864213, at *16 − Atkinson v. Luitpold Pharms., Inc., 448 F. Supp.3d 441, 453-54 (E.D. Pa. 2020) – is a Pennsylvania court misapplying Texas law, as we pointed out here.  If plaintiffs intend to pursue an expiration date claim, they are going to have to plead them separately, and on a state-by-basis.  Id.  Then they will have to defend these novel claims under state law in a new round of motions to dismiss.  Id.  This portion of Zantac closes with one of the finest reiterations of the Mensing independence principle that we’ve yet seen, combined with a warning to plaintiffs:

The question for “impossibility” is whether the private party could independently do under federal law what state law requires of it.”  If a defendant cannot, independently and while remaining in compliance with federal law, do what needs to be done to avoid liability under a state cause of action, the cause of action is pre-empted.  Upon any repleading, Plaintiffs should consider, as to each cause of action, the elements under each state’s law and what state law would require of Defendants to avoid liability.

2020 WL 7864213, at *17.  While we have our doubts about how deterrable MDL plaintiffs are, this time, they cannot say that they weren’t warned.

Another novel plaintiff fallback position was dismissed with prejudice in this Zantac opinion.  They tried to gin up a claim based upon allegations that product labeling lacked proper “storage and transportation” instructions.  Id. at *18-19.  Sorry, but the FDCA’s sameness requirements contains no exemption for these types of instructions:

The Court similarly is not aware of any authority providing that generic drug manufacturers or repackagers can change storage and transportation information on labeling without FDA pre-approval while remaining in compliance with federal law. . . .  Because claims based on labeling defects that a defendant cannot independently change while remaining in compliance with federal law are pre-empted, Plaintiffs’ claims based on allegations that Defendants should have placed different or additional storage and transportation information on their ranitidine products’ labeling are dismissed with prejudice as pre-empted.

Id.  “Testing” claims that would lead to the same result met the same fate.  Id. at *19.  While plaintiffs were allowed to replead storage claims as well, they again face a major problem:

Plaintiffs should be prepared to provide the factual and legal basis for a proposition that, if FDA-approved labeling permits a party to store a drug under certain conditions, a state may nonetheless impose liability for storing the drug under those conditions.

Id.  This sounds like a Rule 11 warning.

Finally, the rest of this Zantac opinion addresses a number of other claims:

  • Failure to Report:  Once again, the plaintiffs failed to plead this claim.  Id. at *20.  One wonders what plaintiffs did in their 7,000+ paragraphs.  Given Eleventh Circuit law, however, this claim looks like a loser.  See Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1330 (11th Cir. 2017) (“[plaintiff’s] failure to report theory is impliedly preempted . . . [b]ecause this theory of liability is based on a duty to file a report with the FDA, it is very much like the ‘fraud-on-the FDA’ claim the Supreme Court held was impliedly preempted in Buckman”).
  • Manufacturing Defect: TwIqballed.  Plaintiffs “fail[ed] to plead any specific facts such as the identification of how any particular batch of ranitidine products departed from their intended design or of any particular manufacturing processes or procedures that should have been but were not followed.”  Zantac, 2020 WL 7864213, at *21.
  • Magnuson Moss Warranty Act: “[C]laims under the MMWA require a valid state-law warranty claim.”  Id. at *22.  Further, “[t]he MMWA is “inapplicable to any written warranty the making or content of which is otherwise governed by Federal law,” so it “is inapplicable to warranty claims based on language on drug labeling that the FDA governs.”  Id. at *23-24.  Plaintiffs are allowed to replead if they can.  Good luck.
  • Absolute Liability: Absolute liability does not exist.  Dismissed with prejudice.  Id. at *24.

Bottom line?  This Zantac decision is another big win for the moving defendants (here, generic drug manufacturers and repackagers).  While plaintiffs are allowed to replead some of their claims, most of those claims are unprecedented under state law, and thus subject to the Erie conservatism principle already recognized in this MDL.  Plaintiffs’ one traditional product liability claim, manufacturing defect, cannot be squared with the chemical breakdown premise that is at the heart of the MDL.