In the third of the three significant decisions issued in the In re Zantac MDL, No. 2924, on New Year’s Eve, preemption prevailed again – this time barring claims asserted against drug retailers and pharmacists, both branded and generic.  In re Zantac (Ranitidine) Products Liability Litigation, ___ F. Supp.3d ___, 2020 WL 7864585 (S.D. Fla. Dec. 31, 2020).  For anyone who hasn’t read our prior “Zantac Chronicles” posts, the relevant facts are these:  the Zantac MDL involves, as a claimed product defect in a drug, the alleged tendency of the active ingredient to break down over time into a substance that “increase[s] the risk of cancer.”  Id. at *2.

This type of substance – nitrosamines − is something anyone who consumes bacon, beer, or cheese has already been exposed to for many years (pills being a lot smaller).  The alleged 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 intermediate sellers, such as pharmacists and retailers.

One of the things we like, as readers, about the Zantac opinions is that the rulings are summarized right up front – so we don’t have to scroll to the end to find the result.  The summary here was short and sweet:

The Court concludes that all of the Plaintiffs’ state-law claims against the [retailer/pharmacy] Defendants are pre-empted by federal law and, as a result, are dismissed.  Without a state-law claim to support it, the Plaintiffs’ sole federal claim is dismissed as well.  The Court will permit the Plaintiffs to re-plead a general negligence claim, subject to certain rulings contained in this Order.

2020 WL 7864585, at *5.

Why?

Once again, we return to what the Supreme Court held in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013).

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 *5 (citations to Mensing omitted).  Then, in Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), the court extended this holding to design defects.  Thus, “the Defendants’ second point − any claim based upon drug design is pre-empted − is also supported by a plain reading of Bartlett.”  Zantac, 2020 WL 7864585, at *5 (block quotation from Bartlett omitted).

The Zantac plaintiffs asserted numerous counts − Failure to Warn (Strict Liability), Design Defect (Strict Liability), Negligence—Failure to Warn, General Negligence, Breach of Express Warranties, Breach of Implied Warranties, Deceptive Acts, and Unjust Enrichment.  Id. at *12-13.  Zantac concluded that “all of the Plaintiffs’ state-law claims against the [retailer/pharmacist] Defendants are based upon [the drug’s] allegedly defective design and inadequate labels/warnings.”  Id. at *13.  Zantac then took the plaintiffs to task:

[C]ourts dismiss design and label-based claims against any defendant that is powerless to alter a design or alter a label.  The Plaintiffs have provided no citation to post-Bartlett authority where a court reached a different conclusion, nor have the Plaintiffs cited to a case where a court held that strict liability is equivalent to absolute liability − a proposition that Bartlett squarely rejected.  Instead, the Plaintiffs rely upon Section 402A of the Restatement of Torts, . . . [b]ut the Supreme Court in Bartlett utilized 402A in reaching its conclusion that strict liability is not equivalent to absolute liability. . . .  In summary, all of the caselaw weighs in favor of a conclusion that the Plaintiffs’ claims are pre-empted. . . .  The Court’s dismissal is with prejudice and without leave to amend.

2020 WL 7864585, at *13-14.  In short, these non-manufacturing defendants were entitled to dismissal because the claims against them were made up from whole cloth, and simply unsupportable post-Mensing/Bartlett.

Zantac then gave special attention to plaintiffs’ “misbranding” and “general negligence” claims, which were the only theories that they seriously attempted to defend.  As for misbranding, first, it amounted to a preempted stop-selling claim.  “[T]he Defendants could not correct the alleged misbranding” by “altering” either the drug’s “composition” or its “label.”  Therefore, even taking plaintiffs’ claim at face value, “[t]he Defendants would have no recourse but to stop selling the drug altogether.”  Id. at *15.  Nor could the misbranding allegations be taken seriously, since, second, they distorted the scope of the FDCA.  “By definition, however, such a claim could only be brought against a manufacturer − not a retailer or a distributor.”  Id.  Third, Zantac again rejected (as it did here) plaintiffs’ reliance on “misbranding” as a get-out-of-preemption-free card:

[A] finding that Plaintiffs can avoid pre-emption by alleging that defects in ranitidine products made the products misbranded under 21 U.S.C. §352 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. (citation omitted).  Fourth, “there is no private right of action to enforce federal misbranding law − a statute that imposes criminal penalties” and “Plaintiffs cannot create a private right of action to enforce federal misbranding rules by disguising it as a state-law strict-liability claim.”  Id. at *16.  Thus, in addition to Mensing and Bartlett, all misbranding clams are also barred by Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  Zantac, 2020 WL 7864585, at *16.

Nor could plaintiffs use “general negligence” as a “very broad” dumping ground for otherwise preempted allegations.  Id.  In this count, “Plaintiffs allege[d] that every Defendant in this MDL engaged in every possible action” during “every possible timeframe,” “regardless of the individual Defendant’s role or purpose in this case.”  Id.  Most of this confusing mess was just another preempted attack on the design and labeling of the product.  Id. at *17.  Mixed in, however, were novel allegations about purported duties relating to post-manufacture drug storage and transportation.  Id.  Zantac referred to as a “temperature-based negligence theory.”  Id.  Of course, nothing of the sort was actually pleaded in plaintiffs’ sprawling “shotgun-style pleading,” id. at *16, so as to this one item plaintiffs were granted leave to amend their complaint, but this leave came with a warning that plaintiffs had better “address the Court’s concerns” if they elect to proceed with temperature based negligence.  Those “concerns” were:

  • “Can the Plaintiffs plead in good faith that any Defendant had a policy to store [these] products at temperatures above those approved by the FDA?”
  • “If individual stores negligently stored [the drug] at unsafe, heated temperatures, how is that a global, MDL-based issue?” “[I]ndividualized and fact-specific” storage/transportation issues “have little, if any, bearing on the broader, more global questions in this MDL.”
  • Are “causation questions inherent in a high-temperature allegation” also individualized?  “Investigation where, in a supply chain, overheating occurred appears to the Court to be an individualized, fact-intensive discovery challenge.”
  • “[H]ow are high-temperature allegations to be squared with the Plaintiffs’ theory of the case,” which has been “that the Plaintiffs’ harm was caused at the very moment [the drug] was manufactured?”  “Plaintiffs must explain how that specific theory of liability is compatible with the Plaintiffs’ global theory of liability.”

2020 WL 7864585, at *18-19 (emphasis original).  As we observed in a prior Zantac post, in their desperation to avoid preemption, plaintiffs’ counsel have let their considerable imaginations run wild, and dreamed up non-FDA regulated scenarios with little concern for consistency or existing law.  “Plaintiffs have provided no authority for the proposition that [retailer/pharmacy] Defendants had a duty under state law to hire independent scientists to determine where, in a federally-approved temperature range, a drug should be stored.”  Id. at *19.  There certainly is no federal duty that they do so.  Id. (citing 21 C.F.R. §211.166(a)).  Plainly, the “concerns” discussed at length in Zantac are an attempt to avoid a reprise of Plaintiffs’ previous failed attempt (discussed here) to use the MDL to create novel tort duties that the states themselves have not recognized.

In addition to implied preemption, the Zantac plaintiffs also purported to make claims against the retailer/pharmacy defendants that impinge on matters governed by the Drug Supply Chain Security Act, 21 U.S.C. §§360eee to 360eee-4.  2020 WL 7864585, at *20.  But as discussed in a previous post, this statute contains an express preemption clause that is even more emphatic than the one that supports broad medical device preemption.  See §360eee-4(a) (preempting state law “inconsistent with, more stringent than, or in addition to, any requirements applicable” under the statute).  Plaintiffs attempted to limit the scope of express preemption to “tracing products through the distribution system,” which does not appear to be an issue in the Zantac litigation.  2020 WL 7864585, at *21.  They got spanked again, for “ignor[ing] . . . additional text in the statute” that included “verification, investigation, disposition, notification, or recordkeeping” within this act’s preemptive scope.  Id. (quoting §360eee-4(a)).

The Zantac plaintiffs’ claims that the defendants should not have accepted these drugs because they were defectively designed as a reason “in addition to − not contained in − the Act.”  Id. at *21.  Zantac did not accept the anti-preemption rationale concerning the same statute in In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2020 WL 7418006 (D.N.J. Dec. 17, 2020), a decision we lambasted here, because the alleged contamination in Zantac arose “within” the drug supply chain.  Id. at *22.  Ultimately, Zantac did not resolve the issue because, once again this was an unpleaded theory made up by plaintiffs’ counsel “at the Hearing.”  Id.

Finally, the Zantac plaintiffs’ Magnuson-Moss warranty claims were dismissed for the same reasons we detailed in our previous post – they require a valid state-law warranty claim a predicate, and plaintiffs have none.  2020 WL 7864585, at *2.

So once again, almost all of the Zantac plaintiffs’ claims against the moving defendants have been held preempted.  What remains are novel and problematic claims that plaintiffs didn’t actually plead, and as to which the MDL judge expressed significant “concerns.”  Will the Zantac plaintiffs continue to lead with their chins?  Stay tuned.