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We’ve written several posts about ridiculous absolute liability theories seeking to hold drug manufacturers liable simply for making an FDA approved prescription drug.  Wilkins v. Genzyme Corp., 2022 WL 4237528 (D. Mass. Sept. 14, 2022), is an even stranger claim, with the plaintiff seeking to hold the defendant liable for not manufacturing a prescription drug.  Fortunately, in Wilkins, those claims (several theories alleging essentially the same thing) did not state a claim.

The defendant’s drug in Wilkins was the only FDA-approved medication for the treatment of a rare disease (Fabry Disease).  Back in 2009, the defendant’s “production stalled due to various problems at its manufacturing facility.”  2022 WL 4237528, at *2.  That shortage led to class-action litigation asserting that the defendant had some sort of duty to maintain a sufficient supply of its drug, which was dismissed in 2016 for the very sensible reason that no such duty existed.  See Our post here, discussing Hochendoner v. Genzyme Corp., 823 F.3d 724 (1st Cir. 2016).  We’ve also addressed similar claims made after unsuccessful clinical trials are terminated.  As discussed, the First Circuit deep-sixed all of the duty-to-supply claims, allowing only one claim to survive.

But the Wilkins plaintiffs (26 of them) wouldn’t take no for an answer.  They could do that because the Hochendoner case (except for one plaintiff) was dismissed for lack of standing – which is a without-prejudice dismissal.  Wilkins, 2022 WL 4237528, at *3.  Nearly four years after the dismissal in Hochendoner, they brought a new class action.  They could do that because they had a tolling agreement with the defendant for the duration of prolonged and ultimately unsuccessful settlement negotiations.  They brought the Wilkins action in a different forum, presumably to avoid the judge who had previously dismissed their claims.  They could not do that, and the action was transferred back to the original judge in the original forum.  Id. at *4.

The defendant moved to dismiss the Wilkins class action for four reasons:  The claims being time-barred; lack of standing (again); failure to plead fraud with particularity; and failure to state a claim.  Id. at *5.

The subject matter jurisdiction question has an interesting issue – cross-jurisdictional class action tolling – dependent on a not-so-interesting issue, the application of certain state statutes of limitations.  Id. at *7-8.  The great majority of the plaintiffs’ various claims were barred by the statute of limitations, mostly under Indiana law, or under the laws of the relevant states’ consumer protection statutes.  Id. at *8-13.

Wilkins then turned to class-action tolling.  It recognized that tolling via American Pipe & Construction Co. v. Utah, 414 U.S. 538 (1974), was inapplicable, since American Pipe “does not by its terms apply where a court sits in diversity, presiding over state law claims.”  Wilkins, 2022 WL 4237528, at *13.  Further, Wilkins found “no reason to believe Indiana’s courts would employ American Pipe tolling.”  Id.  Cross-jurisdictional class action tolling is a controversial and minority position:

Only a small fraction of states have addressed the cross-jurisdictional tolling issue and there is no clear consensus among them.  Recognizing the lack of consensus on the issue and the frequently articulated concern of forum shopping, federal courts generally have been disinclined to import cross-jurisdictional tolling into the law of a state that has not ruled on the issue. . . .  Indiana courts have not explicitly adopted cross-jurisdictional tolling.  For that reason, federal courts have been wary of assuming Indiana would recognize such tolling.

Id. (citations and quotation marks omitted).  However, the tolling agreement, which is purely case specific and not very interesting as a blog issue, preserved most claims, notwithstanding otherwise applicable statutes of limitations.  Id. at *15-16.  Thus, there is more to discuss in Wilkins.

So we turn to standing, which was the primary issue in the earlier Hochendoner decision in the controlling First Circuit.  Wilkins determined that all but four of the 26 plaintiffs once again failed federal-court standing requirements.  Id. at *19.  Plaintiffs offered five theories of harm:

  • Plaintiffs received a “defective” version of the drug that caused their “symptoms to worsen at a faster pace than” had they received non-defective product, with “defective” nowhere defined.  Id.
  • Certain plaintiffs were “sensitized” by low doses taken during the shortage and had adverse reactions when full dosages were reinstated.  Id.
  • Plaintiffs received drug doses having the contaminates that caused the plant closure that led to the shortage in the first place, and were injured by the contamination.  Id.  This seems like a more specific version of the first theory.
  • Low doses reduced the plaintiffs’ ultimate life expectancy.
  • Plaintiffs suffered financial loss because the low doses of the drug were “ineffective,” and therefore “worthless.”  Id. at *20.

The first and third theories – that the drug was “defective” (either due to contamination or something else, such as low doses) were dismissed because plaintiffs utterly failed to plead a factual basis for causation.  The “defect” was undefined, and plaintiffs could not allege that any of them actually received contaminated drug.  Id. at *20.  All of the alleged “injuries” were consistent with the progression of the condition that the drug treated.  Id.  Even if acceleration of the disease “can occur,” plaintiffs alleged no facts that this had happened to them.  Id.  Plaintiffs never alleged that any contaminant was ever found in their bodies.  Id.

Plaintiffs’ allegedly lowered life expectancy wasn’t an injury at all.  Eventual death at some unstated future time was not the sort of “actual or imminent” harm that Article III standing required.  Id.  Nor was there any credible financial loss, since plaintiffs “spent money on a medication that they knew would come in a lesser quantity than what they usually purchased.”  Id. at *21.

But four plaintiffs went one for five, since “the sensitization theory of standing succeeds,” as it did for one plaintiff in the previous Hochendoner decision, and those four claimed some sort of “anaphylactic response upon returning to a full dose.”  Id.  With only four plaintiffs left, there was no longer a credible basis for federal jurisdiction under the Class Action Fairness Act, but those four plaintiffs had diversity of citizenship – thus an alternative basis of subject matter jurisdiction existed.  Id.

So, on to the merits.

The four remaining plaintiffs’ negligence theories (asserted under Indiana, Kentucky, and Virginia law) all failed.  They didn’t allege any particular design defect, and did not plead that they ever actually took any contaminated drug.  Wilkins, 2022 WL 4237528, at *23.  Failure to warn failed because prescription drugs are subject to the learned intermediary rule, which focuses on what warnings plaintiffs’ prescribing physicians received.  Plaintiffs pleaded nothing:  “they have not provided any allegation about what their doctors knew or what they advised, let alone the warnings that [defendant] provided.”  Id. at *24.

Negligence per se likewise failed.  Only one plaintiff alleged a violation of a particular statutory section, but that statute applied only “to adulterated products.”  Id.  No plaintiff alleged exposure to any such drug.  Id.  No other plaintiff alleged any particular violation, which doomed their negligence per se claims.  Id.

Strict liability does not exist in Virginia.  Id.  The other plaintiffs’ strict liability claims failed for the same reasons as their negligence claims.  Id.  The same is true of statutory product liability claims pleaded by the Indiana and Kentucky plaintiffs.  Id. at *26-27.

Plaintiffs’ implied warranty claims failed, first and foremost, because they did not allege any defect in the product.  Id. at *25.  The Florida warranty claims failed for lack of privity.  Id.  Finally, the one Virginia plaintiff could not plead the reliance element of implied warranty of fitness for a particular purpose, because persons taking a prescription drug “made decisions under the care of a physician.”  Id.

The express warranty claims failed because there was no such warranty:

Nowhere does the package insert state that a lower dosage would be as efficacious for use in the treatment of [the] disease as the dose recommended on the packaging and by the FDA.  Nowhere does the package insert state that a lower dosage is FDA-approved.

Id. at *26.

Assorted consumer protection claims also failed to state a claim.  The Florida act did not apply to personal injury.  Id. at *26.  The Kentucky law claim failed for lack of causation under the learned intermediary rule.  Id. at *27.  The Virginia consumer protection statute was inapplicable due to its FDA-based safe-harbor provision, id., and no false advertisement was alleged.  Id.

Plaintiffs also brought fraud claims, which failed primarily “because they cannot trace the harm they experienced to information that [defendant] is alleged to have withheld intentionally.”  Id. at *28.  Nor did plaintiffs plead reliance:

Plaintiffs do not plead with any particularity how they relied on [defendant’s] statements in deciding not to pursue alternative treatment, arrangements, or a compassionate use exemption.  They do not allege, for example, any communications involving their medical providers that they actually reconsidered due to [defendant’s] statements.


Nor does any fiduciary duty exist between a drug manufacturer and patients taking the drug – even with the extra facts pleaded by these plaintiffs.  The learned intermediary rule precludes such claims.

The relationship between [defendant] and [plaintiffs] may appear closer than a standard relationship between a manufacturer and a consumer, but I do not find that Florida or Virginia would recognize this to be a fiduciary relationship. . . .  [They] still saw their own doctors and would necessarily have known they were dealing with a private company. . . .  [B]oth states follow the doctrine of the learned intermediary.  The assumption in these states appears to be that a patient relies on her doctor when making medical decisions, not the manufacturer.

Id. at *29.

Last – and probably least – no claims for unjust enrichment existed.  Plaintiffs knew they were getting reduced dosages.  They had no basis for believing that the reduced dose would be as effective as a full dose.  “Under the [sole remaining] sensitization theory, Plaintiffs may have been harmed by the product, but that is an issue for tort law,” not equity.  Id. at *30.

Predictably, plaintiffs have appealed.  We expect they will lose, because for all the ink that was spilled in Wilkins, the claims that were addressed were only filler being pursued for nuisance purposes.  This litigation was originally brought on the now-defunct theory of breach of a duty to ensure an adequate drug supply, and its earlier Hochendoner phase established no such liability exists.  It’s well past time for this decade-old litigation to come to an end.