446 F.Supp.3d 424
W.D. Ark.2020Background:
- Marilyn Stube was prescribed Xeljanz (tofacitinib) in March 2013; in March 2017 she developed severe infection, septic shock, multi-organ failure, gangrene, and ultimately had all four limbs amputated after hospital staff instructed her to stop Xeljanz.
- Plaintiffs sued Pfizer asserting six state-law claims (strict products liability/failure to warn, fraud/fraudulent inducement, breach of implied warranty, negligence, negligent misrepresentation, and gross negligence) and sought punitive damages.
- Pfizer moved to dismiss under FRCP 8, 9(b), and 12(b)(6), arguing (inter alia) that the FDA-approved label adequately warned physicians, that federal law preempts state-law failure-to-warn claims, that the learned intermediary doctrine bars direct-to-consumer duties, and that several claims fail on pleading standards or as a matter of law.
- The court declined to consider the parties’ voluminous extrinsic exhibits on the Rule 12(b)(6) motion and confined its analysis to the complaint’s allegations.
- The court denied dismissal as to failure-to-warn claims (plaintiffs adequately alleged inadequacy re sepsis and subpopulation risks), rejected Pfizer’s preemption defense as to both pre- and post-approval theories (plaintiffs pleaded ‘‘newly acquired information’’ permitting a CBE change and Pfizer did not show FDA would have clearly rejected it), but dismissed fraud and negligent misrepresentation claims and dismissed claims to the extent they sought direct-to-consumer warnings; gross negligence survived.
Issues:
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Adequacy of Xeljanz warnings (failure-to-warn) | Label failed to warn of sepsis, amputations, and heightened risks to elderly women/female/herpes-zoster patients | FDA-approved label adequately warned physicians; thus no duty breach as a matter of law | Complaint sufficiently pleads inadequate warning to withstand dismissal; motion denied on this ground |
| Federal preemption (impossibility) | Pre-approval: Pfizer could have proposed stronger initial label; Post-approval: CBE rule allowed unilateral changes based on newly acquired information | FDCA/FDA approval made it impossible to comply with state duty to add warnings absent FDA action | Pre-approval claims not preempted; post-approval claims not preempted because plaintiffs alleged newly acquired information and Pfizer failed to show FDA would have clearly rejected a CBE change |
| Learned intermediary / direct-to-consumer duty | Pfizer engaged in direct marketing and provided safety materials to patients, so direct duty exists | Arkansas follows the learned intermediary doctrine; manufacturer may rely on prescribing physician to warn patient | Claims premised on a duty to directly warn Mrs. Stube or the public are dismissed; claims based on failure to warn the prescribing physician may proceed |
| Fraud (Rule 9(b) specificity) | Alleged withholding/misrepresentations via ads, brochures, sales reps, dossiers, labels — put Pfizer on notice | Complaint lacks particularity identifying who made misrepresentations, when/where, and specifics as required by Rule 9(b) | Fraud claim dismissed without prejudice for failure to plead with the requisite particularity |
| Negligent misrepresentation | Plaintiffs alleged inaccurate dissemination to induce physician reliance | Arkansas law does not recognize independent negligent-misrepresentation tort | Claim dismissed (plaintiffs also agreed to voluntary dismissal) |
| Gross negligence | Pfizer intentionally continued marketing despite known risks; meets recklessness standard | Allegations at most show ordinary negligence | Claim survives the motion to dismiss (plausibly alleges reckless/intentional failure to perform duty) |
Key Cases Cited
- Bell v. Pfizer, Inc., 716 F.3d 1087 (8th Cir.) (discusses Arkansas duty-to-warn and learned intermediary doctrine in drug context)
- In re Prempro Prods. Liab. Litig., 514 F.3d 825 (8th Cir.) (labeling to physician deemed a warning to patient under learned intermediary)
- Wyeth v. Levine, 555 U.S. 555 (2009) (CBE regulation permits post-approval warning changes; informs preemption analysis)
- Pliva, Inc. v. Mensing, 564 U.S. 604 (2011) (preemption principles in FDA-regulation context)
- Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013) (FDA approval process and preemption issues for generics and labeling)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (presumption against implied preemption in health-and-safety regulation)
- Geier v. American Honda Motor Co., 529 U.S. 861 (2000) (caution against readily finding conflict preemption)
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (pleading standard: plausibility requirement)
- Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) (pleading standard requiring more than labels and conclusions)
- Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005) (FDCA regulatory framework and congressional purpose)