ATKINSON v. LUITPOLD PHARMACEUTICALS, INC.
2:19-cv-00277
| E.D. Pa. | Aug 6, 2020Background:
- Plaintiffs Melanie Atkinson and Tammie Combs (both Texas residents) sued manufacturers and licensors of Injectafer (ferric carboxymaltose, “FCM”) after receiving the drug and being diagnosed with hypophosphatemia (HPP).
- Plaintiffs allege defendants knew of a link between FCM/Injectafer and severe HPP from published studies, adverse event reports, and an FDA non-approvable letter in July 2006, but failed to conduct adequate testing or post‑marketing surveillance.
- Procedurally, this opinion follows an earlier Atkinson decision that dismissed many theories but allowed negligent failure-to-test and gross-negligence theories to be repleaded; Combs asserts similar claims and also design-defect claims.
- Defendants moved to dismiss all claims under Fed. R. Civ. P. 8(a) and 12(b)(6).
- The court denied dismissal of negligent failure-to-test and gross-negligence (thus preserving punitive‑damage theories), but dismissed Combs’s strict liability design-defect claim (under law-of-the-case/Comment k) and dismissed her negligent design-defect claim for failure to plead a plausible safer design.
Issues:
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Negligent failure to test | Plaintiffs: defendants had independent duty to test post-approval and breached it despite knowledge of FCM/HPP risk | Defendants: claim is really a disguised failure-to-warn (preempted by Texas statute) and is inadequately pled | Court: Claim is a distinct theory from failure-to-warn; factual allegations plausibly state negligent failure to test — claim survives dismissal |
| Gross negligence / punitive damages | Plaintiffs: defendants ignored years of data showing serious risk and consciously proceeded | Defendants: gross‑negligence claim is derivative of failure-to-test and cannot stand; punitive damages unavailable | Court: Allegations show objective extreme risk and subjective awareness — gross negligence survives; punitive damages theory preserved |
| Strict liability design defect (Comment k) | Combs: design-defect claim permissible despite FDA approval and statutory presumption | Defendants: Comment k and Texas law bar strict-liability design claims for prescription drugs with adequate warnings | Court: Applying law-of-the-case (Atkinson), strict‑liability design‑defect claim dismissed with prejudice under Comment k/statutory presumption |
| Negligent design defect | Combs: alleges Injectafer was defectively designed; points to safer alternatives generally available | Defendants: claim is conclusory/duplicative of failure-to-warn and fails to plead a feasible safer alternative | Court: Negligent design claim fails because plaintiff did not plead a plausible, feasible alternative design — dismissed with prejudice |
Key Cases Cited
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (pleading standard: factual plausibility required)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (pleading standard requires more than legal conclusions)
- Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005) (distinguishing failure-to-warn and failure-to-test theories)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (preemption limits FDA-related fraud claims and affects rebuttal of statutory presumptions)
- Lofton v. McNeil Consumer & Specialty Pharms., 672 F.3d 372 (5th Cir. 2012) (rebuttal of statutory presumption of adequate FDA warning requires an FDA finding of fraud)
- Louisiana-Pac. Corp. v. Andrade, 19 S.W.3d 245 (Tex. 2000) (gross‑negligence standard requires disregard of known peril)
- Great Plains Tr. Co. v. Morgan Stanley Dean Witter & Co., 313 F.3d 305 (5th Cir. 2002) (gross negligence has objective and subjective components)
- Hernandez v. Tokai Corp., 2 S.W.3d 251 (Tex. 1999) (plaintiff must prove feasible safer alternative for design-defect claims)
- Am. Tobacco Co. v. Grinnell, 951 S.W.2d 420 (Tex. 1997) (negligent design distinct from strict liability design theory)
- Fearrington v. Boston Sci. Corp., 410 F. Supp. 3d 794 (S.D. Tex. 2019) (permitting punitive damages where manufacturer fails to research known catastrophic risks)