206 F.Supp.3d 1187
E.D. La.2016Background
- Gloria Guidry sued multiple defendants after allegedly suffering acute kidney injury and failure following use of Invokana (an SGLT2 inhibitor) from March–September 2014. She claims Invokana’s mechanism overworks kidneys and causes renal injury.
- Defendants: Janssen Pharmaceuticals, Inc.; Janssen Ortho, LLC; Janssen R&D, LLC; Johnson & Johnson Services, Inc.; Johnson & Johnson; Mitsubishi Tanabe Pharma Corporation (Japan); and Mitsubishi Tanabe Pharma Development America, Inc.
- This is Guidry’s amended complaint after the court previously dismissed the original complaint with leave to amend. Defendants moved to dismiss the amended complaint under Rules 12(b)(2), 12(b)(5), and 12(b)(6).
- The court found no personal jurisdiction over the Mitsubishi defendants (dismissed with prejudice for lack of minimum contacts) and did not reach their other arguments.
- Under the Louisiana Products Liability Act (LPLA), Guidry pleaded five theories: defect in construction/composition, defective design, failure to warn, breach of express warranty, and redhibition; the court parsed each claim under Twombly/Iqbal pleading standards and preemption doctrine.
- Rulings as to Janssen group: claims for construction/composition defect and breach of express warranty were dismissed with prejudice; claims for defective design (narrowly framed), inadequate warning, and redhibition survived. The court held that post-approval design-change duties are preempted but a pre-approval design-duty claim is not.
Issues
| Issue | Guidry's Argument | Janssen/Mitsubishi Argument | Held |
|---|---|---|---|
| Personal jurisdiction over Mitsubishi defendants | Mitsubishi had licensing, development contacts and should have expected to be subject to jurisdiction in Louisiana | Mitsubishi lacked minimum contacts with Louisiana; service was deficient | Court: No specific jurisdiction; claims against Mitsubishi dismissed with prejudice |
| Defect in construction/composition (LPLA) | Invokana caused dehydration/diuresis and so was defective compared to other diabetes drugs | Plaintiff failed to allege an individual pill deviated from specs or manufacturing standards | Court: Claim fails—dismissed with prejudice |
| Defective design (LPLA) and preemption | Invokana’s chemical/design overworks kidneys; a safer alternative design was feasible (pre-approval duty) | Design claims are conflict-preempted because manufacturers cannot unilaterally change drug composition after FDA approval | Court: Post-approval duty to redesign is preempted; but a pre-approval defective-design theory plausibly pleaded and is not preempted — claim survives to discovery |
| Failure-to-warn (LPLA) | Defendants concealed/understated renal risks; warnings were inadequate | FDA-approved label and regulatory regime preempt state-law failure-to-warn | Court: Plaintiff plausibly alleged a potentially damage-causing characteristic and inadequate warnings; claim not preempted at pleading stage |
| Breach of express warranty | Marketing and promotional materials warranted safety/effectiveness and induced purchase/use | Plaintiff failed to plead she was exposed to or induced by specific marketing | Court: Inducement/alleged exposure not plausibly pled; express warranty claim dismissed with prejudice |
Key Cases Cited
- International Shoe Co. v. Washington, 326 U.S. 310 (personal jurisdiction framework)
- Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915 (general jurisdiction principles)
- Daimler AG v. Bauman, 134 S. Ct. 746 (general jurisdiction limits)
- Walden v. Fiore, 134 S. Ct. 1115 (minimum contacts; focus on defendant's contacts with forum)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (plausibility pleading standard)
- Ashcroft v. Iqbal, 556 U.S. 662 (pleading standards and conclusory allegations)
- Wyeth v. Levine, 555 U.S. 555 (brand-name manufacturer failure-to-warn not preempted)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (generic manufacturers’ failure-to-warn claims preempted)
- Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (design-defect claims against generic manufacturers preempted)
- Yates v. Ortho-McNeil-Janssen Pharms., Inc., 808 F.3d 281 (6th Cir. — brand-name design-defect preemption analysis referenced by court)
- Monkton Ins. Servs., Ltd. v. Ritter, 768 F.3d 429 (5th Cir. specific-jurisdiction guidance)