Andrea Guarino v. Wyeth, LLC
719 F.3d 1245
11th Cir.2013Background
- In 2007 Angela Guarino was prescribed and took generic metoclopramide (the generic of Reglan) for >12 weeks and subsequently developed tardive dyskinesia.
- The FDA had directed in 2004 that metoclopramide therapy should not exceed 12 weeks and issued a black-box warning in 2009.
- Guarino sued the generic manufacturer Teva and brand manufacturers Wyeth LLC and Schwarz Pharma alleging negligence, strict liability, breach of warranty, misrepresentation/fraud, and negligence per se based on inadequate warnings/communications about long-term use risks.
- After the Supreme Court decided PLIVA, Inc. v. Mensing (holding failure-to-warn claims against generics are preempted by federal law requiring label sameness), the district court dismissed Guarino’s claims against Teva and granted summary judgment to the brand manufacturers because Guarino only took the generic.
- On appeal the Eleventh Circuit affirmed: it held Guarino’s claims against Teva are preempted (including a “failure-to-communicate” theory) and would fail on the merits under Florida’s learned intermediary doctrine; it also held Florida law does not permit liability against a brand-name manufacturer when the plaintiff consumed only a generic product.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Guarino’s negligence/failure-to-warn claims against the generic (Teva) are preempted by federal law | Guarino contends a “failure-to-communicate” claim (Teva failed to notify doctors of the 2004 label change) is not preempted | Federal law (Mensing) requires generic labels be identical to brand labels, making unilateral changes or extra communications by generics impermissible | Preempted: Mensing bars state-law failure-to-warn and failure-to-communicate claims against generics |
| If not preempted, whether Guarino can prevail on the merits against Teva under Florida law | Guarino claims Teva should have done more to inform physicians/consumers | Teva provided the FDA-required label (including the 12-week warning); under Florida the duty is to the prescribing physician (learned intermediary) | Fails on merits: learned intermediary rule satisfied by providing physician the updated label |
| Whether brand manufacturers (Wyeth/Schwarz) can be liable for injuries caused by a generic product | Guarino argues brand-labels are relied upon and brand manufacturers knew generics would be relied on, so fraud/misrepresentation liability is possible even if plaintiff took only the generic | Brand defendants contend a manufacturer cannot be liable for a product it did not make or sell; Florida courts uniformly reject such claims | Held for defendants: Florida law does not recognize claims against brand manufacturers when plaintiff consumed only a generic drug |
| Whether existing Florida precedent permits alternative theories (market-share, conspiracy) to impose liability on brand manufacturers | Guarino invokes Conley/Engle and other doctrines to support liability | Defendants and the court note Conley limits market-share to unidentified tortfeasors and Engle disavowed liability where defendant did not make the product; conspiracy is not pled here | Court rejects expansion: Conley/Engle do not authorize liability against known non-manufacturing brand defendants; no novel expansion of Florida tort law |
Key Cases Cited
- PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (U.S. 2011) (generic manufacturers’ duty of label "sameness" preempts state-law failure-to-warn claims)
- Felix v. Hoffmann-LaRoche, Inc., 540 So. 2d 102 (Fla. 1989) (learned intermediary doctrine: duty to warn is to prescribing physician)
- E.R. Squibb & Sons, Inc. v. Farnes, 697 So. 2d 825 (Fla. 1997) (manufacturer discharges duty to warn via package insert to physician)
- Christopher v. Cutter Labs., 53 F.3d 1184 (11th Cir. 1995) (discussion of learned intermediary rule under Florida law)
- Morris v. PLIVA, Inc., 713 F.3d 774 (5th Cir. 2013) (failure-to-communicate theory preempted; generics not free to send extra warnings)
- Demahy v. Schwarz Pharma, Inc., 702 F.3d 177 (5th Cir. 2012) (brand manufacturers not liable for injuries from generics)
- Fresenius Med. Care Holdings, Inc. v. Tucker, 704 F.3d 935 (11th Cir. 2013) (conflict preemption framework)