70 F. Supp. 3d 1246
N.D. Ala.2014Background
- This action concerns Wyeth Cordarone and generic amiodarone, alleged to cause pulmonary disease and death in Larry Hale Stephens (2010–2013).
- Plaintiffs allege failures to warn and to provide Medication Guides, and assert AEMLD, negligence, breach of implied warranties, fraud, wrongful death, and loss of consortium claims.
- Teva and Barr move to dismiss; Wyeth moved to stay, which stayed the case and made the motion moot.
- After Alabama Supreme Court’s ruling in Wyeth v. Weeks, the court reinstated the previously filed motion to dismiss and addressed the SAC as amended.
- The SAC alleges Stephens was prescribed amiodarone for atrial fibrillation (off-label) without a Medication Guide; symptoms appeared years later, and death followed.
- The court evaluates Rule 12(b)(6) standards (Iqbal, Twombly) and considers Mensing, Bartlett preemption, and the learned intermediary doctrine in Alabama context.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the SAC survives Iqbal and Twombly plausibility standard | Stephens’ death linked to amiodarone; allegations support plausible causation | Plaintiffs fail to show a concrete link between drug and death | No; SAC fails to plausibly connect defendants’ actions to decedent’s death |
| Preemption of AEMLD and implied-warranty/fraud claims against Teva and Barr | Mensing/Bartlett do not apply to off-label promotion theories | Federal law preempts state-law warning and design-defect claims for generics | Preempted; AEMLD/implied-warranty/fraud claims against Teva and Barr are dismissed |
| Learned intermediary doctrine applicability | Manufacturer failed to warn physicians, thus doctor would be deterred | Warning duty runs to physicians; patient-level claims fail without physician-specific allegations | Fatal to plaintiffs’ claims; duty to warn physician not satisfied by patient-level allegations |
| Wrongful death and loss of consortium viability against Teva/Barr | Surviving spouse seeks damages for decedent’s death | No viable wrongful death/loss claims without underlying tort against Teva/Barr | Dismissed; no surviving wrongdoing against Teva/Barr supports these claims |
Key Cases Cited
- Ashcroft v. Iqbal, 556 U.S. 662 (U.S. 2009) (plausibility standard for pleading)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (U.S. 2007) (test of plausibility; more than a sheer possibility required)
- PLIVA, Inc. v. Mensing, 564 U.S. 606 (U.S. 2011) (preemption of generic-warnings claims)
- Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (U.S. 2013) (preemption of state-law warnings/design claims for generics)
- Wyeth v. Weeks, 159 So.3d 649 (Ala. 2014) (Ala. Supreme Court on medication warnings and off-label use)