Strayhorn v. Wyeth Pharmaceuticals, Inc.
887 F. Supp. 2d 799
W.D. Tenn.2012Background
- Seven consolidated cases involve Wyeth and other defendants alleging injuries from Reglan or metoclopramide.
- Plaintiffs group Brand Name Defendants and Generic Defendants; Amended Complaint identical across seven cases; court relies on Rhodes v. Wyeth for docket references.
- Generic Defendants' Motion to Dismiss filed Dec 12, 2011; responses and replies followed; motion granted.
- Supreme Court Mensing (2011) preemption framework controls scope of labeling duties for generics and informs preemption of failure-to-warn claims.
- Amended Complaint asserts fourteen claims (plus derivative), with all generic-defendant claims subject to preemption under Mensing; FDA labeling history includes 2009 black box warning and REMS requirements.
- TN products liability law (TPLA) analyzed to assess similarity to Minnesota/Louisiana law; court finds Mensing applicable under Tennessee law and dismisses most generic-defendant claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does Mensing preempt all failure-to-warn claims against generics here? | Pleans that Mensing is distinguishable; Tennessee law may permit non-warn claims against generics. | Mensing preempts all failure-to-warn claims against generics because labeling cannot be independently changed. | Yes; all generic-defendant failure-to-warn claims are preempted. |
| Is Tennessee products-liability law sufficiently similar to Minnesota/Louisiana to apply Mensing? | TN law does not require same labeling as FDA; allows non-warn theories. | TN law aligned with Minnesota/Louisiana; based on duty to warn and labeling, thus preemption applies. | TN law is sufficiently similar; Mensing applies. |
| Can plaintiffs preserve non-warn claims against generics as viable theories separate from warnings? | Claims like negligence, strict liability, and concealment are not solely warnings-focused and should survive. | Claims largely rely on warnings; preempted under Mensing; attempts to recast fail-to-warn claims as other theories fail. | All non-warn claims against generics are preempted or dismissed. |
| Do claims like failure to remove from market, unjust enrichment, civil conspiracy, and Dear Doctor communications survive against generics? | Some theories remain independent of labeling and FDA interactions. | These theories either rely on labeling or are preempted by Mensing/Buckman; Dear Doctor communications are labeling. | Dismissed; preempted or unfounded against generics. |
Key Cases Cited
- PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (U.S. 2011) (preemption of state-law failure-to-warn claims for generics when label cannot be changed)
- Smith v. Wyeth, 657 F.3d 420 (6th Cir. 2011) ( Sixth Circuit applying Mensing to generic drug labeling duties)
- Fulgenzi v. PLIVA, Inc., 867 F. Supp. 2d 966 (N.D. Ohio 2012) (Mensing preemption extends to various implied claims; warning focus)
- In re Darvocet, Darvon & Propoxyphene Prods. Liab. Litig., 2012 WL 718618 (E.D. Ky. 2012) (Mensing preemption broadly applied to failure-to-warn in MDL)
- Bartlett v. Mutual Pharm. Co., Inc., 678 F.3d 30 (1st Cir. 2012) (applies Mensing to preempt failure-to-warn under different theory)
- Altria Group v. Good, 555 U.S. 70 (U.S. 2008) (express preemption discussion guiding implied preemption analysis)
- Bates v. Dow AgroSciences LLC, 544 U.S. 431 (U.S. 2005) (express preemption framework influencing labeling-related claims)
- Cipollone v. Liggett Group, Inc., 505 U.S. 504 (U.S. 1992) (preemption principles for labeling and FDA-regulation interactions)