857 F. Supp. 2d 244
D. Conn.2012Background
- Frasers sue Wyeth for failure to warn, strict liability, negligence, misrepresentation, punitive damages, breach of implied/express warranty, CUTPA, and loss of consortium regarding Prempro use.
- Ms. Fraser began Prempro around 1995–1996, continuing until September 2001, before cancer diagnosis in Oct 2001 and subsequent treatment.
- Prempro labeling from 1996 warned of breast cancer risk with equivocal language; later labels added more explicit risk information.
- Dr. Tesoro, who prescribed Prempro, reviewed warnings and acknowledged potential risk; Fraser relied on his treatment decisions.
- Plaintiffs argue Wyeth failed to warn adequately; Wyeth contends FDA-approved warnings were sufficient and direct warnings unnecessary due to learned intermediary doctrine.
- Court grants in part and denies in part: CPLA claims are treated as a unified claim; some claims survive and others (express warranty, CUTPA) are dismissed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| CPLA exclusivity and pleading | CPLA claims can be pled as separate theories within one unified claim. | CPLA is exclusive; separate counts must be dismissed or merged. | CPLA may be pled as unified claim with multiple theories; counts harmonized into one CPLA claim. |
| Adequacy of Prempro warnings | Warnings were inadequate to alert physicians/patients of breast cancer risk. | FDA-approved warnings were adequate; learned intermediary doctrine applies. | Warnings may be inadequate; learned intermediary doctrine does not bar claims; issues for jury. |
| Proximate causation | Different warnings could have changed prescribing and use, causing different outcomes. | Plaintiffs cannot prove causation without showing changed behavior. | Genuine issue of material fact; jury could find warnings impacted decisions. |
| Design defect under Connecticut law | Prempro was unreasonably dangerous; evidence of design defect appropriate. | Comment (k) may bar design defect claims for unavoidably unsafe products. | Comment (k) does not bar here; evidence and Potter standard allow design defect claims. |
| Express warranty viability | Label statements about study results created an express warranty that Prempro was safe. | Warning labels about risk do not create express warranties of safety. | Express warranty claim dismissed. |
Key Cases Cited
- Vitanza v. Upjohn Co., 257 Conn. 365 (2001) (learned intermediary doctrine and adequacy of warnings under CT law)
- Thom v. Bristol-Myers Squibb Co., 353 F.3d 848 (10th Cir. 2003) (ambiguous warnings may be inadequate to convey risk)
- Potter v. Chicago Pneumatic Tool Co., 241 Conn. 199 (1997) (consumer expectations standard for design defect; no need for feasible alternative design in some cases)
- Pabon v. Wright, 459 F.3d 241 (2d Cir. 2006) (summary judgment framework; material facts and evidence evaluation)
- Wyeth v. Levine, 555 U.S. 555 (2009) (FDA labeling authority; manufacturer’s duty to maintain adequate warnings)