Denise Rounds, Thomas Rounds vs Genzyme Corporation
440 F. App'x 753
11th Cir.2011Background
- Rounds allege negligence against Genzyme over Carticel autologous chondrocyte implantation (ACI) injuries to Denise Rounds.
- Denise underwent Carticel ACI on left knee (May 8, 2006) and right knee (May 21, 2007) under Dr. Jurbala.
- Rounds claim Genzyme failed to train Dr. Jurbala to identify Carticel candidates.
- District court dismissed, citing failure to plead causation and application of the learned intermediary doctrine.
- Genzyme attached Carticel package insert with warnings, precautions, contraindications to patient evaluation and use.
- Eleventh Circuit reviews de novo and applies Florida law given diversity; agrees the claims are barred by the learned intermediary doctrine.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does learned intermediary bar claims as a matter of law? | Rounds argue no bar on causation. | Genzyme contends warnings to physician foreclose patient claims. | Yes; doctrine bars the claims. |
| Are the Carticel warnings adequate to satisfy the duty to the physician? | Warnings may be insufficient or misdirected. | Package insert contained clear, unambiguous warnings. | Warnings adequate as a matter of law. |
| Does the training vs. warning distinction affect the outcome? | Training deficiencies could defeat learned intermediary. | Providing clear warnings suffices; training issue is semantic. | No; the distinction is immaterial; warnings suffice. |
Key Cases Cited
- Christopher v. Cutter Laboratories, 53 F.3d 1184 (11th Cir. 1995) (duty to warn runs to physician via warning to physician)
- Felix v. Hoffmann-LaRoche, Inc., 540 So.2d 102 (Fla. 1989) (warnings to physician; adequacy determines liability)
- Beale v. Biomet, Inc., 492 F. Supp. 2d 1360 (S.D. Fla. 2007) (package insert warnings to physician; adequacy forecloses patient claims)
- Ellis v. C.R. Bard, Inc., 311 F.3d 1272 (11th Cir. 2002) (applies learned intermediary to prescription devices/drugs)
- Marshall County Bd. of Educ. v. Marshall County Gas Dist., 992 F.2d 1171 (11th Cir. 1992) (dispositive law on dismissal under Rule 12(b)(6) when appropriate)
- Buckner v. Allergan Pharmaceuticals, Inc., 400 So.2d 820 (Fla. 5th DCA 1981) (learned intermediary doctrine forecloses patient claims)
- Horowitch v. Diamond Aircraft Indus., Inc., 645 F.3d 1254 (11th Cir. 2011) ( Florida law applied; learned intermediary doctrine doctrinally consistent)
- Christopher v. Cutter Laboratories, 53 F.3d 1184 (11th Cir. 1995) (duty to warn through physician intermediary)