Gale v. Smith & Nephew, Inc.
989 F. Supp. 2d 243
S.D.N.Y.2013Background
- Gale underwent a May 6, 2008 right total hip replacement at SSMC using four Birmingham Hip Resurfacing System components with FDA PMA approval two years earlier.
- Dr. Zelicof performed the surgery, assisted by Doctors, PAs, and Nurses from Specialty Orthopaedics and SSMC.
- Between July 3, 2011 and April 30, 2012 Gale experienced five right hip dislocations and acute renal failure from chromium/cobalt poisoning due to the device.
- Gale asserted medical malpractice, negligence, and warranty claims, plus NY GBL § 349 deceptive-trade-practices and FDA-fraud claims.
- S&N and Samocha moved to dismiss the amended complaint; the court granted in part and denied in part.
- The court analyzed MDA pre-emption and pleading standards to determine which claims survive and which are pre-empted.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| MDA pre-emption of design/manufacturing defect claims | Gale argues state-law design/manufacturing claims can proceed despite FDA oversight. | S&N contends such claims are pre-empted as conflicting with federal requirements. | Pre-empted; dismissed. |
| MDA pre-emption of warranty claims | Gale contends warranty claims should not be pre-empted. | S&N argues warranty claims implicate federal scheme and are pre-empted. | Pre-empted; dismissed. |
| GBL § 349 deceptive-trade-practices claim viability | Gale claims S&N deceived consumers about the device. | S&N argues the claim is not meaningfully consumer-oriented and incomplete. | Dismissed. |
| Post-sale duty to warn/pre-market monitoring claim viability | Gale alleges failure to warn and monitor post-approval caused injuries. | S&N contends duty to warn is pre-empted by FDA approvals. | Pre-empted; dismissed. |
| Survival of mislabeled component recall claim | Gale pleads S&N distributed a mislabeled component recalled prior to surgery. | S&N argues recall facts are insufficient to sustain a claim. | Not pre-empted; claim four survives and denial of dismissal affirmed. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (PMAs pre-empt state tort claims to the extent they add to federal requirements; parallel claims possible)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (U.S. 2001) (Fraud-on-FDA pre-emption; private right to sue under MDA limited)
- Gelber v. Stryker Corp., 788 F. Supp. 2d 145 (S.D.N.Y. 2011) (illustrates pleading specific premarket requirements to state a parallel claim)
- Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d 582 (E.D.N.Y. 2009) (rejects vague CGMP allegations as pre-empted without specifics)
- Desabio v. Howmedica Osteonics Corp., 817 F. Supp. 2d 197 (W.D.N.Y. 2011) (discusses pleading requirements for parallel claims)