960 F. Supp. 2d 700
W.D. Ky.2013Background
- Prather claims the PCIP caused glenohumeral chondrolysis after arthroscopic shoulder surgery in 2001.
- PCIP, manufactured by B. Braun under contract to Sgarlato, was implanted in Prather’s shoulder by Dr. Savoie.
- The FDA approved PCIP via 510(k) clearance in 1999, with indications for continuous intraoperative pain management.
- Prather alleges strict liability, negligence, warranties, and fraud theories based on design, warning, testing, and regulatory aspects.
- The court applies Kentucky law and grants summary judgment for defendant, finding no knowable risk at the time of distribution.
- Regulatory and medical literature before 2001 did not establish a link between intra-articular infusion and chondrolysis.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether PCIP is within comment k’s unavoidably unsafe category | Prather asserts PCIP risk warrants strict liability under comment k. | Rodriguez controls; no knowable risk existed pre-2001. | PCIP falls within comment k; rescue defense applies. |
| Whether adequate warning was provided to trigger liability | Defendant failed to warn of cartilage damage risk prior to 2001. | No knowledge of chondrolysis risk pre-2001; learned intermediary doctrine applies. | No duty to warn; no adequate warning breach found. |
| Whether negligence design, failure to warn, testing, or regulatory submission breached duty | Defendant breached by defective design, withholding tests, and improper 510(k) clearance. | Manufacture conformed to state of the art; no foreseeability of risk; no independent duty to test. | All negligence theories fail; no causation or duty established. |
| Whether fraud and misrepresentation claims survive | Sgarlato reps misrepresented use; defendant liable as manufacturer. | No representations by defendant; doctors decided use independently. | Fraud/misrepresentation claims dismissed. |
| Whether warranty claims survive | Defect or unreasonably dangerous product supports warranties. | PCIP not defective or unreasonably dangerous; causation lacking. | Warranty claims dismissed. |
Key Cases Cited
- Rodriguez v. Stryker Corp., 680 F.3d 568 (6th Cir.2012) (pre-2001 knowledge insufficient to impose duty to warn)
- Mack v. Stryker Corp., 893 F.Supp.2d 976 (D.Minn.2012) (no knowledge of specific risk pre-2004; no duty to warn)
- Larkin v. Pfizer, Inc., 153 S.W.3d 758 (Ky.2004) (learned intermediary doctrine; adequate warning to physician suffices)
- Hill v. Searle Labs., 884 F.2d 1064 (8th Cir.1989) (comment k applicability to prescription drugs)
- Toner v. Lederle Labs., 732 P.2d 297 (Idaho1987) (comment k factors for unavoidably unsafe products)
- Moyer v. Ulrich, 47 F.Supp.2d 838 (E.D.Ky.1998) (design defect and proof of defect under Kentucky law)