127 F. Supp. 3d 1306
N.D. Ga.2015Background
- Robyn Christiansen received a Wright Conserve metal-on-metal total hip implant in 2006 and underwent revision in 2012; surgeon Dr. Rasmussen documented a metallosis reaction and loose acetabular cup.
- Plaintiff sued Wright Medical Technology, Inc. and Wright Medical Group, Inc. in MDL alleging design defect, failure to warn, negligence, and fraud-based claims tied to metal debris/metallosis and device loosening.
- Defendants moved to exclude multiple plaintiff experts (Daubert motions) and moved for summary judgment on preemption, learned-intermediary/warning, Comment K, and other grounds.
- Court held most metallosis-related experts admissible to rely on Rasmussen’s operative observations but excluded Dr. Morgan and Dr. Parisian on metallosis and excluded certain expert methodologies (Vincelli’s simulated “immeasurable” wear and Waller’s revision-rate/statistics opinions).
- On summary judgment the court: denied WMG’s motion (personal jurisdiction and factual dispute); denied preemption and Comment K defenses; granted summary judgment for defendants on failure-to-warn claims (learned intermediary: Rasmussen did not read warnings); denied summary judgment on design-defect, fraud/concealment, negligent misrepresentation, and punitive damages issues; prejudgment interest denied.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of metallosis-related expert testimony | Experts may rely on treating surgeon Rasmussen’s operative observations and on implant/explant inspection to opine that metallosis caused implant failure | Experts’ metallosis opinions rest on insufficient objective data (no histology, ion levels); exclude as speculative | Court: Rasmussen’s observations are the kind of data experts reasonably rely on; most metallosis experts admissible; excluded Morgan and Parisian re: metallosis for lack of reliable, helpful opinion |
| Admissibility of Vincelli’s simulated "immeasurable" wear calculation | Vincelli’s CMM measurements and thesis-derived method support higher true wear than measured | Method is untested, not peer-accepted, relies on speculative assumptions; exclude that portion | Court excluded Vincelli’s simulated/immeasurable wear calculation; to the extent other experts rely on it, those aspects excluded |
| Admissibility of Waller’s statistical/registry opinions on revision rates | Waller’s comparison shows Conserve revision rates exceed benchmarks and registry rates support higher failure | Waller used inappropriate comparisons (resurfacing vs total arthroplasty), selective literature, extrapolations beyond data; methodology unreliable | Court excluded Waller’s opinions comparing 2010 Report to registries and his revision-rate conclusions as unreliable under Daubert |
| Failure-to-warn (strict liability & negligence) | Plaintiff contends inadequate warnings and that company reps misled surgeon, causing implantation | Defendants invoke learned intermediary: surgeon is the proper target of warnings; surgeon did not read or rely on package insert so warning adequacy is irrelevant | Court: Learned-intermediary applies; Rasmussen testified he did not read product inserts and would not have read them; failure-to-warn claims dismissed |
| MDA (Riegel) preemption of design-defect claims | Plaintiff: Conserve device not PMA-approved; state-law design claims therefore not preempted | Defendants: other metal-on-metal devices (including Conserve Plus resurfacing device) received PMA — federal preemption of state-law defects | Court: Preemption rejected — Conserve total hip at issue was not PMA-approved and PMA preemption applies to specific approved devices only |
| Fraudulent misrepresentation / concealment | Plaintiff: company reps misrepresented device safety/appropriateness to Rasmussen inducing implantation; plaintiff relied via surgeon | Defendants: no direct misrepresentations to patient; no duty owed to patient | Court: Claims survive summary judgment — learned intermediary doctrine does not bar liability to patient for misrepresentations to prescribing physician; factual disputes exist for jury |
Key Cases Cited
- Daubert v. Merrell Dow Pharm., 509 U.S. 579 (U.S. 1993) (trial court gatekeeping factors for scientific expert admissibility)
- Kumho Tire Co. v. Carmichael, 526 U.S. 137 (U.S. 1999) (Daubert principles extend to non-scientific expert testimony)
- City of Tuscaloosa v. Harcros Chems., 158 F.3d 548 (11th Cir. 1998) (summarizes Daubert/Rule 702 admissibility framework)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (MDA/PMA express preemption applies to specific devices that received PMA)
- Gen. Elec. Co. v. Joiner, 522 U.S. 136 (U.S. 1997) (court may exclude expert opinion when analytical gap between data and conclusion is too great)
- Quiet Tech. DC-8, Inc. v. Hurel‑Dubois UK Ltd., 326 F.3d 1333 (11th Cir. 2003) (Daubert factors are non-exhaustive and court need not make persuasiveness determinations)
- Guinn v. AstraZeneca Pharm. LP, 602 F.3d 1245 (11th Cir. 2010) (expert reliability and analytical gap analysis under Daubert)