Huskey v. Ethicon, Inc.
2014 U.S. Dist. LEXIS 92317
S.D.W. Va2014Background
- Multi-district litigation involving Ethicon’s Gynecare TVT-O transobturator mesh implanted in plaintiff Huskey; many Daubert challenges to experts on both sides.
- Court applies Rule 702/Daubert gatekeeping: reliability and fit; differential diagnosis principles noted.
- Defendants moved to exclude or limit testimony of seven plaintiff experts (Rosenzweig, Klosterhalfen, Guelcher, Dunn, Pandit, Steege, Blaivas). Plaintiffs moved to exclude five defense experts (Greenberg, Pramudji, Johnson, Sexton, Zheng).
- Rulings are mixed: several plaintiff experts admitted in part and excluded in part; defendants’ expert Greenberg excluded entirely; other plaintiff challenges partly granted or reserved for trial on specific topics.
- Court emphasizes experts cannot usurp jury on Ethicon’s state of mind or legal conclusions and warns against cumulative testimony at trial.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of Rosenzweig’s warning opinions and product-risk testimony | Rosenzweig qualified to testify on clinical risks and adequacy of warnings | Ethicon: lacks IFU drafting experience, some opinions outside his expertise | Qualified to opine generally on warnings; opinions on cytotoxicity failure-to-warn admitted; opinions that Ethicon’s testing was insufficient, population-specific warnings, and training opinions excluded |
| Rosenzweig and others — degradation, fraying, particle loss (general vs specific causation) | Plaintiffs: general causation (mesh can degrade) and specific causation (Huskey’s mesh degraded) | Ethicon: no testing on Huskey’s explant; unreliable to opine on specific causation | General causation opinions on degradation admissible; Rosenzweig’s specific-causation opinions excluded for lack of reliable basis |
| Expert opinions on testing, risk assessment, and safer alternative designs (Dunn, Pandit) | Plaintiffs’ experts critique Ethicon’s risk-assessment and testing; propose alternatives | Ethicon: some opinions not disclosed, unreliable, or beyond experts’ qualifications | Dunn’s risk-assessment rebuttal admitted; Dunn’s undisclosed alternative-design testimony excluded; Pandit’s testing, leaching, alternative-design, and laser-cut opinions excluded for lack of foundation or disclosure |
| Qualifications to opine on infection and related rates (Sexton) | Plaintiffs: Huskey alleges non-SSI, chronic/subclinical infection; Sexton’s narrow SSI definition makes testimony irrelevant | Defendants: Sexton adopts CDC/NHSN definitions but also addresses subclinical infection literature | Sexton may testify; his opinions considered helpful and reliable; his use of standard definitions acceptable |
| Biocompatibility and degradation opinions of defense toxicologist (Greenberg) | Plaintiffs: irrelevant (no claim of cancer/systemic toxicity) and beyond Greenberg’s biomaterials expertise | Defendants: toxicologist can opine that polypropylene is not systemically toxic and thus biocompatible | Greenberg excluded entirely for lack of fit and for exceeding qualifications on biocompatibility/degradation |
| Pathology and causation opinions (Zheng) | Plaintiffs: many opinions exceed pathology expertise (materials, biomechanics, clinical causation) | Defendants: Zheng will limit some opinions and has examined many explants | Several topics conceded/moot; Zheng may testify on pathologic reasons for excision but may not opine that mesh causes pain or on unreliable statements (e.g., 50% legal-motivation claim excluded) |
| Clinical-observation opinions (Pramudji, Johnson) | Plaintiffs attack defendants’ clinical experts on degradation and alternative causes | Defendants: clinicians rely on extensive surgical experience and literature review | Pramudji: some alternative-cause opinions excluded (interstitial cystitis, endometriosis, stress, back-surgery causation); Ethicon withdrew some degradation opinions. Johnson: qualified and his opinions on lack of clinically significant degradation admitted |
| Klosterhalfen and Blaivas reliability on degradation/porosity and alternative procedures | Defendants: opinions not helpful or insufficiently supported; plaintiffs: expert reliance acceptable | Court: record incomplete for some topics | Klosterhalfen: admissible in part; degradation and effective-porosity opinions reserved for trial. Blaivas: many opinions admitted, but numerous opinions excluded (degradation, complication rates, marketing, testing competence); some issues reserved for hearing |
Key Cases Cited
- Daubert v. Merrell Dow Pharm., 509 U.S. 579 (1993) (establishes district-court gatekeeping role under Rule 702)
- Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999) (Daubert flexibility applies to all expert testimony)
- Westberry v. Gislaved Gummi AB, 178 F.3d 257 (4th Cir. 1999) (focus on principles and methodology, not conclusions)
- Cooper v. Smith & Nephew, Inc., 259 F.3d 194 (4th Cir. 2001) (experts can be powerful and misleading; court must ensure relevance and reliability)
- Md. Cas. Co. v. Therm-O-Disc, Inc., 137 F.3d 780 (4th Cir. 1998) (proponent must supply evidence to permit court’s admissibility determination)
- United States v. Moreland, 437 F.3d 424 (4th Cir. 2006) (trial judge need not accept expert testimony as irrefutable; cross-examination and contrary evidence remain available)