Burgin v. Ethicon, Inc.
3:20-cv-00111-RGJ-CHL
| W.D. Ky. | Sep 14, 2023Background
- Defendants Ethicon, Inc. and Johnson & Johnson marketed the Gynecare Prolift transvaginal mesh (released 2005; later withdrawn after FDA concluded safety/effectiveness concerns).
- Elizabeth Burgin received a Prolift implant in June 2007 after relying on her surgeon's recommendation; manufacturer brochure/IFU omitted several alleged risks (e.g., dyspareunia, chronic pelvic pain, mesh migration).
- Elizabeth experienced recurrent prolapse and pain; portions of the mesh were surgically removed in 2012 and additional procedures followed; plaintiffs allege significant physical limitations and future care costs.
- Plaintiffs filed an 18‑count short form complaint (many claims later withdrawn); remaining contested claims included negligence, design defect, fraud/constructive fraud/ negligent misrepresentation, gross negligence, and unjust enrichment.
- Defendants moved for partial summary judgment (seeking dismissal of most counts) and filed Daubert motions to exclude four plaintiff experts (Garely, Mays, Graham, Michaels); the court resolved the Daubert motions in part and granted summary judgment on multiple claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of general/case‑specific experts (Garely, Mays, Graham, Michaels) | Experts are qualified by clinical/pathology/polymer experience; MDL rulings largely permit their opinions; challenges go to weight. | Experts lack specialized qualifications for biomaterials/regulatory/labeling; some opinions are legal conclusions, improper state‑of‑mind testimony, or unreliable methodologies. | Daubert motions: GRANTED IN PART / DENIED IN PART. Experts may testify on clinical/causation topics but are precluded from opining on defendants’ state of mind, certain labeling content (what should have been in IFU), and alternative designs tied to dismissed claims; some methodology‑based exclusions (e.g., reliance on certain personal tests) reserved or excluded. |
| Design‑defect (need for feasible alternative design) | Garely and others identify safer options (remove arms, change trocar technique, use different materials) and contend alternatives were feasible. | Plaintiffs failed to present sufficiently detailed, practicable alternative design evidence; proposals are conclusory or constitute different devices/procedures. | Summary judgment GRANTED for design‑defect claims: Kentucky law requires proof of a feasible alternative design and plaintiffs failed to meet the specificity/feasibility standard. |
| Fraud / Constructive fraud / Negligent misrepresentation (reliance) | Plaintiffs argue surgeon relied on defendant materials and relayed representations to Elizabeth; that suffices to establish reliance. | Elizabeth testified she relied solely on her surgeon’s recommendation; there was no direct reliance on defendants’ statements; learned‑intermediary principles preclude imputed reliance. | Summary judgment GRANTED for fraud/constructive fraud/ negligent misrepresentation: plaintiffs failed to show direct reliance by Elizabeth on defendants’ representations. |
| Unjust enrichment (benefit conferred) | Plaintiffs contend defendants were enriched by sale of Prolift kit used on Elizabeth. | Plaintiffs paid hospital (Baptist) for the Prolift kit; no direct payment to Defendants, so no direct benefit conferred by plaintiff to defendant. | Summary judgment GRANTED for unjust enrichment: plaintiffs did not directly confer a benefit on defendants. |
Key Cases Cited
- Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993) (trial courts serve as gatekeepers to exclude unreliable or irrelevant expert testimony)
- Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999) (Daubert gatekeeping applies to non‑scientific expert testimony and trial courts have broad discretion)
- Celotex Corp. v. Catrett, 477 U.S. 317 (1986) (movant meets summary judgment burden by showing absence of genuine factual dispute)
- Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (1986) (standard for assessing whether reasonable jury could find for nonmovant at summary judgment)
- Mannino v. Int’l Mfg. Co., 650 F.2d 846 (6th Cir. 1981) (expert qualifications assessed with focus on whether they will assist the trier of fact)
- Pluck v. BP Oil Pipeline Co., 640 F.3d 671 (6th Cir. 2011) (differential diagnosis is an accepted medical technique but must reliably rule out alternatives)
- Toyota Motor Corp. v. Gregory, 136 S.W.3d 35 (Ky. 2004) (Kentucky applies a risk‑utility test in design‑defect cases and requires proof of a feasible alternative design)