262 F. Supp. 3d 493
E.D. Mich.2017Background
- Plaintiff Robert Avendt received a Permacol (cross-linked porcine dermis) implant in December 2008 for a recurrent ventral hernia; he later developed a chronic non-healing, draining wound and required further surgery.
- Plaintiffs allege Covidien failed to adequately test Permacol and failed to warn surgeons that its cross-linking can make it behave like synthetic mesh (less ingrowth, harder to clear infection), causing Avendt’s injury.
- Dr. Michael Rosen (treating surgeon) is Plaintiffs’ only medical expert; he did not file a Rule 26(a)(2)(B) expert report and was limited to treating-physician testimony; the court held further Daubert proceedings to resolve admissibility.
- Key disputed facts: whether the implant was placed in a Class I (clean) wound (Plaintiffs’ position) or in a wound rendered at least Class II by bowel injury (Defendant’s position); whether Permacol’s cross-linking made it unsafe or merely different.
- The Permacol IFU warned that use in contaminated/infected wounds may weaken the implant; Permacol was FDA cleared via 510(k) for Class I use only.
- Court excluded many of Dr. Rosen’s broader expert opinions (no expert report), found his causation and failure-to-warn/insufficient-testing opinions unreliable or outside scope, and granted Covidien summary judgment; case dismissed with prejudice.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of Dr. Rosen’s causation and product-safety opinions | Rosen can testify from clinical experience that Permacol’s cross-linking caused non‑incorporation and chronic infection | Rosen lacked the requisite scientific methodology, did not prepare an expert report, and his opinions contradict his own publications | Excluded: opinions about Permacol being unsafe in 2009 and specific causation inadmissible under Rule 702 and Daubert; Rosen limited to treatment-level testimony |
| Failure-to-warn / failure-to-test liability | Covidien knew or should have known cross-linking risks and should have tested and warned surgeons (e.g., direct IFU instruction to remove in seroma/infection) | No duty to warn beyond information reasonably available; IFU already cautioned about contamination; treating surgeon did not rely on IFU | Summary judgment for Covidien: Plaintiffs failed to show a legal duty or admissible expert proof that different warnings or tests would have changed clinical decisions or caused a different outcome |
| Proof of specific causation (product caused Avendt’s chronic wound) | Removal of unincorporated Permacol and subsequent healing shows product caused infection | Multiple alternative causes (obesity, diabetes, prior surgeries, seroma) were not excluded; no reliable method tying cross-linking to causation in this patient | Held for Covidien: Plaintiffs’ expert evidence left an analytical gap; causation not shown by admissible expert proof |
| Scope of treating-physician testimony vs. expert-report requirement | Treating physician may give broader expert opinions based on experience without full expert report | Rule 26(a)(2) requires a report for opinions beyond treatment scope; without it, opinions must be within treatment/diagnostic scope | Court enforces Rule 26: Rosen limited to opinions formed for treatment; broader design/testing/warning opinions require expert report and were excluded |
Key Cases Cited
- Celotex Corp. v. Catrett, 477 U.S. 317 (summary judgment burden and standards)
- Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (standard for genuine dispute of material fact)
- Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (trial-court gatekeeping for expert testimony)
- Tamraz v. Lincoln Elec. Co., 620 F.3d 665 (expert testimony must avoid speculation)
- Mitchell v. City of Warren, 803 F.3d 223 (Michigan statutory duty-to-warn standard)
- Rodriguez v. Stryker Corp., 680 F.3d 568 (510(k) clearance and scope; failure-to-test/warn context)