Avendt v. Covidien Inc.
2016 U.S. Dist. LEXIS 52034
E.D. Mich.2016Background
- Plaintiffs allege Covidien’s crosslinked porcine dermis biologic mesh (Permacol) was defectively designed or inadequately warned and caused Robert Avendt a chronic nonhealing infected wound after hernia repair; wife claims loss of consortium.
- Plaintiffs proffered Dr. Michael J. Rosen (treating surgeon) as their sole medical causation expert; Plaintiffs filed only a brief Rule 26(a)(2)(C) disclosure and no Rule 26(a)(2)(B) expert report.
- At deposition Dr. Rosen (experienced hernia surgeon) testified he has clinical experience with biologic and synthetic meshes, has published on mesh complications, but: never used Permacol in practice before this case, lacks material‑science and immunology expertise, and did not prepare a Rule 26(B) report explaining the bases for his causation opinions.
- Covidien moved to limit/exclude large swaths of Dr. Rosen’s testimony for failure to provide a proper expert report and under Daubert; Magistrate Judge previously allowed a (C) disclosure but did not decide admissibility scope.
- The district court held (1) many of Rosen’s opinions that go beyond treatment/diagnosis required a Rule 26(a)(2)(B) report and were subject to exclusion absent justification or harmlessness, (2) Rosen is unqualified to opine on material science, crosslinking processes, immunogenic response, and design/testing of Permacol, and (3) some of Rosen’s causation opinions raise reliability concerns requiring a Daubert hearing rather than immediate admission.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether a treating physician who will offer causation opinions must provide a Rule 26(a)(2)(B) report or may rely on a Rule 26(a)(2)(C) disclosure | Rosen’s treating status permits summary (C) disclosure for his opinions; no full report required | If a treating physician’s opinions go beyond diagnosis/treatment (e.g., after‑the‑fact causation, design critique), Rule 26(a)(2)(B) report is required | Court: Substance controls; opinions formed outside course of treatment require a 26(a)(2)(B) report. Some (C)-disclosed opinions OK if formed during care; others excluded or subject to Daubert. |
| Admissibility standard for Rosen’s expert testimony | Treating‑physician testimony admissible as expert under Rule 702 if based on experience | Same but emphasizes Daubert reliability inquiry and need for proper disclosure to test opinions | Court: Treating physicians still subject to Daubert; relied on Daubert/Kumho framework; ordered Daubert hearing for certain opinions. |
| Qualifications to opine on crosslinking/material science and immunogenic response | Rosen’s clinical experience and coauthorship of mesh literature supports his experience‑based opinions | Rosen lacks technical training; did not vet Permacol design/testing; cannot explain crosslinking chemistry or immune mechanisms | Court: Rosen unqualified to opine on material science, crosslinking process, immunologic response, or Permacol design/testing — those opinions are excluded. |
| Reliability/application of Rosen’s specific‑causation opinion that Permacol’s crosslinking caused Avendt’s chronic wound | Rosen: Observed Permacol remnants in infected wound; removal led to healing — clinical experience supports causation | Covidien: Rosen didn’t consider imperative factors (wound class at implantation, obesity, diabetes, prior repairs), his prior publications contradict his present claim, and lack of a (B) report prejudiced defense | Court: Rosen’s causation opinion raises reliability concerns (failure to consider alternative causes, inconsistent publications); a Daubert hearing is required to test admissibility; exclusion pending hearing for portions not shown reliable. |
Key Cases Cited
- Daubert v. Merrell Dow Pharm., 509 U.S. 579 (1993) (trial courts must ensure expert testimony is reliable and relevant under Rule 702)
- Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999) (Daubert gatekeeping applies to all expert testimony, including experience‑based opinions)
- Gass v. Marriott Hotel Servs., Inc., 558 F.3d 419 (6th Cir.) (treating physician testimony remains subject to Daubert)
- Tamraz v. Lincoln Elec. Co., 620 F.3d 665 (6th Cir.) (experts cannot speculate; reliability requires more than conjecture)
- Fielden v. CSX Transp., 482 F.3d 866 (6th Cir.) (distinguishes treatment‑formed opinions from after‑the‑fact expert opinions by treating physicians)
- In re Aredia & Zometa Prods. Liab. Litig., [citation="483 F. App'x 182"] (6th Cir.) (treating physician testimony is subject to Daubert exclusion if causation opinions are unsupported)
- Lettieri v. Equant Inc., 478 F.3d 640 (4th Cir.) (law‑of‑the‑case doctrine does not limit a district court’s reconsideration of a magistrate judge’s earlier ruling)
- Newell Rubbermaid Inc. v. Raymond Corp., 676 F.3d 521 (6th Cir.) (identifies reliability red flags: reliance on anecdote, failure to consider alternatives, lack of testing)