Avendt v. Covidien Inc., Case No. 11–cv–15538

• Decision Date: 05 July 2017
• Docket Number: Case No. 11–cv–15538
• Citation: 262 F.Supp.3d 493
• Parties: Robert and Karol AVENDT, Plaintiffs, v. COVIDIEN INC., a Delaware Corporation, Defendant.
• Court: U.S. District Court — Eastern District of Michigan

262 F.Supp.3d 493

Robert and Karol AVENDT, Plaintiffs,

v.COVIDIEN INC., a Delaware Corporation, Defendant.

Case No. 11–cv–15538

United States District Court, E.D. Michigan, Southern Division.

Signed July 5, 2017

Courtney G. Howard, Witt & Goldsworthy, PLLC, Denver, CO, Michael D. Witt, Michael D. Witt, PharmD, JD, Flint, MI, for Plaintiffs.

Kelly G. Bieri, Micah L. Hobbs, Devin K. Ross, Bryan Timothy Pratt, Shook, Hardy & Bacon L.L.P., Kansas City, MO, James Aaron Craig, Shook Hardy & Bacon LLP, Kansas, MO, Matthew Letzmann, Brooks Wilkins Sharkey & Turco PLLC, Birmingham, MI, for Defendant.

OPINION AND ORDER (1) EXCLUDING CERTAIN TESTIMONY OF PLAINTIFF ROBERT AVENDT'S TREATING PHYSICIAN; (2) GRANTING DEFENDANT'S MOTION FOR SUMMARY JUDGMENT (ECF NO. 116); (3) DENYING PLAINTIFFS' MOTION FOR PARTIAL SUMMARY JUDGMENT (109); (4) DENYING AS MOOT DEFENDANT'S MOTION TO EXCLUDE TESTIMONY OF DAVID ANCELL (ECF NO. 110); (5) DENYING AS MOOT DEFENDANT'S MOTION TO EXCLUDE TESTIMONY OF DAVID HAMMEL (ECF NO. 113) AND (6) DISMISSING PLAINTIFFS' COMPLAINT WITH PREJUDICE

PAUL D. BORMAN, UNITED STATES DISTRICT JUDGE

This is a product liability action involving Plaintiffs' claim that Defendant Covidien Inc. ("Covidien") failed to appropriately test, and therefore failed to adequately warn practicing physicians about the side effects of, a hernia

repair mesh product that was used to repair Robert Avendt's recurrent hernia. Plaintiffs theorize that Covidien's hernia mesh product caused Mr. Avendt to have a chronic non-healing wound that became infected and required further surgery. Covidien has moved to limit the testimony of Plaintiffs' only medical expert, Mr. Avendt's treating physician, and for summary judgment on Plaintiffs' claims. The Court has received extensive briefing from the parties on Covidien's motions and conducted two lengthy hearings, as discussed below. For the reasons that follow, the Court GRANTS Covidien's motion for summary judgment.

INTRODUCTION

This action involves Plaintiffs' claim that Covidien's biological surgical mesh

product ("Permacol"), an FDA approved medical device which was implanted in Plaintiff Robert Avendt on December 17, 2008 to repair a third recurrent hernia, was not adequately tested before being released to market and therefore Covidien failed to adequately warn practicing surgeons of Permacol's propensity to fail due to its cross-linked design.¹ Plaintiffs claim that had Covidien performed "an adequate clinical trial" on Permacol, and included the results of such a study in the Permacol instructions for use, the surgeon who placed the Permacol mesh in Mr. Avendt would not have chosen the Permacol cross-linked biologic mesh to repair Mr. Avendt's third recurrent hernia

, and/or would not have left the Permacol in Mr. Avendt's abdomen after detecting a seroma, and Mr. Avendt would not have suffered the infected, chronic non-healing wound that allegedly caused his injuries.

I. PROCEDURAL BACKGROUND

On April 19, 2016, the Court issued an Opinion and Order in this case, Avendt v. Covidien , 314 F.R.D. 547 (E.D. Mich. 2016), partially granting Defendant's motion to limit the opinions and testimony of Plaintiff Robert Avendt's treating physician, Michael J. Rosen. The Court determined, after conducting an extensive hearing on Covidien's motion to limit Dr. Rosen's testimony, that it could resolve some but not all of Covidien's challenges to Dr. Rosen's proposed testimony. In summary, the Court determined that Dr. Rosen was required to file a full-blown Fed. R. Civ. P. 26(a)(2)(B) Report with respect to certain of the opinions that Plaintiffs seek to have him offer and that the Fed. R. Civ. P. 26(a)(2)(C) Disclosure that Plaintiffs filed on behalf of Dr. Rosen, see ECF No. 159–7, Pls.' Resp. to Mot. to Exclude Rosen, Ex. G, Plaintiffs' Fed. R. Civ. P. 26(a)(2)(C) Supplemental Disclosure, was insufficient under the Federal Rules of Civil Procedure as to certain of his proposed opinions. Avendt , 314 F.R.D. at 556–57 (observing the Federal Rules of Civil Procedure Rules and Commentary, which notes that "there is no reason to conclude that Rule 26(a)(2)(C) was intended to allow treating physicians to give expert opinions that go beyond the scope of treatment and diagnosis without having to prepare a report with respect to those further opinions ... It is not sufficient for the summary disclosures to mention that the treating physician is going to offer these additional expert opinions"). The Court concluded:

Thus, the substance of a treating physician's testimony, and not his or her status as a treating physician, determine whether a Rule 26(a)(2)(C) disclosure will suffice. In making this call, the distinction made in pre–2010 case law, between treating physicians who opine only matters relating to their treatment and diagnosis on the one hand and treating physicians who offer opinions that fall outside the scope of the treating relationship on the other, continues to be determinative.

314 F.R.D. at 557 (collecting cases).

The Court thus concluded that Dr. Rosen, who did not file a Rule 26(a)(2)(B) expert report in this case, would be limited to testifying as a treating physician and therefore limited to those opinions that were formed for purposes of, and within the scope of, his care and treatment of Mr. Avendt. The Court determined that certain of Dr. Rosen's opinions proposed in Plaintiffs' Rule 26(a)(2)(C) disclosure fell well outside any possible relation to his care and treatment of Mr. Avendt and would be excluded, including Dr. Rosen's proffered opinion that "there is clearly a need for further animal and human trials investigating how varied clinical settings affect the performance of different xenograft

biologic meshes." 314 F.R.D. at 560 (finding that Plaintiffs' Rule 26(a)(2)(C) treating physician disclosure was insufficient and a full blown expert report was required with regard to the opinions proffered in paragraphs three, four, and five of Plaintiffs' Rule 26(a)(2)(C) disclosure).

With regard to other aspects of Dr. Rosen's proposed testimony as set forth in Plaintiffs' Rule 26(a)(2)(C) disclosure, Plaintiffs disclosed that Dr. Rosen would testify regarding certain matters about which Dr. Rosen clearly lacks expertise, as Covidien established in Dr. Rosen's deposition. The Court concluded that Dr. Rosen's "proposed" opinions on such matters, even if Plaintiffs could have established that Dr. Rosen formed them within the scope of his care and treatment of the Mr. Avendt, were well beyond his admitted area of expertise, and were excluded under Daubert² without necessity of further testimony at a Daubert hearing:

[Dr. Rosen] lacks sufficient expertise to opine on the topics of the material science of cross-linking, immunogenic response to cross-linked material or the scientific process related to the fatigue and breakdown of mesh. Similarly unsupported are any opinions relating specifically to the design and testing of Permacol. The Defendant's motion to strike all such opinions is GRANTED without need of a Daubert hearing.

314 F.R.D. at 562.

As to other aspects of Covidien's challenge to Dr. Rosen's testimony, the Court concluded that it lacked sufficient information and ordered that Dr. Rosen appear for a Daubert hearing. Due to Dr. Rosen's busy schedule and limited availability to appear as the Court ordered, the Daubert hearing did not take place until January 26, 2017. Following the Daubert hearing, the Court ordered the parties to submit a round of supplemental briefing on the admissibility of Dr. Rosen's opinions. Those supplemental briefs were submitted in March, 2017. (ECF Nos. 231, 232, 233.)

II. FACTUAL BACKGROUND

A. Plaintiff Robert Avendt's Treatment With Dr. Ash

Mr. Avendt began treating with Dr. Christopher J. Ash, D.O. in August, 2005, weighing approximately 280 pounds and presenting with complaints of a large ventral hernia

. (ECF No. 116, Def.'s Mot. Summ. J. Ex. A, Treatment Notes of Dr. Christopher J. Ash, D.O.) Mr. Avendt was then 54 years old and a Type–2 diabetic with "multiple comorbidities," high cholesterol, hypertension and a history of abdominal surgeries that began in 1997 with a Hartmann procedure for diverticulitis. (Id. ) In 1998, Mr. Avendt had an emergency hernia repair related to an incarcerated ventral hernia, followed by a small bowel resection and primary repair of the ventral hernia. (Id. )

After consultation with Dr. Ash in 2005, Mr. Avendt decided to continue his efforts at weight loss and postpone any surgical repair of his hernia

. (Id. ) Mr. Avendt's hernia went untreated until June, 2008, when Mr. Avendt returned to Dr. Ash, having lost approximately 30 pounds, and seeking to have his abdominal hernia repaired. (Id. ) On August 21, 2008, Dr. Ash repaired Mr. Avendt's recurrent hernia and implanted a large 25 cm x 25 cm Parietex synthetic surgical mesh. (Def.'s Mot. Summ. J. Ex. B, 8/21/08 Operative Note.)

Mr. Avendt had worsening abdominal pain following his August 21, 2008 surgery and his hernia

recurred. On December 17, 2008, Dr. Ash performed another hernia repair. (Def.'s Mot. Summ. J. Ex. C, 12/17/08 Operative Note.) While Mr. Avendt's August, 2008 hernia repair had been done laproscopically, the December, 2008 surgery to repair the recurrence had to be "more invasive" and required a larger incision. (Def.'s Mot. Summ. J. Ex. D, July 11, 2012 Deposition of Christopher Ash 13:21–14:4.) Dr. Ash discovered that the Parietex mesh that he had previously placed in the first repair had "come loose," and "folded transversely" onto itself in the mid-portion of Mr. Avendt's abdomen. (Ash Dep. 75:10–25; 12/17/08 Operative Note.) Dr. Ash removed the entire Parietex mesh, and had to dissect free some portions of the bowel that had adhered to the mesh. (12/17/08 Operative Note.)

In the course of the 12/17/08 surgery, Dr. Ash had "an issue in relation to some scar tissue and [Mr. Avendt's] bowels being up into his hernia

." (Ash Dep. 14:7–8.) "[I]n doing the...