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Avendt v. Covidien Inc.

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

July 5, 2017

ROBERT and KAROL AVENDT, Plaintiffs,
v.
COVIDIEN INC., a Delaware Corporation Defendant.

          Mona K. Majzoub United States Magistrate Judge

         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. and the speed at which that material is replaced with human tissue through ingrowth. In contrast to a non-cross-linked biologic, which is quickly remodeled after implantation (a matter of months maybe a year or so) by the natural collagen of the patient, this process is delayed in the cross-linked material so that the product retains its structure for a longer period of time. The advantage of this is that if the remodeling process goes too fast, then there is a period where the material has lost its characteristics and strength too quickly - before the tissue remodeling has really had a chance to take hold. Id. at 35:18-36:19. This process varies greatly from patient to patient and will depend on prior surgeries and on comorbidities, such as obesity and diabetes, of the patient. Id. at 36:20-25. 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 Daubert[2] 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 dissection [they] had some serosal injury to some of the small intestines and to some of the large intestine.” (Id. at 14:5-6.) Dr. Ash testified that this injury created a “clean contaminated wound, ” which meant that Dr. Ash “cut into the surface of the bowel and bacteria could have escaped, ” but no excrement was visible. (Id. 24:21-25:3, 61:5-14.) Because of the involvement of the injury to the bowel, and the potential for contamination, Dr. Ash choose to use a Permacol biological mesh (rather than a synthetic mesh such as the Parietex that he removed) because he was “uncomfortable putting a plastic prosthetic into [Mr. Avendt's] abdominal cavity for risk of infection.” (Id. at 14:8-12; 24:11-24.) Going into the December surgery, Dr. Ash had “intended to use a synthetic mesh, ” and had it not been for the “worry of infection, ” Dr. Ash “probably never would have put a biologic” in Mr. Avendt. (Id. at 61:5, 62:16-63:15.)[3]

         Dr. Ash had performed many surgeries with biological mesh but this was the first time he had used the Permacol biological mesh. (Id. at 14:13-14; 15:1-5.) Dr. Ash was “apprehensive” because of his lack of experience with the Permacol product. (Id. at 14:19.) But Permacol “fit the bill” because it was known to be “more resistant to infection” and tended “to fix better.” (Id. at 15:18-21.) The Permacol sales representative was present in the operating room and provided the Permacol mesh to Dr. Ash. (Id. at 15:24-16:11.) The decision to use Permacol was completely Dr. Ash's decision. Dr. Ash testified that the Covidien representative, “Matt Aris would never make that decision.” (Id. at 34:1-6.) Dr. Ash may have read some promotional literature about Permacol but had never discussed Permacol with any of the product representatives prior to using it on Mr. Avendt. (Id. at 25:13-21.) Dr. Ash fully understood the advantage of the Permacol mesh and explained why he consciously chose to place the Permacol in Mr. Avendt's wound:

Q: Can you explain the benefits of using the Permacol in Mr. Avendt's case at the time?
A: Alternatives to prosthetic meshes are one of two things, either you maintain a hernia or try to close it primarily, which in this case was just not physically possible, or you use a biologic. The only biologic available and the only one that we had experience or I had experience with prior was an Alloderm product. And we had had plagued recurrences with it, turns out it's a little too flexible to fix the holes. So this biologic mesh product is, and biologic products in general, are more resistant to infection and tend to fix better and more of a clean contaminated type of situation. And this Permacol fit the bill.

(Ash Dep. 15:6-7, 11-21.) Prior to using the Permacol mesh on Mr. Avendt, Dr. Ash may have read a “brochure from Covidien” or “looked at some throw away material, ” but had not “met with the rep or had any formal education, ” reviewed the product literature or read any peer-reviewed materials about the Permacol product. (Id. at 25:7-26:11.) Nonetheless, Dr. Ash felt that he was well educated and informed on the use of biologics and qualified to use a product such as Permacol during a case if needed. (Id. at 61:21-62:2.) Dr. Ash intentionally chose Permacol because the previous biologic he had used was performing poorly and resulting in multiple hernia recurrences and he knew Permacol to be a more durable product and a “remarkably better choice” than doing nothing to repair Mr. Avendt's hernia. (Id. at 24:15-24.) Post-operatively Mr. Avendt's condition was pretty typical and when he did first present with a wound secreting liquid, Dr. Ash suspected an infection but the liquid “didn't grow back any bugs in culture” and so an infection was not present. (Id. at 36:12-14.)

         The Permacol mesh comes out of its sterile packaging with a strong “cat urine smell, ” and required an extensive 10-15 minute “soaking” process to prepare the mesh for implantation. (Id. at 32:19-33:6, 33:12-25, 34:7-15.) Dr. Ash did not specifically discuss with Mr. Avendt in advance of the December, 2008 surgery the specific “type” of mesh, i.e. synthetic or biologic, he was planning to use to do that repair because he believed the risks of both were “essentially the same.” (Id. at 59:20-60:18.)

         Following the December, 2008 surgery, Mr. Avendt was having increasing redness, swelling, pain and abdominal fluid collection. On May 18, 2009, Dr. Ash saw Mr. Avendt and suspected that he had developed a seroma (a collection of fluid anterior to Permacol mesh and peritoneum) that may have become infected. (Def.'s Mot. Summ. J. Ex. K, May 18, 2009 Letter from Dr. Ash to Dr. Daros.) Dr. Ash operated the next day, on May 19, 2009, to drain and debride the abdominal wall seroma. (Def.'s Mot. Summ. J. Ex. A, Treatment Notes; Def.'s Mot. Summ. J. Ex. L, 5/19/09 Operative Note.) Dr. Ash observed the Permacol mesh, which “appeared intact, ” but on closer examination after irrigating the wound and manipulating the mesh, it was found to be “quite brittle” and appeared to have some “cracks and holes.” (5/19/09 Operative Note.) Dr. Ash opted to “stitch” the Permacol mesh and leave it in rather than remove the mesh altogether. (Ash Dep. 70:16-71:5.) Cultures taken from Mr. Avendt's wound after the May, 2009 drainage and repair did not show any sign of infection. (Id. at 69:2-22.)

         Mr. Avendt continued having “difficult, chronic” problems with wound healing, drainage from the wound and ultimately “odd material, ” later determined by Dr. Ash to be pieces of the Permacol mesh, began coming out of Mr. Avendt's wound. (Ash Dep. 18:20-19:22.) The expelled material varied in size from half-dollar to small flecks. (Id. at 37:15-21.) At no time did cultures taken by Dr. Ash come back positive for infection. (Id. at 36:14-15; 51:7-25; 69:2-22.)

         Sometime after the May, 2009 operation, but before referring Mr. Avendt to Dr. Rosen, Dr. Ash presented Mr. Avendt's case at an Abdominal Wall Reconstruction Conference in Washington, D.C. (Ash Dep. 38:5-11.) Representatives from Covidien were present, and Dr. Rosen was a member of the open-mike panel. Dr. Ash said he got at least “five different opinions” from this panel of experts about how to proceed. (Id. at 38:15-40:12.) The Covidien representative asked Dr. Ash to send him more information on Mr. Avendt's case but Dr. Ash never did provide the information because the Covidien sales representative, Matt Aris, who provided Dr. Ash with the Permacol for the 2008 surgery, “had already been given all the information.” (Ash Dep. 41:3-16, 73:22-74:25.)

         Dr. Ash recorded, in a July, 2009 clinic note, that he had “vetted” Mr. Avendt's case with multiple specialists to discuss the proper course of treatment for Mr. Avendt:

07/13/09, Robert Avendt. He is in for follow up on his wound. We have vetted his operation with multiple specialists at multiple different conferences over the last month and the prevailing thought processes consist of two choices. One is that we take him back and clean out this area of the remaining Permacol, do a temporary closure versus a separation of components and primary closure. The second idea is to let him finish the Permacol expulsion which I believe he is close to doing, let the wounds close up and make a plan to move ahead with a primary repair with separation components and mesh placement of nonbiological nature.

(ECF No. 117, Sealed Exhibit 1 to Def.'s Mot. Summ. Judg., Ash Treatment Notes PgID 4220.) Ultimately, Dr. Ash elected to go with the second “consensus” option and decided to let the process of Mr. Avendt “expelling this biological mesh from his wound” continue to work itself through. When Mr. Avendt's hernia recurred again, Dr. Ash referred Mr. Avendt to Dr. Michael Rosen at Case Western, a leading national expert on hernia repair, “to fix [Mr. Avendt's] recurrent recurrence.” (Def.'s Mot. Summ. J., Ex. A, Ash Treatment Notes PgID 4220; Ash Dep. 21:2-8, 35:10-25.)

         B. Mr. Avendt's Treatment With Dr. Rosen

         1. Dr. Rosen's deposition testimony.

         Dr. Rosen, who was at Case Western University Hospital at the time of Mr. Avendt's surgery and is now at the Cleveland Clinic, is a specialist in hernia repair who has spoken, trained, practiced and published on the subjects of hernia repair and mesh, both synthetic and biologic. (Def.'s Mot. Summ. J. Ex. I, May 11, 2105 Deposition of Michael J. Rosen, M.D. 11:11-13; 14:12-21, 37:1-25, 39:18-40:16.)

         Eighty percent of Dr. Rosen's practice is hernia repairs. He uses both synthetic and biologic mesh but “favor[s] synthetic meshes for the vast majority of hernias” he performs. (Rosen Dep. 41:4-12.) At the time of his deposition, Dr. Rosen was the Principal Investigator of an FDA monitored study comparing synthetic and biologic mesh. (Id. at 41:15-18.) Outside of the trial study, he uses biologic mesh less than 2 percent of the time. (Id. at 41:18-20.) He uses Strattice biologic mesh and has never used Permacol. (Id. at 41:21-25.) Dr. Rosen identified obesity and diabetes as factors that predispose a patient to develop an incisional hernia and to have complications with wound healing. (Id. at 43:22-44:2.) Dr. Rosen testified that the success of most hernia operations comes down to good wound healing. Poor wound healing can affect the recurrence of hernias - patients with poor wound healing will have an increased incidence of recurrence. (Id. at 46:17-47:11.) Poorly controlled diabetes also increases the risk of recurrence of hernias due to the body's inability to lay down good collagen to form scar tissue. (Id. at 49:2-16.) Also, the risk of re-recurrence increases with each recurrence - as much as 40-50% following a third repair. (Id. at 50:19-51:18.) “Once you have a failed hernia, unless things change in some meaningful way, it's a vicious cycle.” (Id. at 50:15-18.)

         The Covidien synthetic mesh (not at issue in this case) is polyester and the BARD mesh is polypropylene. Dr. Rosen prefers polypropylene for open procedures. (Id. at 56:17-57:24.) For a biologic mesh, the Cleveland Clinic was using Permacol but is switching over to Strattice, which is a pigskin, non-cross-linked mesh. (Id. at 58:15-59:9.) Permacol biologic is also pigskin, but is cross-linked. Both have their selling points. (Id. at 60:23-61:13.) The processing of the pigskin biologics is “proprietary” and there is “very little” in the way of clinical trial information available. (Id. at 60:15-22.) There is a lot of debate about which mesh is the best, and the ideal mesh has not been found, but “less than ideal meshes have been revealed.” (Id. at 62:8-22.)

         Dr. Rosen reviewed the Permacol Instruction-For-Use (“IFU”) document for a paper that he wrote and recalls that it contained a warning or a contraindication in the presence of infection or contamination which he feels is not what a surgeon wants to hear when they are “reaching for a biologic mesh.” (Id. at 63:19-21; Def.'s Mot. Ex. E, IFU.) Dr. Rosen explained that use of the term “infected” is a bit misleading and prefers to refer to the CDC “crystal clear guidelines” for the four wound classes: Class I (clean), Class II (clean-contaminated), Class III (contaminated) and Class IV (dirty). (Id. at 70:1-5.)[4]

         All mesh on the market is approved for use in a “clean” Class I wound for “reenforcement where soft tissue weakness exists, ” and that is the Permacol IFU terminology. (Id. at 67:3-9.) When bacteria get on these materials, “there is a concern that collagenations in the bacteria can break down the mesh and affect its long-term performance.” (Id. at 67:9-13.) While every company would like to be able to market a mesh with the indication for use in a contaminated field, “no company is going to take the risk of a randomized controlled trial that might disprove that their mesh is worthwhile and spend millions of dollars.” (Id. at 68:23-69:2.) So, no mesh on the market is FDA “approved” for use in anything other than a Class I wound, but biologic mesh is “believed” to tolerate an infected environment better than a synthetic mesh.

         As noted supra, Dr. Rosen has been the Principal Investigator on trials involving synthetic and biologic mesh products. (Id. at 41:15-18, 65:18-66:3.) In 2007 or 2008, the FDA tried to start a trial, which Rosen reviewed, to remove infected mesh and replace it with Permacol but the consensus was that it would probably fail so the trial never got going. (Id. at 67:18-25.) Because such a trial was “beyond the scope of what the FDA requires, ” companies decided not to take the business/financial risk of undertaking the trial. (Id. at 68:6-9.) At the time of his deposition, Dr. Rosen was involved in a randomized trial for Covidien comparing synthetic to biologic mesh in clean and clean contaminated wounds. (Id. at 70:4-11.) If in his practice he was faced with a patient with a Class II or III wound, he would have a conversation with the patient about the risks and benefits of both synthetic and biologic, explaining that the synthetic will have a lower recurrence rate but the biologic, although having a higher long term recurrence rate, “potentially can handle an infection better.” (Id. at 71:6-25.)

         While at Case Western University Hospital in 2007-2009, Dr. Rosen conducted basic science work in his lab on all different types of meshes to determine how they respond to presence of contamination. (Id. at 72:4-11.) The determinants are multi-factorial and include the size of the pores, the weight of the material, the type of material but the studies “to date” (in 2015) indicate that “the larger pore synthetic materials are surprisingly resistant to infection.” (Id. at 73:7-9.) When you place a mesh into a contaminated field, “it basically becomes a race for ingrowth into the tissue or bacterial coating of the material and then infection, puss, biofilms.” (Id. at 73:17-22.) So, the quicker things “ingrow, ” the more resistant the site will be to bacterial colonization that propagates the infection. (Id. at 73:22-25.) In Dr. Rosen's opinion, the best synthetic product for a contaminated wound would be a large pore polypropylene and the best biologic would be a “non-cross-linked porcine dermis, ” (pigskin). (Id. at 74:18-75:4.) For patients who are very infection averse and more tolerant of a recurrence, he might suggest the biologic and for those who are averse to a recurrence but will risk the infection, he would suggest the large pore polypropylene synthetic. (Id. at 75:12-23.)

         While Dr. Rosen has been involved in several clinical trials involving mesh products, he has not studied the underlying design of the product in terms of the methods, such as cross-linking, employed to produce the mesh. (Id. at 78:20-79:8.) Indeed, although Dr. Rosen testified that he doesn't use Permacol because “he [doesn't] like cross-linking, ” Dr. Rosen could not explain the process involved in cross-linking and could not identify the difference between the biologic mesh that he uses (Strattice) and the Permacol biologic mesh other than the fact that the Strattice product is not cross-linked. (Id. at 83:8-84:1.) Nor does Dr. Rosen profess to have expertise in the area of human immune response to the various mesh materials, although he is aware of the data resulting from mostly animal-based studies. (Id. at 80:23-82:8.) His expertise is in the clinical aspects of the competing types of mesh, a subject that is still very much under study. He describes the current competing clinical observations as follows:

Q: So what do you tell your patients about the risks and benefits with your synthetic option versus your biologic option?
A: Well, I think with the large pour [sic] polypropylene mesh, we talk about the fact that it tends to be fairly durable, to have a lower recurrence rate and in our clinical experience up to date, it seems to be fairly resistant to infection and will still incorporate in the face of infection. But the point of the study is that we're trying to figure out if that's actually true.
The biologic mesh tends to be less durable long term, because you have to lay down your own scar tissues and things like that, so recurrence rates can be a little bit higher. But if you were to get an infection, it's often something we can treat through and don't need to reoperate and it might dissolve and go away and you'd be left with a recurrence but not a chronic infection problem.

(Rosen Dep. at 86:18-87:13.)

         Dr. Rosen did the initial portion of the procedure on Mr. Avendt on January 28, 2010. His role was to go in, “get down all the scar tissue, lice the bowel adhesions, remove as much of the infected mesh [sic] and then kind of leave a hole” where they were going to try to reconstruct the herniated area with just a flap, not using any other material or mesh, to try to cure his infection, which was a Class IV wound on the date of surgery. (Id. at 98:17-99:12, 101:20-22.) Dr. Rosen completed his portion of the procedure and was followed immediately by Dr. Salgado, who took skin, fascia and muscle from Mr. Avendt's thighs to create the flap for the abdominal repair. (Id. at 100:12-101:1.) Dr. Salgado placed drains at the surgical site and closed the wound. (Id. at 101:8-19.)

         Six months following the surgery by Drs. Rosen and Salgado, Mr. Avendt had developed a recurrence of his hernia and an infection on his right leg where Dr. Salgado had removed the skin for the abdominal flap. Id. at 105:2-106:20. Mr. Avendt reported to Dr. Rosen on November 5, 2010, that his hernia was fairly asymptomatic but he was having a lot of weakness and pain in his leg and difficulty getting around. (Id. at 107:9-108:5.) Dr. Rosen opines that the hernia recurrence following the surgery performed by Dr. Rosen and Dr. Salgado was due to the fact that the “defect was so big after what had happened to him in the past and in the presence of a Class 4 wound” the ultimate goal was to get the wound to heal and accept a fairly high chance of a recurrence. (Id. at 113:18-25.)

         Dr. Rosen recalls discussing generally with Mr. Avendt the issues about infection with hernia mesh repairs but did not tell Mr. Avendt that Permacol was a defective product and never wrote to the FDA or told anyone in his hospital that Mr. Avendt had a defective mesh. (Id. at 116:17-117:21.) Dr. Rosen did not recall whether he looked into the pathology of Mr. Avendt's removed Permacol mesh or if he included Mr. Avendt's case in any of his case studies. (Id. at 119:13-121:12.)

         Dr. Rosen is of the opinion that in 2009, Permacol was not a reasonably safe product for use based on the data then available which indicated that a cross-linked material would not behave like a biologic mesh and, in 2009, Dr. Rosen would not have chosen a cross-linked biologic material. (Id. at 127:19-25.) Although not “the scientist who vetted it, ” Dr. Rosen opines that in looking at the Permacol mesh the problem was that “they decided to heavily cross-link that material” and consequently made it tougher to break down and more of a barrier to ingrowth. (Id. at 132:7-133:15.) Dr. Rosen opines that every company knows that their biologic mesh 90% of the time is being put in a Class II or III wound situation and even though the FDA does not require biologic mesh to specifically have clearance for use in Class II or III wound, a surgeon asking for a biologic mesh product would reasonably assume that the product was designed to perform in that wound class. (Id. at 142:11-144:22.) Dr. Rosen opines that if Mr. Avendt had received a non-cross-linked biologic mesh, he likely would have had a recurrence but it would have been in a clean field. (Id. at 148:12-149:2.) With a non-cross-linked mesh, the body would have cleared the infection and he would have had a recurrence that could have been repaired with a synthetic mesh. “But because of the size of the hernia, the complexity of the hernia and the active infection in a Class IV wound, that's when essentially all of his reconstructive options were burned due to the chronic, ongoing infection with the big hernia.” (Id. at 149:2-7.) Because the Permacol mesh was cross-linked, “it behaved like a synthetic mesh and was unable to be cleared. That's why it was an ongoing infection when I saw him.” (Id. at 149:18-21.)

         Dr. Rosen is clear that he does not know, and does not profess to know, the scientific process by which the Permacol mesh is cross-linked and is not sure if he has ever even examined a Permacol mesh although he knows it smells like cat urine. He is not a material scientist or a biomedical engineer although he has collaborated with many such experts on his papers. (Id. at 151:24-152:18, 164:4-165:10.) In essence, Dr. Rosen is of the opinion that Covidien knew that Permacol was being used in situations for which it was contraindicated, i.e. off label in Class II or III wounds, and should have studied whether it was safe in those off label applications. (Id. at 151:12-23.)

         Dr. Rosen has written extensively about the clinical performance of cross-linked materials and testified that he supports his conclusions about the cause of Mr. Avendt's damages by his observations during Mr. Avendt's surgery of the Permacol mesh with puss sitting around it and based on his experience with cross-linked biologic mesh, which doesn't go away due to its cross-linking and “just sits there” and doesn't dissolve. (Id. at 154:7-155:16.) Dr. Rosen testified that he would use a Permacol mesh only in a situation in which a synthetic mesh would be indicated, i.e. in a clean or Class I wound. (Id. at 157:1-11.) Dr. Rosen testified that at the Cleveland Clinic, 100% of the uses of biologic mesh is off-label, outside of its indication, because no mesh is indicated for use in a contaminated wound. Dr. Rosen would never elect to use a cross-linked mesh in such a situation. (Id. at 157:11-22.) His only criticism of the Permacol mesh is that it is cross-linked and in his clinical experience, he has never seen a mesh in sitting in puss outside of cross-linked material. (Id. at 167:19-24.) He has never taken care of a case of a non-cross-linked biologic mesh where he has had to go back in and remove an infected piece of mesh. The non-cross-linked biologic mesh will dissolve and clear in the face of infection and at most you are left with a recurrence. (Id. at 169:14-18.) Dr. Rosen has reviewed articles that indicate that other non-cross-linked biologic mesh products are safe in Class II and III wounds, but he has never seen such a statement regarding a Permacol mesh. (Id. at 171:11-172:16.)

         Dr. Rosen summarized his opinion that the cross-linking of the Permacol mesh caused Mr. Avendt's injuries:

Q: So in terms of what was your methodology in coming to your conclusion of the case that it was the cross-linking that -
A: Sure. So my hypothesis was, he had a chronic draining sinus because there was a piece of foreign material in there, Permacol. So my observation was that the wound did not heal for a year. In my experience in maybe managing 2 to 3, 000 of these cases, typically when wounds don't heal, there's some remaining foreign body that the body cannot clear.
So when we operated on him and performed the experiment, we drilled down and actually were able to observe and document unincorporated Permacol cross-linked mesh sitting in a bed of puss and granulation tissue due to ongoing nonhealing. And when we removed it all, you know, my conclusion, even in the setting of contamination, the wound healed. So to me that's conclusive, that for one year the wound didn't heal, you take out the one thing and everything heals from an infectious standpoint, to me, that's pretty good scientific evidence that it's conclusive.

(Rosen Dep. 174:17-175:16.)

         When asked his understanding of his role in testifying in this matter, Dr. Rosen responded:

Q: Do you understand that you're only designated as a treating doctor? Have you had any conversation with the plaintiff's lawyers about that?
A: I asked like what exactly my role is in this and I think they said I'm like a hybrid, so where I was the treating doctor and obviously I can provide expert testimony just because of my clinical experience.
Q: And that's what you expect to do at trial?
A: Sure.
Q: Your opinions about cross-linking were not formed because of Mr. Avendt; they were formed outside of that, correct?
A: Well, no, they were not formed exclusively because of him. They were formed because of my clinical experience in the lab and treating patients with complications ...

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