Wegmann v. Ethicon, Inc.
| Decision Date | 30 September 2020 |
| Docket Number | No. 4:20-CV-00704 JAR,4:20-CV-00704 JAR |
| Parties | ANNE WEGMANN, Plaintiff, v. ETHICON, INC., et al., Defendants. |
| Court | U.S. District Court — Eastern District of Missouri |
This matter is before the Court on Defendants Ethicon, Inc. and Johnson & Johnson (collectively "Ethicon")'s Motion for Summary Judgment (Doc. No. 39) and Motion to Limit the Case-Specific Opinions and Testimony of Bruce Rosenzweig, M.D. (Doc. No. 41).1 The motions are fully briefed and ready for disposition. For the following reasons, the motions will be granted in part and denied in part.
This matter was recently transferred to this Court from multi-district litigation ("MDL") in the United States District Court for the Southern District of West Virginia. In re Ethicon, Inc. Pelvic Repair Systems Products Liability Litigation, No. 2:12-md-2327 (S.D. W.Va.). The MDL involves claims of harm resulting from implantation of various polypropylene-based mesh products, including tension-free vaginal tape ("TVT").
United States District Judge Joseph Goodwin presided over the MDL, which began in 2012. Numerous cases were filed directly in the Southern District of West Virginia, and many were transferred from other jurisdictions. On August 22, 2012, Judge Goodwin entered Pretrial Order 12, which included a plan for streamlining the pleading process. A 63-page First Amended Master Long Form Complaint was filed, which was described as an "administrative device to set forth potential claims individual Plaintiffs may assert against Defendants" in the litigation. (MDL Doc. No. 238). Also filed was an Amended Short Form Complaint, which served as a template for individual plaintiffs to set out their individual allegations and indicate which counts of the Master Complaint they intended to assert against one or more pelvic mesh producers. (Id., Doc. No. 263).
Plaintiff Anne Wegmann filed her Short-Form Complaint on November 10, 2014, alleging that she had been implanted with Ethicon's TVT and wished to proceed against Ethicon on all counts raised in the Master Complaint (with the exception of a claim for loss of consortium) as follows:
(Doc. No. 1).
Plaintiff's case was placed in "Wave 11" of the MDL. The MDL court entered Pretrial Order 328 on February 4, 2019, which included deadlines for completing discovery and filing dispositive and Daubert motions. (Doc. No. 14). Discovery closed in August 2019 and dispositive and Daubert motions were due shortly thereafter pursuant to the Order. The parties were instructed to file dispositive and Daubert motions (with the exception of Daubert motions regarding general causation) in the applicable member cases - not in the Ethicon MDL. In August 2019, Ethicon filed a motion for summary judgment (Doc. No. 39) and both sides filed Daubert motions (Doc. Nos. 41, 43). These motions were pending when Judge Goodwin transferred Plaintiff's case to this Court in May 2020, noting that discovery was complete and that the parties have had time to file dispositive and Daubert motions. He recommended the case be set for trial without reopening discovery, as doing so would "result in unjust delay." (Doc. No. 54).
The Court held a telephonic status conference with the parties on June 18, 2020. Thereafter, the parties submitted an agreed upon schedule for completing any remaining depositions and their available dates for trial. (Doc. No. 86). The Court entered a Case Management Order on June 25, 2018, ordering the parties to complete all remaining discovery, specifically depositions of Plaintiff's friends and/or family members, no later than January 5, 2021, and setting the case for trial on April 5, 2021. (Doc. No. 87).
On May 14, 2003, Plaintiff underwent implantation of Ethicon's TVT Retropubic Support System for treatment of stress urinary incontinence ("SUI"). The surgery was performed by Dr. Robert Feit in St. Louis, Missouri. Dr. Feit testified he was aware of the risks associated with TVT prior to performing Plaintiff's surgery in 2003, including the risks of infection (including urinary tract infections ("UTIs")) and other urinary problems such as frequency, urgency, dysuria, retention and obstruction. . He believed that despite the potential risks, TVT was the best option at the time for treating Plaintiff's SUI. (Id. at 49:11-13). Dr. Feit also testified that he continued to stand by his decision to select TVT for Plaintiff and that TVT was a safe and effective treatment. (Id. at 32:22-33:5; 48:4-7; 49:7-13). Dr. Feit had not, however, seen Plaintiff as a patient since May 2014 and had no knowledge of her current medical condition. (Id. at 44:9-12; 45:24-46:1).
Dr. Feit further testified that although he had read the warnings included in the patient brochure, he did not rely on the patient brochure or TVT Instructions for Use ("IFU") to inform himself of the risks associated with TVT. Rather, he relied on Ethicon for accurate and complete information on the risks, benefits and efficacy of the device. (Id. at 58:7-24, 59:3-9, 19-21; 60:19-23; 70:7-12). Among the types of information Dr. Feit considered important to know was (i) whether the TVT exhibited an increased risk of erosion, extrusion, and contraction (id. at 66:8-14; 76:25-77:17); (ii) whether the TVT mesh is brittle, causing particle loss (id. at 79:1-22); (iii) whether the TVT could curl and rope, increasing the potential for retention (id. at 81:23-82:13); and (iv) whether the TVT causes chronic local irritation at the wound site and a chronic foreign body response (id. at 84:15-25). In addition, Dr. Feit testified that he would have expected Ethicon to inform him of the high number of reported complications associated withSUI repairs received by the FDA between January 1, 2008 and December 31, 2010. (Id. at 63:6-23; 64:4-13; 84:2-9).
Within one year of implantation, Plaintiff began experiencing recurrent UTIs. In addition to UTIs, Plaintiff also reported she could not urinate after sexual intercourse and became bloated due to being unable to urinate. Between 2005 and 2009, Plaintiff was seen by healthcare providers on numerous occasions for follow-up regarding her recurrent UTIs and symptoms of urgency, frequency, dysuria and pain. In February 2015, Plaintiff underwent surgery to remove the TVT. The surgery was performed by Dr. Dionysios Veronikis in St. Louis, Missouri.
Plaintiff's general and case-specific expert Bruce Rosenzweig, M.D., opines, among other things, that Plaintiff's injuries were directly caused by the implantation of Ethicon's TVT Retropubic System. (Rule 26 Case Specific Expert Report of Bruce Rosenzweig, M.D. ("Rosenzweig Report), Doc. No. 45-4 at 3-4). Dr. Rosenzweig also opines that Ethicon's warnings about known risks were inadequate because Ethicon omitted information or minimized the actual risks of the TVT. (Id. at 21, 26-27).
Before addressing Ethicon's motion for summary judgment, the Court must address Ethicon's motion to exclude certain case-specific opinions and testimony of Dr. Rosenzweig. Dr. Rosenzweig is a urogynecologist who has performed over 1000 pelvic floor surgical procedures and over 350 surgeries dealing with complications related to synthetic mesh, including the removal of Ethicon Synthetic midurethral sling systems. (Id. at 2).
Dr. Rosenzweig provided a case-specific expert report in which he reviewed and outlined Plaintiff's medical history relating to the implantation of the Ethicon TVT Retropubic System device. (Id. at 5-19). He opines that Plaintiff's TVT caused her injuries, including "meshcording, a revision procedure, recurrent UTIs, vaginal pain, urge incontinence, frequency, urinary retention, nocturia, dysuria, voiding dysfunction, pelvic pressure, sexual cystitis, urethritis, urinary hesitancy, urethral stenosis, and stricture of urethral meatus." (Id. at 19).
Dr. Rosenzweig also opines that: (1) Ethicon's mesh, used in the TVT devices, is not suitable as a permanent prosthetic implant for SUI (id. at 20-21); (2) Ethicon knew the TVT was not appropriate for use but "failed to modify/change the meshes" (id.); (3) Ethicon's "warnings and disclosures of adverse events in their [IFU] for this device ha[ve] been inadequate based on the adverse reactions and risks associated with it that have been known to Ethicon ... from the time this device was first sold and marketed" (id. at 21-22); (4) that safer "alternative designs" and "reasonably feasible alternatives" existed for Plaintiff that were capable of preventing her injuries (id. at 22, 24-25); (4) Ethicon "failed to use reasonable care to provide adequate warnings" and "failed to act as reasonable and prudent medical device manufacturers by manufacturing and selling these polypropylene mesh products[;]" (id. at 4, 25); and (5) Plaintiff's implanting physician, Dr. Feit, was not able to fully consent on her behalf because surgeons rely on the IFUs and Ethicon failed to include certain information in the TVT IFU (id. at 22, 26).
Ethicon seeks to exclude certain case-specific opinions and testimony of Dr. Rosenzweig, specifically: (1) opinions that amount to opinions regarding Ethicon's state-of-mind, corporate conduct and marketing; (2)...
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