White v. Ethicon Inc

CourtDistrict Court, W.D. Washington
DecidedJanuary 14, 2022
Docket2:20-cv-00952
StatusUnknown

This text of White v. Ethicon Inc (White v. Ethicon Inc) is published on Counsel Stack Legal Research, covering District Court, W.D. Washington primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
White v. Ethicon Inc, (W.D. Wash. 2022).

Opinion

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5 UNITED STATES DISTRICT COURT 6 WESTERN DISTRICT OF WASHINGTON AT TACOMA 7 LESLIE WHITE, CASE NO. C20-0952 BHS 8 Plaintiff, ORDER ON DEFENDANT’S 9 v. SUPPLEMENTAL MOTION FOR SUMMARY JUDGMENT 10 ETHICON, INC., 11 Defendant. 12

13 This matter comes before the Court on Defendant Ethicon, Inc.’s supplemental 14 motion for summary judgment. Dkt. 99. The Court has considered the briefing filed in 15 support of and in opposition to the motion and the remainder of the file and hereby rules 16 as follows. 17 I. PROCEDURAL HISTORY 18 This case originated in the MDL In re Ethicon, Inc. Products Liability Litigation, 19 MDL No. 2327, located in the Southern District of West Virginia. Dkt. 4. Plaintiff Leslie 20 White brings claims against Ethicon arising out of the surgical implantation of its product 21 TVT-Exact, a polypropylene mesh implant. Id. 22 1 Prior to the case’s transfer to this Court, Ethicon moved for partial summary 2 judgment. Dkt. 35. In June 2020, the case was transferred to this Court from the Southern 3 District of West Virginia. Dkt. 56. The parties then stipulated to dismiss with prejudice

4 nine of White’s claims and agreed that Ethicon’s motion for partial summary judgment 5 was moot. Dkt. 71. White’s unconceded claims are: Negligent Design Defect, Strict 6 Liability – Failure to Warn, Strict Liability – Design Defect, Common Law Fraud, 7 Fraudulent Concealment, Constructive Fraud, Punitive Damages, and Discovery Rule and 8 Tolling. Id. Ethicon moves for summary judgment on these remaining claims. Dkt. 99.

9 II. FACTUAL BACKGROUND 10 In February 2014, White was surgically implanted with TVT-Exact to treat her 11 stress urinary incontinence (“SUI”) in Edmonds, Washington. Dkt. 4, ¶¶ 8–11; Dkt. 114- 12 1, Deposition of Douglas Grier (“Grier Depo.”), at 7:17–20. Dr. Douglas Grier performed 13 White’s surgery to implant the device. Dkt. 4, ¶ 12.

14 Dr. Grier has been a board certified urologist since 2000 and has used over 1,500 15 TVT products to treat SUI over the past eighteen years. Grier Depo. at 16:3–9; 10:12–15. 16 Dr. Grier has also surgically removed mesh products before, commonly referred to as 17 mesh revisions, but testified that he still uses TVT products. Id. at 94:19–22; 10:16–17. 18 Prior to White’s surgery in 2014, Dr. Grier served as a lecturer or teacher to surgeons

19 regarding the use of TVT products, including the TVT-Exact. Id. at 19:7–20. Dr. Grier 20 was hired by Ethicon for these courses or seminars over a period of fourteen years. Id. at 21 79:13–25. 22 1 Dr. Grier testified that, prior to 2014, he was generally aware of the potential risks 2 and complications associated with TVT implants, including acute and chronic pain with 3 intercourse, vaginal scarring, infection, urinary problems, fistula formation,

4 neuromuscular problems, recurrence, erosion, exposure, and extrusion. See, e.g., id. at 5 32:15–33:13. But despite those risks, Dr. Grier considered the TVT-Exact to be a safe 6 and effective product and “the gold standard treatment” for SUI. Id. at 11:1–16. 7 Furthermore, Dr. Grier testified that he stands by his decision to use the TVT-Exact to 8 treat White’s SUI. See id. at 92:24–93:16.

9 The TVT-Exact product itself was accompanied by a package insert commonly 10 referred to as “Instructions for Use” (“IFU”). As explained by Dr. Grier, an IFU “is a 11 surgical description of the device and its application, but it’s not intended to be 12 comprehensive and it’s certainly not intended to discuss the indications, risks, or possible 13 complications of the procedure to the patient.” Id. at 61:8–13. Dr. Grier further testified

14 that he did not rely upon the IFU accompanying White’s TVT-Exact in deciding what 15 information to provide her prior to surgery. Id. at 61:3–6. White asserts that the TVT- 16 Exact IFU did not include all known risks and significantly downplayed the frequency or 17 severity of the risks and/or adverse reactions. Dkt. 113 at 6 (citing Dkt. 114-6 at 42–43). 18 TVT-Exact products are made with polypropylene mesh (also referred to as

19 prolene mesh), which White argues is inadequate for permanent implantation. White’s 20 case-specific expert, Dr. Bruce Rosenzweig, opines that the characteristics of 21 polypropylene mesh make it unsuitable for permanent implantation, including: 22 “(1) excessive rigidity of laser-cut mesh; (2) degradation of the mesh; (3) chronic foreign 1 body reaction; (4) infections and bio-films; (5) fibrotic bridging leading to scar plate 2 formation and mesh encapsulation; and (6) shrinkage/contraction of the encapsulated 3 mesh.” Dkt. 114-6 at 12. White further asserts that prolene mesh is not suitable for

4 permanent human implantation because the polypropylene resin used to manufacture the 5 mesh products is incompatible with strong oxizers and/or strong oxidizing agents.1 Dkt 6 113 at 6–7 (citing Dkt. 114-7 at 4, Dkt. 114-8 at 3). Rosenzweig opines that it is well 7 known to physicians with expertise in the pelvic floor that “vaginal and perivaginal 8 tissues are ready sources for peroxide,” which is a strong oxidizing agent. Dkt. 114-6 at

9 16. Dr. Grier testified that he would not use TVT implants if polypropylene was found to 10 not be suitable for human implantation. See Grier Depo. at 99:23–100:11. 11 White additionally represents that alternative, safer designs existed. Dkt. 113 at 9– 12 10. Her general expert, Scott Guelcher, opines that dermal allografts (medical products 13 that have been prepared from human cadaveric fascia and human dermis) and

14 polyvinylidene fluoride (“PVDF”) do not present the same chronic complications 15 associated with TVT mesh and were available when the TVT device was first 16 commercialized. Dkt. 114-10 at 21–23. 17 18

1 White relies upon two Material Safety Data Sheets (“MSDS”) released by Ethicon’s 20 polypropylene resin manufacturer to support this assertion. Ethicon objects, arguing that the MSDSs were issued by non-party material suppliers pursuant to Occupational Safety and Health 21 Administration regulations pertaining to the handling of raw materials. Dkt. 115 at 4; see also 29 C.F.R. § 1910.1200(b)(1). Ethicon thus argues the MSDSs are inadmissible because they have no 22 relationship to or bearing upon Ethicon’s finished medical devices. 1 White alleges that she suffered injuries because of her TVT-Exact implant and 2 thus brings claims under the Washington Products Liability Act (“WPLA”), RCW 7.72, 3 et seq., among others.

4 III. DISCUSSION 5 Ethicon moves for summary judgment on White’s remaining claims. Dkt. 99. In 6 response, White asserts that she is only pursuing her WPLA failure to warn claim, WPLA 7 design defect claim, and punitive damages and concedes the dismissal of her other 8 claims. Dkt. 113 at 2.

9 A. Summary Judgment Standard 10 Summary judgment is proper only if the pleadings, the discovery and disclosure 11 materials on file, and any affidavits show that there is no genuine issue as to any material 12 fact and that the movant is entitled to judgment as a matter of law. Fed. R. Civ. P. 56(a). 13 The moving party is entitled to judgment as a matter of law when the nonmoving party

14 fails to make a sufficient showing on an essential element of a claim in the case on which 15 the nonmoving party has the burden of proof. Celotex Corp. v. Catrett, 477 U.S. 317, 323 16 (1986).

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