DANDY v. Ethicon Women's Heatlh & Urology
| Decision Date | 29 April 2022 |
| Docket Number | Civ. Action 20-00431 (FLW) |
| Court | U.S. District Court — District of New Jersey |
| Parties | REBECCA DANDY, Plaintiff, v. ETHICON WOMEN'S HEALTH AND UROLOGY, a Division of ETHICON, INC., GYNECARE, a Division of ETHICON, INC., ETHICON, INC., and JOHNSON & JOHNSON, Defendants. |
NOT FOR PUBLICATION
This matter concerns product liability claims plaintiff Rebecca Dandy (“Plaintiff”) brought in response to injuries she allegedly sustained from a pelvic mesh product manufactured by defendants Ethicon, Inc. and its division Ethicon Women's Health and Urology (“Defendants” or “Ethicon”). Plaintiff asserts claims for design defect, manufacturing defect, and failure to warn. Defendants filed a motion to exclude testimony from Plaintiff's case-specific expert pursuant to Rule 702 of the Federal Rules of Evidence and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), concerning certain alternative product designs that are allegedly safer than the product Plaintiff received (“Daubert Motion”). Defendants also filed a Motion for Summary Judgment on each of Plaintiff's claims. Defendants move for summary judgment on the design defect claim based only on Plaintiff's purported failure to propose a safer alternative design which Plaintiff must establish to state a claim for design defect, and they move for summary judgment on the failure to warn claim based only on Plaintiff's purported failure to establish proximate causation. Plaintiff opposes both motions, except she does not oppose summary judgment on her manufacturing defect claim.[1]
For the reasons set forth herein, Defendants' Daubert Motion is GRANTED in part and DENIED in part, and their Motion for Summary Judgment is GRANTED in part and DENIED in part. The Motion for Summary Judgment is granted with respect to the manufacturing defect and failure-to-warn claims, and it is denied with respect to the design defect claim.
In accordance with L. Civ. R. 56.1(a), Defendants filed a Statement of Material Facts with their Motion for Summary Judgment, and Plaintiff filed both a Response to Defendants' Statement of Material Facts ( ) and a Statement of Additional Material Facts (“Pl. Supp. SOMF”) with her Opposition brief, ECF No. 86-3. Defendants filed a Response to Plaintiff's Statement of Additional Material Facts. ECF No. 89 ( ). The following factual and procedural background reflects the undisputed facts from the parties' submissions that are relevant and material to the present motions.
Ethicon manufactures the Tension-free Vaginal Tape-Obturator (“TVT-O) sling, a polypropylene mesh product that is surgically implanted in the pelvic region to treat stress urinary incontinence (“SUI”). SUI “is the involuntary leakage of urine during moments of physical activity that increases abdominal pressure.” See ECF No. 85-3 Ex. H, Rule 26 Expert Report of Bruce Rosenzweig M.D. at 4, In re Ethicon, Inc. Pelvic Repair Sys. Prods. Liability Litigation, Civ. No. 12-02327, MDL No. 2327 (“Rosenzweig Gen. TVT-O Rep.”); Stress Urinary Incontinence, Food & Drug Admin. (Apr. 16, 2019), https://www.fda.gov/medical-devices/urogynecologic-surgical-mesh-implants/stress-urinary-incontinence-sui (last visited April 18, 2022). On March 7, 2011, Dr. William E. Nowak implanted a TVT-O sling in Plaintiff's pelvic region to treat her SUI at Munson Medical Center in Traverse City, Michigan. Def. SOMF ¶ 3; Pl. Supp. SOMF ¶ 1. Plaintiff was a resident of Michigan at that time and has remained a resident of Michigan since her surgery.
For several years following her TVT-O implantation surgery, Plaintiff periodically notified healthcare professionals that she was experiencing groin and lower abdominal pain, vaginal discharge, and pain during sexual intercourse (dyspareunia), among other symptoms. See ECF No. 70-2 Ex. A, Case Specific Expert Report of Bruce Rosenzweig, M.D. (“Rosenzweig Rep.”) at 2534. In a report Plaintiff produced during discovery, her case-specific expert, Dr. Bruce Rosenzweig, [2] opines that Plaintiff sustained injuries following her surgery that include “pelvic pain, hip pain, pelvic floor muscle spasm, vaginal pain, dyspareunia, recurrent [urinary tract infections], voiding dysfunction, [and] mixed [urinary infection].” Rosenzweig Rep. at 49. Dr. Rosenzweig opines that polypropylene mesh can lead to the injuries Plaintiff incurred through mechanisms such as mesh “degradation” and “chronic foreign body reaction.” See, e.g., id.; Rosenzweig Gen. TVT-O Rep. at 19; Pl. Supp. SOMF ¶¶ 3-6. Dr. Rosenzweig also opines that heavier, smaller-pore mesh-a characterization he applies to the Prolene mesh used in a TVT-O sling-may cause similar complications because the pores do not allow sufficient room for tissue to regrow properly. See Rosenzweig Gen. TVT-O Rep. at 27-32;[3] Rosenzweig Rep. 50. Defendants dispute Dr. Rosenzweig's opinions on both points. See Def. Resp. SOMF at 6-15.[4]
In 2019, Plaintiff was also diagnosed with pudendal neuralgia, which occurs when the pudendal nerve-a major nerve that runs from the back of the pelvis to the base of the vagina- becomes injured or irritated. See Pudendal Neuralgia, Nat'l Insts. of Health (Jan. 17, 2017), https://rarediseases.info.nih.gov/diseases/10713/pudendal-neuralgia/ (last visited Apr. 18, 2022); Rosenzweig Rep. at 33, 36, 49. In his report, Dr. Rosenzweig explains that surgeons implant the TVT-O sling using a transobturator procedure, in which the sling must “run through the obturator internus muscle as it passes into the groin.” See Rosenzweig Rep. at 10. According to Dr. Rosenzweig, running the sling through the obturator muscle can cause obturator internus muscle spasm and entrapment of the pudendal nerve, which can lead to pudendal neuralgia. See id. at 1011.
Following advice from another healthcare professional, on March 4, 2020, Plaintiff underwent surgery to remove the TVT-O mesh sling. Rosenzweig Rep. at 33-34. After the mesh removal surgery, Plaintiff's pain subsided moderately, but her SUI worsened. See id. at 35-38.
On June 6, 2019, before undergoing mesh removal surgery, Plaintiff filed a Complaint in the U.S. District Court for the Eastern District of Pennsylvania, asserting sixteen counts pertaining to the TVT-O sling she received in 2011. ECF No. 1. Defendants filed a Motion to Dismiss for lack of personal jurisdiction or, in the alternative, a transfer in venue to the U.S. District Court for the Western District of Michigan or the Eastern District of Michigan. ECF No. 3. The court denied Defendants' motion as moot and transferred the case to this Court pursuant to 28 U.S.C. § 1406(a). ECF No. 10. Defendants filed a Motion to Dismiss certain counts of the Complaint, but before the Court ruled on Defendants' motion, the parties entered into a stipulation under which Defendants withdrew their Motion to Dismiss, and the Court issued a Consent Order setting a deadline for Plaintiff to file an amended complaint, ECF No. 22, which was filed on February 27, 2020. ECF No. 25.
The Amended Complaint asserts one count alleging that Defendants were negligent in designing, manufacturing, labeling, marketing, selling, and distributing the TVT-O sling she received in 2011, without specifying whether Plaintiff asserts the claim under a particular state's products liability statute or the common law. See id. at 9. Ethicon and J&J filed separate Answers to the Amended Complaint. ECF Nos. 27, 28. During discovery, Plaintiff disclosed Dr. Rosenzweig as a case-specific expert and produced Dr. Rosenzweig's report. Defendants filed a Daubert Motion seeking to exclude Dr. Rosenzweig's opinions concerning certain safer alternative designs compared to the TVT-O, ECF No. 70, which, for reasons discussed infra, Plaintiff must prove to establish a design defect as part of her negligence claim. See ECF No. 71. The same day, Defendants filed a Motion for Summary Judgment pursuant to Rule 56 of the Federal Rules of Civil Procedure. ECF No. 72. Plaintiff timely filed her opposition to the Daubert Motion and the Motion for Summary Judgment, ECF Nos. 85, 86, and Defendants filed their replies, ECF Nos. 88, 80.
Defendants' motions require the Court to first determine the applicable substantive law. “[I]n a diversity action, a district court must apply the choice of law rules of the forum state to determine what law will govern the substantive issues of a case.” Warriner v. Stanton, 475 F.3d 497, 499-500 (3d Cir. 2007). Because New Jersey is the forum state, New Jersey's choice-of-law rules apply. See Noye v. Johnson & Johnson Servs., Inc., 765 Fed.Appx. 742, 745 (3d Cir. 2019).
New Jersey's choice of law rules follow the Restatement (Second) of the Conflict of Laws. See P. V. v. Camp Jaycee, 197 N.J. 132, 142-43 (2008). “[T]he first step is to determine whether an actual conflict exists.” Id. at 143. An “actual conflict” exists when choosing between two states' laws would be “outcome determinative.” McCarrell v. Hoffmann-La Roche Inc., 227 N.J. 569 584 (2017) (citing Rowe v. Hoffmann-La Roche, Inc., 189 N.J. 615, 621 (2007)) (“[A] true conflict of law arises when choosing between one or another state's statute of limitations is outcome determinative.”); Camp Jaycee, 197 N.J. at 143-44 (). The court must determine whether a conflict exists “on an issue-by-issue basis.” Rowe, 189 N.J. at 621 (quotations and citations omitted). “If there is no actual conflict, then the choice-of-law question...
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