BOND v. JOHNSON & JOHNSON

CourtDistrict Court, D. New Jersey
DecidedDecember 21, 2021
Docket3:21-cv-05327
StatusUnknown

This text of BOND v. JOHNSON & JOHNSON (BOND v. JOHNSON & JOHNSON) is published on Counsel Stack Legal Research, covering District Court, D. New Jersey primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
BOND v. JOHNSON & JOHNSON, (D.N.J. 2021).

Opinion

*NOT FOR PUBLICATION*

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY

MICHAEL BOND,

Plaintiff,

Civ. Action No. 21- 05327 (FLW) v. Civ. Action No. 21- 05333 (FLW)

JOHNSON & JOHNSON and OPINION ETHICON, INC.;

Defendants.

KENNETH ROSEBUSH,

v.

JOHNSON & JOHNSON and ETHICON, INC.;

WOLFSON, Chief Judge: Before the Court are two separate motions (the “Motions”) filed by defendants Johnson & Johnson (“J&J”) and Ethicon, Inc. (“Ethicon”) (collectively, “Defendants”) to dismiss each of the Complaints initiated by plaintiffs Michael Bond and Kenneth Rosebush (collectively, “Plaintiffs”) in the respective matters captioned above. Both Plaintiffs allege that they sustained injuries resulting from the surgical implantation of one of Defendants’ mesh hernia repair products. Plaintiffs assert strict products liability claims pursuant to the New Jersey Products Liability Act (“NJPLA”), N.J.S.A. 2A:58C-1, et seq., for defective design (Count One), failure to warn (Count Two), and manufacturing defect (Count Three). In the alternative, Plaintiffs submit that, “[t]o the extent the Court chooses to apply the law of a state other than New Jersey,” they would assert claims under the law of the state where they underwent their respective surgeries: for Bond, North Carolina; and for Rosebush, Michigan. Plaintiffs assert claims for negligence (Count Four), design defect (Count Five), failure to warn (Count Six), manufacturing defect (Count Seven), breach of implied warranty (Count Eight), breach of express warranty (Count Nine), and punitive damages (Count Ten). Because both

cases involve the same product and similar factual circumstances, I address both Motions in this Opinion. Plaintiffs oppose the Motions. For the reasons set forth herein, Defendants’ Motions are GRANTED. With respect to Rosebush, Counts One, Two, Three, Five, Six, Seven and Ten are dismissed with prejudice; however, Count Four, which alleges claims under Michigan law for design defect, manufacturing defect, and failure to warn, is dismissed without prejudice, and Rosebush is given leave to amend his Complaint, within twenty-one (21) days from the date of the accompanying order, in accordance with this Opinion; and Counts Eight and Nine of Rosebush’s Complaint are also dismissed without prejudice. With respect to Bond, all counts are dismissed with prejudice. I. BACKGROUND AND PROCEDURAL HISTORY

The relevant facts are derived from Plaintiffs’ Complaints and assumed as true for the purposes of these Motions. Defendants J&J and Ethicon, a wholly owned subsidiary of J&J, are incorporated, and maintain their principal places of business, in New Jersey. Bond and Rosebush Complaints (“Compls.”). ¶6. Ethicon manufactures a mesh medical device, named the Prolene 3D Patch (“Prolene 3D”), which is used in hernia repair surgeries. Compls. ¶¶1–2, 20. Mesh patches, such as the Prolene 3D, are intended to “to provide additional support to weakened or damaged tissue” caused by a hernia.1 According to Plaintiffs, the Prolene 3D has two features that are relevant to this litigation. First, the Prolene 3D utilizes the “Ethicon Multi-Layered Hernia Mesh,” “which incorporates two distinct layers of polypropylene.” Compls. ¶¶2, 26. The first layer is a “flat mesh,” whereas the second is an “expandable diamond-shaped mesh patch,” and the two layers “are connected together by a single central polypropylene suture.” Id. ¶26. Second, according to Plaintiffs, “[t]he diamond-

shaped mesh patch portion of the Prolene 3D is a type of mesh ‘plug.’” Id. ¶27. Plaintiffs allege that “Defendants never performed any clinical trials and/or studies before marketing Ethicon Multi- Layered Hernia Mesh, including the Prolene 3D,” and that they “did not fully and/or adequately test these new, multi-layered hernia mesh devices.” Id. ¶¶37–38.2 Plaintiffs allege that the design of the Prolene 3D is defective. First, Plaintiffs claim that the “plug” design used in the Prolene 3D conflicts with guidance published in the International Guidelines for Groin Hernia Management (“International Guidelines”) Id. ¶28.3 According to the

1 Hernia Surgical Mesh Implants, U.S. Food and Drug Admin. (Feb. 4, 2018), https://www.fda.gov/medical-devices/implants-and-prosthetics/hernia-surgical-mesh-implants (last visited Dec. 3, 2021). While Plaintiffs do not provide any explanation in their Complaints as to the intended function of mesh surgical patches used in hernia repair procedures, the Court takes judicial notice of this fact. See Sparks v. Medtronic, Inc., Civ. No. 19-16853, 2021 WL 2649235, at *2 (M.D. Fla. June 28, 2021) (citing, e.g., Funk v. Stryker Corp., 631 F.3d 777, 783 (5th Cir. 2011)) (taking judicial notice in hernia mesh products liability suit of information from the same FDA publication). 2 Plaintiffs make clear in their Opposition briefs that the Prolene 3D entered the market pursuant to Section 510(k) of the Food, Drug and Cosmetic Act, as a device that is “substantially equivalent” to a device that the FDA had already approved. See Plaintiff Michael Bond’s Response in Opposition and Supporting Memorandum to Defendants’ R. 12(b)(6) Motion to Dismiss (“Bond Opp.”), ECF No. 12 at 29; Plaintiff Kenneth Rosebush’s Response in Opposition and Supporting Memorandum to Defendants’ R. 12(b)(6) Motion to Dismiss (“Rosebush Opp.”), ECF No. 12 at 25. 3 Plaintiffs maintain that the “Guidelines were endorsed by the European Hernia Society, Americas Hernia Society, Asia Pacific Hernia Society, Afro Middle East Hernia Society, Australasian Hernia Society, International Endo Hernia Society, and European Associated for Endoscopic Surgery and Other Interventional Techniques.” Compls. ¶28. International Guidelines, “[t]he incidence of erosion seems higher with plug versus flat mesh. It is suggested not to use plug repair techniques.” Id. ¶28. Second, Plaintiffs allege that the “multiple layers of Ethicon Multi-Layered Hernia Mesh increase the intensity and duration of the inflammatory response in Defendants’ hernia repair devices,” including the Prolene 3D. Id. ¶36. “That response,” Plaintiffs explain, “increases dense adhesion formation from underlying structures and organs to the product, resulting in mesh contracture, mesh deformation, chronic pain, foreign body sensation, foreign body reaction, organ and tissue damage, hernia recurrence, and more.” Id. ¶36.4 Finally,

Plaintiffs allege that the “polypropylene mesh material” used in the Prolene 3D “is unreasonably susceptible to in vivo oxidative degradation,” which allegedly “causes or exacerbates excessive inflammation and adverse foreign body reaction, leading to shrinkage, scarification, pain, and mesh deformation.” Id. ¶31.5 Plaintiffs further allege that “feasible, alternative safer designs were known and available” to Defendants. Id. ¶47. Those alternatives include “a flat, non-coated, single-layer, lightweight, large-pore mesh, or a fully resorbable mesh.” Id. On March 17, 2009, Plaintiff Bond, a resident of North Carolina, underwent surgery to repair a “bilateral inguinal hernia” at a hospital in Raleigh, North Carolina. Bond Compl. ¶¶6, 20. During the surgery, Bond’s surgeon implanted the Prolene 3D in Bond’s groin. Id. More than ten years later,

on April 26, 2019, Bond underwent another round of surgery to repair a “left inguinal hernia” and remove mesh from the site of his 2009 surgery. Id. ¶21. Bond’s 2019 surgery also took place in Raleigh, North Carolina. Id. During the 2019 surgery, Bond’s surgeon “noticed that [Bond] had a

4 As Plaintiffs allege, the “two connecting layers of polypropylene [are] intended to occupy two inguinal compartments once implanted, which greatly increases inflammation, adhesions, and mesh deformation.” Compls. ¶46.

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