Bond v. Johnson & Johnson

• Decision Date: 21 December 2021
• Docket Number: 21- 05333 (FLW)],Civ. Action 21- 05327 (FLW)
• Court: U.S. District Court — District of New Jersey
• Parties: MICHAEL BOND, Plaintiff, v. JOHNSON & JOHNSON and ETHICON, INC.; Defendants. KENNETH ROSEBUSH, Plaintiff, v. JOHNSON & JOHNSON and ETHICON, INC.; Defendants.

MICHAEL BOND, Plaintiff,
v.
JOHNSON & JOHNSON and ETHICON, INC.; Defendants.

KENNETH ROSEBUSH, Plaintiff,
v.
JOHNSON & JOHNSON and ETHICON, INC.; Defendants.

Civ. Action Nos. 21- 05327 (FLW), 21- 05333 (FLW)]

United States District Court, D. New Jersey

December 21, 2021

NOT FOR PUBLICATION

OPINION

Hon. Freda L. Wolfson U.S. Chief District 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

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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

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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

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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

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‘scarred and balled up' mesh in the direct space, ” id., which presumably refers to the site of Bond's previous hernia, although Plaintiff does not elaborate. Bond's surgeon was required to “‘tediously dissect[]'” the “‘balled up' mesh . . . from the inferior epigastric vessels and spermatic cord structure.” Id. The surgeon then repaired Bond's hernia using another mesh device. Id. ¶22.

On August 11, 2009, Plaintiff Rosebush, a resident of Michigan, underwent surgery at a hospital in Flint, Michigan, to repair an “umbilical hernia.” Rosebush Compl. ¶¶6, 20. The surgeon implanted a Prolene 3D in Rosebush's abdomen to repair the hernia. Id. Almost ten years later, on January 18, 2019, Rosebush underwent another round of surgery, also in Michigan, to remove mesh from the site of his previous surgery. Id. ¶21. During his 2019 surgery, Rosebush's surgeon discovered “dense adhesions [a]round the umbilical mesh” that was “previously placed” in Rosebush's abdomen during his 2009 surgery. Id. Rosebush alleges that a “portion of the small bowel was resected with [sic] portion of the mesh and removed.” Id.

On March 16, 2021, Plaintiffs filed complaints in this Court asserting various causes of action pertaining to alleged injuries they suffered from the Prolene 3D. Both Plaintiffs assert strict products liability claims pursuant to N.J.S.A. 2A:58C-1, et seq., for defective design (Count One), failure to warn (Count Two), and manufacturing defect (Count Three). Both Plaintiffs also, respectively, assert common law claims under the laws of Michigan and North Carolina for negligence (Count Four), strict liability design defect (Count Five), strictly liability failure to warn (Count Six), strict liability manufacturing defect (Count Seven), breach of implied warranty (Count Eight), and breach of express warranty (Count Nine). Plaintiffs also assert claims for punitive damages (Count Ten). Defendants moved to dismiss both Plaintiffs' Complaints, on all counts, pursuant to Rule 12(b)(6) on May 20, 2021. See Motion to Dismiss Bond's Complaint (“Bond Mtn.”), ECF No. 10; Motion to Dismiss Rosebush's Complaint (“Rosebush Mtn.”), ECF No. 10. Plaintiffs opposed the motions on June 22, 2021. Bond Opp., ECF No. 12; Rosebush Opp., ECF No. 12. Defendants filed their Reply

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Briefs on June 29, 2021. Reply Brief in Support of Defendants' Motion to Dismiss (“Bond Reply”), ECF No. 13; Reply Brief in Support of Defendants' Motion to Dismiss (“Rosebush Reply”), ECF No. 13.

II. LEGAL STANDARD

In reviewing a motion to dismiss for failure to state a claim upon which relief can be granted, pursuant to Rule 12(b)(6), “courts accept all factual allegations as true, construe the complaint in the light most favorable to the plaintiff, and determine whether, under any reasonable reading of the complaint, the plaintiff may be entitled to relief.” Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir. 2009) (internal quotation marks and citation omitted). While Federal Rule of Civil Procedure 8(a)6 does not require that a complaint contain detailed factual allegations, “a plaintiff's obligation to provide the ‘grounds' of his ‘entitle[ment] to relief' requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (citation omitted). Thus, to survive a Rule 12(b)(6) motion to dismiss, the complaint must contain sufficient factual allegations to raise a plaintiff's right to relief above the speculative level, so that a claim “is plausible on its face.” Id. at 570; Phillips v. Cty. of Allegheny, 515 F.3d 224, 231 (3d Cir. 2008). “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009).

To determine...