McGee v. Johnson & Johnson

684 F.Supp.3d 371

Christine MCGEE, Plaintiff, v. JOHNSON & JOHNSON, Ethicon, Inc., and Mentor Worldwide LLC, Defendants.

Civil Action No. 21-639

United States District Court, W.D. Pennsylvania

Signed July 26, 2023

David Randolph Smith, Pro Hac Vice, David Randolph Smith & Associates, Nashville, TN, for Plaintiff.

Dustin B. Rawlin, Pro Hac Vice, Nelson Mullins Riley & Scarborough LLP, Cleveland, OH, Molly E. Flynn, Barnes & Thornburg LLP, Philadelphia, PA, for Defendants.

MEMORANDUM OPINION

W. Scott Hardy, United States District Judge

The above-captioned matter involves product liability claims concerning breast implants, brought pursuant to Pennsylvania law by Plaintiff Christine McGee ("Plaintiff") against Defendants Johnson & Johnson ("J&J"), Ethicon, Inc. ("Ethicon"), and Mentor Worldwide, LLC ("Mentor") (collectively, "Defendants"). Plaintiff, who received Mentor's MemoryShape Siltex textured breast implants, alleges that she suffered damages as a direct and proximate result of the negligent and wrongful conduct of Defendants in connection with such implants. (Docket No. 20, ¶ 1). Presently before the Court is the Motion to Dismiss Plaintiff's Amended Complaint for failure to state a claim upon which relief can be granted, pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure, and brief in support thereof filed by Defendants (Docket Nos. 21; 22), the brief in opposition filed by Plaintiff (Docket No. 27), and Defendants' reply (Docket No. 28). The parties have also filed several notices of supplemental authority and responses thereto (Docket Nos. 29-34; 38-41). On May 16, 2023, the Court held oral argument on the motion to dismiss, after which the parties filed post-argument memoranda and supplemental submissions. (Docket Nos. 42-44; 46-48).

For the reasons set forth herein, Defendants' motion is granted in part and denied in part.

I. BACKGROUND

As alleged in the Amended Complaint, Plaintiff is a resident of Pennsylvania, and J&J is a New Jersey corporation with its principal place of business in New Brunswick, New Jersey. (Docket No. 20, ¶¶ 6-7). J&J's corporate family structure includes a multitude of wholly owned subsidiaries and affiliated companies, including Ethicon (a New Jersey corporation with its principal place of business in Somerville, New Jersey) and Mentor (a Delaware limited liability company with its principal place of business in Santa Barbara, California, and its headquarters in Irvine, California). (Id. ¶¶ 8-11). Mentor is a manufacturer of breast implants, and it touts itself as the global leader in aesthetic medicine and the United States market leader in breast aesthetics. (Id. ¶¶ 13-14).

On or about July 3, 2013, genetic testing revealed that Plaintiff, who has a significant family history of breast cancer and ovarian cancer, tested positive for the BRACI deleterious gene mutation. (Docket No. 20, ¶ 44). On January 9, 2017, as a precaution against developing breast cancer, Plaintiff underwent a bilateral total mastectomy followed by bilateral immediate reconstruction with implantation of Mentor's MemoryShape Siltex textured breast implants (the "Siltex implants"). (Id. ¶¶ 11, 45). On May 30, 2019, Plaintiff underwent a right breast ultrasound due to acute swelling of her breast, and the radiologist's impression was that an implant had ruptured. (Id. ¶ 46). On June 4, 2019, Plaintiff underwent surgery and replacement of her Siltex implants with a similar model of implants. (Id. ¶ 47). After the surgery, results of Plaintiff's surgical pathology showed breast implant-associated anaplastic large cell lymphoma ("BIA-ALCL" or "ALCL"), a rare form of cancer, with tumor cells in the fibrinous exudate of the capsule. (Id. ¶ 48). Therefore, on July 17, 2019, Plaintiff underwent surgery again to remove the Siltex implants. (Id. ¶ 50). According to Plaintiff, she suffered tremendously from the pain of her explant surgery, symptoms of her BIA-ALCL, and recovery. (Id. ¶ 53). Prior to her development, diagnosis, and treatment of ALCL, Plaintiff enjoyed an active, full life and did not experience the symptoms that arose after the Siltex breast implants were placed in her body; but afterward, Plaintiff endured pain, swelling, and embarrassment because of her deformed chest. (Id. ¶ 54).

On May 13, 2021, Plaintiff filed her Complaint against Defendants in this matter. (Docket No. 1). On July 19, 2021, Defendants filed a motion to dismiss Plaintiff's Complaint. (Docket No. 10). On August 2, 2021, Plaintiff filed her Amended Complaint (the operative complaint here), in which she alleges that the Siltex implants that she received caused her to develop BIA-ALCL as a direct and proximate result of the negligent and wrongful conduct of Defendants' violations of the Federal Drug Administration ("FDA") laws, regulations, and requirements applicable to manufacturing, warnings, and post-marketing requirements. (Docket No. 20, ¶¶ 1, 2).

According to the Amended Complaint, the Siltex implants that Plaintiff received have a textured surface, and "[s]ometimes, in contravention with its federal requirements, the peeling away of the polyurethane foam stamp leaves residual polyurethane debris on the surface of the Siltex implants and causes pores and larger than intended cavities." (Docket No. 20, ¶ 243 (emphasis in original)). Plaintiff alleges that this debris that remains on the implants, which is recognized as a foreign body and triggers a T-cell lymphoma, is not part of the FDA-approved design for the MemoryShape Siltex implants. (Id. ¶¶ 244, 246). Plaintiff further avers that Defendants failed to comply with various FDA post-approval reporting requirements. (Id. ¶¶ 3, 302). Plaintiff alleges that Defendants were aware of complaints about BIA-ALCL related to their Siltex implants, but they took no action, did not properly report adverse events, and allowed the nonconforming product to continue to be released into the stream of commerce. (Id. ¶¶ 38, 51, 85, 89, 96, 164, 168-69).

Plaintiff's Amended Complaint alleges four separate Counts against all Defendants under Pennsylvania law: (1) Strict Liability for Manufacturing Defect; (2) Breach of Implied Warranties; (3) Strict Liability for Failure to Warn; and (4) Negligence. (Docket No. 20, ¶¶ 241-306). Defendants have filed their motion to dismiss Plaintiff's Amended Complaint for failure to state a claim upon which relief can be granted pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure. Defendants' motion has been fully briefed, oral argument has been held, and the motion is ripe for decision.

II. STANDARD OF REVIEW

In considering a Rule 12(b)(6) motion to dismiss, the factual allegations contained in the complaint must be accepted as true and must be construed in the light most favorable to the plaintiff, and the court must " 'determine whether, under any reasonable reading of the complaint, the plaintiff may be entitled to relief.' " Phillips v. County of Allegheny, 515 F.3d 224, 231 (3d Cir. 2008) (quoting Pinker v. Roche Holdings Ltd., 292 F.3d 361, 374 n.7 (3d Cir. 2002)); see Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 563 n.8, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). While Federal Rule of Civil Procedure 8(a)(2) requires only "a short and plain statement of the claim showing that the pleader is entitled to relief," the complaint must " 'give the defendant fair notice of what the . . . claim is and the grounds upon which it rests.' " Phillips, 515 F.3d at 231 (quoting Twombly, 550 U.S. at 555, 127 S.Ct. 1955 (internal citation omitted)). Moreover, while "this standard does not require 'detailed factual allegations,' " Rule 8 "demands more than an unadorned, the-defendant-unlawfully-harmed-me accusation." Id. (quoting Twombly, 550 U.S. at 555, 127 S.Ct. 1955); Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (citing Twombly, 550 U.S. at 555, 127 S.Ct. 1955).

It should be further noted, therefore, that in order to survive a motion to dismiss, "a complaint must contain sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face.' " Iqbal, 556 U.S. at 678, 129 S.Ct. 1937 (quoting Twombly, 550 U.S. at 570, 127 S.Ct. 1955). The Supreme Court has noted that 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." Id. (citing Twombly, 550 U.S. at 556, 127 S.Ct. 1955). The standard " 'does not impose a probability requirement at the pleading stage,' but instead 'simply calls for enough facts to raise a reasonable expectation that discovery will reveal evidence of' the necessary element." Phillips, 515 F.3d at 234 (quoting Twombly, 550 U.S. at 556, 127 S.Ct. 1955). Moreover, the requirement that a court accept as true all factual allegations does not extend to legal conclusions; thus, a court is " 'not bound to accept as true a legal conclusion couched as a factual allegation.' " Iqbal, 556 U.S. at 678, 129 S.Ct. 1937 (quoting Twombly, 550 U.S. at 555, 127 S.Ct. 1955 (internal citation omitted)).

III. LEGAL ANALYSIS

In support of their motion to dismiss Plaintiff's Amended Complaint pursuant to Rule 12(b)(6), Defendants argue: that all of Plaintiff's claims, which involve a "Class III PMA medical device," are expressly preempted pursuant to the Supreme Court's decision in Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008); that such claims are impliedly preempted by federal law; and that none of the claims constitute a viable "parallel" claim that fits through the "narrow gap" between express and implied preemption. Defendants also argue that Plaintiff's claims do not satisfy applicable pleading requirements as to all three Defendants because the Amended Complaint "lumps" Defendants together and does not distinguish among their purported acts and omissions. While Plaintiff opposes Defendants' motion, in the...