Paye v. Atrium Med. Corp.

• Decision Date: 19 January 2023
• Docket Number: Civil Action 22-10005-FDS
• Parties: JOSEPH PAYE, Plaintiff, v. ATRIUM MEDICAL CORPORATION; GETINGE AB; and MAQUET CARDIOVASCULAR U.S. SALES, LLC, Defendants.
• Court: U.S. District Court — District of Massachusetts

JOSEPH PAYE, Plaintiff,
v.
ATRIUM MEDICAL CORPORATION; GETINGE AB; and MAQUET CARDIOVASCULAR U.S. SALES, LLC, Defendants.

Civil Action No. 22-10005-FDS

United States District Court, D. Massachusetts

January 19, 2023

MEMORANDUM AND ORDER ON DEFENDANTS' MOTION TO DISMISS

F. DENNIS SAYLOR IV CHIEF JUDGE, UNITED STATES DISTRICT COURT

This is a lawsuit against three medical-device companies. Jurisdiction is based on diversity of citizenship.

Plaintiff Joseph Paye alleges that defendants Getinge AB, Atrium Medical Corporation, and Maquet Cardiovascular U.S. Sales, LLC, manufactured and marketed a polypropylene hernia repair mesh that they knew to be dangerous. He alleges that he has suffered permanent injuries from the surgical implantation of such a mesh in his groin. The complaint asserts various product-liability, contract, and tort claims against the defendants, and seeks compensatory and punitive damages.

Defendants have moved to dismiss the complaint on the ground that it fails to state a claim upon which relief can be granted. Getinge and Maquet have also moved to dismiss the claim for lack of personal jurisdiction.

For the following reasons, the motions to dismiss will be granted in part and denied in

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part.

A. Factual Background

Unless otherwise noted, the following facts are as set forth in the complaint.

Joseph Paye is a resident of Pennsylvania. (Compl. ¶ 6).

Getinge AB is a Swedish corporation with a principal place of business in Gothenburg, Sweden. Among other things, it researches, develops, tests, manufactures, produces, distributes, markets, promotes, and sells medical devices for hernia repair. (Id. ¶ 7).

Atrium Medical Corporation is a Delaware corporation with a principal place of business in New Hampshire. (Id. ¶ 8). Atrium is a wholly owned subsidiary of Getinge. (Id.).

Maquet Cardiovascular U.S. Sales, LLC is a limited liability company based in New Jersey. (Id. ¶ 9). Maquet is also a wholly owned subsidiary of Getinge. (Id.).

Getinge, Atrium, and Maquet allegedly control the development, manufacturing, sale, and marketing of ProLoop polypropylene mesh. (Id. ¶¶ 7-9). Doctors have used polypropylene mesh in hernia repair surgery since 1958. (Id. ¶¶ 14-15). ProLoop is a polypropylene mesh that is intended for repair of inguinal hernias. (Id. ¶ 25). Atrium patented the ProLoop mesh in 2004. (Id. ¶ 26).

The complaint alleges that polypropylene mesh products in general can cause serious medical complications after implantation. It cites several scientific papers that argue that polypropylene mesh is not biologically inert after implementation, leading to inflammation, foreign-body response, and scar-tissue formation. (Id. ¶¶ 16-18). It also cites scientific papers that argue that polypropylene mesh can degrade, crack, and shrink inside the human body, leading to infection, irritation, and serious chronic pain. (Id. ¶¶ 19-22).

The complaint further alleges that defendants brought ProLoop to market without obtaining clearance from the Food and Drug Administration. In 1993, Atrium received FDA

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premarket clearance for ProLite, a flat, low-profile polypropylene monofilament surgical mesh. (Id. ¶ 23). In 2004, Atrium successfully patented ProLoop, a three-dimensional surgical mesh intended to function as a plug, rather than a patch. (Id. ¶¶ 24-27). The complaint alleges that the defendants have used the FDA approval obtained for ProLite to market and distribute ProLoop, bypassing the regulatory approval process. (Id. ¶¶ 28-30).

Finally, the complaint alleges that ProLoop's design is unreasonably dangerous. It alleges that ProLoop's looped filaments, high volume of non-absorbable synthetic polypropylene, and lack of bridging filaments between mesh loops increase the risk of mesh contracture, meshoma, and inflammatory response. (Id. ¶¶ 31-33).^[1]

The complaint alleges that on June 12, 2012, Paye underwent inguinal hernia repair surgery at Sturdy Memorial Hospital in Attleboro, Massachusetts. (Id. ¶ 38). During the surgery, his doctor implanted a ProLoop mesh into his groin. (Id.). Years afterward, his hernia recurred, and he suffered from severe groin pain. (Id.). During later surgery, his doctors discovered that the mesh had contracted into a ball, migrated away from the hernia site, and had become surrounded by scar tissue. (Id. ¶ 40). His doctors were unable to remove the mesh. (Id.). The complaint alleges that the mesh has caused Paye permanent injuries, substantial pain and suffering, emotional distress, medical expenses, lost wages and earning capacity, and diminished quality of life. (Id. ¶ 46).

B. Procedural Background

On January 3, 2022, Paye filed a complaint against defendants. He filed an amended complaint on April 30, 2022. The amended complaint asserts seven claims against the

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defendants: defective design (Count 1), manufacturing defect (Count 2), failure to warn (Count 3), negligence (Count 4), breach of implied warranty (Count 5), breach of express warranty (Count 6), and negligent misrepresentation (Count 7). The amended complaint seeks compensatory and punitive damages.

Atrium has moved to dismiss the amended complaint under Fed.R.Civ.P. 12(b)(6) for failure to state a claim upon which relief can be granted.

Getinge and Maquet have moved to dismiss the amended complaint under Fed.R.Civ.P. 12(b)(2) for failure to establish personal jurisdiction and Fed.R.Civ.P. 12(b)(6) for failure to establish a claim upon which relief can be granted.

II. Personal Jurisdiction

Getinge and Maquet contend that the complaint should be dismissed under Fed.R.Civ.P. 12(b)(2) for lack of personal jurisdiction.

A plaintiff bears the burden of establishing that the court has personal jurisdiction over a defendant. See Daynard v. Ness, Motley, Loadholt, Richardson & Poole, P.A., 290 F.3d 42, 50 (1st Cir. 2002). When considering a motion to dismiss under Fed.R.Civ.P. 12(b)(2), the court may use several standards to assess whether a plaintiff has carried that burden: the “prima facie” standard, the “preponderance of the evidence” standard, or the “likelihood” standard. See id. at 50-51, 51 n.5; Foster-Miller, Inc. v. Babcock & Wilcox Canada, 46 F.3d 138, 145-46 (1st Cir. 1995). Where, as here, the court is called to make that assessment without first holding an evidentiary hearing, the prima facie standard is applied. See United States v. Swiss Am. Bank, Ltd., 274 F.3d 610, 618 (1st Cir. 2001).

Under that standard, the court takes the plaintiff's “properly documented evidentiary proffers as true and construe[s] them in the light most favorable to [the plaintiff's] jurisdictional claim.” A Corp. v. All Am. Plumbing, Inc., 812 F.3d 54, 58 (1st Cir. 2016) (citing Phillips v. Prairie Eye Ctr.,

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530 F.3d 22, 26 (1st Cir. 2008)). The plaintiff may not “rely on unsupported allegations in its pleadings.” Id. (quoting Platten v. HG Bermuda Exempted Ltd., 437 F.3d 118, 134 (1st Cir. 2006)) (internal alteration omitted). Instead, the plaintiff “must put forward ‘evidence of specific facts' to demonstrate that jurisdiction exists.” Id. (quoting Platten, 437 F.3d at 134). “[T]he plaintiff . . . may rely on jurisdictional facts documented in ‘supplemental filings (such as affidavits) [ ] contained in the record.'” Motus, LLC v. CarData Consultants, Inc., 23 F.4th 115, 123 (1st Cir. 2022) (quoting Baskin-Robbins Franchising LLC v. Alpenrose Dairy, Inc., 825 F.3d 28, 34 (1st Cir. 2016)). Facts offered by the defendant “become part of the mix only to the extent that they are uncontradicted.” Astro-Med, Inc. v. Nihon Kohden Am., Inc., 591 F.3d 1, 8 (1st Cir. 2009) (quoting Adelson v. Hananel, 510 F.3d 43, 48 (1st Cir. 2007)).

The exercise of personal jurisdiction over a defendant must be authorized by statute and consistent with the due-process requirements of the United States Constitution. See A Corp., 812 F.3d at 58 (citing Daynard, 290 F.3d at 52). Consistent with those requirements, a court may exercise either general or specific jurisdiction. See Baskin-Robbins, 825 F.3d at 35.

Specific jurisdiction exists when there is a demonstrable nexus between a plaintiff's claims and a defendant's forum-based activities. General jurisdiction exists when the litigation is not directly founded on the defendant's forum-based contacts, but the defendant has nevertheless engaged in continuous and systematic activity, unrelated to the suit, in the forum state.

Swiss Am. Bank, 274 F.3d at 618 (internal citations and quotation marks omitted).

1. General Jurisdiction

As to general jurisdiction, the complaint simply alleges that Getinge is a Swedish corporation doing business in the United States. (Compl. ¶ 7). Plaintiff does not contend that Getinge has “affiliations with [Massachusetts] . . . so ‘continuous and systematic' as to render [it] essentially at home.” Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915, 919 (2011) (quoting International Shoe Co. v. Washington, 326 U.S. 310, 317 (1945)). Nor does

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plaintiff allege that defendant's affiliations with Massachusetts are so substantial that it is “comparable to a domestic enterprise in that State.” Daimler AG v. Bauman, 571 U.S. 117, 133 n.11 (2014). Accordingly, the court may not exercise general jurisdiction over Getinge.

Maquet is a Delaware limited liability company whose single member is a New Jersey corporation. (Ex. A ¶ 4, Defs. Reply). Again, the complaint does not allege either that Maquet has continuous and systemic ties to Massachusetts or that its affiliations with Massachusetts are comparable to those of a Massachusetts enterprise. Accordingly, the court may not exercise general jurisdiction over Maquet.

Plaintiff, however, contends in broad terms that the court has general jurisdiction over defendants because they have consented to suit in Massachusetts. Neither the complaint nor plaintiff's opposition to defendants'...