Mills v. Ethicon, Inc.

• Decision Date: 27 August 2019
• Docket Number: Civ. No. 17-12624-KM-MF
• Citation: 406 F.Supp.3d 363
• Court: U.S. District Court — District of New Jersey
• Parties: Latiese MILLS, Plaintiff, v. ETHICON, INC.; Johnson & Johnson; C.R. Bard Inc.; Davol, Inc.; Atrium Medical Corp.; Maquet Cardiovascular, LLC; Getinge AB; Covidien, Inc.; Covidien LLC ; Covidien PLC; Covidien AG; Sofradim Productions; and John Doe Corporations 1-100, inclusive, Defendants.

406 F.Supp.3d 363

Latiese MILLS, Plaintiff,

v.ETHICON, INC.; Johnson & Johnson; C.R. Bard Inc.; Davol, Inc.; Atrium Medical Corp.; Maquet Cardiovascular, LLC; Getinge AB; Covidien, Inc.; Covidien LLC ; Covidien PLC; Covidien AG; Sofradim Productions; and John Doe Corporations 1-100, inclusive, Defendants.

Civ. No. 17-12624-KM-MF

United States District Court, D. New Jersey.

Signed August 27, 2019

Nicholas Rocco Farnolo, Napoli Shkolnik, Melville, NY, Peter Samberg, Weitz & Luxenberg, Cherry Hill, NJ, for Plaintiff.

Lincoln Davis Wilson, Dechert LLP, New York, NY, Naim S. Surgeon, Akerman LLP, Miami, FL, for Defendants.

KEVIN MCNULTY, U.S.D.J.:

Before the Court are two motions to dismiss the complaint: one filed by defendants Atrium Medical Corporation ("AMC") and Maquet Cardiovascular, LLC ("Maquet") (DE 25), and the other filed by Getinge AB, a Swedish corporation. (DE 26).

In March of 2013, the plaintiff, Latiese Mills, who is a citizen of Pennsylvania, underwent an abdominal hernia

repair surgery, and was implanted with a hernia mesh device. In November of 2015, she went to the hospital to repair a recurrent ventral hernia. During that procedure, it was revealed that Mills "had developed a seroma" and that the mesh implant device had "adhered to her bowels," resulting in significant injuries. Mills's six-count complaint alleges various products liability claims related to the hernia mesh device.

AMC and Maquet seek dismissal of the complaint pursuant to Federal Rule 12(b)(6) on the grounds that the complaint fails to meet pleading standards for statement of a claim. They also contend that Pennsylvania law applies to the complaint, and that Pennsylvania law does not recognize strict liability or warranty claims in medical device products liability cases.

Getinge AB, the Swedish corporate parent of AMC and Maquet, joins in AMC and Maquet's motion. Getinge AB also contends that service was defective and that it is not subject to personal jurisdiction in New Jersey. Specifically, it objects that Mills mailed a copy of the complaint and summons to Maquet, Getinge AB's domestic subsidiary, and did not translate the complaint into Swedish as required by the Hague Convention.

For the reasons provided below, the following claims are dismissed with prejudice as to all defendants because they are invalid as a matter of law: strict liability for defective design (second count); strict liability for failure to warn (third count); breach of the implied warranty of fitness for a particular purpose (fifth count); and breach of the warranty of merchantability (sixth count). The remaining counts, negligence and breach of an express warranty, are dismissed without prejudice for failure to state a claim.

I also conclude that service on Getinge AB by mailing a copy of the summons and complaint to Maquet (Getinge AB's in-state subsidiary) was deficient. Accordingly, dismissal of the complaint as to Getinge AB is warranted for this additional reason. This dismissal is without prejudice.

I. Factual Background¹

In March of 2013, Mills underwent an abdominal hernia

repair surgery at Pennsylvania Hospital in Philadelphia and was implanted with "a hernia mesh device." (Compl ¶36). The hernia mesh is a "medical device" that is made out of polypropylene and is marketed "by Defendants as mesh used in repairing hernias and chest wall defects." (Compl ¶¶44-46). Hernia meshes are designed and are used for permanent implantation in the human body. (Compl ¶48).

In November of 2015, Mills was admitted to the hospital for repair of a recurrent ventral hernia

. At that time, "it was revealed that she had developed a seroma, and that the mesh had adhered to her bowels." (Compl ¶37). Mills claims that had the hernia mesh device "not failed, she would not have suffered a recurrence of her hernia, adhesions and seroma." (Compl ¶38).

Mills alleges that the hernia

mesh device "was designed and is manufactured and distributed by the Defendants, who own the patent on the device that was inserted into Plaintiff's body." (Compl ¶41). Mills claims that "a substantial body of scientific evidence" shows that the polypropylene mesh "is biologically incompatible with human tissue and promotes an immune response" in a "large subset of the population receiving these products." (Compl ¶46). That immune response degrades the mesh, as well as the surrounding tissue, and can contribute to the "severe adverse reactions to the mesh." (Compl ¶46).

Mills further claims that the suppliers of the polypropylene "cautioned all users in their United States Material Safety Data Sheet" that polypropylene "was not to be used for medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues." (Compl ¶49). Mills asserts that the polypropylene mesh is not suited for implantation into the human body "due to its small pore size and weave, high volume of material used, selection of polypropylene resin, and other design features." (Compl ¶52).

Mills claims that the "Defendants failed to warn or notify doctors, regulatory agencies, and consumers of the severe and life-threatening risks associated with polypropylene." Indeed, she says, they marketed the hernia

mesh device to the medical community and patients "as safe, effective" and reliable. (Compl ¶¶50, 64). She also claims that "Defendants paid doctors, surgeons, physicians and/or clinicians to promote the hernia mesh device." (Compl ¶61).

Mills asserts that "Defendants failed to comply with the FDA application and reporting requirements" and that "defendants" misrepresented "and/or falsified pre-clinical and/or clinical studies to bolster the perceived performance of the hernia

mesh device." (Compl ¶¶56, 60). She further claims that the mesh is "unreasonably dangerous, defective, and negligently designed" in a number of ways.² (Compl ¶54). A malfunction of the mesh "can lead to nerve entrapment and damage, fistulae formation, and chronic pain." (Compl ¶55).

On November 30, 2017, Mills filed a complaint in New Jersey state court, alleging the following claims: (1) negligence; (2) strict products liability – defective design; (3) strict products liability – failure to warn; (4) breach of an express warranty; (5) breach of an implied warranty for a particular purpose; and (6) breach of an implied warranty of merchantability. On December 5, 2017, the Covidien defendants³ removed the action to this Court, based on complete diversity. (DE 1).

On December 15, 2017, Mills voluntarily dismissed the following defendants: Ethicon Inc; Johnson & Johnson; C.R. Bard Inc.; Davol Inc.; Covidien, Inc.; Covidien LLC; Covidien PLC; Covidien AG; Sofradim Production; and John Doe Corporations 1-100. (DE 2).

Before the Court are two motions to dismiss the complaint filed by the remaining defendants: (1) AMC and Maquet (DE 25); and (2) Getinge AB (DE 26).

II. Standard

Federal Rule of Civil Procedure 8(a) does not require that a complaint contain detailed factual allegations. Nevertheless, "a plaintiff's obligation to provide the ‘grounds’ of his ‘entitlement 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, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) ; See Phillips v. Cnty. of Allegheny , 515 F.3d 224, 232 (3d Cir. 2008) ( Rule 8 "requires a ‘showing’ rather than a blanket assertion of an entitlement to relief." (citation omitted)). Thus, the complaint's factual allegations must be sufficient to raise a plaintiff's right to relief above a speculative level, so that a claim is "plausible on its face." Twombly , 550 U.S. at 570, 127 S.Ct. 1955 ; see also West Run Student Hous. Assocs., LLC v. Huntington Nat. Bank , 712 F.3d 165, 169 (3d Cir. 2013). That facial-plausibility standard is met "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, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (citing Twombly , 550 U.S. at 556, 127 S.Ct. 1955 ). While "[t]he plausibility standard is not akin to a ‘probability requirement’ ... it asks for more than a sheer possibility." Id.

Rule 12(b)(6) provides for the dismissal of a complaint if it fails to state a claim upon which relief can be granted. The defendant, as the moving party, bears the burden of showing that no claim has been stated. Animal Science Products, Inc. v. China Minmetals Corp. , 654 F.3d 462, 469 n.9 (3d Cir. 2011). For the purposes of a motion to dismiss, the facts alleged in the complaint are accepted as true and all reasonable inferences are drawn in favor of the plaintiff. New Jersey Carpenters & the Trustees Thereof v. Tishman Const. Corp. of New Jersey , 760 F.3d 297, 302 (3d Cir. 2014).

When deciding a motion to dismiss, a court typically does not consider matters outside the pleadings. However, a court may consider documents that are "integral to or explicitly relied upon in the complaint" or any "undisputedly authentic document that a defendant attaches as an exhibit to a motion to dismiss if the plaintiff's claims are based on the document." In re Rockefeller Ctr. Props., Inc. Sec. Litig. , 184 F.3d 280, 287 (3d Cir. 1999) (emphasis and citations omitted); see In re Asbestos Prods. Liab. Litig. (No. VI) , 822 F.3d 125, 133 n.7 (3d Cir. 2016) ; Schmidt v. Skolas , 770 F.3d 241, 249 (3d Cir. 2014) (on motion to dismiss, court may consider, inter alia , "exhibits attached to the complaint"); Arcand v. Brother Int'l Corp. , 673 F. Supp. 2d 282, 292 (D.N.J. 2009) (court may consider documents referenced in complaint that are essential to plaintiff's claim).

Reliance on these types of documents does not convert a motion to dismiss into a motion for summary judgment. "When a complaint relies on a document ... the plaintiff obviously is on notice of the contents the document, and the need for...