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Mills v. Ethicon, Inc.

United States District Court, D. New Jersey

August 27, 2019




         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 Background [1]

         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 Plaintiffs 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 defendants[3] removed the action to this Court, based on complete diversity. (DE 1).

         On December 15, 2017, Mills voluntarily dismissed the following •A defendants: Ethicon Inc; Johnson 6& 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 plaintiffs 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." BellAtl Corp. v. Twombly, 550 U.S. 544, 555 (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 plaintiffs right to relief above a speculative level, so that a claim is "plausible on its face." Twombly, 550 U.S. at 570; see also West Run Student Hous. Assocs., LLC u. 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 (2009) (citing Twombly, 550 U.S. at 556). 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 plaintiffs 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 plaintiffs 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 a chance to refute evidence is greatly diminished." Pension Benefit Guar. Corp. v. White Consol. Indus., Inc., 998 F.2d 1192, 1196-97 (3d Cir. 1993).

         III. Choice of Law

         Mills, AMC, and Maquet all agree that Pennsylvania law applies to Mills's claims. (PABr at 7; DABr at 4-8). Getinge AB does not address the issue. (See generally DGBr). AMC and Maquet suggest that New Jersey could apply to this action, as this litigation was filed in New Jersey, but they ultimately contend that Pennsylvania law should apply.

         As noted above, Mills is a resident of Pennsylvania, and the surgeries took place in Pennsylvania. Mills's injuries also occurred in Pennsylvania. AMC is incorporated under the laws of Delaware. (DE 26-3).[4] Maquet is the "sister corporation" of AMC. (DGBr at 3 n.l). The complaint alleges that Maquet is a New Jersey corporation; the statement of corporate status submitted by Mills in opposition to Getinge AB's motion to dismiss, however, provides that Maquet is a Delaware LLC. (Compl ¶18; DE 30-2). Getinge AB is a Swedish corporation, with a principal place of business in Sweden. (Compl ¶19).

         A. Standard

         "[I]n a diversity action, a district court must apply the choice of law rules of the forum state to determine what law will govern the substantive issues of a case." Warriner v. Stanton, 475 F.3d 497, 499-500 (3d Cir. 2007) (citing Klaxon Co. v. Stentor Elec. Mfg. Co., 313 U.S. 487, 496 (1941)). New Jersey uses the most-significant-relationship test, which consists of two prongs. Maniscalco v. Brother Int'l Corp. (USA), 793 F.Supp.2d 696, 704 (D.N.J. 2011), affd, 709 F.3d 202 (3d Cir. 2013); see also Yocham v. Novartis Pharm. Corp., 736 F.Supp.2d 875, 880 (D.N.J. 2010) ("Although the New Jersey Supreme Court has not explicitly adopted the Restatement's test for contract claims, New Jersey courts have regularly applied the 'most significant relationship' test to such claims." (citing cases)); Agostino v. Quest Diagnostics Inc., 256 F.R.D. 437, 461 (D.N.J. 2009) (applying New Jersey's most significant relationship test to tort and breach of contract claims).

         First, the court must determine whether a conflict actually exists between the potentially applicable laws. P.V. v. Camp Jaycee, 197 N.J. 132, 143 (2008) ("Procedurally, the first step is to determine whether an actual conflict exists. That is done by examining the substance of the potentially applicable laws to determine whether there is a distinction between them.") (internal quotations omitted). "[I]f no conflict exists, the law of the forum state applies." Snyder v. Farnam Companies, Inc., 792 F.Supp.2d 712, 717 (D.N.J. 2011) (quoting P.V., 197 N.J. at 143). However, if a conflict exists, the court goes to the second step of the analysis and must determine "which state has the 'most significant relationship' to the claim at issue by weighing the factors" in the applicable section of the Restatement (Second) of Conflict of Laws. Agostino, 256 F.R.D. at 462; see also P.V., 197 N.J. at 144.

         For the tort claims, the Restatement provides that the case will be "determined by the local law of the state which, with respect to that issue, has the most significant relationship to the occurrence and the parties under the principles stated in § 6." Restatement (Second) of Conflict of Laws, § 145 (1988); see Yocham, 736 F.Supp.2d at 880. Section 146 of the Restatement provides a "default" rule for personal injury cases, and provides that "the local law of the state where the injury occurred determines the rights and liabilities of the parties, unless, with respect to the particular issue, some other state has a more significant relationship under the principles stated in § 6 to the occurrence and the parties." Restatement (Second) of Conflict of Laws, § 146 (1988); Yocham, 736 F.Supp.2d at 880 (citing P.V., 197 N.J. at 147).

         For contract claims, the applicable Restatement section is § 188. Gilbert Spruance Co. v. Pennsylvania Mfrs. Ass'nlns. Co., 134 N.J. 96, 102 (1993). "The standard for contract claims is identical [to the § 145 tort standard], except the word 'transaction' is substituted for 'occurrence,' § 188, and there is no similar default rule regarding the location of the injury." Yocham, 736 F.Supp. at 880.

         Therefore, in determining which substantive law to apply, the evaluation of both the contract and tort claims "involve[s] the significance of the states' relations to the parties and events in light of the principles contained in § 6 of the Restatement, which lists several factors relevant to the choice of law analysis that when 'reduced to their essence . . . are: (1) the interests of interstate comity; (2) the interests of the parties; (3) the interests underlying the field of tort law; (4) the interests of judicial administration; and (5) the competing interests of the states." Yocham, 736 F.Supp.2d at 880-81 (alteration added) (citing P.V., 197 N.J. at 148).

         B. Actual conflict between Pennsylvania and New Jersey law

         The first step of the choice of law analysis requires that the Court determine whether the potentially applicable state laws are in conflict.

         In the products liability context, there is a conflict between New Jersey and Pennsylvania law. Unlike Pennsylvania, New Jersey has enacted the New Jersey Product Liability Act ("NJPLA") to codify its products liability law. Kallman v. Aronchick, 981 F.Supp.2d 372, 378 (E.D. Pa. 2013) (citing N.J. Stat. Ann. § 2A:58C-1, et seq.). As a result, "Pennsylvania law allows negligence and breach of warranty claims, but New Jersey only allows one statutory cause of action for strict liability." Torres v. Lucca's Bakery, 487 F.Supp.2d 507, 513 (D.N.J. 2007) (citing N.J. Stat. Ann. § 2A:58C-2; Green v. Gen. Motors Corp., 310 N.J.Super. 507, 517 (App. Div. 1998) ("Under the New Jersey Products Liability Act ... the causes of action for negligence, strict liability and implied warranty have been consolidated into a single product liability cause of action, the essence of which is strict liability."); Oquendo v. Bettcherlndust, 939 F.Supp. 357, 361 (D.N.J. 1996); 13 Pa. Cons. Stat. §§ 2314, 2315 (creating causes of action for breach of implied warranties); Soufflas v. Zimmer, 474 F.Supp.2d 737, 751-54 (E.D. Pa. 2007) (discussing product liability claims based on implied warranties and negligence under Pennsylvania law)); see also Kallman, 981 F.Supp. at 378 (noting that NJPLA "subsumes common law products liability claims into one statutory cause of action for strict liability."). In addition, Pennsylvania bars strict liability claims that are brought for injuries related to a medical device, while New Jersey does not. See Section IV, A, infra.

         The NJPLA is the "sole basis of relief under New Jersey law available to consumers injured by a defective product." Repola v. Morbark Industries, Inc., 934 F.2d 483, 492 (3d Cir. 1991). The NJPLA, therefore, does not permit negligence or implied breach of warranty claims as separate claims for injuries caused by defective products.[5] Kallman, 981 F.Supp. at 378 (citing Torres, 487 F.Supp.2d at 513); see also Knipe v. Smithkline Beecham, 583 F.Supp.2d 602, 614 (E.D. Pa. 2008) ("Pennsylvania courts allow claims of negligence and breach of implied warranty to be brought in conjunction with a products liability claim."); Borelli v. Everland, 2006 U.S. Dist. LEXIS 6506, at *9 (E.D. Pa. Feb. 21, 2006) ("[U]nder the NJPLA, negligence and breach of warranty are not permitted as separate claims for injuries caused by defective products." (citations omitted)).

         Additionally, "New Jersey applies a reasonableness standard to the manufacturer's design in strict liability cases and insulates a non-manufacturing seller from liability, where Pennsylvania does not." Coppola v. Ferrellgas, 250 F.R.D. 195, 202 (E.D. Pa. 2008) (citation omitted); see also N.J. Stat. Ann. § 2A:58C-9(b) ("Upon filing the affidavit... the product seller shall be relieved of all strict liability claims.").

         "When dealing with liability based on negligence, strict liability, products liability or the like, differing rules as to liability or damages generally represent genuine conflicts since the laws covering these issues take into account both the needs of the injured plaintiffs and the economic viability of the defendants." Torres, 487 F.Supp.2d at 513 (internal quotation omitted) (citing Boyes v. Greenwich Boat Works, Inc., 27 F.Supp.2d 543, 548 (D.N.J. 1998)).

         When two states authorize different causes of action arising out of the same set of facts, a conflict exists between the laws of the two states. See Torres, 487 F.Supp.2d at 513. I therefore conclude that a conflict exists between the products liability laws of New Jersey and Pennsylvania and turn to the second step of the choice of law analysis. See Kallman, 981 F.Supp.2d at 379 (concluding that conflict exists between products liability laws of Pennsylvania and New Jersey); Knipe, 583 F.Supp.2d at 614 (holding same); Torres, 487 F.Supp.2d at 513 (holding same).

         C. Most significant relationship

         The policies underlying products liability law in New Jersey and Pennsylvania "are generally the same: both states seek to compensate people injured by defective products and regulate the conduct of manufacturers and distributors (i.e., ensure production of safe products) within the state." Torres, 487 F.Supp.2d at 513. Each of the states' respective interests would therefore be impaired by the application of the other state's law. Because the policies are in equipoise, the quality of each state's contacts to the underlying action is determinative.

         The quality of the contacts with Pennsylvania leads the Court to conclude that Pennsylvania law should apply. In making this determination, the Court must look to a number of factors: "(a) the place where the injury occurred, (b) the place where the conduct causing the injury occurred, (c) the domicil, residence, nationality, place of incorporation and place of business of the parties, and (d) the place where the relationship, if any, between the parties is centered." Restatement (Second) of Conflict of Laws § 145 (1988); see also Knipe, 583 F.Supp.2d at 614.

         The events essential to this litigation occurred in Pennsylvania. Mills is a resident of Pennsylvania, and the allegedly defective product was used and caused harm in the state of Pennsylvania. Mills's surgeries, during which the product was implanted, also occurred in Pennsylvania. Only Maquet, which is incorporated in this state, has a connection to New Jersey. See Knipe, 583 F.Supp.2d at 616 (applying New Jersey law where "[t]he sole contact Pennsylvania maintains with this litigation is as the situs of Defendant's headquarters and principal place of business.").

         New Jersey has a tenuous connection to the harm caused to Mills, and therefore has little interest in having its products liability law enforced to protect the rights and interests of a non-resident. See Deemer v. Silk City Textile Mach. Co., 193 N.J.Super. 643, 649 (App. Div. 1984) ("New Jersey has no interest in protecting the compensation rights of a non-domiciliary resident. Indeed, our Supreme Court . . . appears to evidence a policy of discouraging forum shopping where, as here, the contacts with the State are at best tenuous." (citations omitted)). Accordingly, I conclude that Pennsylvania law applies to the substantive claims in this action.

         IV. Discussion The complaint contains six counts:

Count One: Negligence;
Count Two: Strict Products Liability - Defective Design;
Count Three: Strict Products Liability - Failure to Warn;
Count Four: Breach of Express Warranties;
Count Five: Breach of Implied Warranty of Fitness for Particular Purpose;
Count Six: Breach of Implied Warranty of Merchantability.

         A. Viability of Causes of Action under Pennsylvania law

         Before addressing the sufficiency of the factual allegations in the complaint, I consider which causes of action are viable under Pennsylvania law. Maquet and AMC argue that Pennsylvania law does not recognize products liability claims for strict liability or breach of warranty relating to a medical device.

         This Court's "role in diversity cases is to apply state law as announced by the state's highest court." LaBarre v. Bristol-Myers Squibb Co., 544 Fed.Appx. 120, 125 (3d Cir. 2013) (citing Sheridan v. NGK Metals Corp., 609 F.3d 239, 253 (3d Cir. 2010) ("A federal court under Erie is bound to follow state law as announced by the highest state court." (internal citations omitted)). "In the absence of a controlling decision by the Pennsylvania Supreme Court, we must predict how it would decide the questions of law presented in this case." Wolfe v. Allstate Prop, & Cas. Ins. Co., 790 F.3d 487, 492 (3d Cir. 2015) (citing Berrier v. Simplicity Mfg., Inc., 563 F.3d 38, 45-46 (3d Cir. 2009)); Leonard v. Tractor Supply Co., 88 F.Supp.3d 459, 461 (W.D. Pa. 2015). A federal district court in this position should consider "relevant state precedents, analogous decisions, considered dicta, scholarly works, and any other reliable data tending convincingly to show how the highest court in the state would decide the issue at hand." Berrier, 563 F.3d at 46 (quotation and citation omitted).

         i. Strict liability claims

         The second count of Mills's complaint alleges strict liability based on defective design, and the third count alleges strict liability based on a failure to warn. As many courts have recognized, the Pennsylvania Supreme Court has not yet decided whether Pennsylvania law recognizes strict liability claims related to medical devices. That court has, however, barred such claims in the analogous context of ...

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