# Paye v. Atrium Medical Corporation

> District Court, D. Massachusetts · January 20, 2023

URL: https://www.frixlaw.com/law-library/cases/10200807

## Case

- **Court:** District Court, D. Massachusetts
- **Decided:** January 20, 2023
- **Opinion:** 100trialcourt
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/10200807

## How later opinions describe it (automated extraction)

- applying the internal-affairs doctrine to determine which jurisdiction’s substantive law should be used for an alter ego determination

## Opinion text

UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS

_______________________________________
)
JOSEPH PAYE, )
)
Plaintiff, )
) Civil Action No.
v. ) 22-10005-FDS
)
ATRIUM MEDICAL CORPORATION; )
GETINGE AB; and MAQUET )
CARDIOVASCULAR US SALES, LLC, )
)
Defendants. )
_______________________________________)

MEMORANDUM AND ORDER ON
DEFENDANTS’ MOTION TO DISMISS
SAYLOR, C.J.
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 US 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
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 US 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
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

1 “Meshoma” occurs when surgical mesh shrinks into a ball, possibly trapping nerves and causing
inflammation. Kristoffer Andresen & Jacob Rosenberg, Management of Chronic Pain After Hernia Repair, 11 J.
PAIN RSCH. 675, 676 (2018).
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., 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
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’ jurisdictional challenge indicate specifically how Getinge
and Maquet have consented to general jurisdiction. Accordingly, plaintiff has not carried his
burden to show that the court has general jurisdiction over Getinge and Maquet through their
consent.

2. Specific Jurisdiction
As to specific jurisdiction, due process requires that a plaintiff establish three conditions:
First, the claim underlying the litigation must directly arise out of, or relate to, the
defendant’s forum-state activities. Second, the defendant’s in-state contacts must
represent a purposeful availment of the privilege of conducting activities in the
forum state, thereby invoking the benefits and protections of that state’s laws and
making the defendant’s involuntary presence before the state’s courts foreseeable.
Third, the exercise of jurisdiction must be reasonable.
Copia Commc’ns, LLC v. AMResorts, L.P., 812 F.3d 1, 4 (1st Cir. 2016) (quoting Phillips, 530
F.3d at 27) (internal alteration omitted); see also Motus, 23 F.4th at 122.
Maquet and Getinge contend that plaintiff’s claims do not arise out of or relate to their
forum-state activities and that they have not purposefully availed themselves of the privilege of
conducting activities in Massachusetts.
a. Maquet
The complaint alleges that Maquet was “involved” in the “research, development, testing,
manufacture, production, distribution, marketing, promotion, and/or sale” of ProLoop mesh “at
all relevant times hereto.” (Compl. ¶ 9). It further alleges that Maquet “is the exclusive

distributor of all surgical mesh products manufactured by [d]efendants.” (Id.). It does not
otherwise specify when Maquet’s involvement in ProLoop distribution began, or whether it
conducted any activities other than distribution. Finally, plaintiff contends (in his opposition, but
not the complaint) that Maquet was the “exclusive” distributor of ProLoop mesh after 2011. (Pl.
Opp. at 9).
Maquet contends that the claim does not arise out of its forum-state activities because it
began distributing ProLoop mesh in 2014, approximately two years after the surgery on plaintiff
in which the mesh was implanted. Defendants have provided an affidavit from Atrium’s
president attesting that Maquet’s promotion, sale, and distribution of ProLoop began in January
2014, and that it did not design or manufacture ProLoop mesh products. (Carlton Aff. ¶¶ 16-17).

Before 2014, according to the affidavit, Atrium promoted, sold, and distributed ProLoop. (Id. ¶
10).
Plaintiff has not carried his burden to show that his claims arise out of Maquet’s contacts
with Massachusetts. He has not offered any evidence contradicting defendant’s affidavit stating
that Maquet only began distributing ProLoop in 2014. Furthermore, the complaint contains no
factual allegations from which it could be plausibly inferred that Maquet had any role in the
design or manufacture of the product, and again plaintiff has offered no evidence to contradict
the statement in the affidavit that it had no such role. Accordingly, plaintiff cannot establish
purposeful availment under a “stream of commerce” theory, because Maquet only became
involved in the stream of commerce for ProLoop after his surgery. See Costa v. FCA US LLC,
542 F. Supp. 3d 83, 95 (D. Mass. 2021).
It is true that the complaint alleges in general terms that all defendants misrepresented
and concealed the dangers of ProLoop mesh for some period of time after the surgery. (Compl.
¶ 45). In some circumstances, manufacturers have a continuing duty to warn customers of

dangers from ongoing product use. Lewis v. Ariens Co., 434 Mass. 643, 648-49 (2001). But
there are no specific allegations in the complaint concerning the conduct of Maquet after 2014—
that is, there are no facts alleged from which it might be plausibly inferred that Maquet (which
did not design or manufacture the product) knew or reasonably should have known of the
dangers of the product after that point. For purposes of establishing personal jurisdiction, at
least, a vague reference that “defendants” concealed the dangers is not enough.
In sum, the complaint does not plead facts sufficient to demonstrate the existence of
specific jurisdiction over Maquet, and plaintiff has not submitted evidence to contradict the
statements in the affidavit submitted by defendants concerning the activities of Maquet.

Accordingly, all counts against Maquet will be dismissed for lack of personal jurisdiction.
b. Getinge AB
The complaint alleges that after Getinge acquired Atrium in 2011, Getinge became
involved in the research, marketing, and sale of ProLoop mesh and also controlled Atrium’s
activities. Getinge contends that Atrium, not it, carried out activities related to ProLoop
distribution. It further contends that it did not control Atrium and that therefore the forum
contacts of Atrium should not be imputed to it.
Based on the pleadings and supplemental filings, it appears that Getinge did not itself
carry out any research, marketing, or sales of ProLoop mesh. The complaint alleges vaguely that
Getinge was “involved” with these activities. (Compl. ¶ 7). The only particularized mention of
Getinge’s involvement in ProLoop is its alleged application to the FDA for a product name
change for ProLoop. (Id. ¶ 29). The complaint characterizes that application as an attempt by
Getinge to evade regulatory scrutiny of ProLoop mesh. (Id.). However, the FDA’s response to
the application is addressed to an officer at Atrium and does not mention Getinge. And there are
no other specific allegations as to the involvement of Getinge in the sale or distribution of the

product. Those allegations, without more, are insufficient to establish specific jurisdiction over
Getinge.
Plaintiff further contends that Atrium is the alter ego of Getinge, and that Atrium’s
(undisputed) forum contacts should be imputed to it. Ordinarily, courts will treat different
corporations as separate entities, even if one wholly owns another. See Lothrop v. North Am. Air
Charter, Inc., 95 F. Supp. 3d 90, 99-100 (D. Mass. 2015). A jurisdictional determination that
one corporation’s forum contacts should be imputed to another requires piercing the corporate
veil. Id. at 99.
Courts in Massachusetts have applied two approaches in determining whether to pierce

the corporate veil. First, some courts have applied the internal-affairs doctrine, which requires
courts to apply the substantive law of a corporation’s place of incorporation. See, e.g., Mariasch
v. Gillette Co., 521 F.3d 68, 71-72 (1st Cir. 2008); Lily Transp. Corp. v. Royal Inst’l Servs., Inc.,
64 Mass. App. Ct. 179, 188 n.15 (2005) (applying the law of Pennsylvania to determine whether
to pierce a corporate veil). Second, some courts have applied the multifactor test prescribed by
the RESTATEMENT (SECOND) OF CONFLICT OF LAWS, § 188 (Am. L. Inst. 1971). See, e.g., Evans
v. Multicon Constr. Corp., 30 Mass. App. Ct. 728, 737 n.7 (1991); John T. Callahan & Sons, Inc.
v. Dykeman Elec. Co., Inc., 266 F. Supp. 2d 208, 230 (D. Mass. 2003).
The former approach appears to be the more appropriate one for this case. Plaintiff’s
contention is that Getinge controlled Atrium’s management and operations, and therefore
applying the choice-of-law rule that directly addresses such matters is appropriate. See, e.g.,
U.S. v. Funds Held in the Name or for the Benefit of Wetterer, 210 F.3d 96, 106 (2d Cir. 2000)
(applying the internal-affairs doctrine to determine which jurisdiction’s substantive law should
be used for an alter ego determination). Application of the internal-affairs doctrine to cases such

as this will also provide certainty and predictability to corporate parents whose subsidiaries
operate in many jurisdictions. VantagePoint Venture Partners 1996 v. Examen, Inc., 871 A.2d
1108, 1112-13 (Del. 2005).
Atrium is incorporated in Delaware, and therefore the Court will apply Delaware law to
determine whether Atrium is an alter ego of Getinge.2 Under Delaware law, piercing the
corporate veil requires that the subsidiary be “a sham entity designed to defraud investors and
creditors.” Crosse v. BCBSD, Inc., 836 A.2d 492, 497 (Del. 2003). A parent entity’s ownership
of a subsidiary, without more, is insufficient to establish that the subsidiary is an alter ego. CMS
Inv. Holdings, LLC v. Castle, 2015 WL 3894021, at *13 n.27 (Del. Ch. June 23, 2015).

“[C]onclusory allegations of domination and control” of the subsidiary by the parents are
insufficient. Wenske v. Blue Bell Creameries, Inc., 2018 WL 5994971, at *7 (Del. Ch. Nov. 13,
2018). A parent’s ownership of the entirety of a subsidiary’s stock and appointment of all of its
directors is likewise insufficient. Id. Instead, the parent must commit wrongful acts “tied to the
manipulation of the corporate form.” Doberstein v. G-P Industries, Inc., 2015 WL 6606484, at

2 While not identical to the Delaware standard, Massachusetts law similarly sets a high bar for piercing the
corporate veil. “[E]ven pervasive control [by a parent of a subsidiary], without more, is not a sufficient basis for a
court to ignore corporate formalities.” Scott v. NG U.S. 1, Inc., 450 Mass. 760, 768 (2008). Ultimately, a “decision
to disregard settled expectations accompanying corporate form requires a determination that the parent corporation
directed and controlled the subsidiary, and used it for an improper purpose.” Id. Massachusetts law examines
several factors as part of that test, including pervasive control, nonobservance of corporate formalities, misuse of
corporate funds, and use of corporate funds for transactions of the dominant corporation. Id. The result of the
jurisdictional inquiry here would be the same under Massachusetts or Delaware law.
*4 (Del. Ch. Oct. 30, 2015). And “[t]he degree of control required to pierce the veil is exclusive
domination and control . . . to the point that the [subsidiary] no longer ha[s] legal or independent
significance of [its] own.” Wallace ex rel. Cencom Cable Income Partners II, Inc., L.P. v. Wood,
752 A.2d 1175, 1184 (Del. Ch. Oct. 12, 1999) (fourth alteration in original) (citations omitted)
(quoting Hart Holding Co. Inc. v. Drexel Burnham Lambert Inc., 1992 WL 127567, at *11 (Del.

Ch. May 28, 1992).
Plaintiff contends that Getinge assumed control of Atrium’s operations after 2011, and
that it did business in the United States through Atrium and Maquet. The complaint alleges that
Atrium, after becoming a wholly-owned subsidiary of Getinge, ceased filing annual reports with
the State of New Hampshire, leading to the suspension of Atrium’s authority to do business in
that state. (Compl. ¶ 8). Getinge then applied for requalification “using Atrium’s corporate
name.” (Id.). The complaint alleges that Getinge now “controls the activities of Atrium and is
the direct employer of the individuals formerly employed by Atrium.” (Id.). Plaintiff has
submitted a copy of Getinge’s 2011 and 2021 annual reports, both of which describe Atrium as a

Getinge subsidiary. (See Exs. 1, 2, Pl. Opp.).
According to its president, Atrium maintains its own officers and board of directors and
has its own bylaws, corporate records, financial records, payroll, and budgets. (Carlton Aff. ¶ 6,
9, 13). Atrium has always filed applications to for authority to do business under its own name.
(Id. ¶ 7). Atrium manages and operates its day-to-day business independently of Getinge. (Id.
¶ 8). Getinge exercises parental oversight over Atrium, but Atrium has authority to enter most
contracts and business agreements without Getinge’s approval. (Id. ¶ 14). Prior to 2014, Atrium
was responsible for marketing, promotion, distribution, and sales of ProLoop mesh. (Id. ¶ 10).
Atrium’s president attests that Getinge has never designed, manufactured, sold, or distributed
ProLoop mesh or any other surgical mesh. (Id. ¶ 17-19).
The pleadings and supplemental evidence are insufficient to show that Atrium is an alter
ego of Getinge. Although Atrium is wholly owned by Getinge, it carries out many activities
independently: entering into contracts, applying for business licenses and regulatory approval,
paying employees, promoting and distributing products, and managing its day-to-day affairs, all

under its own name. Nor is there any evidence that Atrium is a “sham entity” used by Getinge to
commit wrongful acts. Neither the complaint nor the proffered evidence suggest that Getinge
blatantly disregarded corporate formalities in order to manipulate the corporate form. Cf. Harco
Nat. Ins. Co. v. Green Farms, Inc., 1989 WL 110537, at *6 (Del. Ch. Sept. 19, 1989) (suggesting
that poor maintenance of corporate records, commingling of assets between shareholders and
corporation, and undercapitalization, if shown to be true, may justify piercing the corporate veil).
Under the circumstances, Atrium’s forum contacts will not be attributed to Getinge, and
the court therefore lacks specific jurisdiction over Getinge. Accordingly, all counts against
defendant Getinge will be dismissed for lack of personal jurisdiction.

III. Motion to Dismiss
A. Standard of Review
To survive a motion to dismiss, the complaint must state a claim that is plausible on its
face. See Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). In other words, the “[f]actual
allegations must be enough to raise a right to relief above the speculative level, . . . on the
assumption that all the allegations in the complaint are true (even if doubtful in fact).” Id. at 555
(citations omitted). “The plausibility standard is not akin to a ‘probability requirement,’ but it
asks for more than a sheer possibility that a defendant has acted unlawfully.” Ashcroft v. Iqbal,
556 U.S. 662, 678 (2009) (quoting Twombly, 550 U.S. at 556). When determining whether a
complaint satisfies that standard, a court must assume the truth of all well-pleaded facts and give
the plaintiff the benefit of all reasonable inferences. See Ruiz v. Bally Total Fitness Holding
Corp., 496 F.3d 1, 5 (1st Cir. 2007) (citing Rogan v. Menino, 175 F.3d 75, 77 (1st Cir. 1999)).
Dismissal is appropriate if the complaint fails to set forth “factual allegations, either direct or
inferential, respecting each material element necessary to sustain recovery under some actionable
legal theory.” Gagliardi v. Sullivan, 513 F.3d 301, 305 (1st Cir. 2008) (quoting Centro Médico

del Turabo, Inc. v. Feliciano de Melecio, 406 F.3d 1, 6 (1st Cir. 2005)).
B. Analysis
The parties agree that Massachusetts law applies to the substantive claims.
Massachusetts courts use a “functional approach” to choice-of-law questions that relies in part on
the RESTATEMENT (SECOND) OF CONFLICT OF LAWS (Am. L. Inst. 1971). Cosme v. Whitin Mach.
Works, Inc., 417 Mass. 643, 646 (1994). In personal injury cases, Section 146 of the
Restatement suggests that the law of the state where the injury occurred should determine the
rights and liabilities of the parties unless another state has a more significant relationship to the
underlying cause of action. RESTATEMENT (SECOND) OF CONFLICT OF LAWS § 146 (Am. L. Inst.
1971). Massachusetts courts have applied this approach to cases arising from surgical

implantation of a medical product such as this one. Monroe v. Medtronic, Inc., 511 F. Supp. 3d
26, 33 (D. Mass. 2021). Plaintiff’s surgery took place in Attleboro, Massachusetts.
Accordingly, the Court will apply Massachusetts law to his claims.
The complaint styles Counts 1, 2, and 3 as claims of strict liability in tort. Under
Massachusetts law, there is no such cause of action. Swartz v. General Motors Corp., 375 Mass.
628, 629 (1978). Instead, in Massachusetts product-liability cases, breach of the implied
warranty of merchantability claims are functionally identical to strict-liability claims in other
jurisdictions. See Commonwealth v. Johnson Insulation, 425 Mass. 650, 653-54 (1997). The
Court will therefore construe Counts 1, 2, and 3 as claims for breach of the implied warranty of
merchantability. See Fed. R. Civ. P. 8(e). Count 5, in turn, asserts a claim for breach of implied
warranty, which is duplicative of those counts as construed here.
To succeed on a claim alleging breach of the implied warranty, the plaintiff must
demonstrate (1) that the defendant manufactured or sold the product in question, (2) that a defect
or unreasonably dangerous condition existed that rendered the product not suitable for the

ordinary uses for which the product was sold, (3) that he was using the product in a manner that
the defendant intended or could reasonably have foreseen, and (4) that the defect or unreasonably
dangerous condition was a legal cause of his injuries. AcBel Polytech, Inc. v. Fairchild
Semiconductor Int’l, Inc., 928 F.3d 110, 116 (1st Cir. 2019). “A product may be defective and
unreasonably dangerous because of a manufacturing defect, a design defect, or a warning defect,
that is, a failure reasonably to warn of the product’s foreseeable risks of harm.” Evans v.
Lorillard Tobacco, Co., 465 Mass. 411, 422 (2013).
1. Count 1—Strict Liability—Design Defect
For a design-defect claim, a plaintiff must “prove the availability of a technologically
feasible and practical alternative design that would have reduced or prevented the plaintiff’s

harm.” Id. at 428 (quoting RESTATEMENT (THIRD) OR TORTS: PRODUCT LIABILITY § 2 cmt. f
(Am. L. Inst. 1998). This inquiry requires the plaintiff to show that “the product in question
could have been more safely designed, not that a different product was somehow safer.”
Tersigni v. Wyeth, 817 F.3d 364, 368 (1st Cir. 2016).
The complaint here alleges that ProLoop mesh “deviated from its intended design in that
it is unfit for permanent implantation into the human body and fails to provide a permanent
repair for hernia.” (Compl. ¶ 61). It further alleges that reasonable alternative procedures exist
for treating hernias and reasonable alternative designs exist for surgical mesh. (Compl. ¶ 64).
Defendants contend that the design-defect claim should fail because the complaint does
not adequately allege a reasonable alternative design. The complaint alleges, in a single
paragraph, that “[f]easible and suitable alternative procedures and instruments, as well as suitable
alternative designs for implantation and treatment of hernias and soft tissue repair . . . exist[] . . .
as compared to [ProLoop mesh].” (Compl. ¶ 64). It specifically identifies polyvinylidene
fluoride mesh, high-density polyethylene mesh, and non-coated, single-layer mesh as examples

of feasible alternatives. (Id.).
A reasonable alternative design must be a design for the product in question, not a
proposal to use a different product altogether. Tersigni, 817 F.3d at 368. While there is perhaps
some ambiguity in the complaint as to whether the listing of other types of mesh is intended to
represent alternative designs or alternative types of treatment or procedure, the complaint
specifically alleges that they represent the former. Under the circumstances, the allegations are
sufficiently plausible to support a claim of defective design, and dismissal for failure to allege a
reasonable alternative is not warranted. Whether discovery may reveal a different set of facts is
a question for another day.

In short, the complaint alleges sufficient facts to support a breach of warranty claim
based on a design defect. Accordingly, the motions to dismiss will be denied as to Count 1.
2. Count 2—Strict Liability—Manufacturing Defect
The complaint alleges that the ProLoop mesh used in plaintiff’s surgery did “not conform
to [the] manufacturer’s expectations in that, inter alia, it is not safe for implantation in the human
body.” (Compl. ¶ 70). The complaint further alleges that the mesh “failed to incorporate and
migrated.” (Id.).
A manufacturing defect may cause a product to be defective or unreasonably dangerous.
Evans, 465 Mass. at 422. In a manufacturing-defect case, the factfinder must “compare the
propensities of the product as sold with those which the product’s designer intended it to have”
and determine “whether the deviation from the design rendered the product unreasonably
dangerous and therefore unfit for its ordinary purposes.” Back v. Wickes Corp., 375 Mass. 633,
641 (1978).
Here, the complaint fails to allege a plausible basis to conclude that the ProLoop mesh
deviated from its intended design. It alleges that ProLoop mesh contains “a number of design

elements which render the product unreasonably dangerous,” including looped filaments, lack of
bridging filaments, and high volume of non-absorbable synthetic polypropylene material.
(Compl. ¶ 32 (emphasis added)). As the complaint makes clear, those allegedly harmful
elements are part of the product’s design. Their use was not a deviation from the manufacturer’s
design; it was entirely consistent with the design. The complaint further alleges that Atrium
knew that “its chosen polypropylene lacked anti-oxidants” when it elected to begin production of
ProLoop mesh, increasing the risk of complications after implantation. (Compl. ¶¶ 33-37).
Plaintiff characterizes this feature as a deviation from the design because the defendants
“performed [their] own tests demonstrating the faster degradation of said material.” (Pl. Opp. at

9). But that allegation describes a deliberate decision to include a particular feature in a product
line. If true, that is a design defect, not a manufacturing defect.
The complaint therefore fails to allege that the product as manufactured deviated from the
manufacturer’s intended design, and accordingly Count 2 will be dismissed.
3. Count 3— Strict Liability—Failure to Warn
Count 3 alleges that defendants failed to warn plaintiff and his treating physician about
the risks associated with ProLoop mesh, its inadequate research and testing of ProLoop mesh,
and the lack of a safe and effective removal procedure. It also alleges that defendants did not
inform plaintiff’s treating physician of the proper technique and methods of implantation and
patient selection. Finally, it alleges that defendants concealed information about the risks from
defendant and his treating physician.
“A manufacturer of a product has a duty to warn foreseeable users of dangers in the use
of that product of which he knows or should have known.” Mitchell v. Sky Climber, Inc., 396
Mass. 629, 631 (1986). A manufacturer may be held liable “even if the product does exactly
what it is supposed to do, if it does not warn of the potential dangers inherent in the way a

product is designed.” Laaperi v. Sears, Roebuck & Co., 787 F.2d 726, 729 (1st Cir. 1986). “It is
not necessary that the product be negligently designed or manufactured.” Id.
Under the “learned intermediary” doctrine, a medical-device manufacturer’s obligation to
warn of dangers associated with its product runs to the physician, not the patient. Cottam v. CVS
Pharm., 436 Mass. 316, 321 (2002); Langlois v. American Med. Sys., Inc., 462 F. Supp. 3d 1, 4
(D. Mass. 2020). A plaintiff “carries the initial burden of producing sufficient evidence that the
defendant manufacturer failed to warn of a non-obvious risk about which the manufacturer knew
or should have known.” Garside v. Osco Drug, Inc., 976 F.2d 77, 81 (1st Cir. 1992). Factors
relevant to determining the adequacy of a warning include

whether the warning adequately indicates the scope of the danger; whether the
warning reasonably communicates the extent or seriousness of the harm that
could result from misuse of the product; whether the physical aspects of the
warning adequately alert a reasonably prudent person to the danger; and whether
the means to convey the warning are adequate in the given circumstances.
Albright v. Boston Sci. Corp., 90 Mass. App. Ct. 213, 220 n.17 (2016) (quoting In re Meridia
Prod. Liab. Litig., 328 F. Supp. 2d 791, 812 (N.D. Ohio 2004).
Defendants contend that the failure-to-warn claim is too conclusory to survive a motion
to dismiss. It is true that a central question in failure-to-warn cases is a comparison of the actual
warning (if any) given by the manufacturer with the proposed warning that plaintiff says should
have been given. See, e.g., Niedner v. Ortho-McNeil Pharm., Inc., 90 Mass. App. Ct. 306, 309–
10 (2016); Kalivas v. A.J. Felz Co., 15 Mass. App. Ct. 482, 487 (1983); Penn-America Ins. Co. v.
Bay State Gas Co., 96 Mass. App. Ct. 757, 761–62 (2019); KomTek v. Tucker & Rice, Inc., 1993
WL 818821, at *3-4 (Mass. Super. Ct. Dec. 22, 1993). When a complaint simply recites the
elements of a failure-to-warn claim in boilerplate language without providing specific details
about a defendant’s omissions or inadequacies, normally the plaintiff has failed to carry his
burden to show a failure to warn. See, e.g., Bustamante v. Atrium Med. Corp., 2020 WL 583745,

at *7 (S.D.N.Y. Feb. 6, 2020) (dismissing a failure-to-warn claim because “[n]otably absent from
Plaintiffs’ Amended Complaint is the exact language of the warnings contained on the device”);
Nowell v. Medtronic Inc., 372 F. Supp. 3d 1166, 1251-1255 (D.N.M. 2019) (“[Plaintiff] has not
alleged that the Defendants sold their mesh absent any warning, and the Court will not presume
this fact on [plaintiff’s] behalf.”); Bond v. Johnson & Johnson, 2021 WL 6050178, at *11
(D.N.J. Dec. 21, 2021) (“[Plaintiff] has not alleged the specific language in the warnings
associated with the Prolene 3D . . . the Court is unable to assess the warnings against the
omissions [plaintiff] alleges.”).
Here, the complaint alleges that defendants “failed to properly and adequately warn”

plaintiff and his physician of various risks associated with ProLoop. (Compl. ¶¶ 74-76).
Paragraphs 32 through 54 allege in some detail that defendants failed to warn plaintiff and his
physician of a variety of allegedly unsafe characteristics. While the complaint does not
specifically allege what warning was given as to those dangers, it does allege that defendants
“made a deliberate decision to ignore” them. (Id. ¶ 37). The complaint may be plausibly read to
allege that defendant gave no warning at all about those identified dangers, and that defendant
should have provided such a warning.
Under the circumstances, the complaint alleges sufficient facts to sustain a claim for
breach of warranty based on failure to warn, and the motion to dismiss as to Count 3 will be
denied.
4. Count 4—Negligence
Count 4 alleges that defendants were negligent in (1) designing ProLoop mesh, (2) failing
to warn plaintiff and his treating physicians of risks associated with ProLoop mesh, (3) failing to
comply with state and federal regulations concerning ProLoop mesh, and (4) manufacturing and
bringing ProLoop mesh to market despite its alleged dangers.3

Count 4 does not allege one specific theory of negligence. Rather, the claims sound in
negligent design, negligent manufacture, and negligent failure to warn. Under Massachusetts
law, “[i]n most substantive aspects . . . the negligence and warranty inquiries are congruent.”
Gillispie v. Sears, Roebuck & Co., 386 F.3d 21, 26 (1st Cir. 2004). Here, they are entirely
congruent. Count 4 is therefore entirely duplicative of Counts 1, 2, and 3, and will be dismissed
on that basis.
5. Count 5—Breach of Implied Warranty
Count 5 alleges that defendants breached the implied warranty that the ProLoop mesh
implanted in plaintiff was “of merchantable quality” and “safe and fit for the [sic] use in hernia
repair.” Count 5 is likewise duplicative and will be dismissed.

6. Count 6—Breach of Express Warranty
The complaint alleges that defendants expressly represented to plaintiff and his treating
physicians that that ProLoop mesh was safe and effective. The complaint alleges that these
statements were “made by [d]efendants or their authorized agents or sales representatives, orally
and in publications, package inserts and other written materials.” (Compl. ¶ 99).

3 Plaintiff argues that defendants have not moved to dismiss Count 4. (Pl. Opp. at 5). However, Atrium’s
motion to dismiss, which Getinge and Maquet have adopted, makes clear that Atrium moves to dismiss the entire
complaint, applying the same reasoning to plaintiff’s negligence claims as with plaintiff’s strict-liability claims.
(Atrium Mem. at 7).
Under Massachusetts law, an express warranty can be created in three ways:
(a) Any affirmation of fact or promise made by the seller to the buyer
which relates to the goods and becomes part of the basis of the bargain creates an
express warranty that the goods shall conform to the affirmation or promise.
(b) Any description of the goods which is made part of the basis of the
bargain creates an express warranty that the goods shall conform to the
description.
(c) Any sample or model which is made part of the basis of the bargain
creates an express warranty that the goods shall conform to the sample or model.
Mass. Gen. Laws ch. 106, § 14.
Defendant contends that the allegations in the complaint are too conclusory to sustain a
claim for breach of express warranty claim. Courts evaluating express warranty claims must
look to the specific affirmations or promises made by a defendant. See, e.g., Niedner, 90 Mass.
App. Ct. at 313. If a plaintiff has not identified a specific affirmation or promise, then a
factfinder cannot evaluate whether the affirmation or promise relates to the goods, whether the
affirmation or promise is part of the basis of the bargain, or whether the goods conform to the
affirmation or promise. See Taupier, 490 F. Supp. 3d at 438.
Here, the complaint does not identify any specific express affirmation or promise. It does
allege that the defendants “expressly represented and warranted . . . orally and in publications,
package inserts and other written materials intended for physicians, healthcare providers,
medical patients and the general public, that ProLoop polypropylene mesh is safe, effective, fit
and proper for its intended use in hernia repair.” (Compl. ¶ 99). Under other circumstances, that
might well be inadequate to state a claim. However, given the comprehensive regulation of
medical devices, including regulation of package inserts and other forms of labeling, the court
will permit the claim to proceed to the extent it relies upon written representations set forth in
such labeling materials. The claim of express warranty based on oral communications will,
however, be dismissed for failure to identify the alleged express affirmation or promise upon
which that claim relies.
7. Count 7—Negligent Misrepresentation
Count 7 alleges that defendants misrepresented that ProLoop mesh was safe, fit, and
effective to plaintiff, his treating physicians, and the public. It alleges that defendants conducted

“a sales and marketing campaign” to promote ProLoop mesh and “willfully deceive” plaintiff,
his treating physicians, and the public about the dangers and consequences of ProLoop mesh. It
further alleges that defendants themselves, their sales representatives, and other authorized
agents made these misrepresentations in “publications and other written materials.” According
to the complaint, defendants “made the foregoing representations without any reasonable ground
for believing them to be true.”
Under Massachusetts law, a negligent misrepresentation requires the plaintiff to show
that the defendant
(1) in the course of his business, (2) supplie[d] false information for the guidance
of others (3) in their business transactions, (4) causing and resulting in pecuniary
loss to those others (5) by their justifiable reliance upon the information, and (6)
with failure to exercise reasonable care or competence in obtaining or
communicating the information.
Nota Constr. Corp. v. Keyes Assocs., Inc., 45 Mass. App. Ct. 15, 19-20 (1998).
Defendants contend that the complaint should be held to the heightened pleading standard
of Rule 9(b), which requires that a party alleging fraud or mistake “state with particularity the
circumstances constituting fraud or mistake.” Fed. R. Civ. P. 9(b). “In such cases, the pleader
usually is expected to specify the who, what, where, and when of the allegedly false or
fraudulent representation.” Alternative Sys. Concepts, Inc. v. Synopsys, Inc., 374 F.3d 23, 29 (1st
Cir. 2004). The First Circuit has held that Rule 9(b) should be read “expansively to cover
associated claims where the core allegations effectively charge fraud.” North Am. Cath. Educ.
Prog. Found., Inc. v. Cardinale, 567 F.3d 8, 15 (1st Cir. 2009). “[M]isrepresentation is
considered a species of fraud.” Alternative Sys. Concepts, Inc., 374 F.3d at 29. Courts in this
district are split on whether Rule 9(b)’s heightened pleading standard should always apply to
negligent misrepresentation claims. Gardner v. Simpson Fin. Ltd. P’Ship, 2012 WL 1109104, at
*4 n.12 (D. Mass. Mar. 30, 2012) (highlighting split opinions). In the Court’s view, application

of Rule 9(b)’s heightened pleading standard is appropriate where “the claims overall sound in
fraud.” Miller Inv. Tr. v. Morgan Stanley & Co., LLC, 308 F. Supp. 3d 411, 449 (D. Mass.
2018). “The hallmarks of fraud are misrepresentation or deceit.” Ed Peters Jewelry Co., Inc. v.
C & J Jewelry Co., Inc., 215 F.3d 182, 191 (1st Cir. 2000).
The complaint alleges a campaign by the defendants to deceive patients, doctors, and the
public about the risks of ProLoop mesh in order to increase sales. The complaint alleges that
defendants “made misrepresentations” and “willfully deceived” “without any reasonable ground
for believing [their representations about ProLoop] to be true.” (Compl. ¶ 103). Those
allegations clearly invoke misrepresentation and deceit by defendants, and therefore Count 7

sounds in fraud and must be pleaded according to the standard of Rule 9(b). The complaint does
not describe the “who, what, where, and when of the allegedly false or fraudulent
representation.” Alternative Sys. Concepts, Inc., 374 F.3d at 29. It suggests that these
misrepresentations were made by “sales representatives,” “authorized agents,” “publications,”
and “written materials,” but these descriptors do not state the perpetrators or circumstances of
fraud with particularity. The complaint does not identify any particular location where plaintiff
or his physicians were misled. Nor does the complaint provide any temporal particularity; it
alleges that the misrepresentations were made “[a]t all times herein mentioned.” (Compl. ¶ 103).
Accordingly, Count 7 is a “barebones” claim that cannot survive Rule 9(b)’s heightened pleading
standard. Alternative Sys. Concepts, Inc., 374 F.3d at 29.
8. Punitive Damages
Plaintiff contends that defendant’s conduct is so “despicable” and “contemptible” that he
is entitled to punitive damages. (Compl. ¶ 124).
Under Massachusetts law, punitive damages are not permitted “unless expressly

authorized by statute.” Flesner v. Technical Commc’ns Corp., 410 Mass. 805, 813 (1991).
Plaintiff has not identified any Massachusetts statute that would authorize punitive damages for
the alleged conduct. Accordingly, the Court will dismiss the claim for punitive damages.
IV. Conclusion
For the foregoing reasons,
1. Counts 1, 2, and 3 are construed as claims for breach of implied warranty under
Massachusetts law.
2. The motion to dismiss of defendant Atrium Medical Corporation is GRANTED as
to Counts 2, 4, 5, and 7; as to Count 6 to the extent it alleges oral representations;
and as to the claim for punitive damages, and otherwise DENIED.
3. The motion to dismiss of defendants Getinge AB and Maquet Cardiovascular US

Sales, LLC is GRANTED as to lack of personal jurisdiction, and otherwise
DENIED as moot.
So Ordered.

/s/ F. Dennis Saylor IV
F. Dennis Saylor IV
Dated: January 19, 2023 Chief Judge, United States District Court

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/10200807. Public record. Not legal advice.