Wilson v. CooperSurgical, Inc.

IN THE UNITED STATES DISTRICT COURT

FOR THE SOUTHERN DISTRICT OF ILLINOIS

SABRINA WILSON, )

)

Plaintiff, )

)

vs. )

) Case No. 3:22-cv-1651-DWD

COOPERSURGICAL, INC., FEMCARE, )

LTD., a U.K. Subsidiary of Utah Medical )

Products, Inc., and UTAH MEDICAL )

PRODUCTS, INC., )

)

Defendants. )

MEMORANDUM & ORDER

DUGAN, District Judge:

Before the Court are Defendants’ Motions to Dismiss (Docs. 21, 22, 32) Plaintiff’s

Complaint (Doc. 1) under Federal Rule of Civil Procedure 12(b). Plaintiff responded to

each Motion (Docs. 23, 24, 34). For the reasons explained below, each Motion is DENIED.

I. Background

This case involves a female birth control device known as Filshie Clips, which are

“titanium clip[s] with silicone rubber lining[s]” that are implanted on a woman’s

fallopian tubes. (Doc. 1, pg. 4). Filshie Clips “cause bilateral occlusion (blockage) of the

fallopian tubes…elicit[ing] tissue growth[] [and]…causing a closure of the [fallopian]

tubes.” (Doc. 1, pg. 4). Plaintiff claims, over 25% of the time, Filshie Clips detach and

migrate from the fallopian tubes, wreaking havoc on the body. (Doc. 1, pgs. 4, 10-11).

Plaintiff underwent a tubal ligation procedure, resulting in the implantation of

Filshie Clips, in 2015. (Doc. 1, pgs. 4, 13). Thereafter, Plaintiff began experiencing pain

and discomfort in her lower abdominal region. (Doc. 1, pg. 13). Plaintiff’s pain, allegedly

caused by a Filshie Clip detaching and migrating from her fallopian tube, became more

severe. (Doc. 1, pg. 13). Despite Defendants’ knowledge of the risks of using Filshie Clips,

Plaintiff alleges she was never informed of the frequency of detachments and migrations

or the severity and permanency of the resulting injuries. (Doc. 1, pgs. 10, 13).

In August 2020, Plaintiff’s doctor allegedly confirmed from radiological imaging

that a Filshie Clip was missing. (Doc. 1, pg. 14). The Filshie Clip detached and migrated

from her fallopian tube but remained in her body. (Doc. 1, pg. 14). The Complaint alleges

Plaintiff “live[s] under the specter of having the foreign bodies migrating through her

pelvic area and the fear of having to undergo surgery,” as surgery is often necessary to

remove a detached and migrated Filshie Clip from a woman’s body. (Doc. 1, pg. 14).

Based on diversity jurisdiction, Plaintiff filed a 10-count, 93-page Complaint (Doc.

1) against Defendants, CooperSurgical, Inc., Utah Medical Productions, Inc. (“UMP”),

and Femcare, Ltd., which is a subsidiary of Defendant UMP in the United Kingdom. (Doc.

1, pg. 1).1 Defendants were sued jointly and severally as “companies and/or successors

in interest to the companies that designed, developed, manufactured, tested, labeled,

packaged, imported, distributed, marketed and/or sold” Filshie Clips. (Doc. 1, pg. 1).

Defendant Femcare, the manufacturer of Filshie Clips, obtained conditional premarket

approval (“PMA”) from the Food and Drug Administration (“FDA”) in 1996. (Doc. 1, pgs.

1Plaintiff is a citizen of Illinois. (Doc. 1, pg. 2). Defendant CooperSurgical, Inc., is a citizen of both

Delaware, where it is incorporated, and Connecticut, where it maintains its principal place of business.

(Doc. 1, pg. 2). Defendant Femcare is a citizen of Romsey, Hampshire, England, where it maintains its

principal place of business. (Doc. 1, pg. 2). Defendant UMP is a citizen of Utah, where it maintains its

principal place of business. (Doc. 1, pg. 2). Plaintiff seeks over $75,000 in damages.

5, 9). The Filshie Clip is a Class III medical device, meaning it “is purported or represented

to be for a use in supporting or sustaining human life or for a use which is of substantial

importance in preventing impairment of human health, or…presents a potential

unreasonable risk of illness or injury.” See 21 U.S.C. § 360c(1)(C); (Doc. 1, pg. 5).

The FDA evaluated the safety and effectiveness of Filshie Clips before granting

PMA and authorization for commercial distribution. (Doc. 1, pg. 5). It was allegedly

reported to the FDA that Filshie Clips migrated or expulsed .13% of the time. (Doc. 1, pg.

11). Further, the PMA allegedly imposed conditions on Defendant Femcare’s sale of the

product, including labeling requirements and restrictions on advertisements. (Doc. 1, pg.

5). Until 2019, Defendant CooperSurgical imported, distributed, marketed, and sold

Filshie Clips in the United States. (Doc. 1, pg. 9). Thereafter, Defendant UMP imported,

sold, distributed, and marketed Filshie Clips in the United States. (Doc. 1, pg. 9).

This case is based on Defendants’ failure to comply with the FDA mandates in the

PMA and violations of state and federal law. (Doc. 1, pgs. 5-7). Under 21 C.F.R. §§ 803,

814, and 820 et seq., Plaintiff alleges: (1) strict product liability against Defendant Femcare

for design defects (Count 1); (2) strict product liability against Defendant Femcare for a

failure to warn (Count 2); (3) product liability against Defendant Femcare for negligence

(Count 3); (4) gross negligence against Defendant Femcare (Count 4); (5) punitive

damages against Defendant Femcare (Count 5); (6) strict product liability against

Defendants CooperSurgical and UMP for design defects (Count 6); (7) strict product

liability against Defendants CooperSurgical and UMP for a failure to warn (Count 7);

(8) product liability against Defendants CooperSurgical and UMP for negligence (Count

8); (9) gross negligence against Defendants CooperSurgical and UMP (Count 9); and

(10) punitive damages against Defendants CooperSurgical and UMP (Count 10).

II. Analysis

Defendants’ separate Motions to Dismiss under Rule 12(b) present overlapping

issues. Each Defendant argues Plaintiff failed to state a claim because her claims are

preempted by federal law, are not cognizable under Illinois law, and are barred by the

applicable statute of limitations. Defendant UMP also argues Plaintiff failed to state a

claim because it cannot be held liable as the parent company of Defendant Femcare.

Finally, Defendants UMP and Femcare argue the Court lacks personal jurisdiction and is

an improper venue. The Court addresses each argument in the separate sections below.

A. Failure to State a Claim Under Rule 12(b)(6)

A motion to dismiss under Rule 12(b)(6) challenges a complaint for the failure to

state a claim for which relief may be granted. See Firestone Fin. Corp., 796 F.3d 822, 825

(7th Cir. 2015) (quoting Camasta v. Jos. A. Bank Clothiers, Inc., 761 F.3d 732, 736 (7th Cir.

2014)). To survive such a motion, which tests the sufficiency of the complaint but not the

merits of the case, a plaintiff must allege enough facts to state a facially plausible claim

for relief. See Kloss v. Acuant, Inc., 462 F. Supp. 3d 873, 876 (7th Cir. 2020) (quoting

McReynolds v. Merrill Lynch & Co., Inc., 694 F.3d 873, 878 (7th Cir. 2012)); Fosnight v. Jones,

41 F.4th 916, 921-22 (7th Cir. 2022) (quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544,

570 (2007)). Facial plausibility means a plaintiff pled enough facts to draw reasonable

inferences as to liability. See Fosnight, 41 F.4th at 922 (quoting Ashcroft v. Iqbal, 556 U.S.

662, 678 (2009)). A complaint need not allege “detailed factual allegations,” but it must

state enough facts to lift the claim above the speculative level. See Kloss, 462 F. Supp. 3d

at 876 (citing Twombly, 550 U.S. at 555). “Threadbare recitals” of the elements, supported

by mere conclusions, do not suffice. See Trivedi v. Wells Fargo Bank, N.A., 609 F. Supp. 3d

628, 631 (N.D. Ill. 2022) (quoting Iqbal, 556 U.S. at 678). When ruling, the Court accepts all

well-pled facts as true and draws all inferences for Plaintiff. See id. (quoting Tamayo v.

Blagojevich, 526 F.3d 1074, 1081 (7th Cir. 2008)); accord Kloss, 462 F. Supp. 3d at 874-75.

Especially notable in this case, there are no special pleading requirements for

claims of product liability, generally, or for claims related to Class III medical devices,

such as the Filshie Clip, specifically. See Bausch v. Stryker Corp., 630 F.3d 546, 558 (7th Cir.

2010). The ordinary federal pleading standards, discussed above, apply. See id. However,

in cases involving the defective manufacture of a medical device under federal law,

“courts must keep in mind that much of the product-specific information about

manufacturing needed to investigate such a claim fully is kept confidential by federal

law.” See id. Therefore, formal discovery is necessary before a plaintiff can fairly be

expected to provide detailed statements on the specific bases of the alleged claims. See id.

1. Preemption

Through the Supremacy Clause of the United States Constitution, Congress may

expressly or impliedly preempt any state law. See McMullen v. Medtronic, Inc., 421 F.3d

482, 486-87 (7th Cir. 2005) (quoting U.S. Const. art. VI; Chambers v. Osteonics Corp., 109

F.3d 1243, 1246 (7th Cir. 1997); Boomer v. AT&T Corp., 309 F.3d 404, 417 (7th Cir. 2002);

Hoagland v. Town of Clear Lake, Ind., 415 F.3d 693 (7th Cir. 2005)). The Medical Devices

Amendments (“MDA”) to the Federal Food, Drug, and Cosmetic Act (“FDCA”) contain

an express preemption provision for Class III medical devices. See 21 U.S.C. § 360k(a); see

also Gravitt v. Mentor Worldwide, LLC, No. 17-cv-5428, --- F. Supp. 3d ----, 2022 WL

17668486, *2 (Dec. 14, 2022) (“[F]ederal law limits the state law claims that a plaintiff may

pursue for injuries allegedly caused by Class III medical devices.”). It states:

(a) General Rule

Except as provided in subsection (b), no State or political subdivision of a

State may establish or continue in effect with respect to a device intended

for human use any requirement—

(1) which is different from, or in addition to, any requirement

applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any

other matter included in a requirement applicable to the device.

See 21 U.S.C. § 360k(a); see also McMullen, 421 F.3d at 487 (noting § 360k(a) preemption

requires (1) a requirement relating to a device intended for human use that a state

establishes or continues in effect, (2) a federal requirement under the FDCA that applies

to the specific device and is relevant to the conduct subject to the state requirement, and

(3) a state requirement that is different from, or in addition to, the federal requirement);

accord Laverty v. Smith & Nephew, Inc., 197 F. Supp. 3d 1026, 1030 (N.D. Ill. 2016).

Federal requirements, specific to individual products, are imposed through the

PMA process that Filshie Clips underwent in 1996, and lawsuits filed under state law

against medical device manufacturers who acquire PMA are preempted when liability is

premised on violations of state law and § 360k(a)(1) is satisfied. See McMullen, 421 F.3d at

487-88 (citing Mitchell v. Collagen Corp., 126 F.3d 902, 911 (7th Cir. 1997)); Bausch, 630 F.3d

at 550 (discussing Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008)); accord Link v. Zimmer

Holdings, Inc., 604 F. Supp. 2d 1174, 1177 (N.D. Ill. 2008) (“The PMA process as applied to

Class III medical devices by the FDA constitutes a federal ‘requirement’ specific to an

individual device as defined in the MDA.”); McCutcheon v. Zimmer Holdings, Inc., 586 F.

Supp. 2d 917, 921 (N.D. Ill. 2008).2 However, consistent with § 360k(a), a plaintiff may

maintain such a lawsuit if the state and federal requirements are parallel. See Gravitt, 2022

WL 17668486, *2 (citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996)). For a state

requirement to be parallel to a federal requirement, as opposed to “different from, or in

addition to,” a federal requirement under § 360k(a)(1), “the plaintiff must show that the

requirements are ‘genuinely equivalent.’ ” See McMullen, 421 F.3d at 489 (quoting Bates v.

Dow Agrosciences LLC, 544 U.S. 431, 454 (2005) (Emphasis in original)); accord Laverty, 197

F. Supp. 3d at 1031. If a manufacturer can be liable under state law but not federal law,

then the state and federal requirements are not “genuinely equivalent.” See McMullen,

421 F.3d at 489 (quoting Bates, 544 U.S. at 454). Put another way, if a federal requirement

permits a course of conduct that is obligatory under state law, then the state requirement

is preempted as “different from, or in addition to,” the federal requirement. See id.

The Court emphasizes that Section 360k(a) provides immunity to manufacturers

of Class III medical devices, such as the Filshie Clip, only to the extent that they comply

2The PMA process operates as a federal safety review that is specific to individual devices. See Link,

604 F. Supp. 2d at 1177. In that process, the FDA grants PMA “only to individual devices that it determines

provide a reasonable assurance of safety and effectiveness.” See id. (citing Riegel, 552 U.S. at 323). The FDA

weighs considerations related to the device, reaches a conclusion, then implements the conclusion through

a specific mandate on manufacturers and producers. See id. at 1177, 1179 (quoting Mitchell, 126 F.3d at 911).

with and do not violate federal law. See Bausch, 630 F.3d at 550, 553; accord Gravitt v.

Mentor Worldwide, LLC, 289 F. Supp. 3d 877, 885 (N.D. Ill. 2018); Garross v. Medtronic, Inc.,

77 F. Supp. 3d 809, 814 (E.D. Wisc. 2015). Therefore, nothing in § 360k(a) denies a state

the right to provide a traditional damages remedy for violations of common law duties,

including as to medical devices granted PMA, when those duties parallel federal

requirements. See Bausch, 630 F.3d at 550, 553 (quoting Lohr, 518 U.S. at 495); accord Gravitt,

289 F. Supp. 3d at 885; Laverty, 197 F. Supp. 3d at 1032; Garross, 77 F. Supp. 3d at 814. Such

remedies do not impose requirements “different from, or in addition to,” federal

requirements; instead, the remedies further incentivize a manufacturer’s compliance

with federal requirements. See Garross, 77 F. Supp. 3d at 814 (citing Lohr, 518 U.S. at 513).

Next, as to implied preemption, claims based on well-recognized duties owed in

product liability actions under state law, as opposed to claims of “fraud on a federal

agency,” are assumed to be within the police powers of the States and are not superseded

by federal law unless that was the clear and manifest intent of Congress. See Bausch, 630

F.3d at 557-58; accord Gravitt, 2022 WL 17668486, *2 (“[S]tate law claims are impliedly

preempted to the extent that they are ‘fraud-on-the-FDA’ claims rather than traditional

state law torts.”); Laverty, 197 F. Supp. 3d at 1034; Gravitt, 289 F. Supp. 3d at 888. For

example, a plaintiff’s claims are impliedly preempted if they seek to use state law to

police fraud against a federal agency based on statements a defendant was required to

make to the agency under federal law. See Gravitt, 289 F. Supp. 3d at 888 (quoting Buckman

Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 347 (2001)). Again, though, claims based on

well-recognized duties owed in product liability actions under state law are not impliedly

preempted. See Bausch, 630 F.3d at 557-58; Gravitt, 289 F. Supp. 3d at 888.

In light of these principles, the Seventh Circuit has discussed a gap through which

plaintiffs may avoid preemption. See Bausch, 630 F.3d at 557-58 (quoting In re Medtronic,

Inc., Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1204 (8th Cir. 2010)). Plaintiff

must be suing Defendants for conduct that violates the FDCA or her claims will be

expressly preempted under § 360k(a), but she cannot be suing Defendants merely because

the conduct violates the FDCA or her claims will be impliedly preempted. See id. (quoting

Medtronic Leads, 623 F.3d at 1204); accord Garross, 77 F. Supp. 3d at 814. Plaintiff must be

able to show harm stemming from a violation of the FDCA at the same time as a breach

of a well-recognized and parallel duty owed under state law. See Bausch, 630 F.3d at 557-

58 (discussing Medtronic Leads, 623 F.3d at 1204); see also Garross, 77 F. Supp. 3d at 814

(“[A] state law claim which alleges a violation of the FDCA but which alleges that

violation in the context of an independent, ‘well-recognized duty owed to [plaintiff]

under state law’ can survive both express and implied preemption.”).3

3Notably, in Illinois, a violation of a statute, designed to protect human life, is prima facie evidence

of negligence. See Bausch, 630 F.3d at 553. Also, Illinois recognizes negligence and strict liability claims

arising from a manufacturer’s failure to warn, i.e., to disclose known defects. See Laverty, 197 F. Supp. 3d at

1032 (citing Woodill v. Parke Davis & Co., 79 Ill. 2d 26, 29 (1980); Hernandez v. Schering Corp., 2011 IL App

(1st) 093306, ¶ 38). The associated duty is not limited to issuing warnings directly to end users “but rather

‘depends on whether [the defendant] and [the plaintiff] stood in such a relationship to each other that the

law imposed upon [the defendant] an obligation of reasonable conduct for the benefit of [the plaintiff].”

See id. at 1035 (quoting Solis v. BASF Corp., 2012 IL App (1st) 110875, ¶ 64). Further, “in Illinois, ‘in a products

liability action, all persons in the distributive chain are liable for injuries resulting from a defective product,

including suppliers, distributors, wholesalers[,] and retailers.’ ” See Smith v. Phoenix Seating Sys., LLC, 894

F. Supp. 2d 1088, 1093 (S.D. Ill. 2012) (quoting Hammond v. North Am. Asbestos Corp., 97 Ill. 2d 195 (1983)).

The MDA codified standards for reporting, but it did not “eviscerate the longstanding state-imposed duty

to warn simply by redefining the way medical device manufacturers satisfy that obligation.” See id.

In this case, Defendants argue the FDA granted PMA to the Filshie Clip in 1996,

and neither the original nor the supplemental PMA approvals were suspended or

revoked. (Docs. 21, pg. 4; 22, pg. 10; 32, pg. 8). Therefore, Defendants argue the Filshie

Clip, at all times, was deemed safe and effective. (Docs. 21, pg. 7; 22, pg. 13; 32, pg. 12).

Defendants also argue Plaintiff’s claims would require courts and juries to contradict or

second guess the FDA in order to find Filshie Clips were “accompanied by inadequate

warnings and/or…[were] defectively designed.” (Docs. 21, pg. 7; 22, pg. 13; 32, pg. 12).

Such findings would allegedly require different or additional warnings or designs than

those approved and required by the FDA. (Docs. 21, pg. 7; 22, pgs. 13-14; 32, pg. 12).

Further, even if Plaintiff can prove violations of the FDA regulations, Defendants

argue her claims do not provide a basis for non-preempted state claims. (Docs. 21, pg. 7;

22, pg. 14; 32, pg. 13). Defendants state breaches of the FDA regulations—e.g., by failing

to report product complaints, literature, and unpublished studies to the FDA or to

provide related warnings and labeling that could have led to a different course of action

by the FDA—are breaches of duties owed to the FDA, such that Plaintiff’s claims are

impliedly preempted. (Docs. 21, pgs. 8-9; 22, pgs. 15-16; 32, pgs. 11, 13-15).

In response, Plaintiff argues Defendants claim, relating to Illinois judges and

juries, is “incredibly vague” and “based on a fundamental misunderstanding” of her

claims and preemption. (Docs. 23, pg. 6; 24, pg. 4; Doc. 34, pg. 3). Plaintiff argues each

Count is premised on specific factual allegations related to Defendants’ failure to comply

with various Current Good Manufacturing Practices “to the extent that they are parallel

to and not different from or in additional [sic] to the requirements of federal law.” (Doc.

23, pg. 7; 24, pg. 5; Doc. 34, pg. 5). Further, Plaintiff submits her allegations are based on

Defendants’ post-PMA actions, i.e., on Defendants’ violations of the FDA regulations as

a manufacturer or distributor of Filshie Clips after PMA. (Doc. 23, pgs. 7-8; Doc. 24, pg.

5; Doc. 34, pg. 5). Plaintiff argues such claims, “alleging harm caused by conduct that

violates a federally imposed requirement,” are precisely the type the Seventh Circuit has

found can survive express preemption. (Doc. 23, pg. 8; 24, pg. 5; Doc. 34, pg. 5). Finally,

Plaintiff indicates courts must be cautious when considering whether to dismiss product

liability claims, as information related to the nature of the defects in the product may not

be available to the Plaintiff before discovery. (Doc. 23, pg. 8; 24, pg. 6; Doc. 34, pg. 5).

As to implied preemption, Plaintiff states her claims are not based entirely on a

“fraud-on-the-FDA” theory and do not seek to privately enforce duties owed to the FDA.

(Doc. 23, pgs. 9-10; 24, pgs. 6-7; Doc. 34, pgs. 7-8). As such, Plaintiff indicates she may use

evidence of Defendants’ FDA violations to prove breaches of well-recognized state law

duties. (Doc. 23, pgs. 9-10; 24, pg. 7; Doc. 34, pg. 8). She argues, “the claim[s] do[] not seek

to remedy the breach of a duty to the FDA, but look[] to federal law only to give content

to the Defendant[s’] traditional state common-law dut[ies],” so there is a presumption

against implied preemption. (Doc. 23, pg. 11; 24, pg. 9 n. 10; Doc. 34, pg. 10 n. 15).

Now, the Court must address a procedural tripwire, set by the parties without

discussion, when drafting the Complaint and the briefing on the Motions to Dismiss.

Federal Rule of Civil Procedure 8 “carefully distinguishes between” defenses that are

denials in subpart (b) and affirmative defenses in subpart (c)(1). See Luna Vanegas v. Signet

Builders, Inc., 46 F.4th 636, 640 (7th Cir. 2022); Fed. R. Civ. P. 8(b), (c)(1). Under Rule 8(c)(1),

a defendant “[i]n responding to a pleading…must affirmatively state any…affirmative

defense.” See Fed. R. Civ. P. 8(c)(1) (Emphasis added). That rule “provides a nonexclusive

list of such defenses” requiring the defendant to “come back with a responsive pleading,”

i.e., to answer the complaint under Federal Rule of Civil Procedure 7(a)(2), “unless it is

raising one of the seven defenses listed in Rule 12(b) as appropriate for a motion.”

See Luna Vanegas, 46 F.4th at 640. The Seventh Circuit has noted that affirmative defenses,

like preemption, do not appear on Rule 12(b)’s list of defenses appropriate for a motion.

See id.; see also Doe v. GTE Corp., 347 F.3d 655, 657 (7th Cir. 2003) (“Affirmative defenses

do not justify dismissal under Rule 12(b)(6).”); Benson v. Fannie May Confections Brands,

Inc., 944 F.3d 639, 645 (7th Cir. 2019) (noting preemption is an affirmative defense on

which a defendant bears the burden of pleading and proof). Indeed, from the structure

of the Rules and the plain language of Rule 8(c)(1), the Seventh Circuit stated: “It

follows…an affirmative defense must be raised in the answer, not by motion.” See Luna

Vanegas, 46 F.4th at 640 (Emphasis added) (citing Vazquez v. Indiana Univ. Health, Inc., 40

F.4th 582, 588 (7th Cir. 2022)); accord King v. King, No. 23-cv-355, 2023 WL 3346974, *6 (S.D.

Ill. May 10, 2023); Johnston v. Kashi Sales, L.L.C., 626 F. Supp. 3d 997, 1006 (S.D. Ill. 2007).

Further, in Luna Vanegas, the Seventh Circuit posited that “[t]here is real

consequence to this structure” because a plaintiff, when drafting a complaint, is not

required to anticipate or refute affirmative defenses. See Luna Vanegas, 46 F.4th at 640;

see also Bausch, 630 F.3d at 561 (stating, in the case of a Class III medical device, the MDA,

and the FDCA, “[p]reemption is an affirmative defense…and pleadings need not

anticipate or attempt to circumvent affirmative defenses.”). Also, motions under Rule

12(b)(6) are limited to instances where “the law does not confer a right to relief,” and it is

rare that “the face of the complaint [will] so clearly prove the opponent’s affirmative

defense that immediate dismissal, prior to the filing of an answer, will be proper.” See

Luna Vanegas, 46 F.4th at 640 (citing Hecker v. Deere & Co., 556 F.3d 575, 588 (7th Cir. 2009)).

It is true, as a practical matter, courts have “taken shortcuts” when “the complaint

leaves no doubt that there is a good” affirmative defense. See id. at 640, 645. However, the

Seventh Circuit has emphasized, “it is safer to insist on compliance with the rules.” See id.

at 640; accord Johnston, 626 F. Supp. 3d at 1006. The “shortcut[],” which has been followed

in this Circuit, has also been described as “a narrow and pragmatic exception” to the

above-described structure of the Rules. See Gunn v. Cont’l Cas. Co., 968 F.3d 802, 806 (7th

Cir. 2020). Absent an application of that exception, which is available if a plaintiff pleads

out of court, the proper vehicle for resolving an affirmative defense is a Rule 12(c) motion

for a judgment on the pleadings after the filing of an answer. See id. (citing Benson, 944

F.3d at 645; Burton v. Ghosh, 961 F.3d 960, 964-65 (7th Cir. 2020); Brooks v. Ross, 578 F.3d

574, 579 (7th Cir. 2009)); accord Luna Vanegas, 46 F.4th at 640; H.A.L. NY Holdings, LLC v.

Guinan, 958 F.3d 627, 632 (7th Cir. 2020). A plaintiff pleads out of court if the complaint

sets forth all that is necessary to satisfy the affirmative defense, i.e., if the complaint

“present[s] ‘all relevant facts,’ [citation], such that…[the plaintiff] has essentially

‘admit[ted] all the ingredients of an impenetrable defense.’ ” See Novotney v. Walgreen Co.,

No. 22-cv-3439, 2023 WL 4698149, *2 (N.D. Ill. July 20, 2023) (quoting Sidney Hillman

Health Ctr. of Rochester v. Abbott Labs, Inc., 782 F.3d 922, 928 (7th Cir. 2015); Brownmark

Films, LLC v. Comedy Partners, 682 F.3d 687, 690 (7th Cir. 2012); Xechem, Inc. v. Bristol-Myers

Squibb Co., 372 F.3d 899, 901 (7th Cir. 2004)); accord Luna Vanegas, 46 F.4th at 640, 645.

If the “narrow and pragmatic” exception applies, “the difference between Rules

12(b)(6) and 12(c)…[may] be disregarded.” See Benson, 944 F.3d at 645 (citing Logan v.

Wilkins, 644 F.3d 577, 582-83 (7th Cir. 2011); Brooks, 578 F.3d at 579). Otherwise, the

distinction between the rules is “ ‘necessary to allocate correctly the burdens of pleading

and proof,’ [citation], and serves an important notice function.” See Gunn, 968 F.3d at 806

(quoting H.A.L. NY Holdings, LLC, 958 F.3d at 632); citing Burton, 961 F.3d at 964-65).

Here, the Court declines to dismiss Plaintiff’s Complaint based on Defendants’

affirmative defense of preemption. While Plaintiff positively addressed preemption in

the Complaint and did not object to the Court’s consideration of that affirmative defense

under Rule 12(b)(6), the Court finds Plaintiff did not plead out of court for purposes of

the “narrow and pragmatic” exception to the structure of Rules 8 and 12. See King, 2023

WL 3346974, *7 (noting the Seventh Circuit’s statements in Benson, Luna Vanegas, and

Gunn, including the necessity of observing the distinction between Rules 12(b)(6) and (c),

before declining to dismiss the plaintiff’s claims based on a preemption affirmative

defense under Rule 12(b)(6)); Johnston, 626 F. Supp. 3d at 1006 (same, and also finding, in

the context of the FDCA and FDA regulations, the plaintiff did not plead herself out of

court); Crawford v. AriZona Beverages USA LLC, No. 22-cv-220, 2023 WL 1100260, *6 (S.D.

Ill. Jan. 30. 2023) (declining, under Benson and Luna Vanegas, to determine whether, in the

context of the FDCA and FDA regulations, a preemption affirmative defense barred the

plaintiff’s claims under Rule 12(b)(6), where, inter alia, a motion for a judgment on the

pleadings was the appropriate way to address preemption since the plaintiff did not

plead out of court and the difference between Rule 12(b)(6) and (c) could not be

disregarded). Notably, Defendants do not identify or address the procedural quirks

related to their Motions to Dismiss, let alone suggest Plaintiff pled out of Court under the

stringent standard articulated above. See Williams v. City of Chicago, No. 22-cv-1084, 2022

WL 3716214, *6 (N.D. Ill. Aug. 29, 2022) (declining to consider affirmative defense of

immunity under Rule 12(b)(6), where such a consideration would be “procedurally

improper,” would require ignoring the “clear pronouncement” of the Seventh Circuit in

Gunn and Luna Vanegas, and the defendants did not argue the plaintiff pled out of court

for purposes of disregarding the difference between Rule 12(b)(6) and (c)).

Further, the Court notes that this is a complex product liability case involving

various federal and state law requirements. It cannot seriously be doubted that

compliance with the mandates of the Rules, including through the filing of an answer

and participation in discovery, will serve to flesh out Plaintiff’s detailed factual

allegations related to, inter alia, those requirements and the pre- and post-PMA process.

It is notable, at least at the time of the Complaint, “Plaintiff d[id] not have access to the

complete Filshie Clip PMA approval order, Femcare’s PMA application, specific post

approval requirements, or any supplementary orders[] along with specified

requirements listed therein.” (Doc. 1, pg. 17 n. 3). Plaintiff indicated, once she “obtain[ed]

[the] PMA approval order and related documents through discovery, Plaintiff w[ould]

amend th[e] Complaint based on the specific requirements set forth therein as necessary.”

(Doc. 1, pg. 17 n. 3). As noted above, in cases alleging the defective manufacture of a

medical device, “courts must keep in mind that much of the product-specific information

about manufacturing needed to investigate such a claim fully is kept confidential by

federal law,” such that formal discovery is necessary before a plaintiff can fairly be

expected to make detailed statements on the specific bases of her claims. See Bausch, 630

F.3d at 558. Compliance with the Rules will identify and contextualize the precise nature

of the aforementioned requirements, which are vital to preemption and, perhaps

tellingly, have been discussed by the parties in fairly broad terms to this point in the case.

Thus, the Court declines to take the “shortcut[],” identified in Luna Vanegas, and instead

finds it safer to insist on compliance with the Rules. See Luna Vanegas, 46 F.4th at 640.

2. Breaches of the FDA Regulations Under Illinois Law

Defendants argue, while Illinois recognizes a duty to warn about medical devices,

it extends only to prescribing physicians. (Docs. 21, pg. 11; 22, pg. 19; 32, pg. 18).

According to Defendants, Plaintiff has not identified a duty to warn governmental

agencies of potential damages caused by medical devices. (Docs. 21, pg. 11; 22, pg. 19; 32,

pg. 19). Plaintiff disagrees, claiming the duty to warn requires product manufacturers to

engage in reasonable conduct for the benefit of end users. (Doc. 23, pg. 13; 24, pg. 19; Doc.

34, pgs. 19-20). She claims that includes compliance with FDA disclosure requirements.

(Doc. 23, pg. 13; 24, pg. 19; Doc. 34, pgs. 19-20).

As noted at footnote 3, a violation of a statute, designed to protect human life, is

prima facie evidence of negligence in Illinois. See Bausch, 630 F.3d at 553. Also, Illinois

recognizes negligence and strict liability claims arising from a manufacturer’s failure to

disclose known defects in a product. See Laverty, 197 F. Supp. 3d at 1032 (citing Woodill,

79 Ill. 2d at 29); Hernandez, 2011 IL App (1st) 093306, ¶ 38). The associated duty, which is

not limited to issuing warnings directly to end users, looks to the relationship of the

parties and assesses whether the defendant had an obligation of reasonable conduct for

the benefit of the plaintiff. See id. at 1035 (quoting Solis, 2012 IL App (1st) 110875, ¶ 64).

And, notable here, all persons in the distributive chain may be liable in a product liability

action in Illinois. See Smith, 894 F. Supp. 2d at 1093 (quoting Hammond, 97 Ill. 2d at 195).

Again, the MDA did not “eviscerate the longstanding state-imposed duty to warn simply

by redefining the way medical device manufacturers satisfy that obligation.” See id.

In light of these legal principles, the Court rejects Defendants’ arguments at this

stage in the case. Plaintiff alleged enough facts to state a facially plausible claim for relief

against Defendants. See Kloss, 462 F. Supp. 3d at 876; Fosnight, 41 F.4th at 921-22); Bausch,

630 F.3d at 558.

3. The Statue of Limitations

Defendants argue Plaintiff cannot benefit from the discovery rule to excuse

compliance with the statute of limitations. See 735 ILCS 5/13-213(d); (Docs. 21, pg. 10; 22,

pg. 16; 32, pg. 16). They argue Plaintiff’s claims accrued when she began experiencing

severe pain from the tubal ligation procedure that implanted the Filshie Clips. (Docs. 21,

pg. 10; 22, pg. 17; 32, pg. 16). Defendants note, according to Plaintiff, the “severe pain”

began “shortly after” the tubal ligation procedure, which occurred at some time in 2015.

(Docs. 21, pg. 10; 22, pg. 17; 32, pg. 16). Defendants also note this case was filed

approximately 7 years after that procedure. (Docs. 21, pg. 10; 22, pg. 17; 32, pg. 16).

In response, Plaintiff argues Defendants’ failure to disclose to the FDA that Filshie

Clips had a migration rate of 25%, not .13%, meant Plaintiff and her healthcare providers

were deprived of sufficient information related to the risk of injury and pain. (Doc. 23,

pg. 12; 24, pg. 19; Doc. 34, pg. 19). Plaintiff notes that deprivation of information resulted

in her choice to undergo the tubal ligation procedure that implanted the Filshie Clip,

which resulted in “severe pain” for which the cause was unknown. (Doc. 23, pg. 12; 24,

pg. 19; Doc. 34, pg. 19). Plaintiff suggests it was not until August 2020 that she discovered

a Filshie Clip was causing her pain. (Doc. 23, pg. 12; 24, pg. 19; Doc. 34, pg. 19).

Section 13-213(d) of the Illinois Code of Civil Procedure provides: “[I]f the injury

complained of occurs within any of the periods provided by subsection (b) and paragraph

(2) of subsection (c), the plaintiff may bring an action within 2 years after the date on

which the claimant knew, or through the use of reasonable diligence should have known,

of the existence of the personal injury.” See 735 ILCS 5/13-213(d). Obviously, applying

this statutory provision requires a highly factual analysis. Therefore, as with preemption,

Defendants hit a procedural snag when invoking the affirmative defense of untimeliness

under Section 13-213(d). See Sidney Hillman Health Center of Rochester v. Abbott Labs, Inc.,

782 F.3d 922, 928 (7th Cir. 2015).

A dismissal of a complaint as untimely under Rule 12(b)(6) is an “unusual step,”

as a complaint need not anticipate or attempt to circumvent affirmative defenses and the

analysis usually depends upon facts not before the Court. See id. (quoting Cancer

Foundation, Inc. v. Cerberus Capital Mgmt., LP, 559 F.3d 671, 674 (7th Cir. 2009); Brownmark

Films, LLC, 682 F.3d at 690); accord Rokowsky v. Vericity, Inc., 632 F. Supp. 3d 797, 805 (N.D.

Ill. 2022); see also Perry v. Sullivan, 207 F.3d 379, 382 (7th Cir. 2000) (“Rule 8 specifically

requires statute of limitations defenses to be stated in the defendant’s responsive

pleading.”). Of course, as with preemption, an exception applies when the plaintiff pleads

out of court. See Sidney, 782 F.3d at 928 (quoting O’Gorman v. City of Chicago, 777 F.3d 885,

889 (7th Cir. 2015); citing Cancer Foundation, Inc., 559 F.3d at 674); accord Rokowsky, 632 F.

Supp. 3d at 805. However, the Seventh Circuit has cautioned that applying the exception

is the “ ‘irregular’ approach.” See Sidney, 782 F.3d at 928 (quoting Chicago Building Design,

P.C. v. Mongolian House, Inc., 770 F.3d 610, 613-14 (7th Cir. 2014); citing U.S. v. N. Trust

Co., 372 F.3d 886, 888 (7th Cir. 2004)). If there is “a conceivable set of facts” that defeats

the affirmative defense of untimeliness, then questions of timeliness are left for summary

judgment or trial, when the analysis may be conducted “based on a more complete factual

record.” See id. (citing Clark v. Braidwood, 318 F.3d 764, 767 (7th Cir. 2003); Early v. Bankers

Life & Cas. Co., 959 F.2d 75, 80 (7th Cir. 1992)); accord Rokowsky, 632 F. Supp. 3d at 805.

In light of these authorities, and the fact that there is clearly “a conceivable set of

facts” that defeats Defendants’ affirmative defense of untimeliness under Section 13-

213(d), the Court declines to take the “unusual step” of dismissing the Complaint under

Rule 12(b)(6). See Sidney, 782 F.3d at 928; Rokowsky, 632 F. Supp. 3d at 805.

4. UMP as the Parent Company of Femcare

Defendant UMP concedes it is the parent company of Defendant Femcare, which

is the manufacturer of Filshie Clips. (Doc. 22, pg. 8). However, Defendant UMP argues

Plaintiff cannot maintain this action against an uninvolved parent company. (Doc. 22, pg.

8). Plaintiff notes the two exceptions to this general legal principle, related to the direct

liability of the parent company or its control over the misconduct, are inapplicable under

the circumstances of this case. (Doc. 22, pg. 8). In short, Defendant UMP argues it cannot

be liable for any general oversight of Defendant Femcare. (Doc. 22, pg. 8). Defendant

UMP reminds the Court that Defendant Femcare has its own corporate headquarters in

Romsey, Hampshire, England, and it is a separate and distinct legal entity. (Doc. 22, pg.

9). Defendant UMP also suggests Plaintiff makes no allegation that it was involved with

the Filshie Clips utilized in Plaintiff’s tubal ligation procedure. (Doc. 22, pg. 9).

Here, the Court declines to dismiss Plaintiff’s claims against Defendant UMP

based on its conclusory argument that it is an “uninvolved” parent company. In other

words, the Court declines Defendant UMP’s invitation to decide a merits question, i.e.,

whether it is directly or indirectly liable, on the pleadings before discovery. In so

declining, though, the Court notes Defendant UMP acquired Defendant Femcare, the

manufacturer of Filshie Clips, in 2011, at which time Defendant Femcare had a

distribution agreement with Defendant CooperSurgical to market and sell Filshie Clips

in the United States. In 2019, Defendant UMP acquired the distribution rights to Filshie

Clips in the United States. As is discussed in more detail below, the record indicates

Defendant UMP benefitted financially from the marketing and sale of Filshie Clips in the

United States between 2011, when it “merge[d]” with Defendant Femcare, and the

present. (Doc. 24-5, pgs. 4, 13). Also, the Court notes that Defendants’ post-PMA

misconduct allegedly prevented Plaintiff from discovering her injuries until 2020, at

which time Defendant UMP was undisputedly the distributor of Filshie Clips in the

United States. Therefore, at present, the Court finds Plaintiff satisfied her light burden of

alleging enough facts to state a facially plausible claim for relief against Defendant UMP.

See Kloss, 462 F. Supp. 3d at 876; Fosnight, 41 F.4th at 921-22; Bausch, 630 F.3d at 558.

B. Personal Jurisdiction

In a Rule 12(b)(2) motion, a defendant may assert a lack of personal jurisdiction.

The plaintiff bears the burden of proof in response. See Rogers v. City of Hobart, Indiana,

996 F.3d 812, 818 (7th Cir. 2021) (citing Curry v. Revolution Labs., LLC, 949 F.3d 385, 392-98

(7th Cir. 2020)). If all factual disputes are resolved for the plaintiff, then the Court may

decide the motion, without a hearing, on the parties’ written materials. See McAdams v.

Daedong Indust. Co. Ltd., 409 F. Supp. 3d 660, 663 (S.D. Ill. 2019) (citing Purdue Research

Foundation v. Sanofi-Synthelabo, S.A., 338 F.3d 773, 782 (7th Cir. 2003); uBID, Inc. v.

GoDaddy Group, Inc., 623 F.3d 421, 423-24 (7th Cir. 2010)). The plaintiff must make a prima

facie case of personal jurisdiction. See id. (citing Purdue Research Foundation, 338 F.3d at

782); see also Karraker v. Rent-A-Center, Inc., 239 F. Supp. 2d 828, 839 (C.D. Ill. Jan. 8, 2003)

(“Plaintiffs need only assert a prima facie case of personal jurisdiction…and the motion

will be denied if Plaintiffs allege ‘sufficient facts to support a reasonable inference’ that

Defendants can be subjected to th[e] court’s personal jurisdiction.”).

Relevantly, specific personal jurisdiction requires “minimum contacts” between

the defendant and the forum state, i.e., “ ‘an affiliation between the forum and the

underlying controversy, principally, an activity or an occurrence that takes place in the

forum State and is therefore subject to the State’s regulation.’ ” See In re Sheehan, 48 F.4th

513, 522 (7th Cir. 2022) (quoting Bristol-Myers Squibb Co. v. Superior Ct., 528 U.S. 255, 262

(2017)); Rogers, 996 F.3d at 818. The Seventh Circuit has stated the following requirements

for specific personal jurisdiction: (1) the defendant must purposefully direct its activities

at the forum state or purposefully avail itself of the privilege of conducting business in

the forum state; (2) the injury alleged by the plaintiff must arise out of or relate to the

defendant’s activities in the forum state; and (3) the Court’s exercise of specific personal

jurisdiction must comport with traditional notions of fair play and substantial justice. See

In re Sheehan, 48 F.4th at 522 (citing Rogers, 996 F.3d at 819; Tamburo v. Dworkin, 601 F.3d

693, 702 (7th Cir. 2010)); see also Rogers, 996 F.3d at 818 (“Because the Illinois long-arm

statute extends as far as the Constitution permits, [citation], we need only look to whether

exercising personal jurisdiction here would comport with federal due process.”).

As to the first requirement for specific personal jurisdiction, the Court focuses on

the acts of the defendant and not those of the plaintiff or third parties. See In re Sheehan,

48 F.4th at 522-23 (citing Walden v. Fiore, 571 U.S. 277, 284 (2014); NBA Properties, Inc. v.

HANWJH, 46 F.4th 614, 620-21 (7th Cir. 2022)). The defendant’s relationship with the

forum state must arise out of its contacts with the forum state. See id. at 522-23 (quoting

Walden, 571 U.S. at 284; citing Asahi Metal Indus. Co. v. Superior Ct. of Cal., Solano County,

480 U.S. 102, 109 (1987)); accord Rogers, 996 F.3d at 819. The plaintiff cannot be “the only

link” to the forum state. See In re Sheehan, 48 F.4th at 523 (citing Walden, 571 U.S. at 285).

Also, particularly relevant here, the Seventh Circuit applies the stream of

commerce theory, articulated in World-Wide Volkswagen Corp. v. Woodson, 444 U.S. 286

(1980), as a means of satisfying the first requirement for specific personal jurisdiction in

product liability cases. See J.S.T. Corp. v. Foxconn Interconnect Tech. Ltd., 965 F.3d 571, 575

(7th Cir. 2020); accord Dehmlow v. Austin Fireworks, 963 F.2d 941, 946 (7th Cir. 1992);

see also Neterval-Quiel v. CMC SRL, No. 21-cv-1279, 2022 WL 4131921, *3 (E.D. Wisc. Sept.

12, 2022) (stating the stream of commerce theory is a method for satisfying the first

requirement for specific personal jurisdiction); Felland v. Clifton, 682 F.3d 665, 674 (7th Cir.

2012) (“[T]he nature of the purposeful-direction/purposeful-availment inquiry depends

in large part on the type of claim at issue.”). This is despite other Circuits splitting on the

continued viability of the theory and the Supreme Court, in two cases, being unable to

resolve that split. See J.S.T. Corp., 965 F.3d at 575 (citing J. McIntyre Mach., Ltd. v. Nicastro,

564 U.S. 873 (2011); Asahi Metal Indus. Co., 480 U.S. 102); Dehmlow, 963 F.2d at 946. The

Seventh Circuit has stated: “In the absence of intervening guidance from the Supreme

Court, we have reasoned that the Court adopted the stream of commerce theory…and

has not overruled it since.” See J.S.T. Corp., 965 F.3d at 575-76 (citing Dehmlow, 963 F.2d at

946-47; Jennings v. AC Hydraulic A/S, 383 F.3d 546, 550 n. 2 (7th Cir. 2004)).

Under the stream of commerce theory, specific personal jurisdiction “may be

appropriate over ‘a corporation that delivers its products into the stream of commerce

with the expectation that they will be purchased by consumers in the forum State.’ ”

See J.S.T. Corp., 965 F.3d at 575 (quoting World-Wide Volkswagen Corp., 444 U.S. at 297-98);

see also Jennings, 383 F.3d at 550 (“If a defendant delivers products into a stream of

commerce, originating outside the forum state, with the awareness or expectation that

some of the products will be purchased in the forum state, that defendant may be subject

to specific [personal] jurisdiction in the forum state.”); accord Neterval-Quiel, 2022 WL

4131921, *3; see also Morris v. Daimler Trucks North America, LLC, No. 20-cv-246, 2020 WL

4436330, *4 (S.D. Ill. Aug. 3, 2020) (stating courts in the Seventh Circuit still apply the “less

stringent” stream of commerce theory in product liability cases, meaning, “if a products

liability defendant in a court in Illinois is aware and expects its product to be marketed

and regularly sold in Illinois in the stream of commerce, it will be subject to personal

jurisdiction in Illinois.”). By way of an example of the stream of commerce theory, the

Seventh Circuit has found personal jurisdiction in a product liability lawsuit where “a

defendant sold fireworks to a middleman ‘with the knowledge that its fireworks would

reach Illinois consumers in the stream of commerce.’ ” See J.S.T. Corp., 965 F.3d at 576.

Such downstream sales to consumers can support specific personal jurisdiction

because the sales bear on the relationship between the defendant, the forum, and the

litigation. See id. (quoting Walden, 571 U.S. at 277). The defendant must have minimum

contacts with the forum state and the litigation must arise from those minimum contacts.

See id. In a product liability case, the underlying allegation relates to the development of

a product that is harmful to consumers. See id. Therefore, if the defendant takes steps to

reach consumers in the forum state, it has created a relationship with the forum state that

has “special relevance” to the litigation. See id.; accord Forde, 2021 WL 148877, *6; see also

Morris, 2020 WL 4436330, *4 (stating, under J.S.T. Corp., if a defendant places a product in

the stream of commerce “with the awareness and expectation that it could reach Illinois

consumers…, and the litigation arose out of those downstream sales, [then] the Court has

specific personal jurisdiction.”). The point of consumer sale is relevant to the relationship

between the defendant, the forum state, and the litigation, even if the product travels

through middlemen before reaching the consumers. See J.S.T. Corp., 965 F.3d at 576.

Further, in the context of the second requirement for specific personal jurisdiction,

the Seventh Circuit has “declined to definitively resolve” what is required to prove a

causal connection between the plaintiff’s injury and the defendant’s activities in the

forum state, but it “suggested in passing that a mere ‘but for’ causal relationship is

insufficient to establish the required nexus.” See Felland, 682 F.3d at 676-77; accord Lab

Verdict, Inc. v. Lab Equip Ltd., 436 F. Supp. 3d 1181, 1188-89 (S.D. Ind. 2020). Also, as to the

third requirement for specific personal jurisdiction, the Court considers the

inconvenience to the defendant, the forum state’s interest in adjudicating the dispute, the

plaintiff’s interest in obtaining convenient and effective relief, the interstate judicial

system’s interest in obtaining an efficient resolution of the controversy, and the shared

interests of the States in advancing fundamental substantive social policies. See Rogers,

996 F.3d at 819 (quoting Curry, 949 F.3d at 396); accord Dehmlow, 963 F.2d at 945. The

defendant cannot be put “at a severe disadvantage” by the jurisdictional rules; however,

if the defendant purposefully directed its activities at the forum state or availed itself of

the privilege of conducting business in the forum state, then the defendant must make a

compelling showing that the circumstances render specific personal jurisdiction

unreasonable. See Felland, 682 F.3d at 677 (quoting Burger King Corp., 471 U.S. at 477).

Finally, the Court notes, in Jennings, the Seventh Circuit discussed the situation in

which a foreign manufacturer was a defendant in a product liability case. The Seventh

Circuit stated, “[w]ith the free flow of commerce within the United States today, it may

seem counterintuitive that a foreign manufacturer…sell[ing] goods to a distributor in the

United States should not be assumed to have the expectation that its goods may end up

for sale in any one of the fifty states.” See Jennings, 383 F.3d at 551. However, the Seventh

Circuit noted, as was stressed in World-Wide Volkswagen, State lines are not irrelevant for

purposes of jurisdiction, even though the United States is meant to be a common market.

See id. (quoting World-Wide Volkswagen Corp., 444 U.S. at 293). The minimum contacts

requirement protects a nonresident defendant in a diversity case. See id. Personal

jurisdiction cannot be exercised over such a nonresident defendant if it lacks minimum

contacts with the forum state. See id. (quoting Burger King Corp., 471 U.S. at 474).

1. Defendant UMP

Defendant UMP argues Plaintiff provides “mere formulaic recitations” of personal

jurisdiction without discussing its contacts with Illinois or Filshie Clips. (Doc. 22, pg. 2).

Defendant UMP argues, at all relevant times, it did not do business related to Filshie Clips

or engage in purposeful contacts with physicians in Illinois. (Doc. 22, pgs. 3, 6). Defendant

UMP submitted the Declaration of Mr. Kevin Cornwell, the Chairman and CEO of

Defendant UMP, who noted Defendant UMP acquired Defendant Femcare in 2011. (Doc.

21, pgs. 6, 13-14). However, Mr. Cornwell states Defendant UMP “did not design,

research, conduct safety surveillance, develop, manufacture, test, label, package,

distribute, market, or sell the Filshie Clips utilized in plaintiff[’s]…2015 tubal ligation

[procedure].” (Doc. 22, pgs. 13-14). Mr. Cornwell indicates it was not until February 2019,

when Defendant UMP purchased the distribution rights of Defendant CooperSurgical,

that Defendant UMP directly sold Filshie Clips to medical facilities in the United States.

(Doc. 22, pg. 14). Before that time, Mr. Cornwell attests that Defendant UMP “did not sell

or market the Filshie Clips in Illinois or elsewhere…[and] was not involved in the sale or

marketing of the Filshie Clips involved in this lawsuit.” (Doc. 22, pg. 14).

In response, Plaintiff attacks Mr. Cornwell’s “carefully worded” Declaration. (Doc.

24, pg. 10). First, Plaintiff notes Defendant UMP has owned Defendant Femcare, the

manufacturer of Filshie Clips, since 2011. (Doc. 24, pg. 10). Plaintiff suggests Defendant

UMP has been profiting from the sale of Filshie Clips in the United States, including in

Illinois, since that time. (Doc. 24, pg. 10). Defendant admits, though, she is unaware of

how many Filshie Clips have been sold in Illinois. (Doc. 24, pg. 10). However, since

Defendant UMP touts Filshie Clips as a globally recognized and recommended product

that is sold in the United States, and Filshie Clips have been sold in significant numbers

in the United States since 2011, Plaintiff argues it is reasonable to conclude that Filshie

Clips have also been sold in significant numbers in Illinois. (Doc. 24, pgs. 10-11).

Second, Plaintiff notes Defendant UMP currently sells, markets, and distributes

Filshie Clips in Illinois. (Doc. 24, pg. 10). Indeed, Defendant UMP has done so since 2019,

when it purchased the distribution rights from Defendant CooperSurgical. (Doc. 24, pg.

10). Further, Plaintiff argues Defendant UMP, as the seller and distributor of Filshie Clips

since 2019, is subject to the regulations of the FDA. (Doc. 24, pg. 11). Therefore, Plaintiff

submits Defendant UMP had an obligation to continuously monitor, market, and report

complaints or adverse health consequences related to Filshie Clips in a manner consistent

with the PMA and the FDA regulations. (Doc. 24, pg. 11). The failure to do so allegedly

led to Plaintiff “not knowing the source of her injuries for years.” (Doc. 24, pg. 10).

2. Defendant Femcare

Defendant Femcare argues Plaintiff states “mere formulaic recitations” of personal

jurisdiction without discussing its contacts with Illinois or Filshie Clips. (Doc. 32, pg. 2).

Defendant Femcare notes its principal place of business is in England. (Docs. 32, pg. 2;

32-1, pg. 1). It was acquired by Defendant UMP in 2011, but it remains a separate legal

entity. (Docs. 32, pgs. 2-3; 32-1, pg. 1). Defendant Femcare is the manufacturer of Filshie

Clips, but it did not design, research, conduct safety surveillance, develop, manufacture,

test, label, package, distribute, market, or sell Filshie Clips in Illinois. (Doc. 32-1, pg. 2).

Defendant Femcare states it did not sell Filshie Clips “with the intent that they be used

by medical professionals treating patients in Illinois.” (Doc. 32-1, pg. 2). As such,

Defendant Femcare argues it does no business or advertising in Illinois, and it has not

directed the distribution of Filshie Clips in that State. (Docs. 32, pg. 3; 32-1, pg. 2). Also,

Defendant Femcare states it does not derive substantial revenue in Illinois. (Doc. 32-1, pg.

2). At the time of Plaintiff’s procedure, Defendant CooperSurgical “distributed Filshie

Clips in the United States.” (Doc. 32-1, pg. 2). These assertions are stated in the

Declaration of Paul Hill, who is a Director of Defendant Femcare. (Doc. 32-1).

Contrary to these arguments, Plaintiff argues the Court has personal jurisdiction

over Defendant Femcare because her injuries arose from a product that Defendant

Femcare manufactured and distributed to Illinois residents. (Doc. 34, pg. 11). Plaintiff

notes Defendant Femcare applied for FDA approval in 1996 for the purpose of selling

Filshie Clips in the United States. (Doc. 34, pg. 11). Upon receiving PMA, Defendant

Femcare entered an exclusive distribution agreement with Defendant CooperSurgical in

2003, and then subsequently entered a similar agreement with Defendant UMP in 2019.

Plaintiff notes, by virtue of those agreements, Defendants CooperSurgical and UMP

distributed Filshie Clips in the United States from 2003 to the present. (Doc. 34, pg. 11).

Notwithstanding “the intent” of Defendant Femcare, as described by Mr. Hill in his

Declaration, Plaintiff argues Defendant Femcare knew Filshie Clips were sold to and

utilized by women in Illinois. (Doc. 34, pg. 14). By extension, Plaintiff argues Defendant

Femcare profited from the sale and use of Filshie Clips in Illinois. (Doc. 34, pgs. 13-14).

Plaintiff notes Defendant UMP, in an Answer to an Interrogatory in another case with

Defendants stated, “Filshie Clips have likely been sold in all US states.” (Doc. 34-9, pg. 3).

Also, Defendant Femcare allegedly retained control over the sale, distribution,

marketing, and safety of Filshie Clips, despite the distribution agreements. (Doc. 34, pgs.

11-14, 17-18). Plaintiff states “Femcare purposefully entered into a contract that allowed

it to retain a great amount of control over its product, including determining the markets

in which the Filshie Clips were sold, the actual marketing of the product, and [the]

training [of] individuals who would be selling the product in the U.S.” (Doc. 34, pg. 13).

3. Application to Defendants UMP and Femcare

Resolving all specific personal jurisdiction factual disputes for Plaintiff, the Court

finds she made a prima facie case of specific personal jurisdiction over Defendants UMP

and Femcare. See McAdams, 409 F. Supp. 3d at 663; Karraker, 239 F. Supp. 2d at 839. As to

the first requirement, Plaintiff provides sufficient facts to show Defendants UMP and

Femcare delivered Filshie Clips into the stream of commerce with the awareness or

expectation that they would be used by Illinois patients. See World-Wide Volkswagen Corp.,

444 U.S. at 297-98; J.S.T. Corp., 965 F.3d at 575; Jennings, 383 F.3d at 550. Notably, Filshie

Clips received PMA in 1996. Defendant Femcare, the manufacturer of Filshie Clips and a

subsidiary of Defendant UMP since 2011, was a party to distribution agreements with

Defendant CooperSurgical from 2003 to 2019 and Defendant UMP from 2019 to the

present. The agreements targeted customers in the United States, broadly, but it is

undeniable Filshie Clips reached Illinois, specifically. In 2015, Filshie Clips reached

Illinois for the use by Plaintiff’s doctor in her tubal ligation procedure. As Plaintiff notes,

however, Filshie Clips assuredly reached Illinois at other times, too, as Defendant UMP

admitted in another 2022 case, involving these Defendants, “Filshie Clips have likely been

sold in all US states.” See Rebando v. CooperSurgical, Inc., et al., No. 22-cv-177 (M.D. Fla.

2022); see also O’Neal v. Bumbo Intern. Trust, 16 F. Supp. 3d 952, 958-59 (S.D. Ind. 2014)

(finding, unlike in Jennings, the defendant acknowledged, inter alia, its products were sold

in the forum state); (Doc. 34-9, pg. 3).

Certainly, the distribution agreements and other record evidence indicate

Defendant Femcare benefitted financially from the marketing and sale of Filshie Clips in

the United States, including in Illinois, from 2003 to the present. Defendant Femcare’s

Director, Mr. Hill, attested to these circumstances, stating Filshie Clips were not sold

“with the intent that they be used…in Illinois,” were not directed for distribution in Illinois,

and did not “derive substantial revenue” in Illinois. (Doc. 32-1, pg. 2). (Emphasis added.).

Mr. Hill essentially suggests, by reverse inference, Filshie Clips were, indeed, used by,

distributed to, and a source of revenue in Illinois by virtue of Defendant Femcare’s

distribution agreements with Defendants CooperSurgical and UMP. (Doc. 32-1, pg. 2).

Likewise, the record evidence suggests Defendant UMP benefitted financially

from the distribution agreements and resultant marketing and sale of Filshie Clips in the

United States between 2011 and 2019, as the parent company of Defendant Femcare, and

between 2019 and the present, as the distributor and “direct[] market[er]”of that product

in the United States. (Doc. 24-10, pgs. 9, 11). On its website, Defendant UMP described

Filshie Clips as “one of the most popular permanent sterilization methods in the United

States.” (Doc. 24-3, pg. 2). Also, in its Annual Report for 2011, Defendant UMP described

its acquisition of Defendant Femcare as a “merger” and noted the following in relation to

gynecology, electrosurgery, and urology (“ES/gyn”) sales in the United States:

ES/gyn sales in 2011…[w]ith Femcare…increased 226%. U.S. domestic

sales increased 60%.... The domestic sales increase was primarily due to

sales to Cooper Surgical Inc., which has an agreement with Femcare for

distribution of the Filshie Clip System in the U.S. Cooper Surgical is now…

[UMP’s] largest customer, with 2011 sales of $2.2 million, about 6% of

total…[UMP] sales.

(Doc. 24-5, pgs. 4, 13).

In 2012, Defendant UMP desired to “realize distribution and manufacturing

synergies by integrating capabilities and resources obtained in its recent acquisition of

Femcare.” (Doc. 24-5, pg. 20). Further, as Plaintiff notes, Defendant UMP indicated in its

Form 10-K for fiscal year 2015, which was filed with the United States Securities Exchange

Commission, that it “acquired the Filshie Clip System as part of its acquisition of Femcare

in March 2011. In 2015, sales of Filshie Clips, applicators and accessories represented 35%

of…[Defendant UMP’s] U.S. Dollar denominated sales.” (Doc. 24-2, pg. 8). It is also

notable, again, that Defendant UMP admitted in another 2022 case, involving these

Defendants, “Filshie Clips have likely been sold in all US states.” See Rebando, No. 22-cv-

177; (Doc. 34-9, pg. 3). These facts suggest, in 2015, Defendant UMP was not nearly as

separated from Defendant Femcare or Filshie Clips as its present arguments suggest.

Further, the Court emphasizes that it is undisputed, as of early 2019, Defendant

UMP was charged with distributing Filshie Clips across the United States. Indeed, Mr.

Cornwell noted, “[b]efore February 2019,” [UMP] did not sell or market the Filshie Clips in

Illinois or elsewhere.” (Doc. 21, pg. 14) (Emphasis added.). In other words, by that time,

Defendant UMP was not a mere parent company of Defendant Femcare; instead, it was

firmly positioned in the chain of distribution in the United States, including in Illinois.

This is important because Plaintiff alleges Defendants’ post-PMA conduct prevented the

discovery of her injury, caused by a detached and migrating Filshie Clip, until 2020.

Also, the above-discussed sales, stemming from the distribution agreements, are

akin to those discussed in J.S.T. Corp. and are not “merely ‘random, fortuitous, or

attenuated contacts” with Illinois. See Tamburo, 601 F.3d at 702; see also O'Neal, 16 F. Supp.

3d at 959 (“There is nothing random, fortuitous, or attenuated about…[the Defendant’s]

use of a distribution network that it knows results in the sale of” a product in the forum

state). The sales bear on the relationship between Defendants, the State of Illinois, and the

litigation filed by Plaintiff because Defendant Femcare, as the manufacturer of Filshie

Clips, and Defendant UMP, as the parent company of Defendant Femcare and the actual

distributor of Filshie Clips, profited from agreements to market and sell Filshie Clips in

the United States, including in Illinois, where the use of the product in a tubal ligation

procedure allegedly harmed Plaintiff. See J.S.T. Corp., 965 F.3d at 576. In other words,

Defendants took steps to reach patients in Illinois, which created a relationship of “special

relevance” between Defendants and Illinois. See id.; Morris, 2020 WL 4436330, *4.

And, critically, it is inconsequential that Filshie Clips traveled from Defendant

Femcare, through Defendant CooperSurgical or Defendant UMP, to Plaintiff. See J.S.T.

Corp., 965 F.3d at 576; see also O'Neal, 16 F. Supp. 3d at 959 (“If…[a defendant] utilizes a

distribution network for its…[product] ‘with the expectation that they will be purchased

by consumers in [the forum state],’ [citation], it has purposefully availed itself of the

privilege of conducting business in” the forum state); Richter v. INSTAR Enterprises

Intern., Inc., 594 F. Supp. 2d 1000, 1014 (N.D. Ill. 2009) (“[I]f the sale of the product of a

manufacturer or distributor is not simply an isolated occurrence, ‘but arises from the[ir]

efforts…to serve directly or indirectly, the market for its product in other States, it is not

unreasonable to subject it to suit in one of those States.’ ”). For these reasons, the Court

finds Plaintiff has adequately shown Defendants UMP and Femcare purposefully

directed their activities at Illinois and availed themselves of the privilege of conducting

business in this State. See In re Sheehan, 48 F.4th at 522; see also Sagez v. Columbus McKinnon

Corp., No. 14-cv-1397, 2016 WL 11634571, *5 (S.D. Ill. Dec. 9, 2016) (finding the evidence

supported an inference that Defendants knew and intended for a product to be purchased

in Illinois, where, inter alia, the product arrived in Illinois through an established

distribution system, the defendants had an agreement to “sell[] ‘to the United States of

America,’ ” that language “include[d] all fifty states,” the defendants had “ample reason

to know and expect” the product would be marketed in “any or all states” due to the

established distribution system, the defendant distributor purchased 250,000 units of the

product over ten years from the other defendants, sales of the product in the United States

totaled around four million dollars a year in recent years, the defendant distributor

evinced that a “substantial number” of the product were sold in Illinois over 10 years, the

defendant manufacturer and defendant distributor garnered “significant income” from

their contacts with Illinois, and the defendant marketer received regular updates on the

marketing and sale of the product in the United States) (Emphasis in original.);

compare Jennings, 383 F.3d at 550-51 (noting, in response to stream of commerce argument,

the Court did not know how the product arrived in the state or whether the product was

sold in that state, where, inter alia, the plaintiff produced no evidence that the defendant’s

products were sold in the state and presented no information as to the volume of sales to

or the resale of the product by distributors, such that the scope of any distribution in the

United States or the state could not be determined); Richter, 594 F. Supp. 2d at 1016-17

(noting, unlike in other stream of commerce cases, the plaintiff presented no evidence the

defendant sold the product with an expectation of serving a broader market, derived

direct benefits from that market, knew purchasers would likely resell the product in

Illinois, or caused the product to enter Illinois in quantities establishing a predictable

distribution pattern from which the defendant’s awareness could be assumed).

Next, as to the second requirement for specific personal jurisdiction, the record

indicates Defendant Femcare manufactured and, via its distribution agreement with

Defendant CooperSurgical, marketed and sold Filshie Clips in the United States,

including in Illinois. The record also indicates in 2015, as a result of Defendant Femcare’s

Illinois activities, Plaintiff underwent a tubal ligation procedure, during which Plaintiff’s

doctors implanted her with Filshie Clips. Sometime thereafter, Plaintiff allegedly suffered

injuries from the detachment and migration of a Filshie Clip from her fallopian tubes.

Importantly, Plaintiff alleges Defendants’ post-PMA misconduct prevented the discovery

of her injuries until 2020, when Defendant UMP was undisputedly the distributor of

Filshie Clips in the United States, including in Illinois. As such, even under a strict

understanding of the second requirement for specific personal jurisdiction in Plaintiff’s

prima facie case, the Court finds she has sufficiently shown her injuries arose out of or

relate to Defendant Femcare and UMP’s activities in Illinois. See In re Sheehan, 48 F.4th at

522; Felland, 682 F.3d at 676-77; Lab Verdict, Inc., 436 F. Supp. at 1188-89; see also Sagez, 2016

WL 11634571, *5 (finding second requirement for specific personal jurisdiction was met,

where “[t]he subject chain hoist was sold through an established distribution channel to

a customer in Illinois, and it was involved in an accident that took place in…Illinois.”).

Finally, as to the third requirement for specific personal jurisdiction, Plaintiff’s

alleged injuries, stemming from the detachment and migration of a Filshie Clip that was

implanted on her fallopian tubes in 2015, occurred in Illinois after that product arrived in

the State through the stream of commerce. Illinois has an interest in rectifying injuries to

its citizens like Plaintiff, allegedly caused by the use of products arriving in the State

through steps taken by Defendants. Similarly, Illinois has an interest in providing citizens

like Plaintiff with convenient and effective relief. The Court finds Defendants Femcare

and UMP have failed to make a compelling showing that their foreign statuses outweigh

these important interests, such that an exercise of specific personal jurisdiction would be

unreasonable. See Felland, 682 F.3d at 677. Therefore, for all of the reasons discussed in

this section, the Court concludes an exercise of specific personal jurisdiction over

Defendants Femcare and UMP would not offend the traditional notions of fair play and

substantial justice. See Sagez, 2016 WL 11634571, *5-6 (finding an exercise of specific

personal jurisdiction would not offend traditional notions of fair play and substantial

justice, where the decedent and his representative were residents of Illinois, the accident

occurred in Illinois after the product at issue arrived in the State through an established

distribution channel, and the accident involving that product resulted in death in Illinois).

For these reasons, when resolving all factual disputes in her favor, the Court finds

Plaintiff has made a prima facie case of specific personal jurisdiction for Defendants UMP

and Femcare. See McAdams, 409 F. Supp. 3d at 663; Karraker, 239 F. Supp. 2d at 839.4

C. Venue

Defendants UMP and Femcare argue they do not reside in this judicial district.

(Docs. 22, pg. 18; 32, pg. 17). They also reiterate the argument that the Court does not

have personal jurisdiction. (Docs. 22, pg. 18; 32, pgs. 17-18). Similarly, Defendants UMP

and Femcare reargue that there is no evidence that they manufactured or distributed

Filshie Clips in Illinois, as necessary for a finding that a substantial part of the events or

omissions giving rise to Plaintiff’s claims occurred in Illinois. (Docs. 22, pg. 18; 32, pg. 18).

In response, Plaintiff argues Defendant UMP and Femcare’s venue argument is

the same as that related to personal jurisdiction. (Docs. 24, pg. 20 n. 44; 34, pg. 20 n. 37).

Under the venue statute discussed below, Plaintiff suggests this District will be a proper

4By virtue of this conclusion, the Court does not consider Plaintiff’s alter ego argument.

venue for the case if the Court finds there is personal jurisdiction over Defendants. (Docs.

24, pg. 20 n. 44; 34, pg. 20 n. 37).

Rule 12(b)(3) allows a defendant to assert, by motion, a defense of improper venue.

See Fed. R. Civ. P. 12(b)(3). A plaintiff has the burden of establishing a proper venue but,

as with personal jurisdiction, factual disputes are resolved in his or her favor. See Allstate

Life Ins. Co. v. Stanley W. Burns, Inc., 80 F. Supp. 3d 870, 875 (N.D. Ill. 2015); Clark v.

McDonald’s Corp., No. 22-cv-628, 2023 WL 2648467, *2 (S.D. Ill. March 27, 2023). Venue

refers to the proper place, i.e., the proper district court, to exercise personal jurisdiction.

See Ford-Reyes v. Progressive Funeral Home, 418 F. Supp. 3d 286, 289 (N.D. Ill. 2019) (citing

17 James Wm. Moore et al., Moore’s Federal Practice § 110.015 (3d ed. 2019); Arthur R.

Miller, 14D Fed. Prac. & Proc. Juris. § 3801 (4th ed. 2019)). Section 1391(b) states:

A civil action may be brought in—

(1) a judicial district in which any defendant resides, if all defendants are

residents of the State in which the district is located;

(2) a judicial district in which a substantial part of the events or omissions

giving rise to the claim occurred…; or

(3) if there is no district in which an action may otherwise be brought as

provided in this section, any judicial district in which any defendant is

subject to the court’s personal jurisdiction with respect to such action.

28 U.S.C. § 1391(b).

As to the first option for venue, a defendant entity with the capacity to sue and be

sued, in its common name under the applicable law, whether or not incorporated, is

deemed to reside in any judicial district where there is personal jurisdiction. See id.

§ 1391(c)(2). Further, as to the second option, “a substantial part” does not mean “most,”

and venue may be proper in multiple districts. See Ford-Reyes, 418 F. Supp. 3d at 290.

Indeed, a district court need not be “the best” venue. See id. To constitute “a substantial

part,” however, the Court looks to the overall nature of the claims and the specific events

or omissions occurring in the forum. See Curtis-Campbell, 2019 WL 13229723, *6. The

events or omissions “must be encompassed in the historical predicate of the claim.”

See Clark, 2023 WL 2648467, *3 (citing Schwarz v. National Van Lines, Inc., 317 F. Supp. 2d

829, 834 (N.D. Ill. 2004); Dickerson v. Perdue, No. 7-cv-206, 2007 WL 2122418, *6 (S.D. Ill.

July 20, 2007)). The analysis focuses on the activities of the defendant, not the plaintiff,

and those activities must “share a connection to the elements of the claim.” See id.

Here, the Court has already found that Plaintiff made a prima facie case of specific

personal jurisdiction as to Defendants UMP and Femcare. By virtue of that finding, the

Court further finds that Plaintiff has shown Defendants UMP and Femcare may be

deemed to reside in the Southern District of Illinois under § 1391(b)(1). See § 1391(b)(1),

(c)(2); see also Curtis-Campbell v. Premiere Building Materials, Inc., No. 19-cv-63, 2019 WL

13229723, *4 (N.D. Ind. July 23, 2019) (“Personal jurisdiction is relevant to the subsection

(b)(1) residency analysis…because a corporate defendant…is a resident of ‘any judicial

district in which such defendant is subject to the court’s personal jurisdiction with respect

to the civil action in question’ for purposes of venue.”). Alternatively, the Court finds

Plaintiff has shown a substantial part of the events or omissions, giving rise to her claims,

occurred in this District under § 1391(b)(2). As was discussed at length with respect to

specific personal jurisdiction, Plaintiff has adequately shown Defendants UMP and

Femcare delivered Filshie Clips, via exclusive distribution agreements, into the stream of

commerce in the United States with the awareness or expectation that they would be used

by Illinois patients. The Court will not repeat those discussions here. However, Plaintiff

demonstrated that those activities resulted in the use of Filshie Clips in her 2015 tubal

ligation procedure in the Southern District of Illinois. Further, Defendants’ post-PMA

misconduct allegedly prompted Plaintiff to undergo that tubal ligation procedure in the

Southern District of Illinois and prevented the discovery of her injuries, allegedly caused

by the detachment and migration of a Filshie Clip from her fallopian tubes, until 2020.

For these reasons, when resolving all factual disputes in Plaintiff’s favor, the Court

finds she has sufficiently shown venue is proper in the Southern District of Illinois.

See Allstate Life Ins. Co., 80 F. Supp. 3d at 875; Clark, 2023 WL 2648467, *2.

III. Conclusion

For the foregoing reasons, Defendants’ separate Motions to Dismiss are DENIED.

SO ORDERED.

Dated: September 25, 2023

s/ David W. Dugan

__________________________

DAVID W. DUGAN

United States District Judge