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Aquino v. C.R. Bard, Inc.

United States District Court, N.D. Illinois, Eastern Division

September 19, 2019

Milady Aquino, Plaintiff,
C.R. Bard, Inc.; Becton Dickinson and Company; Boston Scientific Corporation; and Cambridge Polymer Group, Inc. Defendants.



         Plaintiff Milady Aquino filed this products liability action against defendants C.R. Bard, Inc. and Becton Dickinson and Company[1] (together, “Bard”), Boston Scientific Corporation (“BSC”), and Cambridge Polymer Group, Inc. (“Cambridge”) seeking relief following the implantation of Bard transvaginal and BSC transabdominal pelvic mesh products.[2] Each of the defendants moved to dismiss some or all of the claims against it under Federal Rule of Civil Procedure 12(b)(6). For the following reasons, BSC’s, Bard’s and Cambridge’s motions are granted.


         A Rule 12(b)(6) motion challenges the “sufficiency of the complaint.” Berger v. Nat. Collegiate Athletic Assoc., 843 F.3d 285, 289 (7th Cir. 2016). A complaint must provide “a short and plain statement of the claim showing that the pleader is entitled to relief, ” Fed.R.Civ.P. 8(a)(2), sufficient to provide defendant with “fair notice” of the claim and the basis for it. Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). This standard “demands more than an unadorned, the-defendant-unlawfully-harmed-me accusation.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). While “detailed factual allegations” are not required, “labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Twombly, 550 U.S. at 555. The complaint must “contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’” Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 570). “‘A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.’” Boucher v. Fin. Sys. of Green Bay, Inc., 880 F.3d 362, 366 (7th Cir. 2018) (quoting Iqbal, 556 U.S. at 678). In applying this standard, the Court accepts all well-pleaded facts as true and draws all reasonable inferences in favor of the non-moving party. Tobey v. Chibucos, 890 F.3d 634, 646 (7th Cir. 2018).


         This case involves two surgical mesh products used to treat urogynecologic conditions: BSC’s Upsylon Traditional Y Mesh, and Bard’s AlignTM Urethral Support System (respectively, “BSC Device” and “Bard Device, ” and together, “Defendants’ Mesh Products”). Defendants’ Mesh Products were implanted in Milady Aquino in July 2016 via differing methods, into different areas of her body, to serve different purposes. That is, the BSC Device was implanted transabdominally outside the vagina to treat pelvic organ prolapse (“POP”), and the Bard Device was implanted transvaginally inside the vagina to treat stress urinary incontinence.

         FDA and industry communications regarding transvaginal mesh.

         Transvaginal mesh had been the subject of scrutiny for years prior to Aquino’s implantation procedure. In July 2011, the FDA issued a statement indicating that “serious complications associated with surgical mesh for transvaginal repair of POP” were “not rare, ” and identifying mesh “contraction (shrinkage)” as associated with vaginal shortening, tightening and pain, and as a previously unidentified risk (“FDA Safety Communication”). SAC ¶¶ 11-12 (emphasis in original).[3] According to the FDA Safety Communication, it was “not clear” that transvaginal POP repair with mesh was more effective than non-mesh repair, and such mesh repair “may expose patients to greater risk.” Id. ¶ 14.

         The FDA contemporaneously published “Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse” (“FDA White Paper”), which also noted the “serious adverse events” and “complications” associated with transvaginal mesh for POP repair, and the lack of evidence that transvaginally placed mesh “improves clinical outcomes any more than traditional POP repair.” Id. ¶¶ 15-18.

         Later in 2011, the American College of Obstetricians and Gynecologists (“ACOG”) and the American Urogynecologic Society (“AUGS”) issued a Joint Committee Opinion noting “increasing reports” of vaginal pain associated with vaginal mesh “contraction, retraction, or shrinkage” (“ACOG/AUGS Joint Committee Opinion”). Id. ¶ 20. It warned that some women “require surgical intervention” and that pain may be intractable, and recommended vaginal mesh repair only in “high-risk individuals in whom the benefit . . . may justify the risk.” Id. ¶¶ 20-21.

         Polypropylene used in Defendants’ Mesh Products.

         Defendants’ Mesh Products were initially constructed from Marlex HGX-030-01 (“Marlex”), a specific polypropylene manufactured and trademarked by a joint venture between Chevron and Phillips Sumika (“Phillips”) in Texas, and sold in its raw form in pellets. Id. ¶¶ 55-56, 59. At all relevant times, Marlex’s Material Safety Data Sheet (“MSDS”) warned that Marlex should not be used for “permanent implantation in the human body or permanent contact with internal body fluids or tissues” unless “provided directly from Phillips . . . under an agreement which expressly acknowledges the contemplated use.” Id. ¶¶ 59-60.

         At a certain point, Phillips stopped selling Marlex to Bard and BSC. Id. ¶¶ 61, 63. Thereafter, Bard began purchasing Marlex from third parties, while BSC considered seeking FDA approval of a mesh made from a different polypropylene. Id. ¶¶ 62, 65, 67. But BSC ultimately concluded that the FDA was unlikely to approve the change given its “anti-mesh” position, and that even if it did, the process would take too long and impact BSC’s profits too significantly. Id. ¶ 67. Accordingly, beginning in 2011, BSC also sought Marlex from third parties. Id.

         In the end, BSC purchased a 25-year supply of raw polypropylene pellets from Chinese distributor EMAI Plastic Raw Materials Co., Ltd. (“EMAI”) at well below market price (“Chinese polypropylene”). Id. ¶¶ 68, 74, 78, 91. BSC learned from Phillips that the lot number on the bags EMAI sold it-and which bore the Phillips/Marlex labels-was not genuine. Id. ¶¶ 76-79, 84-89, 91. EMAI also could not produce the Certificate of Compliance or the Certificate of Analysis that would have been required had EMAI imported genuine Marlex pellets from Phillips in the United States to EMAI in China. Nor could EMAI produce documentation either of any import tax paid, or to establish that the polypropylene had cleared Chinese customs- both of which would have occurred had the polypropylene originally shipped from the United States to China, and both of which were required in order to lawfully export from China a good that was originally manufactured elsewhere. Id. ¶¶ 80-81. Accordingly, BSC had to determine how to ship the undocumented goods to the United States for its use without raising any red flags. Id. ¶¶ 81, 92.

         With this knowledge and in order to clear Chinese customs, BSC arranged to “over-bag” the bags of Chinese polypropylene pellets, placing them inside plain bags to cover up their Phillips/Marlex labels. Id. ¶ 96. BSC then split the shipment in three to reduce the risk of scrutiny, telling Chinese customs that the product was made by EMAI, and telling United States customs that the bags contained Marlex manufactured in Texas and returning to the United States for use. Id. ¶¶ 97-98, 100.

         Cambridge, a research laboratory, performed various tests on the Chinese polypropylene at BSC’s request. The testing categories differed from those used by Phillips for Marlex, and the tests themselves were not performed to industry standards. Id. ¶ 103. Ultimately, the tests revealed (among other things) that the Chinese polypropylene: (1) produced weaker fibers than Marlex; (2) had a different melt rate; and (3) contained high levels of selenium, an element that reacts with hydrogen peroxide to form an acid that attacks polypropylene. Id. ¶ 105. Cambridge’s initial report to BSC stated that “[a]ll the samples showed high levels of selenium.” Id. ¶ 106. The report referred to selenium as “rare and toxic” and the result as “unusual, ” and recommended that it be “verified using another technique.” Id. BSC and Cambridge discussed the report by phone. Three days later, Cambridge issued an amended report, again indicating that “[a]ll the samples showed high levels of selenium, ” but omitting the “rare and toxic” characterization, and the suggestion for further testing. Id. ¶¶ 106-107. BSC mentioned neither the presence of selenium nor the additional testing Cambridge initially recommended in its own internal report. Id. ¶ 108.

         About 5 years later in April 2016, Polymer Solutions-another laboratory- conducted additional testing on the same lots of Marlex and Chinese polypropylene. That testing demonstrated differences in the two products’ additives. Specifically, that: (1) the Chinese polypropylene contained over a dozen chemicals that the Marlex did not, including an additive that was highly susceptible to ultraviolet degradation; and (2) although both the Marlex and Chinese polypropylene contained an additive designed to slow natural degradation of the polypropylene caused by peroxides, it was detected in significantly lower amounts in the Chinese polypropylene. Id. ¶¶ 120-122. Beginning in June 2011 and continuing until fall 2012, BSC incorporated the Chinese polypropylene into its mesh products. Id. ¶ 68.

         Aquino’s treatment with and complications from Defendants’ Mesh Products.

         Aquino was implanted with the Bard Device transvaginally to treat urinary incontinence, and with the BSC Device transabdominally to treat POP in July 2016. Id. ¶¶ 2-3. The BSC Device implanted was constructed from Chinese polypropylene.[4] Aquino claims that Defendants’ Mesh Products have caused numerous side effects and conditions, including: inability to void; urinary incontinence/leaking; urinary urgency and frequency; incomplete emptying of the bladder; severe pain with urination requiring her to stand when urinating; pelvic floor spasms; a chronic pain syndrome in the vagina, suprapubic area, perirectal area, pelvis and lower abdomen; recurrent urinary tract infections; bladder lesions; bladder spasms; loss of sexual activity; erosion, mesh contraction and wading; infection; fistula; inflammation; scar tissue; dyspareunia (pain during sexual intercourse); prolapse of female genital organs; neuropathic and other acute and chronic nerve damage; pelvic floor damage; and other associated symptoms and exacerbations of her medical conditions. Id. ¶ 23.

         As a result, Aquino underwent procedures in February, September, October and December 2017, including a revision of her Bard Device. Aquino continues to require treatment for chronic conditions she claims are attributable to Defendants’ Mesh Products. Id. ¶ 24.

         Aquino’s claims.

         Aquino initially filed her case in state court in June 2018. Bard and BSC timely removed her complaint in August 2018, and this Court denied Aquino’s motion to remand. Aquino subsequently amended her complaint twice, including to remove her claim against BSC and Cambridge for violation of the Illinois Counterfeit Trademark Act, 765 ILCS 1040-a claim arising out of their conduct relative to the Chinese polypropylene. The SAC spans 64 pages and alleges a smorgasbord of claims: (1) negligence as to Bard (Count I); (2) strict liability – design defect as to Bard (Count II); (3) strict liability – manufacturing defect as to Bard (Count III); (4) strict liability – failure to warn as to Bard (Count IV); (5) breach of express warranty as to Bard (Count V); (6) breach of implied warranty as to Bard (Count VI); (7) willful and wanton misconduct as to Bard (Count VII); (8) negligence as to BSC (Count VIII); (9) strict liability – design defect as to BSC (Count IX); (10) strict liability – manufacturing defect as to BSC (Count X); (11) strict liability – failure to warn as to BSC (Count XI); (12) breach of express warranty as to BSC (Count XII); (13) breach of implied warranty as to BSC (Count XIII); (14) willful and wanton misconduct as to BSC (Count XIV); (15) negligence as to Cambridge (Count XV); and (16) willful and wanton misconduct as to Cambridge (Count XVI). The Court held oral argument on Defendants’ motions to dismiss at the parties’ request, at which time Aquino voluntarily dismissed her claims for breach of implied warranty (Count VI as to Bard, and Count XIII as to BSC). Further, while Bard denies liability on Aquino’s design defect claims (theories plead in Counts I and II), its motion takes no issue with them. The Court addresses the remaining claims below, beginning with those against BSC.


         I. BSC’s Motion to Dismiss

         BSC argues that dismissal of the claims against it is proper for three reasons: (1) Aquino’s claims are preempted and precluded; (2) Aquino’s factual allegations overwhelmingly concern transvaginal mesh, and cannot support claims regarding its transabdominal mesh product at issue here; and (3) Aquino otherwise makes only formulaic recitations of her claims and thus fails to adequately plead them.

         A. Preliminary Matters

         The Court notes at the outset BSC’s argument that because each of Aquino’s claims against it incorporates by reference the factual allegations concerning Chinese polypropylene, each is premised only on the dangers of Chinese polypropylene, and not the dangers of polypropylene implantation generally. This, BSC argues, means that to the extent claims regarding the Chinese polypropylene are preempted, Aquino’s claims against it are barred. But the Court does not read the SAC so narrowly. Although far from a model of clarity, taking the allegations in the light most favorable to Aquino as it must, the Court finds that the SAC more than sufficiently alleges the dangers of polypropylene generally, and also incorporates those allegations in the claims against BSC. See, e.g., SAC ¶ 9 (“scientific evidence shows that [polypropylene] . . . is biologically incompatible with human tissue” and “promotes inflammation of the pelvic tissue” and “can contribute to . . . severe adverse reactions”); id. ¶ 60 (quoting Marlex MSDS warning against the use of Marlex “in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues”). Accordingly, even if preempted to the extent based on Chinese polypropylene, Aquino’s claims proceed because they also concern the dangers of polypropylene generally.

         B. Preemption and Preclusion

         A bit of background on the FDA’s medical device approval process is necessary to understand the parties’ preemption and preclusion arguments. Congress granted the FDA sole authority to regulate medical devices and created a “regime of detailed federal oversight” through the Medical Device Amendments Act of 1976, 21 U.S.C. § 360 (the “MDA”), which amended the Food, Drug, and Cosmetics Act (“FDCA”). Riegel v. Medtronic, Inc., 552 U.S. 312, 327-30 (2008). The MDA divides medical devices into three categories based on the risk they pose to the public: (1) Class I devices, which present no unreasonable risk of illness or injury; (2) Class II devices, which possess a greater potential dangerousness warranting more stringent controls; and (3) Class III devices, which “present[ ] a potential unreasonable risk of illness or injury, ” and are therefore subject to the most regulation. 21 U.S.C. § 360c(a)(1)(A)-(C).

         Class III devices generally are required to undergo a “rigorous” premarket approval (“PMA”) process. Reigel, 552 U.S. at 317. During that process, a manufacturer submits detailed information concerning the safety and efficacy of its device-typically in the form of a multivolume application-which the FDA then spends an average of 1, 200 hours reviewing. Id. at 317-18. Once such a device has received premarket approval, the MDA prohibits its manufacturer from making changes that would impact safety or effectiveness without FDA permission. Such permission is typically granted through a supplemental PMA application “evaluated under largely the same criteria as an initial application.” Id. at 319 (citing 21 U.S.C. § 360e(d)(6) and 21 CFR § 814.39(c)).

         Nevertheless, many Class III devices, as well as all new Class I and II devices, are subject only to a “limited form of review” under which manufacturers submit a “premarket notification” to the FDA. Medtronic, Inc. v. Lohr, 518 U.S. 470, 476-78 (1996). Known as the Section 510(k) process, the FDA’s determination rests not on safety, but rather on a finding of substantial equivalence to an already-approved medical device. Id. 478, 493. It is “by no means comparable to the PMA process, ” and is completed in “an average of only 20 hours.” Id. at 478-79. As such, Section 510(k) approval provides “little protection to the public.” Id. at 493.

         Both of Defendants’ Mesh Products received FDA clearance for marketing under Section 510(k) as “substantially equivalent” to devices already on the market, and both were classified as Class II devices. But on March 31, 2016, a citizen petition was filed with the FDA concerning the Chinese polypropylene BSC had begun to use in certain products (the “Citizen Petition”). The Citizen Petition was the result of the decision in Stevens v. Boston Scientific Corporation, 152 F.Supp. 3d 527');">152 F.Supp. 3d 527, 537 (S.D. W.Va. 2016), a putative class action asking the court to enjoin BSC from marketing, selling, or importing mesh products constructed from Chinese polypropylene. There, Judge Joesph Goodwin declined to order the injunctive relief requested and stayed and deferred the case to the FDA under the doctrine of primary jurisdiction. The court reasoned that deferral was appropriate because the plaintiff’s allegations were “based on alleged violations of statutes and regulations over which the FDA exercises its expertise and impressive administrative dominance, ” and because the FDA was “in the best place to determine whether Boston Scientific’s mesh device [was] in compliance with the FDA’s own statutes, regulations, and directives.” Stevens, 152 F.Supp. 3d at 537. Although it did not issue a formal response to the Citizen Petition, almost 18 months later, the FDA issued a public letter indicating among other things that BSC’s “change in supplier” (from Phillips to EMAI) did not “raise new safety or effectiveness concerns, ” and the differences between Marlex and the Chinese polypropylene did not “require submission of a new premarket notification” (the “FDA Letter”).[5] R. 72, Ex. 5 at 1.

         BSC argues that Aquino’s claims against it fail because each is based on allegations concerning the safety of the Chinese polypropylene used in the BSC Device between 2011-2012-allegations considered and rejected by the FDA through the FDA Letter, and thereby expressly and impliedly preempting, and precluding, Aquino’s claims. In response, Aquino contends that because the BSC Device received only 510(k) approval, no preemption lies, and that her claims concern the use of any polypropylene (not just the Chinese polypropylene) in any event. The Court addresses the parties’ arguments below.

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