Aquino v. C.R. Bard, Inc.

413 F.Supp.3d 770

Milady AQUINO, Plaintiff,

v.C.R. BARD, INC.; Becton Dickinson and Company; Boston Scientific Corporation; and Cambridge Polymer Group, Inc., Defendants.

No. 18-cv-5291

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

Signed September 19, 2019

Christopher Patrick Ford, Chicago, IL, for Plaintiff.

Lori G. Cohen, Atlanta, GA, Paul Alexis Del Aguila, Faegre Baker Daniels LLP, Gregory Edward Ostfeld, Martin S. Kedziora, Greenberg Traurig, LLP, Ruben Ignacio Gonzalez, Tess Godhardt, Faegre Baker Daniels LLP, Brian H. Eldridge, John Backes Prior, Hart McLaughlin & Eldridge, LLC, Chicago, IL, Jack A. Wilson, Pro Hac Vice, Lisa Sokolowski, Pro Hac Vice, William S. Ohlemeyer, Pro Hac Vice, Boies Schiller Flexner LLP, Armonk, NY, Jose P. Sierra, Pro Hac Vice, Holland & Knight, Boston, MA, for Defendant.

MEMORANDUM OPINION AND ORDER

Honorable Thomas M. Durkin, United States District Judge

Plaintiff Milady Aquino filed this products liability action against defendants C.R. Bard, Inc. and Becton Dickinson and Company¹ (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.

STANDARD

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, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). This standard "demands more than an unadorned, the-defendant-unlawfully-harmed-me accusation." Ashcroft v. Iqbal , 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (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, 127 S.Ct. 1955. 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, 129 S.Ct. 1937 (quoting Twombly , 550 U.S. at 570, 127 S.Ct. 1955 ). " ‘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, 129 S.Ct. 1937 ). 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).

BACKGROUND

This case involves two surgical mesh products used to treat urogynecologic conditions: BSC's Upsylon Traditional Y Mesh, and Bard's Align™ 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...