Dains v. Bayer Healthcare Inc.

1

KRYSTAL DAINS, Plaintiff, v. BAYER HEALTHCARE LLC, BAYER ESSURE INC., formerly known as Conceptus, Inc., and BAYER HEALTHCARE PHARMACEUTICALS, INC., Defendants.

No. 5:22-cv-208 (BKS/TWD)

United States District Court, N.D. New York

November 1, 2022

For Plaintiff: Harris Marks, Belluck & Fox, LLP.

For Defendants: Alan E. Rothman, Sidley Austin LLP, John L Gibbons, Sidley Austin LLP

MEMORANDUM-DECISION AND ORDER

Hon Brenda K. Sannes, Chief United States District Judge:

I. INTRODUCTION

Plaintiff Krystal Dains filed suit in New York Supreme Court, Cayuga County, on January 31, 2022, asserting various state-law claims arising out of the implantation of the Essure medical device and subsequent complications. (See Dkt. No. 2 (complaint)). Defendant Bayer HealthCare Pharmaceuticals, Inc. removed the action to this Court by notice of removal on March 4, 2022, based on diversity jurisdiction. (Dkt. No. 1).^[1] Defendants Bayer HealthCare LLC; Bayer Essure Inc., formerly known as Conceptus, Inc. and Bayer HealthCare Pharmaceuticals, Inc. (collectively, “Bayer” or “Defendants”) now move to dismiss Plaintiff's complaint under Federal Rule of Civil Procedure 12(b)(6). (Dkt. No. 10).^[2] Plaintiff opposed the motion, and Defendants replied. (Dkt. Nos. 27, 28). For the following reasons, Defendants' motion is granted.

II. FACTS^[3]

A. The Essure System

Essure is a medical device designed, manufactured, marketed, and sold by Defendants. (Dkt. No. 2, ¶ 12). Essure is a form of permanent birth control which is not intended to be removed. (Id. ¶ 13). It consists of two metal “micro-inserts” which are “implanted into the fallopian tubes,” expand to fit the contours of the fallopian tubes, and “elicit tissue growth which causes blockage of the tubes” to prevent conception. (Id. ¶¶ 10, 14, 16). The inserts are “constructed of a stainless-steel inner coil, a dynamic outer coil made from a nickel and titanium alloy, called Nitinol, and a layer of polyethylene terephthalate, or polyester fibers wound between the inner and outer coils.” (Id. ¶ 15). An individual must be “trained in Essure” and a “skilled operative hysteroscopist” to implant an Essure device. (Id. ¶ 19).

Over a three-month period after implantation of the device, the fibers on the micro-inserts “elicit tissue growth around the coils, which causes bilateral occlusion (blockage) of the fallopian tubes.” (Id. ¶ 17). This tissue buildup prevents sperm from reaching the ovaries, thereby preventing conception. (Id.). After this three-month period, the patient undergoes a “confirmation test” to “determine whether the Essure micro-inserts have created a complete occlusion in each fallopian tube.” (Id. ¶ 18).

Essure is regulated by the Food and Drug Administration (“FDA”) as a Class III medical device.^[4] Plaintiff alleges that Bayer Essure Inc. has been “repeatedly cited by regulatory authorities” for violations that impacted patient safety. (Id. ¶ 20). For example, in July 2002, the FDA cited Bayer Essure Inc. for “failing to report adverse events identified by patients.” (Id. ¶ 21). Bayer Essure Inc. was aware that certain failures could occur with the Essure device leading to adverse consequences, including, for example, rusting, traces of lead, degradation of the nitinol and increased toxicity, degradation of the fibers leading to chronic inflammation and possible autoimmune issues, and fracture and breakage. (Id. ¶ 22). Plaintiff alleges that Bayer Essure Inc. “concealed thousands of migrations and perforation reports” and never reported the “vast majority of complaints.” (Id. ¶¶ 23-25; see also id. ¶ 71 (alleging that, after a December 2010 FDA inspection, Defendants were cited for deficiencies in “Medical Device Reporting”)).

B. Plaintiff's Essure Implantation

Plaintiff was implanted with the Essure device in September 2015. (Id. ¶ 26). At a “later date,” she returned to have the “confirmation test” to determine whether the device had achieved complete occlusion in both fallopian tubes. (Id. ¶ 27). It was “discovered that one of the Essure inserts was missing.” (Id. ¶ 28).

Following this discovery, Plaintiff had “additional surgery and a tubal [ligation] as the result of the migration of the Essure device.” (Id. ¶ 29). She also had “a series of additional surgeries due to continued pain in her lower left pelvic area, all caused by the defective Essure devices.” (Id. ¶ 30). Plaintiff alleges that she has “continued to treat . . . up to an[d] including the present with continuous pain[] and heavy bleeding.” (Id. ¶ 31). On February 18, 2021, Plaintiff underwent another surgery “where it was found that the fallopian tube had connected to the uterus,” which will require further surgery. (Id.). Plaintiff and her family have had to “adjust their lives to accommodate her ongoing injuries.” (Id. ¶ 32; see also id. ¶ 36 (alleging that she continues to suffer “severe and permanent disabling injuries”)). Plaintiff alleges that she and her physician relied on Defendants' marketing of the Essure device and that, had she known the Essure device “would cause the injuries she has suffered, she would not have elected the Essure device for permanent birth control.” (Id. ¶¶ 33-35).

III. STANDARD OF REVIEW

To survive a motion to dismiss under Rule 12(b)(6) for failure to state a claim, “a complaint must provide ‘enough facts to state a claim to relief that is plausible on its face.'” Mayor & City Council of Balt. v. Citigroup, Inc., 709 F.3d 129, 135 (2d Cir. 2013) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). The plaintiff must provide factual allegations sufficient “to raise a right to relief above the speculative level.” Id. (quoting Twombly, 550 U.S. at 555). The Court must accept as true all factual allegations in the complaint and draw all reasonable inferences in the plaintiff's favor. See EEOC v. Port Auth., 768 F.3d 247, 253 (2d Cir. 2014) (citing ATSI Commc'ns, Inc. v. Shaar Fund, Ltd., 493 F.3d 87, 98 (2d Cir. 2007)).

However, “the tenet that a court must accept as true all of the allegations contained in a complaint is inapplicable to legal conclusions.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009).

IV. ANALYSIS

Plaintiff's complaint lists seventeen separately enumerated causes of action. (Dkt. No. 2, ¶¶ 40-165). Not all of the causes of action are labeled; it is unclear what theory of liability Plaintiff advances in these causes of action, and there is great overlap and duplication among the causes of action. Nevertheless, Plaintiff appears to assert the following claims: product liability claims for design defect, manufacturing defect, and failure to warn, under strict liability and/or negligence theories; negligent training and/or treatment; negligence and negligence per se; breach of implied warranty; breach of express warranty; negligent and intentional misrepresentation; constructive fraud; unfair and deceptive trade practices under New York General Business Law (“GBL”); and unjust enrichment. (See id.).^[5] Defendants move to dismiss Plaintiff's complaint in its entirety, generally arguing that Plaintiff's claims are preempted by federal law and/or otherwise inadequately pleaded. (See generally Dkt. No. 10-1).

A. Applicable Law Regarding Preemption

The FDA regulates medical devices pursuant to the Federal Food, Drug, and Cosmetic Act (“FDCA”), as amended by the Medical Device Amendments of 1976 (“MDA”), 21 U.S.C. § 301 et seq. The MDA categorizes medical devices based on the risks they present. See Riegel v. Medtronic, Inc., 552 U.S. 312, 316-17 (2008). Class III devices “present[] a potential unreasonable risk of illness or injury” and are subject to “premarket approval to provide reasonable assurance of [their] safety and effectiveness.” 21 U.S.C. § 360c(a)(1)(C). The premarket approval process is “rigorous,” and the FDA will grant such approval “only if it finds there is a ‘reasonable assurance' of the device's ‘safety and effectiveness.'” Riegel, 552 U.S. at 317-18 (quoting 21 U.S.C. § 360e(d)); see id. at 318 (describing the premarket approval process and the materials considered). As part of this process, the FDA reviews the device's “proposed labeling” and “must determine that the proposed labeling is neither false nor misleading.” Id. at 318 (citing 21 U.S.C. § 360e(d)(1)(A)). “Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness.” Id. at 319 (citing 21 U.S.C. § 360e(d)(6)(A)(i)). Approved devices are also subject to continuing reporting requirements, including “the obligation to inform the FDA” of new data concerning the device and the obligation “to report incidents in which the device may have caused or contributed to death or serious injury, or malfunctioned in a manner that would likely cause or contribute to death or serious injury if it recurred.” Id. (citations omitted).

The MDA contains an express preemption clause which provides, with an exception not relevant here, that:

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 under this chapter.

21 U.S.C. § 360k(a). Thus, any claim arising from a state obligation which imposes a requirement “different from, or in addition to” the requirements of the MDA is expressly preempted. Id.; see also Riegel, 552 U.S. at 321, 324 (“Absent other...