MEMORANDUM DECISION AND ORDER 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. FACTS3 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.
