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Norman v. Bayer Corp.

United States District Court, D. Connecticut

July 26, 2016

APRIL NORMAN, Plaintiff,
v.
BAYER CORP. et al., Defendants

          RULING GRANTING MOTION TO DISMISS

          JEFFREY ALKER MEYER UNITED STATES DISTRICT JUDGE.

         This is a products liability case about Essure, a permanent contraceptive device that is allegedly manufactured and marketed by defendant Bayer Corp. and related defendants. Plaintiff April Norman alleges that this device caused her injuries after she had it implanted. Essure is a Class III medical device that passed the Food and Drug Administration‘s stringent premarket approval process before being sold to the general public. Because all of plaintiff s claims are either preempted by the federal law or fail to allege facts that give rise to plausible grounds for relief, I will grant defendants‘ motion to dismiss.

         Background

         The following facts are described as alleged in the complaint. Essure is a Class III medical device designed to effect permanent female birth control. The device involves insertion of metal coils called ''micro-inserts'' to block the fallopian tubes and prevent pregnancy. It is manufactured, marketed, and sold by defendants.[1]

         The complaint extensively describes the device‘s features, history, and associated marketing materials. The following allegations are the most significant: The federal Food and Drug Administration (FDA) issued a pre-market approval (PMA) of Essure as a Class III medical device in 2002. Such approvals involve an intensive application process and also impose extensive and ongoing regulatory requirements to ensure the safety and effectiveness of the device. Among other requirements were that defendants had to report certain adverse events involving the device. Defendants‘ manufacturing plants were also subject to FDA inspection.

         According to the complaint, the FDA cited defendants for multiple violations of FDA regulations on various dates from 2003 to 2013, including that defendants were producing devices at an unlicensed facility, that defendants had used ''non-conforming material'' for the devices at one facility, and that defendants had failed to report to the FDA adverse events including perforations of the fallopian tubes from the device. Plaintiff also alleges that defendants inadequately trained doctors to perform the Essure insertion procedure by, for example, allowing trained company representatives-who were not physicians-to conduct the training.

         In plaintiff‘s 29-page complaint, only four short paragraphs relate to her personal experience with Essure. In March 2013, plaintiff wanted a traditional tubal ligation, but her doctor instead recommended the Essure device, and she underwent the procedure. She later suffered from pelvic pain, weight gain, heavy bleeding, blood clots, painful intercourse, hair loss, and depression, and had a hysterectromy to remove the device. The complaint does not allege any facts to indicate that the device was improperly implanted, that it broke, or that it had any other manufacturing defect. Nor does the complaint allege that plaintiff or her doctor consulted or relied upon any particular information or warnings about the device.

         Plaintiff now brings this lawsuit alleging seven counts, titled as follows: Strict Products Liability (Count One); Negligent Failure to Warn (Count Two); Negligence in Training (Count Three); Negligence in Manufacturing (Count Four); Negligence / Negligence Per Se (Count Five); Negligent Misrepresentation (Count Six); and Breach of Express Warranty (Count Seven). Defendants have moved to dismiss the complaint in its entirety, contending that every count of the complaint is either preempted by the FDA‘s regulatory scheme, or fails to allege sufficient facts to give rise to plausible grounds for relief. Doc. #31.

         Discussion

         The principles governing this Court‘s consideration of a Rule 12(b)(6) motion are well established. First, the Court must accept as true all factual matter alleged in a complaint and draw all reasonable inferences in the plaintiffs‘ favor. See Johnson v. Priceline.com, Inc., 711 F.3d 271, 275 (2d Cir. 2013). But, ''‗[t]o survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face.‘'' TechnoMarine SA v. Giftports, Inc., 758 F.3d 493, 505 (2d Cir. 2014) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)).

         Preemption of State Law Claims Involving Medical Devices

         Defendant argues that many, if not all, of plaintiff‘s claims are preempted by the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq. It is well established that ''Congress has the power to preempt state law.'' Arizona v. United States, ___U.S.___, 132 S.Ct. 2492, 2500-01 (2012). But a federal statute will not be found to preempt claims arising under state law unless Congress‘ intent to do so is ''clear and manifest.'' Wyeth v. Levine, 555 U.S. 555, 565 (2009).

         Medical devices are governed by the Medical Device Amendments (MDA) to the FDCA, and the MDA includes the following express preemption provision:

[N]o 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 ...

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