Hill v. Bayer Corp.

• Decision Date: 08 September 2020
• Docket Number: Case No. 19-CV-12198
• Parties: April L. HILL, Plaintiff, v. BAYER CORPORATION, et al., Defendants.
• Court: U.S. District Court — Eastern District of Michigan

485 F.Supp.3d 843

April L. HILL, Plaintiff,

v.BAYER CORPORATION, et al., Defendants.

Case No. 19-CV-12198

United States District Court, E.D. Michigan, Southern Division.

Signed September 8, 2020

Jerard M. Scanland, Mussin and Scanland, PLLC, Southgate, MI, for Plaintiff.

Alison L. Carruthers, Jill M. Wheaton, Dykema Gossett, Ann Arbor, MI, Gabriel Schonfeld, Sidley Austin LLP, Washington, DC, for Defendants.

ORDER GRANTING DEFENDANTS’ MOTION TO DISMISS [ECF No. 12] AND GRANTING DEFENDANTS’ SECOND REQUEST FOR JUDICIAL NOTICE [ECF No. 27]

GEORGE CARAM STEEH, UNITED STATES DISTRICT JUDGE

I. Overview

Plaintiff April Hill brought this products liability suit arising out of injuries allegedly caused by an Essure permanent birth control device manufactured by Defendants. Plaintiff has sued Defendants Bayer Corp., Bayer Healthcare, LLC, and Bayer Healthcare Pharmaceuticals Inc. (collectively "Bayer"). Now before the court is Defendants’ motion to dismiss for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6) on the grounds that Plaintiff's claims are preempted or fail to state plausible claims. Oral argument was held, and the parties were permitted to file supplemental briefs. Defendants filed a second request for the court to take judicial notice of Patient Information Booklet (2009). For the reasons set forth below, Defendants’ motion to dismiss shall be GRANTED such that all of Plaintiff's claims are DISMISSED. Defendants’ second request for judicial notice is also GRANTED.

II. Factual Background

The recitation of the facts below comes from the allegations of the Amended Complaint or from those documents that the parties agreed may be judicially noticed by the court. (ECF No. 4). Essure is a permanent female birth control device that is intended to cause a blockage of the fallopian tubes by the insertion of micro-inserts into the fallopian tubes which then anchor and elicit tissue growth. Id. at PageID.99, ¶ 15. The micro-inserts are comprised of two metal coils which are inserted using hysteroscopic (camera) guidance. Id. at PageID.105, ¶ 33. Plaintiff alleges the device migrates from the fallopian tubes and perforates organs. Id. at PageID.99, ¶ 15. The device is inserted as part of a "non-surgical" outpatient procedure to be done without anesthesia

. Id. at PageID.106, ¶ 41.

Essure had Conditional Premarket Approval ("CPMA") by the Food and Drug Administration ("FDA"). Id. at PageID.99, ¶ 17; ECF No. 13-1. As a Class III medical device, Essure required premarket approval ("PMA") by the FDA. Id. at PageID.107, ¶ 48. Class III devices receive the most federal oversight. Riegel v. Medtronic, Inc. , 552 U.S. 312, 317, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). Bayer discontinued sales of Essure after December 31, 2018. The FDA reviews a device's proposed labeling, which includes the Instructions for Use ("IFU") (for physicians) and Patient Information Booklet ("PIB") (for patients), as part of the premarket approval process. It "evaluates safety and effectiveness under the conditions of use set forth on the label," and "must determine that the proposed labeling is neither false nor misleading" before granting approval. Id. at 318, 128 S.Ct. 999 (citing 21 U.S.C. §§ 360c(a)(2)(B), 360e(d)(1)(A) ). FDA may also specify requirements that apply to the training of practitioners who use the device, and these requirements must appear in the FDA-approved labeling. 21 U.S.C. § 360j(e). Once a device has been approved, a manufacturer cannot make changes to the labeling without FDA permission under "largely the same criteria" as the initial application. Riegel , 552 U.S. at 319, 128 S.Ct. 999.

Plaintiff was implanted with the Essure device on or around December 21, 2011. (Amended Complaint, ¶ 97). Plaintiff alleges that as a result of the implantation of Essure she has suffered abdominal pain, depression, fatigue, heavy bleeding, pain during intercourse, weight fluctuations, severe back pain, migraines, urgent and frequent urination, heart palpitations, loss of libido, bowel issues, pelvic pain, and hot flashes. (ECF No. 4, PageID.127-28, ¶ 98). She further alleges that the device has potentially migrated and embedded in areas outside of her fallopian tubes which she alleges will require her to have a hysterectomy

. (ECF No. 4, PageID.128, ¶ 98).

Plaintiff's Amended Complaint alleges five counts: (I) negligent training, (II) negligent risk management, (III) breach of express warranty, (IV) negligent misrepresentation, and (V) negligent failure to warn. Defendants argue that Plaintiff's claims are preempted and inadequately pled.

III. Standard of Law

Rule 12(b)(6) allows the Court to make an assessment as to whether the plaintiff has stated a claim upon which relief may be granted. Under the Supreme Court's articulation of the Rule 12(b)(6) standard in Bell Atlantic Corp. v. Twombly , 550 U.S. 544, 554-56, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007), the court must construe the complaint in favor of the plaintiff, accept the allegations of the complaint as true, and determine whether plaintiff's factual allegations present plausible claims. " ‘[N]aked assertions’ devoid of ‘further factual enhancement’ " are insufficient to " ‘state a claim to relief that is plausible on its face.’ " Ashcroft v. Iqbal , 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (quoting Twombly , 550 U.S. at 557, 570, 127 S.Ct. 1955 ). To survive a Rule 12(b)(6) motion to dismiss, plaintiff's pleading for relief must provide " ‘more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.’ " D'Ambrosio v. Marino , 747 F.3d 378, 383 (6th Cir. 2014) (quoting Twombly , 550 U.S. at 555, 127 S.Ct. 1955 ). Even though the complaint need not contain "detailed" factual allegations, its " ‘factual allegations must be enough to raise a right to relief above the speculative level on the assumption that all of the allegations in the complaint are true.’ " New Albany Tractor, Inc. v. Louisville Tractor, Inc. , 650 F.3d 1046, 1051 (6th Cir. 2011) (quoting Twombly , 550 U.S. at 555, 127 S.Ct. 1955 ).

IV. Analysis

A. Judicial Notice

Defendants request that the Court take judicial notice of the 2009 Patient Information Booklet, approved by FDA in 2009 and in force at the time that Plaintiff received Essure. Federal Rule of Evidence 201(b) authorizes the Court to take judicial notice of facts that are "not subject to reasonable dispute" because they "can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned." The 2009 Patient Information Booklet is a publicly available federal agency document related to FDA premarket approval and the Court grants Defendants’ request and takes judicial notice thereof. See, e.g., Int'l Bhd. of Teamsters v. Zantop Air Transp. Corp. , 394 F.2d 36, 40 (6th Cir. 1968) ("[A] Court may take judicial notice of the rules, regulations and orders of administrative agencies issued pursuant to their delegated authority.")

B. Preemption under the FDCA

The FDCA includes an express preemption clause that provides, in relevant part:

[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 to the device under this chapter.

21 U.S.C. § 360k(a).

The Supreme Court addressed the meaning of § 360k(a) in Riegel , supra, which involved a Class III medical device that had received premarket approval. The Court explained that to the extent that a state common-law duty imposes requirements "different from, or in addition to" the requirements imposed by the FDCA, those state common-law duties are expressly preempted by § 360k(a). Id. To escape preemption by § 360k(a), then, a state-law claim must be premised on the breach of a state-law duty that is the same as a duty imposed under the FDCA (or one of its implementing regulations). Id. at 330, 128 S.Ct. 999 ("Thus, § 360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, federal requirements."). Put another way, the conduct that is alleged to give the plaintiff a right to recover under state law must be conduct that is forbidden by the FDCA. Thus, to determine whether Hill's claims are preempted, it is first necessary to identify precisely what conduct by Bayer is alleged to give rise to a claim under Michigan law. If that conduct is not prohibited by the FDCA, then Hill's claim, if successful, would have the effect of imposing on Bayer a requirement that is different from or in addition to the requirements imposed by the FDCA—and, for that reason, Hill's claim would be expressly preempted by § 360k(a).

If the conduct is prohibited by the FDCA, then a state-law claim premised on that conduct is not expressly preempted by § 360k(a). But that is not the end of the inquiry, for even if a claim is not expressly preempted by § 360k(a), it may be impliedly preempted under Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). In Buckman, the Supreme Court held that, because enforcing the FDCA is exclusively the province of the federal government, there is no private right of action under the FDCA. Id. at 349 n. 4, 121 S.Ct. 1012 ("The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions: ‘[A]ll such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.’ 21 U.S.C. § 337(a).’ "). Thus, a private litigant cannot sue a defendant for violating the FDCA....