Noel v. Bayer Corp.

• Decision Date: 26 August 2020
• Docket Number: CV20-27-BLG-SPW
• Citation: 481 F.Supp.3d 1111
• Parties: Amanda NOEL and Joseph Noel, Plaintiffs, v. BAYER CORPORATION, et al., Defendants.
• Court: U.S. District Court — District of Montana

481 F.Supp.3d 1111

Amanda NOEL and Joseph Noel, Plaintiffs,

v.BAYER CORPORATION, et al., Defendants.

CV20-27-BLG-SPW

United States District Court, D. Montana, Billings Division.

Signed August 26, 2020

Ben Alvin Snipes, Mark Kovacich, Odegaard Kovacich Snipes, PC, Great Falls, MT, Christina E. Mancuso, Pro Hac Vice, Simon Greenstone Panatier, P.C., Dallas, TX, for Plaintiffs.

Lee A. Mickus, Evans Fears & Schuttert LLP, Denver, CO, for Defendants.

ORDER GRANTING MOTION TO DISMISS

SUSAN P. WATTERS, United States District Judge Before the Court is Defendants’ (collectively "Bayer") motion to dismiss the Complaint for failing to state a claim upon which relief can be granted under Federal Rule of Civil Procedure 12(b)(6). (Doc. 7.)¹ Plaintiff Amanda Noel filed a response, (Doc. 20), and Bayer filed a reply, (Doc. 21). For the following reasons, the Court grants the motion but will provide Noel leave to amend her complaint.

I. Background

Bayer manufactures and sells a female contraceptive device known as Essure. (Doc. 1 at ¶ 16.) Essure is a permanent form of birth control that is intended to cause bilateral blockage of the fallopian tubes. (Id. at ¶ 41.) Bayer designed, marketed, and manufactured Essure to be implanted without anesthesia through a non-surgical outpatient procedure. (Id. at ¶ 51.)

Noel was implanted with the Essure device in November 2012. (Id. at ¶ 109.) After the procedure, she began to suffer from severe pelvic pain, excessive and frequent menses, and severe and excessive bleeding during menstruation. (Id. at ¶ 110.) Because of these complications, in April 2017, she underwent a surgery to remove the Essure device along with her fallopian tubes. (Id. at ¶ 111.)

Noel filed the instant Complaint against Bayer alleging eleven counts: (1) Negligent Training; (2) Negligent Entrustment; (3) Negligent Distribution and Overpromotion; (4) Negligence – Risk Management; (5) Breach of Express Warranty; (6) Unfair Trade Practices and Consumer Protection; (7) Fraudulent Concealment; (8) Fraudulent Misrepresentation; (9) Negligent Misrepresentation; (10) Strict Liability; and (11) Negligent Design. (Id. at ¶¶ 137–273.) Bayer now seeks dismissal of her claims, arguing federal law preempts them and they are otherwise deficient. (Doc. 7-1 at 8.)

II. Discussion

When Congress passed the Medical Device Amendments ("MDA") to the Federal Food, Drug, and Cosmetic Act ("FDCA"), it "imposed a regime of detailed federal oversight" for medical devices. Riegel v. Medtronic, Inc. , 552 U.S. 312, 316, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). The MDA separates medical devices into three categories with progressively more stringent regulations. Buckman Co. v. Plaintiffs’ Legal Comm. , 531 U.S. 341, 344, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). A Class III device, such as Essure, "presents a potential unreasonable risk of illness or injury" and therefore incurs the most stringent regulations. Section 360c(a)(1)(C)(ii)(II). Class III devices must complete a thorough review and premarket approval process through the FDA before a company may market them. Buckman , 531 U.S. at 344, 121 S.Ct. 1012. The process requires demonstrating "reasonable assurance of [the device's] safety and effectiveness." Section 360c(a)(1)(C). Premarket approval is "rigorous," and requires a manufacturer to submit what is typically "a multivolume application" with numerous components. Riegel , 552 U.S. at 317, 128 S.Ct. 999.

After the FDA grants a device premarket approval, the MDA forbids a manufacturer from making, without FDA permission, "changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness." Riegel , 552 U.S. at 319, 128 S.Ct. 999 (citing § 360e(d)(6)(A)(i)). An applicant wishing to make such a change must apply for supplemental premarket approval through the FDA, which the FDA evaluates under largely the same criteria as the initial application. Id. (citing § 360e(d)(6); 21 CFR § 814.39(c) ).

Section 360i also subjects premarket-approved devices to several reporting requirements. An applicant must inform the FDA of any new clinical investigations or scientific studies concerning the device of which the applicant knows or reasonably should know. Riegel , 552 U.S. at 319, 128 S.Ct. 999 (citing 21 CFR § 814.84(b)(2) ). The applicant must also "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. (citing § 803.50(a)). The FDA must withdraw a device's approval if it determines the device is unsafe or ineffective under the conditions in its labeling. Id. (citing 21 USC § 360e(e)(1) ).

Critically, upon its passage, the MDA pre-empted and otherwise limited independent state obligations for medical devices. It includes an express federal pre-emption provision stating, as a general rule:

[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).

Section 360k(a) therefore expressly pre-empts state requirements, including common law requirements, to the extent that they are "different from, or in addition to" the requirements imposed by federal law. Riegel , 552 U.S. at 330, 128 S.Ct. 999. Not all state requirements are pre-empted, however. States can still provide remedies for claims premised on a violation of the FDA regulations as long as "the state duties in such a case ‘parallel,’ rather than add to, federal requirements." Id. (quoting Medtronic, Inc. v. Lohr , 518 U.S. 470, 495, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) ). Furthermore, under federal law, the MDA does not provide a private right of action for enforcement. Section 337 ("[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."); see also Buckman , 531 U.S. at 348, 121 S.Ct. 1012 (holding the FDCA impliedly pre-empted the plaintiffs’ fraud-on-the-FDA claims because the FDCA empowers the FDA to punish and deter fraud against it, and allowing state-law claims would skew the balance of statutory objectives).

Therefore, the actions a plaintiff may bring regarding a medical device are few. The plaintiff can neither maintain such an action under federal law alone nor under any state law that is "different from, or in addition to" the FDCA. Sections 337, 360k(a). Instead, the plaintiff must bring her action under a parallel state law. Put another way, "The plaintiff must be suing for conduct that violates the FDCA (or else [her] claim is expressly pre-empted by § 360k(a) ), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly pre-empted under Buckman )." In re: Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig. , 623 F.3d 1200, 1204 (8th Cir. 2010) (emphasis in original); accord Perez v. Nidek Co. , 711 F.3d 1109, 1120 (9th Cir. 2013). Under this framework, the Court turns to Noel's claims against Bayer.

a. Design and Manufacturing Defects (Counts X and XI)

Noel primarily alleges Bayer failed to design Essure in a safe and reasonable manner. (Doc. 1 at ¶¶ 242–73.) She also asserts Bayer departed from the design the FDA approved for the device. She alleges Bayer used "nonconforming material," (Doc. 1 at ¶¶ 40, 77, 78(e), 132, 251(c), 261(e)), nonsterile cages, (Id. at ¶¶ 40, 77), and that the device was "adulterated," (Id. at ¶¶ 27–29, 34, 39, 63, 88, 106, 132, 168). She alleges the changes were not approved by the FDA because the FDA cited Bayer for them. (Id. at ¶¶ 31, 217.) She also alleges Bayer manufactured Essure without a license and at an unlicensed facility. (Id. at ¶¶ 31(d),(e), 40, 77(c),(d), 106.)

In De La Paz v. Bayer HealthCare Ltd. Liab. Co. , 159 F. Supp. 3d 1085, 1094–95 (N.D. Cal. 2016), the California Northern District Court addressed nearly identical claims and issues stemming from a plaintiff's complaint against Bayer for the Essure device. Like Noel, De La Paz claimed the Essure device had fundamental design defects. Id. at 1090. De La Paz also claimed her specific device was adulterated because Bayer used nonconforming material, non-sterile cages, and manufactured Essure without a license and at an unlicensed facility. Id. at 1094–95.

The district court first noted it was nearly impossible for a design-defect claim to survive pre-emption because such a claim would challenge the FDA-approved design. Id. at 1092 ("Every design-defect claim considered within our circuit has been held pre-empted (such a claim would require allegations of deviations from the FDA-approved design).") (emphasis in original).

The district court then turned to De La Paz's specific manufacturing-defect claims. It explained that a device is adulterated under the MDA if "the methods used in, or the facilities or controls used for, its manufacture, packing, storage, or installation are not in conformity with applicable requirements" in the FDA's requirements for that device. Id. (quoting § 351(h)). To escape pre-emption, the complaint must allege the irregularities resulted in a manufacturing defect that caused the plaintiff's injuries. The claim could not exist solely because it violated the MDA's requirements. Id. (citing Buckman , 531 U.S. at 353, 121 S.Ct. 1012 ). Finding De La Paz had not alleged the defects caused her injuries, the court dismissed the claims, but it provided that De La Paz could seek leave to amend. Id.

This Court finds the California Northern District Court's reasoning was sound. First, Noel's design-defect claims are pre-empted on their face. The parties do...