Green v. Bayer Corp.

• Decision Date: 22 February 2021
• Docket Number: 4:20-CV-1489-BRW
• Citation: 522 F.Supp.3d 492
• Parties: Kristen GREEN, Plaintiff v. BAYER CORPORATION, Bayer Healthcare, LLC, Bayer Essure, Inc., and Bayer Healthcare Pharmaceuticals, Inc., Defendant
• Court: U.S. District Court — Eastern District of Arkansas

522 F.Supp.3d 492

Kristen GREEN, Plaintiff

v.BAYER CORPORATION, Bayer Healthcare, LLC, Bayer Essure, Inc., and Bayer Healthcare Pharmaceuticals, Inc., Defendant

4:20-CV-1489-BRW

United States District Court, E.D. Arkansas, Central Division.

Signed February 22, 2021

David A. Hodges, David Hodges Law Office, Little Rock, AR, for Plaintiff.

Adria W. Conklin, Lyn Peeples Pruitt, Mary Catherine Way, Mitchell, Williams, Selig, Gates & Woodyard, P.L.L.C., Little Rock, AR, Christopher A. Eiswerth, Pro Hac Vice, Erika L. Maley, Pro Hac Vice, Sidley Austin LLP, Washington, DC, for Defendant.

ORDER

Billy Roy Wilson, UNITED STATES DISTRICT JUDGE

Pending are Defendants’ Motion to Dismiss (Doc. No. 6), Plaintiff's Motion to Amend (Doc. No. 17), and Defendants’ Motion to Stay Discovery (Doc. No. 22). Plaintiff has responded¹ and Defendant has replied.² For the reasons set forth below, the Motion to Dismiss is GRANTED; Plaintiff's Motion to Amend is DENIED; and Defendants’ Motion to Stay Discovery is DENIED as moot.

I. BACKGROUND

Defendants manufacture and sell a female contraceptive device known as Essure.³ Essure is a permanent form of birth control that is intended to cause bilateral blockage of the fallopian tubes.⁴ Defendants designed, marketed, and manufactured Essure to be implanted without anesthesia through a non-surgical outpatient procedure.⁵ Essure had Conditional Premarket Approval ("CPMA") by the Food and Drug Administration ("FDA").⁶

Plaintiff was implanted with the Essure device in April 2009.⁷ After the procedure, she began to suffer from severe pain and abnormal bleeding.⁸ In March 2020, she had a hysterectomy to resolve these issues.⁹

Plaintiff filed the her Complaint bringing three claims against Defendants: (1) negligent training; (2) negligent risk Management; and (3) breach of express warranty.¹⁰ Defendants seek dismissal of all claims because federal law preempts them and they are insufficiently pled.¹¹ Plaintiff denies any federal preemption and seeks leave to amend her Complaint.¹²

II. APPLICABLE LAW

To survive a motion to dismiss for failure to state a claim, Plaintiff's allegations must contain "sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’ "¹³ The plausibility requirement is satisfied when the Plaintiff "pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged."¹⁴

The reviewing court accepts the plaintiff's factual allegations as true and draws all reasonable inferences in favor of the nonmoving party.¹⁵ However, "[c]ourts are not bound to accept as true a legal conclusion couched as a factual allegation, and factual allegations must be enough to raise a right to relief above the speculative level."¹⁶ The issue is not whether the Plaintiff will ultimately prevail, but whether the Plaintiff is entitled to present evidence in support of her claim.¹⁷

III. DISCUSSION

Congress passed the Medical Device Amendments ("MDA") to the Federal Food, Drug, and Cosmetic Act ("FDCA"), to "impose[ ] a regime of detailed federal oversight" for medical devices.¹⁸ The MDA expressly preempts certain state laws. "[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."¹⁹

The United States Supreme Court has set out a two-part test for applying the express preemption principles from Section 360k of the MDA.²⁰ First, I must determine whether "the Federal Government has established requirements" applicable to a particular device.²¹ Second, I must decide whether a plaintiff's claims "are based upon [state] requirements with respect to the device that are different from, or in addition to the federal ones, and that relate to safety and effectiveness."²² If I answer yes to both questions, the state laws are expressly preempted by the MDA.²³

However, " § 360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; where the state duties in such a case ‘parallel,’ rather than add to, federal requirements."²⁴ Premarket approval is a federal "requirement" that meets the first prong of the test for § 360k preemption.²⁵ Common law negligence and strict liability claims are included in the meaning of "state requirements" subject to federal preemption.²⁶

In Buckman Co. v. Plaintiffs’ Legal Committee ,²⁷ the Supreme Court construed § 337(a) of the MDA—which provides that all actions to enforce FDA requirements "shall be by and in the name of the United States"—"as barring suits by private litigants ‘for noncompliance with the medical device provisions.’ "²⁸ The Eighth Circuit has read Buckman and Riegel together to create a "narrow gap through which a plaintiff's state-law claim must fit if it is to escape express or implied preemption."²⁹ Plaintiff "must be suing for conduct that violates the FDCA (or else her claim is expressly preempted by § 360k(a) ), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman )."³⁰

Here, the parties do not dispute that Essure is a "Class III" device, regulated by the MDA, subject to PMA procedures, and granted CPMA by the FDA. This means that suits by private parties concerning its use will generally be preempted.³¹ Plaintiff must state a claim under a parallel Arkansas law that is based solely on the federal violations to avoid preemption.

A. Negligent Training

Plaintiff alleges Defendants "took on an independent duty to train physicians on how to properly use Essure and place the micro-inserts, which failed to abide by FDA training guidelines."³² She alleges Defendants "had a duty to abide by the FDA training guidelines for the implanting physicians on how to place Essure using its own delivery system, certify the implanting physicians, and oversee this particular procedure."³³ Plaintiff assert Defendants breached this duty, and parallel state laws, by failing to train her physicians in "competent procedures" and the management of "possible technical issues."³⁴ Defendants argue the claims are preempted because Arkansas law provides no parallel requirement to train, and, alternatively, Plaintiff has failed to offer factual support for her claims.³⁵

To the extent that Plaintiff claims that Defendants deviated from FDA-approved training requirements,³⁶ such claims do not seek to impose obligations beyond those mandated by the FDA, and are not expressly preempted. However, Plaintiff must plead a parallel state law cause of action to avoid implied preemption.

Plaintiff cites Anderson v. Mitts ,³⁷ to support her position that Arkansas law supports negligent training claims outside of the employee-employer context. However, that case discussed the duty imposed on a volunteer babysitter to supervise a child.³⁸ The court held that the babysitter's duty of care did not depend on the status of the child as a licensee on the property.³⁹ The case had nothing to do with training the babysitter, and doesn't apply to the allegations in this case.

Plaintiff also points to Ballinger v. Heritage Log Homes, Inc. ,⁴⁰ to support her position Arkansas law imposes liability to third parties outside of the employee-employer context. There, the court held that "that one who gratuitously renders services to another may be subject to liability to a third person for physical harm resulting from his failure to use reasonable care."⁴¹ The court cited the Restatement (Second) of Torts § 324A to support its decision.⁴²

Another federal district court considering similar claims involving Essure recently found that where a state's supreme court explicitly adopted § 324A and set specific circumstances for its application, a parallel state law claim for negligent training was present.⁴³ The court reasoned that "[Defendants] undertook to render services (Essure training) to another (physicians providing the device to their patients). [Defendants] should recognize the training as necessary for the protection of third parties (patients like [Plaintiff]), and [Defendants] are subject to liability to those patients for physical harm resulting from its failure to exercise reasonable care in training the physicians if, for example, its failure to exercise reasonable care increased the risk of such harm to the patients."⁴⁴

Plaintiff contends Defendants assumed a duty when it voluntarily trained physicians. As set out in § 324A and recognized by the Arkansas Supreme Court in Wilson v. Rebsamen Insurance., Inc. ,⁴⁵ "one who voluntarily assumes a duty owed another is liable to a third party injured by a breach of that duty" under Arkansas law.⁴⁶ In Wilson , the court held that a company's duty to maintain a safe workplace was assumed though a contract by an insurance company, and an employee who was injured when that duty was breached was allowed to recover damages from the insurance company.⁴⁷ Applying this analysis here may create a parallel state law claim for negligent training.

However, even if I apply Wilson , Plaintiff's complaint fails to allege sufficient facts demonstrating Defendants’ negligent training were a proximate cause of her injuries. Though the Complaint states Plaintiff was harmed when Defendants failed to adequately train her physician, it offers no facts indicating how that training differed from the FDA-approved requirements and how the alleged differences led to her injuries. The Complaint must show "more than a sheer possibility that [D]efendant[s] [have] acted unlawfully."⁴⁸ Accordingly, Plaintiff's claim relating to negligent training fails to state a claim upon which relief can be granted and is...