Court: District Court, W.D. North Carolina; May 10, 2017; Federal District Court
The court is addressing a Motion to Dismiss and a Motion to Reconsider or Certify for Appeal related to a lawsuit involving the Essure birth control device. The plaintiff experienced complications post-insertion and subsequently filed suit against the Bayer defendants and medical providers in North Carolina state court, asserting claims including negligence, products liability, and medical malpractice. The case was removed to federal court, and a Motion to Remand was denied. The court is now evaluating the Bayer defendants' Motion to Dismiss under Rule 12(b)(6). The standard for survival of such a motion requires that the complaint contains sufficient factual allegations to raise a right to relief above a speculative level, moving beyond mere labels and conclusions. The court references the Supreme Court's decision in Bell Atlantic Corp. v. Twombly, emphasizing the need for factual enhancement in the pleadings to survive dismissal.
A claimant must provide sufficient factual allegations to establish a claim for relief that is "plausible on its face," as outlined in the Supreme Court's rulings in Twombly and Iqbal. To survive a motion to dismiss under Rule 12(b)(6), a complaint must present enough factual content for the court to reasonably infer that the defendant is liable for the alleged misconduct. The Court emphasizes that mere consistency with a defendant’s liability is insufficient; there must be more than just a possibility of unlawful conduct. While courts accept factual allegations as true and view them favorably for the plaintiff, they are not obliged to accept unwarranted inferences or unreasonable conclusions. A complaint must provide the defendant with fair notice of the claims and their grounds. It is sufficient for a plaintiff to cross the threshold from conceivable to plausible without needing to show that the claim is probable.
Regarding motions for reconsideration, Rule 54(b) allows courts to revise any order adjudicating fewer than all claims at any time before final judgment. Courts hold inherent authority to reconsider interlocutory orders, and the standard for doing so is less stringent than for final judgments. The Fourth Circuit indicates that district courts generally refer to Rule 59(e) for guidance on reconsideration standards, maintaining the ability to modify interlocutory judgments as warranted.
Under the ruling in Ruffin v. Entm’t of E. Panhandle, the Fourth Circuit identifies three grounds for amending a judgment: changes in controlling law, new evidence not available at trial, or correcting clear errors to prevent manifest injustice. Rule 59(e) is viewed as an extraordinary remedy, to be used sparingly and at the discretion of the district court, and cannot be employed to relitigate previously settled matters or raise arguments that could have been presented before judgment. The plaintiff failed to provide sufficient reasons to modify the court's prior ruling, merely citing a Fourth Circuit decision that clarifies a federal defense, such as preemption, does not establish federal jurisdiction. The court distinguishes the current case from Pinney v. Nokia, noting that unlike Pinney, where federal law was not directly invoked, the plaintiff's claims here explicitly cite violations of the FDCA. The court reaffirms that the case meets the criteria for federal jurisdiction as established in Gunn v. Minton, emphasizing a significant federal interest. The plaintiff's attempt to reassert previously stated arguments in hopes of a different outcome was denied. Additionally, the motion for certification to appeal was also denied. On the issue of preemption, federal law typically presumes against it unless Congress's intent is clear. For Class III medical devices, the statute includes an express preemption clause, indicating that state laws conflicting with federal requirements are preempted. Furthermore, state law claims can be impliedly preempted under the FDCA if they are based solely on FDCA violations.
Avoiding express and implied preemption in legal claims is complex. A plaintiff's claim must be based on conduct that violates the Federal Food, Drug, and Cosmetic Act (FDCA) to avoid express preemption, but cannot be solely due to violations of the FDCA to evade implied preemption under Buckman. Claims must be fully parallel to federal law, not derivative, to fit within a "narrow gap." This challenge is likened to navigating between Scylla and Charybdis. The Bayer defendants assert that all of the plaintiff's claims are preempted, while the plaintiff contends that state law claims mirroring federal regulations should not face indiscriminate preemption and requests denial of the Motion to Dismiss.
The primary issue is whether the state law claims are preempted by federal law, with a secondary focus on allegations of fraud and violations of North Carolina’s unfair trade practices act. The court will also consider a medical malpractice claim based solely on state law. The plaintiff claims negligence primarily through a failure-to-warn theory, alleging the Bayer defendants did not adequately warn of adverse events related to the Essure device. The court finds that the defendants had a continuous duty under the FDCA, and since a private suit cannot enforce the Medical Device Amendments (MDA) per Buckman, the failure-to-warn claim is preempted.
Additionally, the plaintiff's inability to prove causation weakens her negligence claim. She claims that had the relevant adverse event information been adequately reported to the FDA, she would not have had Essure implanted. However, since the FDA was already aware of these adverse events before her device was inserted, the plaintiff fails to establish a causal link between the alleged failure to warn and her injuries. The introduction of a black box warning is noted as not providing new information beyond that which was already available on prior labeling.
California law cited by the plaintiff is deemed inapplicable as North Carolina law governs this case. The plaintiff claims that the Bayer defendants inadequately trained Dr. Travis regarding the implantation and management of the device, but this negligent training claim is preempted under the Medical Device Amendments (MDA). The court finds that such a claim can only survive preemption if it demonstrates a failure to meet MDA training requirements, which the plaintiff has not adequately shown. The complaint lacks specific details on how the training violated FDA standards and does not establish a direct causal link between the alleged training failure and the plaintiff's injuries.
Additionally, the claim of improper manufacturing is also preempted, as the plaintiff fails to connect any alleged manufacturing defect to the specific device received and its impact on the injuries claimed. The assertion that the Essure product deviated from intended specifications does not satisfy the requirement for factual allegations necessary to support the claim under Twombly and Iqbal standards.
Regarding the products liability claim, particularly the failure to warn theory, the court finds it preempted by Buckman’s implied preemption, given that the FDA oversees the safety and effectiveness of such devices. The plaintiff's assertion of design defect claims is also preempted, as the FDA has approved the safety and effectiveness of the product, and the plaintiff cannot demonstrate any deviation from this approved design. Furthermore, if state law were applied to the products liability claim, it would be subject to N.C. Gen. Stat. 99B-1.1, which does not recognize strict liability in such actions, undermining the plaintiff's strict liability arguments.
Breach of express and implied warranties concerning the Essure Class III medical device is asserted by the plaintiff, who claims that the Bayer defendants warranted the device as safe, which was allegedly untrue. These claims are preempted by federal law, as the FDA has the authority to regulate Class III medical devices and granted pre-market approval for Essure, confirming its safety and effectiveness. The plaintiff's claim of breach of implied warranty is also dismissed on similar preemption grounds.
Additionally, the plaintiff's claims of fraud and violations of the state’s unfair trade practices act are considered redundant, as they largely restate previous allegations regarding the concealment of risks associated with Essure. Many of these claims mirror FDA-approved labeling, and federal regulations prohibit misleading advertising inconsistent with FDA approvals. Thus, these claims are also preempted.
Furthermore, the Federal Rules of Civil Procedure require specific pleading standards for fraud claims, which include detailing the time, place, and content of misrepresentations. Although the plaintiff argues reliance on Bayer's information in the decision to implant Essure and highlights misrepresentations about its safety, even assuming compliance with Rule 9(b), the claims face plausibility challenges under the standards set by Twombly and Iqbal. The FDA's prior safety and effectiveness determination, along with the reporting of adverse events, undermines the plaintiff's allegations.
Claims of misrepresentation are preempted and will be dismissed. The plaintiff's medical malpractice claim against defendants Travis and Biltmore OB-GYN is not preempted by federal law as it is based solely on state law. To succeed in this claim under North Carolina law, the plaintiff must demonstrate the applicable standard of care, breach of that standard by the defendants, and that the breach caused the plaintiff's injury. North Carolina law requires special pleading, which mandates that an expert witness review the medical care and records and testify regarding the standard of care. Although the plaintiff objected to these requirements, they appear to have complied. The court notes that the state supreme court has upheld the constitutionality of these pleading requirements. North Carolina's contributory negligence rules may affect the plaintiff's potential damages.
All claims except for the medical malpractice claim are preempted and dismissed. The court, under 28 U.S.C. 1367(c)(3), declines to exercise supplemental jurisdiction over the remaining malpractice claim, which may be reasserted in state court. The court also denies a request to certify the issue for appeal, as all original jurisdiction claims have been dismissed. The medical device in question, Essure, is classified as a Class III medical device by the FDA, and the plaintiff's other claims, including negligence, products liability, and fraud, are dismissed due to preemption concerns under federal law.
The court has granted the Motion to Dismiss, resulting in the dismissal with prejudice of several claims: negligence, products liability, breach of express warranty, breach of implied warranty, fraud, and unfair or deceptive trade practices. These claims are preempted by federal law under the Medical Device Amendments (MDA), which grants the FDA authority over the safety and effectiveness of Class III medical devices, such as Essure. The court will not exercise supplemental jurisdiction over the medical malpractice claim. The Motion to Reconsider or Certify for Appeal has been denied.
Claims regarding design defects are also preempted, as the plaintiff cannot allege that Bayer deviated from the FDA-approved design. State law, specifically N.C. Gen. Stat. 99B-1.1, does not recognize strict liability in product liability actions, which undermines the plaintiff's products liability claim. The breach of express warranty claims, asserting that Essure was marketed as safe, are preempted as the FDA's pre-market approval establishes the product's safety. Similarly, breach of implied warranty claims, which argue that Essure was not safe for its intended purpose, are also preempted due to the FDA's authority.
The claims of fraud and unfair trade practices, which allege that Bayer concealed risks associated with Essure, are dismissed as they largely mirror previously addressed allegations and many misrepresentations are similar to FDA-approved labeling statements, rendering them preempted as well.
Federal regulations prohibit the labeling or advertising of medical devices in a manner inconsistent with FDA pre-market approval, as stated in 21 C.F.R. 814.80. Claims based on minor deviations from approved language do not substantiate allegations of fraud or unfair trade practices and are therefore preempted. Additionally, under Federal Rules of Civil Procedure Rule 9(b), parties claiming fraud must detail the specific circumstances of the alleged fraud, including the time, place, contents of misrepresentations, and the identity of those making them.
The plaintiff claims reliance on information from the Bayer defendants regarding the Essure device, asserting that had she known of adverse reports, she would not have undergone the procedure. The plaintiff alleges affirmative representations about the device's safety and effectiveness, claiming ignorance of multiple reports of perforations and significant complaints. Even if the pleading standards of Rule 9(b) are met, claims must still survive plausibility tests under Twombly and Iqbal. The FDA had already determined the safety and effectiveness of Essure, and since adverse event reports were available before the plaintiff's surgery, the misrepresentation claims are preempted and will be dismissed.
Regarding the medical malpractice claim against defendants Travis and Biltmore OB-GYN, this claim is not preempted by federal law as it is based solely on state law standards. To succeed in a medical malpractice claim in North Carolina, the plaintiff must prove the applicable standard of care, a breach of that standard, and that the breach caused the injury. The court may exercise supplemental jurisdiction over this state law claim as it arises from the same core facts as the other claims.
State law mandates specific pleading requirements for medical malpractice claims, including that pleadings must confirm a putative expert witness has reviewed the medical care and records and is willing to testify that the care deviates from the standard of care (N.C. R. Civ. Procedure 9(j)). Although the plaintiff objected to these requirements, they have complied with them. The North Carolina Supreme Court has upheld Rule 9(j), despite the plaintiff's constitutional challenge (Anderson v. Assimos, 356 N.C. 415, 572 S.E.2d 101 (2002)). The state is a contributory negligence jurisdiction, meaning any plaintiff's negligence post-operation can reduce potential damages (Andrews v. Carr, 135 N.C.App. 463, 521 S.E.2d 269, 273 (1999)).
The court determined that all the plaintiff's claims, except for medical malpractice, are preempted by federal law and will be dismissed. Under 28 U.S.C. 1367(c)(3), the court declines to exercise supplemental jurisdiction over the remaining state law claims. The plaintiff is warned that the statute of limitations for the tort claim may be affected by 28 U.S.C. 1367(d).
Essure, the subject of the claims, is a Class III medical device regulated by the FDA, and federal preemption principles (both express and implied) under the Medical Device Amendments (MDA) complicate the viability of the claims. The plaintiff's claims—negligence, products liability, breach of express and implied warranty, fraud, and unfair trade practices—are dismissed. The court finds no need to certify the dismissal for appeal, as the medical malpractice claim remains the sole actionable cause of action, grounded in state law and not preempted by the FDCA.
North Carolina's law recognizes contributory negligence for the tort claim at issue. The court has dismissed all claims under its original jurisdiction and will not exercise supplemental jurisdiction over the medical malpractice claim, leading to its dismissal. However, this claim may be reasserted in state court. The court has granted a motion to dismiss, resulting in the dismissal with prejudice of claims related to negligence, products liability, breach of express and implied warranty, fraud, and unfair or deceptive trade practices, as they are preempted by federal law. Additionally, a motion to reconsider or certify for appeal has been denied. A motion to dismiss filed by defendants Travis and Biltmore OB-GYN, P.A. for failure to state a claim is not yet ready for judicial review. The plaintiff's husband has filed a similar complaint, which has been consolidated into this case. Remaining defendants include Dr. Travis and Biltmore OB-GYN, with the plaintiff acknowledging the express preemption clause of the Medical Device Amendments (MDA).
