Dupere v. Ethicon, Inc.

Background

Betty Dupere brought claims against Ethicon, Inc. and Johnson & Johnson concerning the surgical implantation and later removal of Ethicon’s Gynecare TVT pelvic mesh. She alleged strict-liability claims for failure to warn and defective design, negligence, negligent misrepresentation, fraud, fraudulent concealment, constructive fraud, violation of New York’s consumer-protection law, and gross negligence.

Dupere alleged that she received the TVT implant on March 9, 2010, to treat stress urinary incontinence and later developed vaginal mesh exposure. She underwent surgery to remove the device on March 1, 2019. The defendants moved under Federal Rule of Civil Procedure 12(b)(6), which tests whether a complaint states a legally sufficient claim, to dismiss part of Count III and all of Counts IV through IX.

Negligence and Gross Negligence

The defendants did not seek dismissal of the portions of Count III alleging negligent design and failure to provide adequate warnings. They did seek dismissal of Dupere’s allegation that the defendants negligently failed to test TVT before and after marketing it.

The court predicted that New York’s highest court would not recognize an independent products-liability claim based solely on negligent failure to test. Under the court’s analysis, testing evidence could be used to support or defend other products-liability theories, but negligent testing itself was not a separate claim. The court treated the alleged failure to test as part of Dupere’s design-negligence claim.

The court also dismissed the gross-negligence claim because the first amended complaint did not allege facts showing an extreme departure from ordinary care or conduct reflecting reckless disregard for others’ rights or intentional wrongdoing.

Misrepresentation and Fraud Claims

The court held that negligent misrepresentation, fraud, fraudulent concealment, and constructive fraud were subject to Federal Rule of Civil Procedure 9(b). That rule requires fraud allegations to identify the allegedly false statement or omission, who made it, when and where it was made, and why it was fraudulent. Fraud and constructive-fraud claims also require facts supporting a strong inference of fraudulent intent.

The court found that the complaint referred generally to marketing materials and statements by sales representatives but did not identify the specific statements Dupere or her physician saw or heard, when or how they encountered them, or why the statements were fraudulent. The complaint also offered only general allegations that the defendants knowingly concealed risks, without facts showing when the defendants knew of the alleged complications or that they acted with fraudulent intent.

For omission-based theories, the court further found that Dupere had not adequately alleged a duty to disclose. It rejected the argument that the defendants’ status as medical-device manufacturers, without more, created the required special relationship or duty.

Consumer-Protection Claim

The court construed Count VIII as a claim under New York General Business Law §§ 349(a) and 350, which address deceptive business practices and false advertising. The court held that Rule 9(b)’s heightened fraud-pleading standard did not apply to this claim. Even so, Dupere failed to identify any specific false advertisement or misleading consumer-facing statement about TVT. The court therefore dismissed the consumer-protection claim.

Disposition

The court granted the defendants’ July 9, 2021 motion to dismiss part of Count III and Counts IV through IX. The opinion does not state that the ruling was with or without prejudice. Denise Cote signed the opinion as United States District Judge.