Howe v. Ethicon, Inc.

Background

Rachel Howe sued Ethicon, Inc. and Johnson & Johnson over an Ethicon Gynecare TVT pelvic mesh product implanted in her in 2016. She alleged that the product caused pain and other physical conditions, required later surgeries, and was marketed without adequate warnings about its risks. Her First Amended Complaint asserted nine counts: strict liability for failure to warn; strict liability for manufacturing and design defects; negligence; negligent misrepresentation; fraud; fraudulent concealment; constructive fraud; violation of the New York Consumer Protection Act; and gross negligence.

The defendants moved under Federal Rule of Civil Procedure 12(b)(6), which allows dismissal when a complaint does not plead enough facts to make a claim legally plausible. They sought dismissal of the manufacturing-defect claim in part, the negligence claim in part, and all claims in Counts IV through IX. They did not challenge the failure-to-warn and design-defect claims in the motion described by the opinion.

Manufacturing-Defect Claim

Under New York law, a manufacturing-defect claim requires facts showing that the specific product unit differed from other identical units because of a manufacturing problem, defective materials, or improper workmanship, and that the defect caused the injury. The court found that Howe alleged problems with the general design and risks of pelvic mesh, but did not allege that the TVT with Lot Number 3880812 differed from other TVT units. The court therefore dismissed the manufacturing-defect claim without prejudice.

Negligence and Failure-to-Test Theory

Howe alleged that the defendants negligently designed and marketed the product and failed to conduct adequate testing, including testing after reports of adverse events. The court held that her failure-to-test theory was subsumed by her design-defect claim rather than being a separate negligence theory recognized under New York law. The court dismissed that failure-to-test theory with prejudice, meaning the opinion expressly barred refiling that theory in an amended complaint.

Fraud-Based Claims

The court applied Federal Rule of Civil Procedure 9(b), which requires fraud to be pleaded with particularity. A complaint generally must identify the allegedly false statements or omissions, who made them, when and where they were made, and why they were fraudulent. The court found that Howe’s allegations referred generally to promotional materials and broad representations that the product was safe, effective, and reliable, without identifying the statements and their timing and location with enough detail.

The court also rejected the negligent-misrepresentation claims because Howe did not allege facts showing a special relationship of trust or confidence with Ethicon or Johnson & Johnson. In particular, she did not allege that she or her doctors had spoken with representatives of either defendant about implanting the product. The court dismissed the negligent-misrepresentation, fraud, fraudulent-concealment, constructive-fraud, and New York Consumer Protection Act claims without prejudice.

Gross Negligence

The court explained that New York’s gross-negligence standard requires facts plausibly showing reckless disregard for others’ rights, intentional wrongdoing, or an extreme departure from ordinary care. It found that Howe’s general allegations about manufacturing defects, design defects, and withheld safety information did not meet that high standard. The court dismissed the gross-negligence claim without prejudice.

Disposition and Amendment

The court granted the defendants’ motion to partially dismiss the First Amended Complaint. It dismissed the manufacturing-defect claim, negligent-misrepresentation claim, fraud claim, fraudulent-concealment claim, constructive-fraud claim, New York Consumer Protection Act claim, and gross-negligence claim without prejudice. It dismissed the failure-to-test theory in the negligence claim with prejudice. The court granted Howe leave to file a Second Amended Complaint as to claims dismissed without prejudice and set July 27, 2022, as the filing deadline.

The conclusion contains a typographical reference to the failure-to-test theory as being in “Count II,” although the discussion identifies it as part of the negligence claim in Count III.