Paesano v. Ethicon, Inc.

Background

Deborah Paesano received Ethicon’s Gynemesh PS pelvic mesh device and TVT mid-urethral sling on January 19, 2009. She later experienced vaginal and pelvic pain, burning, pain and bleeding during intercourse, and difficulty starting urination. In 2018, she reported fecal matter and air passing through her vagina, and doctors diagnosed and treated a colovaginal fistula. In 2019, further treatment included removal of the fistula and placement of an ileostomy.

Deborah and Anthony Paesano’s remaining claims against Ethicon, Inc. and Johnson & Johnson were negligence, strict liability for failure to warn, strict liability for design defect, gross negligence, punitive damages, and loss of consortium. The defendants moved for summary judgment, which is a ruling without a trial when the evidence shows no genuine dispute over a fact that could affect the result and the moving party is entitled to judgment under the law.

Statute of Limitations

The case was in federal court based on diversity jurisdiction. The court therefore applied New York’s choice-of-law rules and statutes of limitations. Under the New York law applied by the court, personal-injury tort claims—including negligence, strict liability, gross negligence, and loss of consortium—generally must be filed within three years of the injury. For an allegedly malfunctioning medical device, the limitations period begins when the plaintiff first notices symptoms resulting from the malfunction, rather than when a doctor later identifies the condition.

The Paesanos argued that the relevant injury was the fistula that became apparent in 2018, which they described as a serious and distinct condition from the earlier mesh erosion and discomfort. The defendants identified earlier events, including the 2009 symptoms, as the injury date.

The court rejected the Paesanos’ argument. It found that Deborah’s vaginal discomfort, burning, pelvic pain, and pain and bleeding during intercourse began within months of the January 2009 surgery and continued over the following years. The court held that these symptoms were traceable to the mesh and marked the beginning of the process that later culminated in the fistula. The later worsening of the condition did not restart the limitations period. The court also stated that a patient need not know the precise cause of the physical condition for the limitations period to begin.

Ruling

Because the symptoms began well before September 24, 2016—three years before the lawsuit was filed on September 24, 2019—the court held that the claims were time-barred. The court further stated that the punitive-damages and loss-of-consortium claims were derivative of the personal-injury claims and were therefore also time-barred.

Judge Cathy Seibel granted the defendants’ motion for summary judgment. The Clerk was directed to enter judgment for the defendants, terminate the motion, and close the case.