Health Law Daily Wrap Up, PRODUCTS LIABILITY (DEVICES)—D. Md.: Surgical mesh patient failed to show causation in strict liability suit, (Nov 5, 2025)

By Jody Coultas, J.D.

The patient failed to provide sufficient evidence that the design defect in the Align System was a cause of her injuries.

The federal district court in Baltimore, Maryland dismissed without prejudice a strict liability suit alleging that C. R. Bard, Inc. and Becton, Dickinson, and Company sold a urethral support system that caused pain and injuries that required surgery. The patient had a Bard Retropubic Urethral Support System (Align System) surgically implanted into her body. After the surgery, the patient suffered acute and chronic pain that she alleged was caused by mesh erosion from the Align System. The court dismissed the suit for lack of standing because the allegations of causation were conclusory statements that lacked factual enhancement (Marsiglia v. C.R. Bard Incorporated, No. RDB-24-3170 (D. Md. Oct. 31, 2025)).

The patient alleged that the Align System caused her to suffer mesh erosion into her bladder, colovestical and enterovestical fistulae, and acute and chronic pelvic pain, for which she received remedial surgeries. Based on this harm, the patient alleged claims for (1) negligence, (2) strict liability-failure to warn, (3) strict liability-design defect, and (4) fraudulent concealment. C.R. Bard moved to dismiss.

Under Maryland law, a plaintiff makes out a prima facie case of strict liability design defect by showing that “(1) the product was in defective condition at the time that it left the possession or control of the seller, (2) that it was unreasonably dangerous to the user or consumer, (3) that the defect was a cause of the injuries, and (4) that the product was expected to and did reach the consumer without substantial change in its condition.” In a strict liability action, “as opposed to a traditional negligence action, the plaintiff need not prove any specific act of negligence,” as the “relevant inquiry focuses not on the conduct of the manufacturer but rather on the product itself.”

The court dismissed the strict liability claim for failure to show causation. The patient alleged that she sought treatment for stress urinary incontinence, had the Align System surgically implanted, and suffered debilitating complications that required surgeries. The complaint, however, included only one conclusory statement that the alleged design defects caused her injuries. There was no “connective thread” between the alleged harm and the Align System. Although her complications, such as mesh erosion into the bladder, acute and chronic pelvic pain, and scarring are similar to frequent complications from surgical mesh devices, the allegations of causation consisted of conclusory statements that lack factual enhancement.

The case is No. RDB-24-3170.

Judge: Bennett, R.

Attorneys: Juan Puga Nieto (Saiontz & Kirk, LLC) for Kimberly Marsiglia. Stephen Todd Fowler (Greenberg Trauring LLP) for C.R. Bard, Inc. and Becton, Dickinson and Co.

Companies: C.R. Bard, Inc.; Becton, Dickinson and Co.

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