A certified class proceeding alleged that a manufacturer negligently designed, tested, marketed, and monitored mechanical heart valves coated with a silver-based antimicrobial surface.
The plaintiffs argued that the coating impaired tissue healing and increased the risk of complications including paravalvular leak, thromboembolism, and death.
After an extensive common‑issues trial involving scientific, epidemiological, and regulatory evidence, the court found the manufacturer exercised reasonable care in product design, testing, and post‑market surveillance.
The court concluded that the coating did not adversely affect tissue healing and did not materially increase the risk of most alleged complications, except for a temporary increase in paravalvular leak risk in the early post‑implant period.
Because negligence and causation were not established, the class action was dismissed.