STORY FROM: Drugs & Medical Devices
Claims Against Heart Catheter Maker Preempted, Ky. Appeals Court Affirms
November 12, 2018
FRANKFORT, Ky. — A Kentucky appellate court has upheld dismissal of a case involving a heart catheter, ruling that the claims against Biosense Webster Inc. are preempted because the plaintiff did not assert state law claims that are based upon violations that parallel federal regulations.
On Nov. 9, the Kentucky Court of Appeals found the plaintiffs’ claims unlawfully target the Food and Drug Administration’s approval of the device. The court further deemed it irrelevant that the device received premarket approval after the surgical procedure at issue took place because it had been cleared for clinical testing.
Clifford Russell underwent ...