FRANKFORT, Ky. (Legal Newsline) – The Kentucky Supreme Court will let a lawsuit proceed against Johnson & Johnson over a catheter – despite preliminary approval for use by the federal Food and Drug Administration.
The court ruled Oct. 29 that the state law claims of Clifford and Jeanene Russell are not preempted by the FDA’s approval of the ThermoCool SmartTouch SF Catheter, which perforated Clifford’s pulmonary vein rather than burn and destroy heart tissue, as it was intended to do during a medical procedure.
“Approximately 14 months after Mr. Russell’s surgery, the SF Catheter received full market preapproval, but importantly the SF Catheter was only at the investigational device exemption stage at the time of the surgery,” Chief Justice John Minton wrote.
The catheter is classified as Class III medical device, meaning it has the most potential for danger. It “generally” must receive premarket approval from the FDA, Minton wrote.
There is a limited preemption clause but the court interpreted it to apply only to state standards and regulations and not state claims and causes of action.
“Therefore, when this preemption clause applies, it only preempts the state regulations that apply to the medical device,” Minton wrote. “This preemption is not blanket federal preemption of state causes of action; rather, it allows state claims that seek to impose parallel standards on the medical device.”
The FDA had approved the catheter under the investigational device exemption for human trials less than a month before it was used for Russell’s surgery.
“Even if we assume medical devices with the investigational device exemption are able to qualify for federal preemption, Kentucky’s parallel tort claims are allowed; the federal preemption would only restrict the state standard that applies to the device,” Minton wrote.
The decision overturns a win at the trial court for Johnson & Johnson’s Biosense. The case will proceed.