SUPREME COURT REJECTS CLAIM AGAINST MEDTRONIC
The U.S. Supreme Court has refused to hear a claim against Medtronic alleging the company produced faulty devices, ensuring manufacturers liability protection for devices that have been approved by the FDA.
The Court's denial of a request for review leaves intact a lower court ruling that Medtronic was not liable for faulty leads in its pacemakers. The company had pulled its 4004 and 4004M leads from the market because of concerns that the polyurethane insulation would degrade. But the company did not ask doctors to remove leads that had already been implanted in patients.
Fourteen patients challenged this practice, alleging negligence. Of those patients, 12 needed additional heart surgeries to replace the leads and two had theirs capped.
The rejection marks the third time in five years that the high court has refused to intercede on behalf of patients seeking to sue Medtronic. Lower courts have generally rejected such claims.