The Wall Street Journal is reporting that Medtronic has received a subpoena from the Department of Health and Human Services‘ Office of Inspector General on issues relating to their heart-rhythm devices. According to a filing with the Securities and Exchange Commission, the government requested documents related to revenue, marketing, reimbursement communications to customers, and scientific studies.
While we don’t know what will come of this subpoena, and if Medtronic was hiding safety studies it should have been reporting to the Food and Drug Administration (FDA), we do know the company has complete immunity for injuries caused by class III medical devices, because of the Supreme Court ruling in Riegel v. Medtronic in 2008.
The Court ruled that because the FDA had approved a medical device through the pre-market approval process, patients injured do not have any recourse to hold the manufacturers accountable, even when a faulty product has harmed or killed a patient. A year later, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can hold manufacturers accountable in state courts, creating disturbing double standard between prescription drugs and medical devices.
Congress has introduced The Medical Device Safety Act (HR 1346/S540) that would restore patients’ right to hold the manufacturer responsible for their defectives products.
Thousands of patients are harmed by defective medical devices, like five-year-old Avery DeGroh, who had her implanted defibrillator misfire when she was just three, shocking her nine times. Medtronic refused to pay for the cost to replace her defective device, and could be immune because of the Riegel ruling.
Michele Meyer of Cambridge, Minnesota, lost her 30-year-old daughter, Katie. Katie beat cancer but died from complications to remove the faulty lead to her Medtronic defibrillator. Medtronic again might be immune from liability.
Whatever the subpoena yields, Congress needs to pass The Medical Device Safety Act (HR1346/S540) to protect patients. No company should be above the law when their products prove defective and dangerous.