DeLauro and Schakowsky Demand Answers from FDA on Dangerous, Faulty Defibrillators

WASHINGTON, DC (April 28, 2017) — Congresswomen Rosa DeLauro (CT-03) and Jan Schakowsky (IL-09) today sent a letter to the U.S. Food and Drug Administration (FDA), strongly urging the agency to take action in response to new revelations that St. Jude Medical knowingly sold defective defibrillators and did little to correct the problem, even after a patient died. Despite those serious transgressions, the FDA has yet to take significant action to penalize St. Jude Medical.

The FDA confirmed that St. Jude Medical downplayed the seriousness of the battery depletion issues it had discovered in its defibrillators, which can be fatal for patients. The FDA also confirmed that St. Jude Medical continued to sell those potentially deadly devices even after they became aware of the problem. Worse yet, St. Jude Medical failed to inform their management and advisory board after a patient died due to premature battery depletion. These egregious acts make it clear that the FDA needs to take action to hold St Jude Medical accountable for their actions.

"St. Jude Medical made the unconscionable decision to implant faulty medical devices in high risk patients, leaving them at risk of serious injury and death. Not only did St. Jude Medical know that its actions were wrong, the company refused to pull the device from the market for years while profiting," said DeLauro. "St. Jude Medical claims to ‘take quality and safety seriously, knowing that patients' lives depend on our products.' However, nothing in the company's actions denote that it took these issues seriously. The FDA must immediately take action against St. Jude Medical to ensure that their products do not harm more patients and I urge the agency to investigate St. Jude Medical's actions to ensure this situation does not happen again. American lives depend on it."

"St. Jude Medical has acted recklessly and without regard for patient safety time and time again and yet, the FDA has done little to penalize them," said Schakowsky. "The fact that St. Jude continued to allow those devices to be surgically implanted even after they knew they were defective and potentially fatal is absolutely inexcusable. The FDA must take swift and immediate action to deter this type of behavior in the future. The affected patients, including a dedicated and wonderful staffer of mine, deserve answers."

The letter sent today by DeLauro and Schakowsky requests information by May 26, 2017, as to what actions the FDA has taken or plans to take to penalize St. Jude Medical. The letter also asks how they will better protect patient safety and deter harmful actions by device manufacturers in the future.

The full letter is available here.