Schakowsky and DeLauro demand answers from FDA on dangerous, faulty defibrillators

Washington D.C.– Today, Congresswomen Jan Schakowsky (IL-9) and Rosa DeLauro (CT-3) sent a letter to the Food and Drug Administration (FDA) strongly urging it 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. Those egregious acts make it clear that the FDA needs to take action to hold St Jude Medical accountable for their actions.

“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 Rep. 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.”

“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 Congresswoman 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.”

The letter sent today by Congresswomen Schakowsky and DeLauro 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 text of the letter is below:

Dear Acting Commissioner Ostroff:

We write with great concern about the ongoing and accumulating safety concerns for patients using defibrillators manufactured by St. Jude Medical (which was recently acquired by Abbott) and the lack of action on behalf of the FDA. Those concerns have only grown in response to the letter the FDA sent to St. Jude Medical on April 12, 2017 citing the ongoing safety issues and the lack of action taken by St. Jude Medical to correct those problems. This is not the first time that the FDA has warned patients of the defects associated with those devices, and yet, the FDA has done little to rebuke St. Jude Medical for jeopardizing the health of patients utilizing its devices. We write to strongly urge the FDA to take immediate action to protect patients and to hold St. Jude Medical accountable for its actions.

We are deeply troubled that the FDA has not penalized St. Jude Medical for selling defibrillators that it knew to be faulty for years and downplayed the seriousness of battery failure in its defibrillators. In addition, the FDA confirmed that St. Jude Medical failed to tell their own management and advisory board after a patient died due to battery failure, and yet, the FDA has not taken any action against St. Jude Medical. Simply put, there is no excuse for inaction. We are extremely concerned the FDA has yet to outline exactly what corrective actions, if any, will be taken against St. Jude Medical. In your letter, you state that the FDA could take corrective actions within the next fifteen business days and that you may impose penalties after that if St. Jude Medical’s response is inadequate. To that end, we request answers to the following questions:

1. What actions does the FDA plan to take against St. Jude Medical in response to the significant problems outlined in your warning letter? If any actions have already occurred, please advise us of what those actions were and what the outcome was.
2. What is the FDA doing to ensure that the faulty devices sold by St. Jude Medical through December 2016 are not implanted in patients? Has the FDA contacted medical device wholesalers and providers who typically perform those procedures to alert them of the danger?
3. How is the FDA working to inform patients who had faulty devices implanted? What remedies will be provided to those patients?
4. What steps will the FDA take to prevent St. Jude Medical from engaging in similar practices in the future?

We strongly believe that serious actions need to be taken against St. Jude Medical to deter this incredibly dangerous behavior. Moreover, we believe that patients who have been given faulty devices need to be notified and provided with appropriate remedies at no cost to the patient. We sincerely hope that the FDA will treat this situation with the seriousness it deserves. We look forward to your response to those questions no later than May 26, 2017.