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Congresswoman Rosa DeLauro

Representing the 3rd District of Connecticut

DeLauro, Schakowsky, Fitzpatrick Reintroduce Medical Device Safety Act

May 10, 2019
Press Release

WASHINGTON, DC Congresswoman Rosa DeLauro (CT-03), Congresswoman Jan Schakowsky (IL-09), and Congressman Brian Fitzpatrick (PA-01) today reintroduced the Medical Device Safety Act, a bill to increase access to legal recourse for victims of unsafe devices. Earlier this week, the New York Times wrote an editorial on changes the Food and Drug Administration (FDA) should make to improve the safety of medical devices.

Unsafe medical devices have led to the injury or death of millions of patients. However, under current law, the manufacturer cannot be held liable for their deaths or the harm and suffering the device has inflicted. The Medical Device Safety Act resolves this injustice by giving victims and their families the pathway to seek legal recourse for injuries or deaths from devices that received premarket approval from the Food and Drug Administration (FDA).

“The United States has a systemic problem with medical device oversight, and the FDA is not living up to its mission as a regulatory agency,” said Congresswoman DeLauro. “Faulty medical devices have had tragic and life-changing effects on the lives of people across the country. It is heartbreaking, and we have a moral obligation to right these wrongs. That is why Congress should step up and pass the Medical Device Safety Act to give patients the legal resources they deserve.”

“Americans deserve to know that the medical devices they rely on for their health and wellbeing are safe,” said Congresswoman Schakowsky. “If those devices are not safe, manufacturers should be held liable and consumers should have full access to the power of our justice system to seek recourse. I am proud to join my friend Rep. DeLauro in introducing the Medical Device Safety Act to empower victims of dangerous medical devices like Essure. I hope the Food and Drug Administration will join us in strengthening their regulatory authority over all medical devices.”

“Every day, patients place their trust in medical safety devices to preserve their health and wellbeing,” said Congressman Fitzpatrick. “Americans injured through faulty medical devices—through no fault of their own—deserve the legal recourse necessary to sustain themselves. I am proud to partner with Congresswoman DeLauro on this issue and to advocate for those who have suffered injustice due to ineffective medical devices.”

The Medical Device Safety Act will also ensure medical device manufacturers have the incentive to maintain the safest and most effective products for all patients. In order to maintain medical device innovation, the law would only affect a small number of devices that are approved each year by the FDA. As such, it will start to align device laws with drug laws, which currently do not get the same blanket liability protection device manufacturers currently receive.

“The Medical Device Safety Act is absolutely essential to correct a Supreme Court ruling that was based on a misunderstanding of FDA regulations,” said Dr. Diana Zuckerman, President of National Center for Health Research. “Because of that misunderstanding, patients who are seriously harmed by high-risk medical devices such as cardiac implants, breast implants, sterilization devices, and brain stimulators currently cannot seek legal redress in the courts. That makes no sense, since experts agree that FDA standards for prescription drugs are higher than those for high-risk medical devices, and yet patients who are seriously harmed by prescription drugs can seek legal redress. The bottom line is that the risks of many high-risk medical devices have not been made public, the scientific standards for FDA approval for medical devices are much lower than for prescription drugs, and yet when patients are harmed by high-risk devices they have almost no legal rights. This bill would correct that situation, which is putting millions of patients at risk.”

"We are thankful for the Congresswoman’s and co-sponsors’ continued support of our efforts to protect the American consumer,” said Amanda Rusmisell, Legislative Liaison for Medical Device Problems. “Next week, the Medical Device Problems Action Campaign made up of consumers representing Breast Implants, Essure, Mesh, and Metal on Metal Hips look forward to meeting with Members of Congress to continue to gain support for the Medical Device Safety Act.”