Patients Harmed By Medical Devices Rally Lawmakers

1 in 10 Americans will rely on a medical device in their lifetime

More than 150 medical devices in the US are currently protected from liability

The Medical Device Safety Act H.R 2669 would restore a patient’s rights to seek restitution if harmed or killed by a medical device



People who have seen the Netflix Documentary The Bleeding Edge are now educated on the dangers of medical devices and the FDA loopholes that protect manufacturers from accountability. Now, patient activists are facing lawmakers head-on to fight for new legislation that will protect Americans who rely on medical devices.

On Wednesday, May 15th and Thursday May 16th, patient activists harmed by medical devices (hip Implants, permanent birth control device Essure, breast implants, andmesh), along with Madris Tomes of Device Events and attorney Holly Ennis of Ennis & Ennis, will be lobbying in Washington, DC. The Medical Device Problems Action Campaign will meet with Members of Congress to garner more support for The Medical Device Safety Act, which already has bipartisan sponsorship.

The Medical Device Safety Act will simply amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting all Class III devices. This bill will restore a patient’s rights to seek restitution if harmed or killed by a medical device.

Initially introduced on April 26, 2017, the bipartisan Medical Device Safety Act H.R.2669 was reintroduced on May 10th, 2019 by Congresswoman Rosa DeLauro (CT-3), Congressman Brian Fitzpatrick (PA-1), and Congresswoman Jan Schakowsky (IL-9). On this trip, the coalition is hoping to garner more support in the House and get a companion bill introduced in the Senate.

There are currently more than 150 Class III medical devices on the market protected by preemption. Preemption significantly protects the manufacturers of these devices from liability, even if the medical device is found to be defective, dangerous, ineffective, or it has been recalled or withdrawn from the market.

“We must restore the consumers’ rights,” said Angie Firmalino, a patient harmed by the medical device Essure and now advocate for change. “If a patient has an adverse event from a medical device and is injured or killed, they should be able to hold the manufacturer accountable. Medical bills, lost wages, and permanent disability can destroy a person’s quality of life and put a huge strain on an individual and their family. Often, it takes legal action to put pressure on the manufacturer to recall or remove a device from the market and help those who were harmed. Without accountability, the manufacturer has no incentive to withdraw a device from the market that may be harming tens of thousands of people. The FDA leaves it in the hands of the manufacturer to recall or withdraw unsafe medical devices; therefore consumers must have the right to take legal action to ensure manufacturers are being held accountable.”

The Medical Device Safety Act will balance the scales of justice and allow people to hold device manufacturers to a higher standard of care: a standard that is currently non-existent. We want safe and effective medical devices. No legal blanket of protection should ever overshadow the voice of a large group of injured citizens.

For statements and/or media inquiries, contact the Medical Device Problems Group at Someone from our team will reply within 30 minutes.

Interviews can be scheduled via Skype, Facebook Messenger, in person in Washington, DC, or our group can coordinate an in-person interview in your city with someone suffering from medical device malfunction.

About Medical Device Problems: Medical Device Problems (MDP) was established in August of 2016 and founded by ASHES Nonprofit. In the past decade, more than 70-million people have been implanted with a medical device.

We have a Facebook community page to share important news on medical device problems, as well as a Facebook support group for harmed patients.

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To help support the activists of ASHES traveling to DC, you can donate to their fundraiser here.