H.R. 2164- Fighting for Your Right to Take Defective Medical Devices to Court

Jane Akre
April 12, 2019

Mesh Medical Device News Desk, April 12, 2019 ~ H.R. 2164 would restore an Americans right to take a defective medical device maker to trial and receive compensation.

Under current law, if a device is Class III, you have lost that right. This group wants to change that and they could use your help.

A group of women injured by medical devices, including Essure birth control and pelvic mesh, is going to Washington D.C. next month to fight a restriction that prevents Americans from taking their medical device injuries to court.

In all, nine women will be there who have been impacted by medical devices - Essure birth control, Metal-on-metal hips, breast implants, and pelvic mesh.

H.R. 2164 , known as The Medical Device Safety Act (#MDSA) amends the FDA so that your lawsuit for a defective product is not thrown out under what's known as “federal preemption."

Essure, ABC, Tampa

“In layman’s terms, it restores people right to litigation,” says Angie Firmalino referring to H.R. 2164. She was featured in the film, The Bleeding Edge and is an Essure survivor.

Amanda Rusmisell

Firmalino and Amanda Rusmisell tried to find a law firm to take their Essure cases but were turned down because Essure was a Class III device which underwent Premarket Approval, supposed to be the most stringent review for safety and efficacy by the FDA.

Amanda says, “Anyone who approaches an attorney with a Class III device, they automatically say "preemption" and will not take that on. We fought for years to take on preemption hurdle. By the time we found one, statutes of limitations had run out. It’s not fair. We knew we were harmed, no one would take it. Now we are fighting a statute of limitations problem.”

Class III Devices

At the present time there are currently 157 medical devices that are premarket approved (PMA) and if you are injured by them, you are prevented from filing a lawsuit to be compensated.

They include Essure birth control device, heart valves, implanted pacemakers, implanted cerebral simulators and an IUD among others.

How Did Federal Preemption Happen?

How did we get to the point where the public lost its right to go to court to seek compensation?

Consider the case of Charles Riegel v. Medtronic.

Riegel had a blocked artery so his doctor implanted a Medtronic catheter and tiny balloon which was supposed to stretch open a blocked artery. Instead it ruptured during Riegel’s heart surgery. Riegel went on life support but survived.

The Medtronic device is a Class III medical device that received the FDA’s premarket approval (PMA) that is supposed to guarantee safety.

In their lawsuit, the Riegels' argued the device was defective and the company negligent. But eventually the U.S. Supreme Court ruled the FDA’s Medical Device Amendment of 1976 (MDA) prevents state lawsuits that challenge safety or effectiveness. Since the device went through premarket approval from the FDA, and Medtronic had allegedly provided evidence of safety and effectiveness during the so-called rigorous approval process, state law could not require more than what the FDA imposed.

The case has set a precedent for all of the Class III devices that followed.

Device makers favor “Federal Preemption” because it shields them and provides immunity from lawsuits and punitive damages often awarded by state court juries.


Disintegrating J&J TVT mesh

Class II Devices

Pelvic and hernia mesh along with more than 90% of medical devices are cleared for marketing in the U.S. through the controversial and fast-tracked 510(k) process. The process requires naming a similar “predicate device” already on the market, pay a few thousand dollars, and exchanging paperwork then wait a few months before being cleared to sell.

Pelvic mesh for incontinence is a Class II device and therefore not subject to federal preemption, however in 2012 pelvic organ prolapse (POP) mesh was reclassified as Class III which would shield manufacturers. Any new Class III meshes to be marketing in the future would also not be subject to litigation.

Pelvic and hernia mesh, metal-on-metal hips, and power morcellators, devices are cleared through 510(k). While clinical trials are not required, an injured plaintiff can file a lawsuit to seek compensation and punitive damages.

The Group

Essure women on Capital Hill

Led by ASHES, Advocating Safety in Health Care – E Sisters, the group will talk to Congress to advocate for - HR 2164 – which will be reintroduced to Congress in May.

The plans are to lobby the House one day (May 15) and the Senate the next (May 16). Melynda Fitt and Tonya David from the mesh community will be there. They could use your help with a GoFundMe (below).

H.R. 2164 amends the Federal Food, Drug, and Cosmetic Act by adding the following:
“NO EFFECT ON LIABILITY UNDER STATE LAW - Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.”

Six members of the House are co-sponsoring the bill and Senators are needed to introduce a companion bill. Ashes has the links to your representative and a suggested script here.

Amanda Rusmisell at 704-968-5824 rusmisell@att.net is your contact for any questions.

Update on Essure

Angie Firmalino, Essure Problems

Angie Firmalino says Essure, was fast-tracked onto the market because there was not another device like it.

“The approval was full of conflicts of interest between regulators and industry. Normally you have a 2 year waiting period to start clinical trials but with Essure it was started in a couple of months. Many lead investigators had stock and investment in the product themselves.”

Angie and Amanda say it was the revelation that Conceptus withheld 33,000 adverse event reports from the FDA that broke open the doors to litigation on the basis of failure to warn.

So far there are more than 29,400 lawsuits filed by Essure victims seeking compensatory and punitive damages against Bayer including 25,000 pending cases in California, and 4,000 between Philadelphia, St. Louis, Illinois, Pittsburgh, and Indianapolis.

With Bayer announcing it would stop selling Essure as of the end of 2018, women were expected to file even more claims which launched a barrage of late night legal ads for Essure clients.

The first Essure trials are scheduled for November of this year.

Future Actions Needed

There is a national grassroots movement growing by patients injured by medical devices to further address what they believe are the failings of the FDA. After federal preemption, ASHES intends to address overhauling the 510(k) clearance process after the thousands of injuries reported from the lax regulation, including about 150,000 pelvic mesh injury lawsuits filed in the U.S.

The adverse event reporting system is broken too, says Amanda, as complication reports go to the manufacturer first and in a fox watching the hen house move. If the device maker deems the injury related to its device, only then does it forward the complaint to the FDA. ###


ASHES Nonprofit- Advocating Safety in Healthcare

Suggested ASHES Script to talk to your member of Congress:

GoFundMe for Melynda and Tonya

H.R. 2164

Cornell Law on Riegel

Jump to Comments

Downloads for this Article:

Also in this Section:

More articles coming soon...

Categories for this Page

More categories coming soon...
No items found.

Related to this Article:

More articles coming soon...