“The current laws make it very difficult, presenting extreme hurdles for the plaintiffs to overcome to have their day in court, to file suit,” Holly Ennis, pharmaceutical and medical device liability attorney and activist, said.

“It’s like threading a needle," Ennis said. "You know, the stars have to align the exact way to find the exact concept so you can squeak in and file a claim." 

Ennis should know. She’s represented many of the thousands of women harmed by Essure birth control as featured in the 2018 Netflix documentary, “The Bleeding Edge,” and has assisted clients participating in major mass settlements against the manufacturers of Yaz Birth Control, Vioxx, Avandia, Zyprexa, Seroquel, Fosamax and other drugs and devices.

Class III devices, which comprise 10 percent of all regulated medical devices, are well known to be potentially dangerous. Even the FDA website describes Class III devices as those that “Usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury.”

In contrast to the notoriously lengthy and painstaking FDA approval process for pharmaceuticals, most medical devices are not tested on humans. In fact, medical devices weren’t even regulated at all until the passage of the 1976 Food, Drug and Cosmetics Act.

Essure Problems advocates visiting Congress while filming The Bleeding Edge.

The Medical Device Safety Act: Hope for Healthcare Consumers

The Medical Device Safety Act, a bi-partisan bill introduced in April 2017 by Rep. Brian Fitzpatrick (R-PA) and currently co-sponsored by Rosa DeLauro (D-CT), Jan Schakowsky (D-IL), Peter DeFazio (D-OR), Bobby Rush (D-IL) and Lloyd Doggett (D-TX), would make it much easier for consumers to sue Class III device manufacturers.

“The Medical Device Safety Act is a critical bill based on a simple principle: people should feel confident that the FDA has their safety in mind when they review and approve medical devices. Too often, that does not seem to be the case. And when patients fall ill or are killed by unsafe devices, someone needs to be held accountable. But our current laws protect the device manufacturers from liability. That is wrong, and we need to fix that. People’s lives are at stake,” DeLauro stated by email.

Advocates and activists along with 14 individuals harmed by Essure, mesh, breast implants and hip replacements are traveling to Washington to lobby representatives in May, which is when the bill will be reintroduced to the new Congress, Amanda Rusmisell, legislative liaison for the 42,000 member Essure Problems Facebook Group, said.

“We’re going to have a lot of movement before we go up. Reaching out, doing a lot of conference calls before we go up with offices to try to gain support,” Rusmisell said.

“A lot of this is done from constituents - people start lobbying on their own directly face-to-face in those district offices. There’ll be a push there, there’ll be a push on our end in DC. I would love to have this in front of (the Energy and Commerce) committee by the end of the year. That would be my great wish,” Rusmisell said.

The Supreme Court Protected Medical Device Manufacturers

“It’s complicated,” as they say, when it comes to the legalities.

In Riegel v. Medtronic, the Supreme Court ruled that the federal preemption clause of the Food, Drug and Cosmetic act limits lawsuits in state courts against medical devices approved under the FDA’s Pre-Market Approval (PMA) process for Class III devices. Federal preemptionmeans that federal law trumps state and local law on a particular matter. The PMA process is the more stringent of the FDA’s two medical device approval pathways.

The court basically said that the PMA process is so reliable that consumers shouldn’t be able to sue devices manufacturers that have met the PMA standard. 

Not everyone agrees. 

In response to the 2008 ruling, Sen. Ted Kennedy co-sponsored the original 2009 Medical Device and Safety Act. That bill had the same wording as the current version, but lost legislative momentum amidst the effort to pass Obamacare, Rusmisell said.

The FDA's Role in Medical Device Regulation

“The thought around (the PMA process) is that you’ve got these products and they’ve got the gold standard of studies, which is supposed to be flawless. You’ve done all your background work, it’s gone on for years, you’ve got great records, you’ve tested these products, you’re well aware of all the issues with them,” Rusmisell said.

But things aren’t always as they seem.

“When you look at it (the PMA process), it looks great. But in reality, it’s not happening. The FDA post-market surveillance is so poor on that side. No one can read 60,000 adverse events that are coming in for all products. There’s just not the staff for that, there’s no follow through,” Rusmisell said.

Ennis painted a similar picture.

Theoretically, at least, Class III devices are supposed to go through a lot of clinical trials and testing and are supposed to be followed with post-market surveillance, she said.

“The post-market follow-up is really pretty poor," Ennis said. "The FDA literally just doesn’t have the staffing and the manpower to oversee it, and the manufacturers are notoriously lax about doing it."

"I think the first Essure post-market study was three years late, things like that. It’s pretty lax all around,” she added.

Why Civil Litigation is to Protecting Patients

According to Ennis, passage of the Medical Device Safety Act is important not only for patients, but also as an industry incentive.

“Unfortunately, civil litigation is really the only thing that keeps manufacturers trying to make their products safe, and safer," Ennis said.

"If you take away that threat, manufacturers know that they can put products on the market that aren’t safe and cause injury, and they’re not going to be held accountable for it. Because the FDA is slow to act, if at all,” Ennis said.

By their own admission, Ennis said, the FDA has made clear that they’ll apply pressure on manufacturers to withdraw from the market, but they won’t revoke the PMA, which the agency has the power to do.

“I really don’t think your average person understands how important the Medical Device Safety Act is,” Ennis said.

“Clearly, Congress must feel pressure from the public on this issue. That means educating others, and it means not letting up,” DeLauro stated.

Take Action

If you’d like to support the passage of the Medical Device Safety Act, please consider donating to the Medical Device Problems fundraiser to meet with Congress in Washington, D.C., this May.