Three important pieces of legislation, one introduced last year and two introduced this month, could change the way certain women’s health issues are handled. These women’s health bills are now in Committee. The bills were introduced by Rep. Mike Fitzpatrick (R-PA), a long-time supporter of women’s health causes and champion of the move to reform the FDA’s broken processes for medical device approval.

The bill introduced last year is the E-Free Act, legislation that if passed, would strip Bayer of the FDA-issued Pre-Market Approval (PMA) status on its “permanent” birth control device, Essure. It would also force the product off the market. To date, tens of thousands of women have been harmed by this device, some irreparably so. However, the PMA status of the Essure device prevents injured women from suing except on a few points, such as negligent misrepresentation, negligent failure to warn, negligent training of doctors, negligent risk management and negligent manufacture. The E-Free Act would open the gates barring injured women from suing on several other counts, offering them full access to the justice system.

One of the bills introduced earlier in June also takes aim at the PMA protection, but not just for Essure. Despite being named for a victim of the Essure device, Ariel Grace’s Law would allow anyone harmed by a medical device with PMA protection to pursue legal action to address their injuries.

Rep. Fitzpatrick, in the Floor Speech given about Ariel Grace’s Law said, “Mr. Speaker, one year ago tomorrow, Ariel Grace’s life ended before it had a chance to begin–killed by the failure of the unsafe medical device, Essure. Despite her tragic passing, there remains no legal recourse to seek justice. That is why, on the one-year anniversary of her death, I will introduce Ariel Grace’s Law in order to resolve the broken law that prevents the families of Ariel Grace and thousands of others to have their voices heard in court.”

Some background on Ariel Grace from a story I did in October, 2015:

“Ariel Grace was born only 27 weeks into the pregnancy at 1 pound, 5.3 ounces. She got to spend five days with her family before she passed away. In her case, Essure caused a placental abruption – the detachment of the placenta from the womb.”

The second bill Rep. Fitzpatrick introduced this month deals with yet another FDA-approved device, the power morcellator. This device, as disgusting as it sounds, essentially grinds up uterine tissue during certain types of hysterectomies. Sadly, if the patient has an undiagnosed cancer in that region, the morcellator spreads it to healthy tissues, thus decreasing the chances for the patient’s survival.

From Rep. Fitzpatrick’s Floor Speech on the Medical Device Guardians Act:

“I will offer legislation to reform the flawed FDA process that allowed another dangerous device–a laparoscopic power morcellator–to spread deadly cancer throughout the bodies of women like shrapnel. Despite case after case, no one reported the harm to the FDA–not even their own doctors. The Medical Device Guardians Act will add doctors into the list of entities that must report unsafe devices so that lifesaving action can be taken quickly when it is needed to protect others.”

Image courtesy of
Image courtesy of

Rep. Fitzpatrick continued, saying, “The institutions and regulations that are designed to protect our constituents from unsafe devices in these cases and others have failed. It is time we take action to address them.”

I couldn’t agree more. Since covering the Essure crisis, I’ve had the honor of knowing and befriending some of the brave women who daily face injuries caused by this device. Bayer and the FDA have both responded to the crisis with an attitude of “profits before patients” and likely aren’t going to make things right until our nation’s lawmakers (or one of the limited-in-scope suits) force them to do so.

Rep. Fitzpatrick is not alone in his advocacy for change. Along with tens of thousands of injured women and their supporters, the recently introduced bills also have the support of Dr. Diana Zuckerman, president of the National Center for Health Research.

The NCHR, according to its website, “is a nonprofit, nonpartisan think tank focused on research that can improve the lives of adults and children. Throughout our country, there are programs and policies that have the potential to save lives and improve the quality of life for many adults and children. Unfortunately, these programs and policies do not always live up to their potential. The National Center for Health Research conducts and analyzes research that is then used to encourage new, more effective programs, policies, and medical treatments.”

In short, the NCHR is committed to finding ways to better address such issues as Essure and a broken FDA approval process. Dr. Zuckerman said, “We think both bills would be very important ways to protect patients from harmful devices.”

I agree and I hope all of this important legislation speeds its way through Committee review and meets with approval in the House. Then, it’s on to the Senate and, ultimately, to the President. If justice is done, we will eventually see three new laws focused on making medical devices safer for us all.


Ariel Grace’s Law Floor Speech

Congressman Introduces Law to Abolish Medical Device Companies’ Preemption Defense

H.R.5403 — 114th Congress (2015-2016)

National Center for Health Research

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