BY Jay W. Bell Isle, Legal Reader
June 28, 2016
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 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.”[…]
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