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https://www.petition2congress.com/ctas/the-medical-device-safety-act-hr-2164

The Medical Device Safety Act H.R. 2164

440 Messages Sent So Far

The Medical Device Safety Act 2017 H.R. 2164 #MDSA17

The Medical Device Safety Act of 2017 was introduced in the house on April 26, 2017 by Congressman Brian Fitzpatrick. It is a bi-partisan bill currently co-sponsored by Rosa DeLauro, Louise Slaughter, and Jan Schakowsky. The bill would amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting all Class III devices. Including, but not limited to, essure, nerve stimulators, hip implants, defibrillators, pacemakers, infusion pumps, surgical mesh, cochlear implants, and breast implants.

There are over 157 Class III medical devices on the market in the USA. Class III medical devices currently fall under federal preemption protection. This is due to the Riegel vs Medtronic supreme court ruling in 2008, when a United States Supreme Court case held that the preemption clause of the Medical Device Amendment bars state common-law claims that challenge the effectiveness or safety of a medical device marketed in a form that received premarket approval from the Food and Drug Administration.

What does this mean? It means that patients who are harmed by Class III medical devices have a very difficult, if not impossible, time pursuing litigation if injured, disabled, or killed by a Class III medical device. The manufacturers are, in essence, protected. Most Class III cases get thrown out on the grounds of Federal Preemption.

The purpose of this bill is to restore a patient’s right to litigation should he/she be harmed by a Class III medical device. Even decades after the FDA’s pre market approval of a Class III device, if it is proven to be ineffective or proven to cause harm, individuals still cannot hold the manufacturer liable for injury, even in the case of a recall.

We are asking for your support of The Medical Device Safety Act 2017, H.R.2164, as our representatives. Please consider co sponsoring in the House, or introducing/sponsoring in the Senate! We are tens of thousands of consumers who have been harmed by, disabled by, or lost a loved one to a Class III medical device. We all deserve the same rights as consumers. Help restore our rights by supporting this bill! Thank you.

#MDSA17

Harmed Patients Notified of/Included in a 'Groundbreaking Conference'?

June 13th, 2014 Conference

Evidence for New Medical Products:
Implications for Patients and Health Policy

Date: June 13th, 2014
Time: 8:30 a.m. – 6:00 p.m.
Location: American Association for the Advancement of Science, Washington, D.C.
Register here: http://www.aaas.org/oZT

This event is co-sponsored by the American Association for the Advancement of Science, Division of Pharmacoepidemiology and Pharmacoeconomics of Brigham and Women’s Hospital/Harvard Medical School, and National Center for Health Research.

Conference Focus

Better implementation of evidence-based medicine can improve the quality and cost-effectiveness of health care in the U.S. This can be challenging in evaluating newly approved drugs and medical devices. While current law requires that medical products be proven safe and effective, there is growing pressure to expedite access to promising therapies and to lessen the research and regulatory requirements for manufacturers. Unmet medical needs and patient demands call for a flexible approach to prescription drug and device regulation, but truncated premarket review may also lead to approval of products that are less effective than expected or have unanticipated safety problems. This groundbreaking conference will review the growing body of research on the medical and public health implications of medical product approval criteria, and examine these findings in the context of patient outcomes, costs, and health policy.

Confirmed Speakers Include (where are the harmed patient speakers?)

Jerry Avorn, MD, Professor, Harvard Medical School; Greg Curfman, MD, Executive Editor, New England Journal of Medicine; Congresswoman Rosa DeLauro; Aaron Kesselheim, MD, Harvard Medical School; Bernard Lo, MD, President, Greenwall Foundation; Rita Redberg, MD, Editor, JAMA Internal Medicine; Joseph Ross, MD, Yale Medical School; Patrick Ryan, PhD, Janssen Research and Development; Sebastian Schneeweiss, MD, Harvard Medical School; Lisa Schwartz, MD, Dartmouth; Joe Selby, MD, Executive Director, Patient Centered Outcomes Research Institute; Steven Woloshin, MD, Dartmouth; Robert Yarchoan, MD, National Cancer Institute; Diana Zuckerman, PhD, National Center for Health Research.

For more details on the program and registration, please go to http://www.aaas.org/oZT. There is no cost for attending the event, but space is limited and advance registration is required.