Great hearing today in front of the House Energy and Commerce Committee’s Subcommittee on Health on the need to pass Medical Device Safety Act.
There was a great deal of convincing testimony including Gregory Curfman, M.D., Editor of the New England Journal of Medicine who said, (for his full testimony click here)
Since the Supreme Court ruling in Riegel, thousands of lawsuits against medical-device manufacturers have been tossed out of court by judges following the Court’s lead in deeming such lawsuits to be preempted. We believe that preemption not only strips patients of their rights but also results in medical devices that are less safe for the American people.
There was also compelling testimony from Bridget Robb, the victim of a faulty Medtronic Medical defibrillator lead. Her story is as follows (for her full testimony click here)
My name is Bridget Robb, and I am a thirty-five year old mother and resident of Gwynedd, Pennsylvania. On December 31, 2007, I suffered greatly and thought I was going to die because of a defective heart device implanted in my body. I am thankful to be here today and am pleased that Chairman Pallone has reintroduced the Medical Device Safety Act, which would restore the rights of patients like me to hold device manufacturers accountable when their products cause injury and sometimes, even death.
Robb had a Medtronic cardiac defibrillator implanted in her chest, which failed, sending shocks to her heart which (31 shocks in total), she said, “felt as if a cannon was being repeatedly shot at my chest at close range.” Her terrified six-year old daughter told their pet cat that “Mommy’s dying” while Robb called 911. “Each time I was shocked, I saw my life flash before my eyes. It was excruciating pain. At one point, I began to pass out and thought that I would never see Emma again. Ever since that day, I have been unable to sleep in my own bed due to the trauma I experienced.” She continued,
I would like to have the opportunity to hold Medtronic accountable for the injuries that I suffered that day and the physical and emotional after-effects that I continue to experience on a daily basis. I find it discouraging and demoralizing that I have no recourse for my injuries, and that a company that manufactured a defective product that has harmed me and thousands of other individuals has no accountability.
It is extremely important that injured patients have a remedy for their injuries and that the costs of their medical expenses and other needs are not borne by Medicare, private insurance, employers and the patients themselves. The medical device industry should be accountable for its products just like drug companies or any other industry.
Meanwhile, yesterday the FDA announced it would review its approval of Menaflex, a knee-surgery device made by ReGen Biologics. According to the Wall Street Journal, this affair raised “legitimate concerns about whether the agency's review process and decision...were compromised.”
The bigger problem is that unless Congress fixes the law, anyone harmed or killed by the device has no legal recourse.