House Energy and Commerce Subcommittee Considers Ability of FDA to Regulate Medical Devices

Two years ago 35-year-old Bridget Robb awoke by what she describes as the feeling of “cannons repeatedly being shot at her chest at close range,” followed by a strong electrical current racing through her body. The episode was a real-life nightmare as the lead to Bridget’s defibrillator fractured, sending 31 dangerous shocks to her heart and throughout her body. Bridget has a heart condition and was implanted with a defibrillator to prevent her from dying from a fatal arrhythmia. Instead, the defibrillator, intended to save her life, has given her nothing but heartache.

Ms. Robb testified before the US House Energy and Commerce’s Subcommittee on Health about her ordeal and how the Medical Device Safety Act would restore patients like her the right to hold the manufacturer responsible for their defectives products. Committee Chairman Henry Waxman (D-CA), Subcommittee Chair Frank Pallone (D-NJ), Rep. John Dingell (D-MI), Rep. Bruce Braley (D-IA) Rep. Chris Murphy (D-CT) and Rep. Kathy Castor (D-FL) all spoke in favor of the legislation. To hear about Bridget and the Medical Device Safety Act, see NPR’s clip about the hearing.

The Supreme Court ruled in Riegel v. Medtronic that because the Food and Drug Administration (FDA) had approved a medical device through the pre-market approval process, patients injured, like Bridget, do not have any recourse to hold the manufacturers accountable. The Supreme Court ruled a year later in Wyeth v. Levine that patients harmed by prescription drugs can hold manufacturers accountable in state courts, creating a double standard between prescription drugs and medical devices.

Bridget is not alone. Thousands of patients are harmed by defective medical devices. To see a few tell their stories, go to www.StopCorporateImmuntiy.org, where victims like five-year-old Avery DeGroh tells her story about her implanted defibrillator misfiring when she was just three, shocking her nine times. Her mother heard her screaming that monsters were attacking her.

Len Stavish, of Bear Creek, Pennsylvania had a 33-year career in Medical Device Design and Process Engineering. He was shocked 47 times over a five-hour period before his defibrillator was able to able to be deactivated.

Donald Miller of Windham, Maine was shocked 40 times, 800 volts each time. The incident left Don with Acquired Brain Injury, cataracts, broken teeth and post traumatic stress disorder.

Michele Meyer of Cambridge, Minnesota, also shares the story of her 30-year-old daughter, Katie. Katie beat cancer but died from complications to remove the faulty lead to her defibrillator.

Unfortunately, as patients continue to be harmed by faulty medical devices, cases continue to be dismissed. Just yesterday Judge Richard H. Kyle of the federal district court in Minneapolis dismissed over 200 cases related to faulty Medtronic Sprint Fidelis defibrillator leads.