Food and Drug Administration Improvement Act of 2010

We are pleased to see that Rep. Maurice Hinchey (D-NY) has introduced legislation designed to correct some of the problems in the FDA governing framework. Congress must take action to help the FDA fulfill its mission of protecting the public safety, since consumers cannot ask the courts to protect them from faulty medical devices.

As a result of the Supreme Court’s 2008 ruling in Riegel v. Medtronic, thousands of victims of faulty medical devices are denied their day in court and left unable to recoup damages for medical expenses or pain and suffering. Take for example Avery deGroh. Born with a hereditary heart defect called Long QT Syndrome, Avery received a surgically implanted defibrillator at age two. One year later, Avery’s defibrillator began sending unnecessary electric shocks to her heart, and a terrified Avery believed that monsters were attacking her. Avery’s mother, Molly, held her helpless daughter as the device fired nine times, causing Avery intense pain.

Doctors deactivated the device, and Avery underwent another surgery to replace the defibrillator with a new unit from a different manufacturer. Years later, Avery’s parents are still struggling to pay for the $30,000 cost of surgery, which was not covered by insurance or Medtronic, the manufacturer of the defective device.

What the Avery’s parents did not know at the time of surgery was that Medtronic had received other reports of shocks in patients. Medtronic ultimately revealed that 2,200 people were injured and thirteen killed as a result of its defective product. Because of Riegel v. Medtronic, none of the people injured are able to bring claims against Medtronic for the harm it caused.

Help end corporate immunity for medical device manufacturers: sign our petition urging Congress to pass the Medical Device Safety Act.