Medical Device Safety Act Hearing Scheduled in Sentate Today

August 4, 2009 - The Senate HELP (Health, Education, Labor and Pensions) Committee will hold a hearing at 2:30pm (ET) today titled, "Protecting Patients from Defective Medical Devices". The hearing is being held to discuss the Medical Device Safety Act of 2009. This Act, if passed, will undue the Supreme Court's ruling in the Riegel case last year. Basically, the Riegel ruling prevents people injured by defective medical devices from being able to file a lawsuit to recover damages caused by the device.

The committee will hear from the following people at the hearing today:

William H. Maisel, MD, MPH, Director, Medical Device Safety Institute, Beth Israel, Deaconess Medical Center, Harvard Medical School, Boston, MA

Professor Thomas O. McGarity, Joe R. and Teresa Lozano Long Endowed Chair in Administrative Law, University of Texas School of Law, Austin, TX

Michael Mulvihill, Patient, Bettendorf, IA

Peter Barton Hutt, Esq., Senior Counsel in Food and Drug Law, Covington & Burling, Washington, DC

Michael Roman, Patient, Kirkwood, MO

Major League Baseball Umpire Advocates for Passage of Medical Device Safety Act

July 21, 2009 - The New Haven REgister reprots that Mark Hirschbeck, a Major League Baseball umpire, is among those advocating for Congress to pass the Medical Device Safety Act of 2009. According to the article, Hirschbeck states that what started as routine hip replacement surgery cost him his career and has led to years of pain.

Hirscbeck underwent hip replacement surgery in June 2003. About a month after his surgery, while recovering on his couch he heard a "pop". The ceramic hip used in his surgery had shattered.

Hirschbeck underwent several surgeries to replace the hip suffering several infections along the way. Finally, a doctor removed all the ceramic and metal from his hip and started himon antibiotics to clear the infection. Once he was free of infection he received a non-ceramic hip replacement. While Hirschbeck is doing better, he still has pain and can't sit or stand for long periods of time. His career as a Major League umpire is over.

Hirschbeck has filed a lawsuit against the manufacturer of the original hip he received. However, a U.S. Supreme Court case decided last year ruled that medical device manufacturers like the one who made Hirschbeck's hip, are immune from lawsuits challenging the products safety or effectiveness.

The Medical Device Safety Act of 2009, if passed, would allow cases like Hirschbeck's to proceed to trial. That is why Hirschbeck has gone to Washington, D.C. to lobby lawmakers to pass the Medical Device Safety Act. The bill is currently in committee.

Hirschbeck and many others like him just want their day in court and tell a jury their story. So many who have been seriously injured by faulty medical devices just want the companies to be held accountable, but that won't happen without the passage of the Medical Device Safety Act.

FDA Medical Device Approval System Broken

At the subcommittee's hearing on the Medical Device Safety Act of 2009, Rep. Frank Pallone Jr. (D-NJ), chairman of the health subcommittee of the House Energy and Commerce Committee said that "there is evidence that the Food and Drug Administration (FDA) approval system for medical devices is 'broken' and a comprehensive review of the major issues and potential problems is needed" according to CQ HealthBeat. During the same hearing, Marcia Crosse, the Goverment Accountability Office's director of Healthcare, said "that the GAO has repeatedly pointed to shortcomings in the medical device approval process that continue today." Pallone called for the standards, procedures and rules for certain approving certain devices need to be adjusted to meet modern needs in getting the devices to those in need with confidence in their safety.