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.

Executives Plead Guilty in Illegla Trials of Bone Cement

According to Bloomberg News, two executives from Synthes Inc., a medical device maker, pleaded guilt for their role in the company's illegal trials of bone-mending cement that led to the death of three patients. The 52-count indictment accuses executives at Synthes Inc, which is based in West Chester, Pa., of bypassing FDA approval of the trials while knowing that their products, Norian XR and Norain SRS, posed significant risks.

Michael D. Huggins and John J. Walsh pleaded guilty on Monday in federal court in Philadelphia to one misdemeanor count of shipping misbranded Norian XR across state lines. Each faces as much as one year in prison and a $100,000 fine according to United States attorney Michael Levy. Mr. Huggins' lawyers, Gregory Poe and Catherine Recker said in an e-mailed statement that "Mr. Huggins has always made clear that he did not do anything knowingly or intentionally wrong."