“In recent years, concerns have been raised both inside and outside of the FDA about whether the current 510(k) program achieves its goals of making safe and effective devices available to the public while fostering innovation.”
"FDA Considers Changes to Medical Device Regulation"
Information Week, 8/9/10
“Less than a week after its recall of a pair of hip implants, DePuy Orthopaedics was hit with another series of lawsuits over the devices, this time alleging that the Johnson & Johnson (NYSE:JNJ) subsidiary knowingly sold defective products.”
"Lawsuits Continue to Pile Up for Johnson & Johnson’s DePuy Orthopedics Over its Hip Implant"
Mass Device, 9/1/10
“Hirschbeck, at 42, was then among the best umpires in professional baseball and unwilling to quit a job that paid more than $350,000 a year.
Dr. John Keggi offered a hip replacement that could get him back on the field by 2004, Hirschbeck says. That didn't happen.
The ceramic joint made by Wright Medical Group Inc. shattered, leading to an infection and four more surgeries that left Hirschbeck permanently sidelined.”
"Ex-baseball Ump Claims Botched Hip Surgery Ruined His Career"
Connecticut Post, 6/11/10
"The Supreme Court dealt a defeat to the pharmaceutical industry and the Bush administration Wednesday, ruling that federal approval of a prescription drug does not provide a shield against lawsuits from injured patients."
"Suprume Court Rules Patients can Sue Drug Makers"
LA Times, 3/5/09
"Influential members of Congress plan to introduce a bill soon that would supersede last year’s Supreme Court device ruling, their aides say. If that legislation became law, injured people or their survivors would have the same right to sue device makers that the Supreme Court on Wednesday gave to people claiming injury or death from unsafe drugs."
"Drug Ruling Puts Devices in Spotlight"
New York Times, 3/5/09