RT @BreakingNews: Typhoon Nesat update: Hong Kong suspends port services; some flights delayed at airport - AFP http://t.co/pBRIuaFA
246 days ago
RT @4uhealth: Laughter good medicine for dementia patients:study: Laughter may be good medicine for elderly dementia patients ... http:/ ...
246 days ago
QUICK POST: Medical device liability law examined in SenateAugust 9, 2009
Posted Oct 04 2009 11:14pm
Foes and advocates of changing liability laws for certain medical devices squared off Tuesday in a hearing before the Senate Health, Education, Labor and Pensions committee. The groups debated whether Congress should try to reverse an eight-to-one US Supreme Court decision handed down in February 2008 in Riegel v. Medtronic, Inc, which held that the Medical Devices Amendment of 1976 allows the most risky medical devices – those that gain approval from the Food and Drug Administration in the pre-market approval process – to gain immunity from liability lawsuits in state courts. Sen. Tom Harkin (D-IA) said the decision has meant complete immunity from lawsuits for corporations that endanger consumers with unsafe devices. However, William Maisel, a cardiologist at Beth Israel Deaconess Medical Center and founder of the Medical Device Safety Institute said that a manufacturer must demonstrate reasonable assurance of safety and effectiveness to gain FDA approval.
Foes and advocates of changing liability laws for certain medical devices squared off Tuesday in a hearing before the Senate Health, Education, Labor and Pensions committee. The groups debated whether Congress should try to reverse an eight-to-one US Supreme Court decision handed down in February 2008 in Riegel v. Medtronic, Inc, which held that the Medical Devices Amendment of 1976 allows the most risky medical devices – those that gain approval from the Food and Drug Administration in the pre-market approval process – to gain immunity from liability lawsuits in state courts. Sen. Tom Harkin (D-IA) said the decision has meant complete immunity from lawsuits for corporations that endanger consumers with unsafe devices. However, William Maisel, a cardiologist at Beth Israel Deaconess Medical Center and founder of the Medical Device Safety Institute said that a manufacturer must demonstrate reasonable assurance of safety and effectiveness to gain FDA approval.
http://www.cq.com/login.do?jumpto=http%3A%2F%2Fwww.cq.com%2Fdisplay.do%3Fdocid%3
www.condron.us www.bloglines.com www.blogburst.com www.blogcatalog.com www.clusty.com