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Health Subcommittee Considers Bill To Eliminate Pre-Emption For Medical Devices
The House Energy and Commerce Health Subcommittee on Tuesday heard testimony on the Medical Device Safety Act of 2009 (HR 1346), which would allow consumers to sue medical device manufacturers in state courts, CQ HealthBeat reports. The bill responds to last year"s Supreme Court ruling that says medical devices with FDA pre-marketing approval can be pre-empted from lawsuits under state law, in accordance with the Medical Device Amendments of 1976. Rep. Frank Pallone (D-N.Y.), who introduced the bill, said that the 2008 Supreme Court ruling "ignor[ed] congressional intent" by providing blanket immunity for medical device makers. According to Rep. John Dingell (D-Mich.), a co-sponsor of the bill, the original 1976 law sought to grant regulatory authority to FDA for medical devices, but it did not aim to eliminate state liability. Committee Chair Rep. Henry Waxman (D-Calif.), another co-sponsor, said last year"s ruling already has caused 1,400 injury cases to be thrown out of court, adding that the threat of litigation provides manufacturers with additional safety incentives. David Vladeck -- a law professor at Georgetown University Law Center who testified at the hearing -- added that immunity from lawsuits "removes incentive to manufacturers to fix devices quickly and get defective devices off the market."Rep. Nathan Deal (R-Ga.) said the class of device that must obtain pre-marketing approval -- which includes pacemakers and replacement heart valves -- represents only 2% of all approved medical devices each year. Rep. Michael Burgess (R-Texas) added that the measure could create an inconsistent system that allows both FDA experts and jurors in various states to make decisions on medical device safety standards. In addition, Rep. Joe Pitts (R-Pa.) cautioned that the bill might encourage manufacturers to limit distribution of their devices to certain states (Kim, CQ HealthBeat, 5/13). Related Editorial Don't forget to buy zoloft online no prescription.

Medtronic-Supported Clinical Trial Shows ICD Patients Less Likely To Develop Need For Pacing When Device Uses MVP(R) Mode
MVP® (Managed Ventricular Pacing), exclusive programming on Medtronic pacemakers, which is proven to be effective in reducing unnecessary pacing in pacemaker patients, was applied in the MVP Trial of implantable cardioverter-defibrillator (ICD) patients. Data from MVP trial, sponsored by Medtronic, Inc. (NYSE: MDT), were presented today as a late breaking clinical trial at Heart Rhythm 2009, the annual scientific sessions of the Heart Rhythm Society.

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Greater Likelihood Of Becoming An Adult Smoker If Mother Smoked During Pregnancy And Early Childhood
Children of mothers who smoked during pregnancy and their early childhood years may be predisposed to take up smoking as teens and young adults, compounding the physical damage they sustained from the smoke exposure.
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American Chemical Society Praises Nomination Of Collins As National Institutes Of Health Director

The President of the American Chemical Society, Thomas H. Lane, Ph.D., issued the following statement on President Obama"s nomination of Francis Collins, M.D., Ph.D., to be Director of the National Institutes of Health (NIH): "At no other time in recent memory has there been such a sense of opportunity - and expectation - in the power of science to deliver solutions to the grand challenges facing our nation, and indeed, all of humanity. As the nation"s largest of basic research funding, NIH will be looked to lead and deliver. "Dr. Collins, a chemist, has made tremendous contributions to the advancement of science, most notably in the sequencing of the human genome which holds the promise of decoding the genetic causes of cancer and other major human illnesses. The work and accomplishments of Dr. Collins certainly bring to life the ACS vision of "Improving people"s lives through the transforming power of chemistry." "As the world"s largest scientific society, the ACS strongly supports the Collins nomination. NIH will be well-served to have a scientist of such caliber play a key leadership role in guiding the agency in the years ahead. ACS wishes Dr. Collins a speedy and successful Senate confirmation and many years of accomplished success leading NIH." The American Chemical Society


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