Patients Call for Continued FDA Preemption...( FDA Best Positioned to Review Medical...),Health

FDA Best Positioned to Review Medical Technology

WASHINGTON, May 11 /PRNewswire-USNewswire/ -- Patients from across the country came to Washington, D.C., to share their stories about how medical technology has helped improve or save their lives in advance of a May 12 U.S. House of Representatives Energy & Commerce Committee hearing on the Medical Device Safety Act of 2009, legislation to repeal the Food and Drug Administration's (FDA) preemption authority.

"Without my medical device, I would not be here today," said Laura Doud of Arlington, Virginia, who received life-saving implantation of cardiac resynchronization therapy with defibrillation in 2004 after suffering almost fatal viral cardiomyopathy. "If the proposed legislation were passed, would the lawsuits facing inventors and manufacturers prevent devices like mine or future medical innovations from ever making it to patients like me?"

"Every day millions of patients' lives are saved or enhanced thanks to innovative and safe medical technology," said Stephen J. Ubl, president and CEO of AdvaMed. "Unfortunately, you are not likely to hear these patients' stories in tomorrow's hearing."

Ubl added, "The Supreme Court's 8-1 decision in Riegel v. Medtronic foreshadowed what we will see in courtrooms and what we will see in the hearing tomorrow -- that the thousands of patients who have benefited from these technologies will not be considered."

The 8-1 majority Supreme Court decision asks, "How many more lives will be saved by a device which, along with its greater effectiveness, brings a greater risk of harm? A jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court."

Patients came to Washington from across the country to explain the importance of medical devices in savin
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