Oral Argument Scheduled for Monday, November 3, 2008
ALEXANDRIA, Va., Oct. 30 /PRNewswire-USNewswire/ -- On August 14, 2008, The Senior Citizens League (TSCL) filed an amicus brief in support of a courageous Vermont woman's fight to preserve her common law right to damages for the amputation of her gangrenous arm caused by the tortious conduct of a large pharmaceutical company.
Wyeth, with the wholehearted backing of the Food and Drug Administration (FDA), argued that the administration of its drug in a manner not prohibited by the FDA trumped the decision by a jury that Wyeth was liable under state law for the harm suffered by Diana Levine, a professional musician. According to Wyeth, the federal food and drug law provides the only protection that a medical patient has from harm caused by an FDA-approved drug, if that drug was administered in accordance with the FDA-approved methods and warnings.
Ms. Levine claimed that the FDA decision to permit Wyeth to market its drug -- in this case Phernegan -- sets only a minimum standard. Noting that FDA approval is based upon limited clinical trials conducted before the drug is made available to the general public, Ms. Levine argued that preservation of her individual common law right was necessary to protect her from FDA-undetected risks.
In its amicus brief, TSCL pointed out that the FDA's own science board has recently concluded that the FDA is ill-equipped both in personnel and technology to protect the health of the American people. Further, the brief emphasized that it would be unconstitutional for Congress to take away Ms. Levine's right to sue for Wyeth's wrongdoing, a right that has been secured to the people by the Tenth Amendment to the U.S. Constitution and the Vermont Bill of Rights.
Our brief in this case is not the first time that TSCL has gone to battle for the individual right of every American to have informed and unimpeded individual choice in health care.
Launched in the fall of 2005, TSCL's Seniors' Health Initiative has undertaken efforts to intervene on behalf of seniors and others in opposition to FDA's recent efforts to: (a) squelch free market access to complementary and alternative medicine; (b) raise barriers to the free flow of information concerning health enhancing vitamins and other dietary supplements; and (c) deny access to developmental drugs to terminally-ill patients without treatment alternatives.
Not only has TSCL's Health Initiative propelled it to file formal comments with the FDA -- including ground-breaking comments undermining the FDA's self-serving Science and Mission at Risk Report of November 2007 -- and to file amicus briefs in the Supreme Court, it has driven TSCL to take action in Congress, helping to draft a bill that would give terminally-ill patients ready access to drugs approved by the FDA for human testing. Additionally, TSCL is monitoring other bills limiting the power of the FDA's efforts to limit individual choice.
With oral argument scheduled in Wyeth for November 3, 2008, and a Freedom of Information Act request seeking records regarding FDA policy against Estriol and other natural Hormonal Replacement Therapies, TSCL's Health Initiative will continue to strive to preserve the freedoms of all Americans to make informed health care choices.
With 1.2 million members and supporters, The Senior Citizens League (http://www.SeniorsLeague.org) is one of the nation's largest nonpartisan seniors groups. The Senior Citizens League is a proud affiliate of The Retired Enlisted Association.
|SOURCE The Senior Citizens League|
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