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 The Senior Citizens League Filed Briefs in Supreme Court Case to Support Seniors Rights

On March 4, 2009, in Wyeth v. Levine, the United States Supreme Court ruled by a 6 to 3 vote that approval of a drug by the Food and Drug Administration (FDA) does not prohibit a state court jury from finding a pharmaceutical manufacturer liable for personal injury caused by the inadequacy of an FDA-approved warning label on that drug. 

“We are very pleased with the court’s ruling,” declared Dan O’Connell, Chairman of The Senior Citizens League’s (TSCL) Board of Trustees.   “As part of our organization’s Seniors’ Health Initiative, we filed a friend-of-the-court brief urging the justices to take the position they did — rejecting the FDA’s claim that its approval of labels for pharmaceutical drugs is failsafe, and the only protection from dangerous drugs that Americans should have.”

Months before filing its amicus brief in August 2008, TSCL had filed comments critical of an FDA Science and Technology Report, pointing out that the FDA’s connections to the food, pharmaceutical, and other FDA-regulated industries jeopardized the FDA’s independence and objectivity, and cautioning against the FDA’s attempt to extend its regulatory activities beyond its scientific capabilities.

In its amicus brief, TSCL repeated these concerns, attacking the FDA’s claim that it alone is sufficient to ensure a drug’s safety and effectiveness, as being based upon what TSCL called the faulty assumption that “the FDA drug approval process is scientifically sound, unbiased and comprehensive.”  In a lengthy footnote, the majority in the Wyeth case essentially agreed with TSCL’s assessment, relying on many of the same authorities that TSCL had cited in its brief.
 
The majority agreed with the legal position also argued by TSCL that “the historic police powers of the States” — including the power to provide money damages for personal injuries caused by the wrongful acts of another, such as the loss of Ms. Levine’s arm in Wyeth — are not superseded by a federal law, especially a federal law that does not provide for any redress whatsoever should a government regulatory agency, like the FDA, make a mistake.

TSCL was especially gratified by Justice Clarence Thomas’s opinion which emphasized, as TSCL had in its brief, that the States were not a constitutional afterthought to fill in the gaps left by an all-powerful federal government.  To the contrary, as the TSCL brief and Justice Thomas both stressed, the Tenth Amendment secures to the states and the people common law rights that a federal agency, like the FDA, cannot trespass upon with impunity.

Although pleased with the result in Wyeth, TSCL is committed to continue monitoring the actions of the FDA and certain other federal agencies as part of its Seniors’ Health Initiative, in keeping with President Andrew Jackson’s warning, in his 1837 Farewell Address, that “eternal vigilance by the people is the price of liberty, and that you must pay the price if you wish to secure the blessing.”      

 


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