New England Journal of Medicine Urges the U.S. Supreme Court to be Skeptical

Peter Wetherall
Peter Wetherall
Contributor
Posted by Peter WetherallAugust 26, 2008 8:33 PM

Last week, physicians came to the aid of Plaintiff's lawyers, citizens of Clark County and the American consumer of prescription medication.    The editors of the New England Journal of Medicine filed a "friend-of-the-court brief" in the case of Wyeth v. Levine.  Readers will know the Wyeth v. Levine case is pending before the United States Supreme Court.  

The New England Journal of Medicine wrote in the brief, that lawsuits can serve as "a vital deterrent" and protect consumers if drug companies don't disclose risks of their drugs.  The New England Journal acknowledged that the FDA is often called the "gold standard" in drug evaluation, but the journal urged the Supreme Court justices to be skeptical.   The editors stated "The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety,"  The journal noted that discoveries made by plaintiff's lawyers through liability litigation serve an important function and that the "FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decision, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct."   Many consumers recognize that importance of litigation for harmful drugs such as Vioxx, Chantix, Ketek, Reglan and Digoxin. 

The editors joined 47 state attorneys general and two former FDA commissioners-David Kessler and Donald Kennedy in supporting Levine's position.   The Bush Administration is supporting the position of Wyeth, and if this position is successful, the ability of a consumer to sue drug companies for harmful side effects will be non-existent.

 

Journal Editor, Dr. Jeffrey M. Drazen in an interview, stated that the FDA is overwhelmed in trying to keep up with drug safety problems, which can range from rare but serious side effects, to shortcomings in manufacturing plants oversees.  He also said that the "court system represents one of the key defense mechanisms that individuals have if a manufacturer has not made the risks of a product clear to the public. 

2 Comments

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Brian Smalley
Posted by Brian Smalley
August 27, 2008 1:13 PM

As a resident of the United Kingdom,I keep a close watch on events regarding drug safety in the United States. If the rights of an individual are taken away,and then suffers serious side effects as the result of taking a drug, where the manufacturer does not give the totally accurate details or risks of the product,then this would be totally against the freedom, equality and fairness for the people for which the United States is renowned worldwide.

I make this comment as the result of my wife suffering a serious heart attack in 2004, just prior to Merck removing Vioxx from the market.She had been in good health,apart from arthritis,up to that time. This has completely ruined our lives, and yet, in the United Kingdom we have no right of redress against against Merck and co.

tm
Posted by tm
August 27, 2008 1:27 PM

big mistake if the supreme court rules in favor of preemption.
where is our justice for all if you take away our right to be protected against neglegent drug companys...........who make us beleive the product is safe for use.

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