Bush-Controlled FDA Moonlights as Big Pharma Pusher
Americans need to stop and consider how many consumers will be killed and injured by dangerous drugs by the time George Bush heads back to Texas at the end of his Presidency, as a direct result of his allowing the interests of the pharmaceutical industry to take control of the FDA.
For nearly 70 years, the common-law tort systems in the individual states have provided a remedy for citizens injured by prescription drugs. However, in one of the most blatant paybacks for political contributions in US history, in January 2006, Bush-appointed officials at the FDA announced that the agency's approval of a drug and its labeling acts to preempt product liability lawsuits filed by patients against the pharmaceutical giants.
On February 23, 2006, Democratic lawmakers Rep Henry Waxman, of the Committee on Government Reform, and Reps John Dingell and Sherrod Brown of the Committee on Energy and Commerce, sent a letter to the Secretary of Health and Human Services, and voiced their outrage.
"The announcement," the lawmakers wrote, "provides unfortunate evidence that the Bush Administration is more committed to protecting drug industry profits than to building a sound system for ensuring drug safety."
"The FDA's preemption announcement," the letter said, "is particularly troubling at a time when FDA's own ability to protect Americans from unsafe drugs has been called into question by a series of cases in which the FDA was slow to warn consumers of significant drug risks."
The new rules went into effect on June 30, 2006, and preemption is now being used in litigation all over the country in an attempt to dismiss lawsuits filed by private citizens against drug companies.
Unbeknownst to average Americans, the administration's gift of preemption is not limited to industries regulated by the FDA. Bush-appointed officials in all federal regulatory agencies are working in concert to ensure that major corporations subject to product liability lawsuits can claim that federal regulation of their products preempts any recovery for consumers harmed, whether the injury involves defective automobiles, pesticides or whatever.
In return, the major corporations are ganging up on private citizens by filing amicus briefs in support of pharmaceutical companies involved in litigation. For instance, the drug giant Wyeth is arguing preemption in a petition currently pending before the US Supreme Court in a case involving one lone woman in Vermont, in an attempt to overturn a jury verdict that was affirmed by the Vermont Supreme Court.
Amicus briefs to support Wyeth's preemption argument are piling up, including one filed by the Product Liability Advisory Council on behalf of just about every major product manufacturer in America.
The plaintiff, Diana Levine, a professional musician, has the support of the Public Citizen Litigation Group. Ms Levine went to the hospital to seek treatment for a headache and left with injuries that led to the amputation of her arm after the drug Phenergan was administered by IV to alleviate the nausea associated with a migraine headache.
Specifically, her arm had to be amputated because the drug reached Ms Levine's arteries, and the lawsuit alleges that Wyeth was aware of the risk of arterial contact when the drug was administered by IV and failed to warn against using a method to administer Phenergan that caused the injury.
In the petition, Wyeth does not dispute that Ms Levine's arm was amputated because the company failed to warn about using this method. Its sole argument is that she is not entitled to damages because the FDA did not require Wyeth to warn about the danger of administering the drug this way.
The Vermont Supreme Court rejected this argument. The agency's claim of conflict with federal law, the Court held, did not warrant deference because it was flatly at odds with both the FDA's regulation permitting manufacturers "to add or strengthen a warning 'to increase the safe use of the drug product' without prior FDA approval," and with Congress' express directive that state law concerning prescription drugs be superseded only when it poses a '"direct and positive conflict' with federal law."
On May 21, 2007, the Supreme Court invited the Solicitor General to file a brief to express the views of the government, which will no doubt add support for a favorable preemption ruling for Wyeth, potentially affecting tens of thousand of private citizens with cases pending all over the country.
A favorable ruling on preemption could provide an escape hatch for GlaxoSmithKline in lawsuits filed by patients injured by the diabetes drug Avandia (rosiglitazone), even though the FDA is aware of the fact that Glaxo concealed the serious cardiovascular risks known to be associated with the drug for years.
