Top FDA Staff Opposed the Bush Administration’s Attempt To Shield Drug Companies

By October 31, 2008Dangerous Drugs

The Food and Drug Administration’s top staff regulators were against shielding drug makers from lawsuits, the Los Angeles Times reports.
Internal documents released by Rep. Henry A. Waxman (D-Beverly Hills) reveals that top FDA regulators did not trust pharmaceutical companies to warn patients of new risks associated with prescription drugs. However, Bush Administration appointees argued that, under the legal doctrine known as preemption, the FDA process approving drug labels should be sufficient to shield drug makers from consumer lawsuits.
But the FDA’s own experts on the drug approval process disagreed.
Dr. John Jenkins, director of the Office of New Drugs, wrote in a 2003 memo:

“The premise of the basis for much of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA-approved labeling is fully accurate and up-to-date in a real-time basis. We know that such an assumption is false.”

As the LA Times’ reporter David Savage points out, the FDA has regulated new drugs for more than 100 years. At the same time, the FDA did not attempt to block lawsuits filed against drug makers by patients who were hurt by dangerous drugs.
Now that right is at stake. In a case before the U.S. Supreme Court, Wyeth is asking the Court to shield it from a lawsuit filed by a musician who lost her arm as a result of gangrene caused by an anti-nausea drug.
Like the experienced staff regulators at the FDA, attorneys who represent victims who have been harmed by dangerous drugs understand that drug makers are not eager to disclose all the risks associated with their medicines. Lawsuits play a vital role in protecting the American consumer.
My law firm currently represents victims and their families in lawsuits against most of the major drug companies including Merck, Pfizer, Bayer, Eli Lilly and others. The lawyers of Carey, Danis & Lowe are experienced in helping people injured by dangerous prescription drugs. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.