David Kessler, the U.S. Food and Drug Administration’s (FDA) Commissioner from 1990 – 1997 has testified in front of Congress that the FDA simply can’t do its job with its current resources. Kessler, along with actor Dennis Quaid, presented testimony about whether injured consumers should be preempted from suing drug and medical device companies.

Should FDA drug and medical device regulation bar state liability claims?

The testimony is being heard by the Congressional Committee on Oversight and Government Reform entitled, “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?” Drug and medical device manufacturers maintain that injured consumers are preempted, or barred, from suing them if the FDA was ultimately responsible for approving the drug or device. Their argument is supported by the Bush Administration and the U.S. Supreme Court, at least concerning medical devices, and is what’s at the center of the controversy.

The controversy: In a nutshell

In a nutshell, the Bush Administration is saying that the FDA should be responsible for protecting the public and that drug and medical device manufacturers shouldn’t be liable for defective or dangerous products. However, the current FDA Commissioner, Andrew von Eschenbach, has testified before Congress that the FDA cannot do its job with the resources it currently has – leaving consumers with little confidence of being adequately protected from injury.

The issue continues to be a sore spot for many and members of Congress are asking for additional information. Some of that information recently came from David Kessler, the FDA’s former Commissioner from 1990 – 1997. Kessler says that, “Even if the FDA's funding were doubled or tripled, its resources and ability to detect emerging risks on the thousands of marketed drugs and devices would still be dwarfed” by pharmaceutical and medical device manufacturers.

Additional testimony came from actor Dennis Quaid whose newborn twins were given overdoses of the blood thinning drug, Heparin. Although the twins are fine, he sued the manufacturer – Baxter International – but it is claiming preemption.

The bottom line, according to consumer advocate groups, is that injured patients are the ones who end up paying the price in the end. If you’ve been injured due to a defective or dangerous medical device or have been injured by a drug, contact an attorney to discuss your situation. We may be able to help. To contact a qualified attorney whose practice focuses in this area of the law, please click here.