The threat of federal preemption has become a major issue in this country. A most interesting article appeared in the New England Journal of Medicine recently that addressed this issue. The authors focused on the Wyeth case which is before the U.S. Supreme Court. It was pointed out that if the drug manufacturer, Wyeth, prevails in the case “drug companies could effectively be immunized against state-level tort litigation if their products that have been approved by the Food and Drug Administration (FDA) are later found to be defective.”

As we all know, a recent case decided by the Supreme Court involving a product liability claim against Medtronic was found to be preempted. Medtronic won its case in the Supreme Court because the 1976 law that grants the FDA authority to regulate medical devices contains a specific clause asserting that state requirements with regard to medical devices are preempted by federal requirements. Although the preemption clause is silent on common-law tort actions, the Supreme Court interpreted the clause broadly to include such actions. Many constitutional purists are questioning how the court reached its conclusion on preemption in that case.

Unlike the law governing medical devices, however, the Food, Drug, and Cosmetic Act, which provides the statutory framework for the regulation of drugs by the FDA, contains no such preemption clause. That should be a most significant distinction in the two cases. We have set out the facts in the Wyeth case in previous issues, but they are worth revisiting briefly. A patient lost her arm after an injection of Wyeth’s antiemetic drug Phenergan. The High Court will decide whether preemption of state tort litigation is implied by the law, even though it is not explicitly stated. Previous administrations and the FDA considered tort litigation to be an important part of an overall regulatory framework for drugs and devices.

It has been accepted over the years that product-liability litigation by consumers complements the FDA’s regulatory actions and enhances patient safety. While persons who are harmed have a constitutional right to seek legal redress, federal preemption would take away that right. Due to pressure from the Bush Administration, and the drug and medical device manufacturers, the FDA has reversed its position. The FDA now says that common-law tort actions are preempted. It appears pretty basic that Congress, not unelected appointees of a federal agency, has the sole authority to decide whether preemption should apply. To this date, Congress has never said that a regulatory agency could usurp its authority and make laws relating to preemption and the common-law of the states.

Patient safety should be a top priority for the manufacturers of drugs and medical devices. It should be undisputed that product-liability litigation has helped to remove unsafe products from the market and has prevented others from entering it. Through the process of pretrial discovery, litigation may also uncover information about drug toxicity that would otherwise not be known. On the preemption issue, the NEJM article states:

Preemption will thus result in drugs and devices that are less safe and will thereby undermine a national effort to improve patient safety. Owing in part to a lack of resources, approval of a new drug by the FDA is not a guarantee of its safety. As the Institute of Medicine has reported, FDA approval is usually based on short-term efficacy studies, not long-term safety studies. Despite the diligent attention of the FDA, serious safety issues often come to light only after a drug has entered the market. The FDA, which — unlike most other federal agencies — has no subpoena power, knows only what manufacturers reveal.

Based on conversations that I have had with friends in the medical community, I am convinced that most doctors don’t understand preemption. It follows that they don’t understand how preemption affects the health and safety of American citizens. The authors of the NEJM article discuss in detail why doctors should be concerned about preemption. The following is a good assessment of why federal preemption is bad for doctors and their patients:

In stripping patients of their right to seek redress through due process of law, preemption of common-law tort actions is not only unjust but will also result in the reduced safety of drugs and medical devices for the American people. Preemption will undermine the confidence that doctors and patients have in the safety of drugs and devices. If injured patients are unable to seek legal redress from manufacturers of defective products, they may instead turn elsewhere.

The authors, Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D., testified at the congressional hearing on preemption held before the House Committee on Oversight and Government Reform. They wrote in the Journal concerning their testimony:

As we stated in our testimony to the committee, to ensure the safety of medical devices, we urge Congress to act quickly to reverse the Riegel decision. Congressman Waxman and Congressman Frank Pallone, Jr. (D-NJ), are poised to introduce legislation that would unambiguously eliminate the possibility of preemption of common-law tort actions for medical devices. And if the Supreme Court rules for preemption in Wyeth v. Levine, which we hope it will not, Congress should consider similar legislation for drugs. Such legislation is in the best interest of the health and safety of the American public.

It’s most significant that the article was written by top officials with the NEJM. They are concerned for the health and welfare of the American people when it comes to the safety of drugs and medical devices, and rightly so. If preemption is allowed to prevail, the American people will be the losers!

Source: New England Journal of Medicine

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• Federal Preemtion Of Medical Product Cases Is Bad For People
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• No Real Conservative Could Support Federal Preemtion
• Federal preemption is un-American