Doctors, trial lawyers, and consumers actually have mutual interests in the continuing battle over “preemption.” Preemption is the doctrine, whether by statute or case law that basically says if a product, such as a medical device or drug, is approved by an underfunded and understaffed federal agency, then consumers who are later harmed because the product was defective are “preempted” from suing the manufacturer.The purpose of the doctrine is to protect product and drug manufacturers.
It’s obvious why consumers and their advocates, trial lawyers, should be opposed to preemption. But what about doctors —should they care? Yes, because if injured consumers are forbidden from making claims against drug manufacturers, they may instead make claims against the doctors who prescribed those drugs. This is explained in an article in the July 3, 2008, edition of the New England Journal of Medicine titled “Why Doctors Should Worry about Preemption.” Here are excerpts:
Previous administrations and the FDA considered tort litigation to be an important part of an overall regulatory framework for drugs and devices; product-liability litigation by consumers was believed to complement the FDA’s regulatory actions and enhance patient safety. Margaret Jane Porter, former chief counsel of the FDA, wrote, “FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection.”3 Persons who are harmed have the right to seek legal redress. Preemption would erase that right.
But in the past few years, the government’s views have shifted, and the FDA has reversed its position, now claiming that common-law tort actions are preempted. The FDA argues that tort liability stifles innovation in product development and delays the approval process, and that lay juries are incapable of making determinations about product safety. It has been argued, however, that Congress, not unelected appointees of a federal agency, has the power to decide whether preemption should apply.
Drug and device companies have chosen an inauspicious moment to attack the right of patients to seek redress. A series of pivotal reports on patient safety from the Institute of Medicine, as well as numerous articles in scholarly journals, has put the issue of patient safety in the national spotlight. Although frivolous lawsuits should not be condoned, product-liability litigation has unquestionably helped to remove unsafe products from the market and to prevent others from entering it. Through the process of legal discovery, litigation may also uncover information about drug toxicity that would otherwise not be known. 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.
Why should doctors be concerned about preemption? 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.
In May, a Congressional hearing on preemption was held by Representative Henry Waxman (D-CA) and the House Committee on Oversight and Government Reform. 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.