Not surprisingly, the editors of The New England Journal of Medicine say 'yes.' Preemption, you may recall, is the notion that FDA approval supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness.
This fall, the US Supreme Court will hear a case that could determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA. And in an editorial, the NEJM editors offer a cautionary note.
"Drug and device companies have chosen an inauspicious moment to attack the right of patients to seek redress," they write. "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."