Dr. Catherine DeAngelis, the Editor in Chief for the Journal of American Medical Association and Dr. Phil Fontanarosa, the Executive Deputy Editor for the Journal of American Medical Association recently penned a rather insightful editorial discussing the importance of tort litigation in product liability cases. Referencing their serious concerns about the Food & Drug Administration’s ability to keep us safe, they explained:
Given the current imperfect process for approval and the flawed postmarketing surveillance system, the drug and device regulation process is at best an inexact and incomplete science. Until these deficiencies in the system are remedied,some patients inevitably will continue to experience harm from the use of newly marketed products as well as from use of other approved medications. Just as with other consumer products that cause harms, consumers (i.e., patients) who are injured by defective medical devices or by pharmaceutical products with inadequate warnings of potential harms may have to resort to legal action as recourse for their injuries. According to Gostin, litigation and state tort law “provides a system of civil justice designed to compensate patients, deter unreasonably hazardous conduct, and encourage innovation in product design, packaging, labeling, and advertising.”
Thus,tort law serves in effect as away to close regulatory gaps in the FDA remarketing approval process and to provide a mechanism for postmarketing surveillance. Moreover, litigation has been a rich source of information about how drug and device manufacturing companies behave, such as with off-label promotion, guest and ghost authorship, and reporting of safety findings. Without the information revealed by the public release of documents in tort liability actions, many of these behaviors would remain unknown, some drug manufacturers’ judgments about safety issues would be hidden from view, review, or oversight, and the FDA would not be able to uncover them either.
One of the most important ways to ensure the health of the nation is to be certain that medical devices and pharmaceutical agents are safe. The FDA is not infallible and the recently increased resources do not include a crystal ball. Therefore, unless and until the FDA drug approval process and the postmarketing surveillance system improve significantly, patients must have a means to seek recourse through tort litigation against product manufacturers. Anything less may well preempt the well-being and safety of the public.
Rarely do people stand up and recognize the fact that civil litigation protects us as consumers. Civil lawsuits provide an additional layer of accountability that encourages those in the business of making products, whether they be medical devices or toys for our children, to ensure those products are safe. Anything that reduces the impact of those civil lawsuits, reduces the accountability for those who make and distribute products to us.