In the latest preemption battle casualty, the Wisconsin Supreme Court recently ruled that Medtronic is not liable for injuries caused by a defibrillator because the FDA approved the device.
Interestingly, in March of last year, an article published in the New England Journal of Medicine explained how the Medtronic Sprint Fidelis recall is a “prime example” of the failure of not only medical device companies but the FDA as well. The FDA’s ability to anticipate risks of approved devices and react once defects are discovered is severely limited. Manufacturers learn of serious adverse events related to their products long before the FDA ever does, through Adverse Event Reports (AERs) and other communications from doctors and consumers. Consequently, at every stage of the process, the company’s knowledge about a problem is superior to the FDA’s. Moreover, even if a company appropriately reports to the FDA, the FDA is under-funded, overwhelmed and ill prepared to timely take all of the appropriate actions to protect the public. The Government Accountability Office (“GAO”) and the congressionally chartered National Academy of Science’s Institute of Medicine (“IOM”) criticized the agency’s abilities to keep unsafe products off the market and respond effectively to observed hazards. Even the current director of the FDA has publicly stated concern over the strained agency’s ability to do everything it is charged to do and work within its budget.
During a Congressional hearing, Dr. David Graham, a 20 year employee of the FDA and Associate Director for Science and Medicine in the FDA’s Office of Drug Safety, testified that the FDA is “broken” and has “let the American people down.” During this appearance before Congress related to the Vioxx recall, he concluded that “the FDA, as currently configured, is incapable of protecting the America against another Vioxx. We are virtually defenseless .”
Since the FDA is not fulfilling its mission statement of “protecting the public health,” the American justice system must remain the safety net for injured patients.
During the regulatory process, the FDA conducts no independent testing, and is largely dependent on device manufacturers to provide the information on which the agency bases its decisions in both the pre-approval and post-approval reporting stages. Obviously, the concern is that the FDA only knows what the manufacturer chooses to tell it. Because the responsibility for reporting the information on which the FDA relies rests with the party most interested in bringing the product to market, an inherent conflict of interest is inevitable. Regardless, even under the best of circumstances, the FDA often lacks the ability to interpret the data generated by those conducting a study.
In a NEJM article titled, “Why Doctors Should Worry about Preemption,” the authors observe that “. . . product-liability litigation has unquestionably helped to remove unsafe products from the market and to prevent others from entering it.” As one federal district court recently explained, tort law plays an important gap filler, “. . . and is consistent with a regulatory system that puts the obligation to warn on the party with the most comprehensive information available: the drug manufacturer.”
Renowned healthcare providers recognize that the FDA is not up to the task of being the sole protector of American patients. Six current and former editors of NEJM have recently and publicly attacked the concept of preemption. One former editor has gone so far as to say that “we all agree that preemption is a terrible idea . . .” These experts correctly note that lawsuits are a formidable deterrent against misbehavior of device and drug manufacturers, in part because the FDA is not a reliable gatekeeper. The Knipe court agreed that a state-law based failure to warn claim “will not usurp or undermine the FDA’s responsibilities to ensure an accurate label, but rather will close the void in the authority of the FDA, which can neither independently regulate off label use nor require additional clinical trials.”
The current regulatory environment is unquestionably broken and no longer provides the safeguards for which it was designed. The “rigorous” review and “stringent” enforcement policy arguments advanced by manufacturers simply do not exist. Rather, we have a system plagued by a “lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs’ risks and benefits.”
Immunizing manufacturers through preemption will result in a “radical restructuring of the American civil justice system.” Without the existence of viable state tort law claims, injured patients have no practical means of redress against the entities responsible for their damages. Often they struggle and eventually many must look to the public sector (and your tax dollars) instead of whoever is really responsible, to provide what they should have recovered. This needs to change.