Legal News You Can Use

In an interesting twist to the usual discourse between law and medicine, The New England Journal of Medicine recently published a perspective (July 3, 2008) alerting doctors to the upcoming Supreme Court hearing of Wythe v. Levine. In this landmark case, Wythe, a pharmaceutical manufacturer, is vying for a ruling to make Federal Drug Administration (FDA) approval subject to preemption. If Wythe gets their way, it will set a major precedent in the history against consumer protection, a return to 19th century consumer rights.

Preemption is a function of the U.S. Constitution, whereby any contradiction between state and federal law errs on the side of the Feds. In this situation, it means that if a drug has received FDA approval, patients will not have the right to seek restitution for dangerous, and in some cases lethal drugs prescribed to them.

In recent years, there has been a lot of ink spilled and tempers’ lost over frivolous lawsuits. Critics of tort litigation argue that such litigation dissuades pharmaceutical companies from experimenting and thereby limiting possible new miracle drugs. They also say that the drawn out process of testing drugs for customer safety is excessive and costly to the company. The truth of the matter is that the pharmaceutical industry lives by the quest for the next miracle drug. Any serious contender in the field must experiment, because the real profits come when a company holds the patent to a new drug. Until that patent expires, the company holds a virtual monopoly on that drug, so the cost of research is peanuts compared to the profits.

It should also be noted that FDA turnover has been increasing for over a decade. As drugs become more complex to meet the demands of the growing sophistication of the medical community, the vigilance of those entrusted to regulate those drugs has to equal this sophistication, and quite frankly, the resources at the FDA have been cut back. They cannot handle the demand. Therefore, tort litigation is a necessary member of the regulating bodies.

Margaret Jane Porter, a former chief counsel of the FDA, says “FDA product approval and state tort legislation usually operate independently, each providing a significant, yet distinct, layer of consumer protection”1.

However, current FDA officials are not inclined to agree. One may consider the fact that since passing The Prescription Drug User Fee Act (PDUFA) in 1992, over 50% of FDA funding has come from the companies seeking product approval. The act was passed to meet growing demands for FDA staff without petitioning Congress for more funding. Instead, an agreement was struck between the pharmaceutical industry and the federal government, whereby the company pays a user fee for every time they wish the FDA to test a product. In exchange, the FDA must reach a decision within a specific timeframe.

To some this may appear to be the Reaganomics ideal, but in effect this gives the pharmaceutical industry the power of the purse. Hence the paradigms shift over at the FDA. In the history of consumer protection, tort litigation that holds the producer liable for product safety has been a natural and effective deterrent to unsafe drugs. FDA approval has never been considered a 100% guarantee against harmful side effects. In fact, FDA approval is a minimum standard within the industry, not a gold standard, but the minimum. Hardly the vote of confidence necessary to negate legal censure; especially when one considers that the FDA is one of the few federal agencies that have no power of subpoena. The only test data they see is what the company applying for the stamp of approval gives to them.

Regardless of what one believes about the mechanisms of quality control in a market economy, the last word on this issue is accountability. The FDA, in the pitch of arrogant self-regard, argues that a jury of lay-people lacks the qualifications to judge the nuances of drug safety. I don’t know about you, but if a group of appointees (that’s right, FDA officials are not elected) getting their funds and data from the defendant think they are the only ones capable of fair and balanced judgments, then I say they need to get their heads examined. We owe a lot to tort litigation in the development of consumer safety, like safe air bags and safe tires.

The irony in this situation is that such a dissenting voice should come not from the American Trial Lawyers Association, but from the New England Journal of Medicine. The Journal’s staff wrote this article for other doctors. If doctors are concerned that granting preemption to drug companies will undermine their profession, then what are the rest of us to think? Clearly, such measures are in the best interest of a single group: the drug companies. Everyone else will be forced to live with the consequences of their legal immunity.

Ultimately, these lawsuits are not frivolous so long as we value the trust between doctors and patients, and the safety of the general public. Granting preemption to drug companies will only harm this trust and endanger the pubic. If Wythe gets what they want, the drug companies will be in a good position to start selling snake oil.