“The Hill” today ran an article on June 15, titled “Trial lawyers’ win on suit provision threatens FDA bill.” The article discusses a provision added to several discussion drafts of an unidentified FDA bill (presumably Prescription Drug User Fee Act [PDUFA] reauthorization) before the House Energy & Commerce Committee. The provision would state:

“Nothing in this act or the amendments made by this act may be construed as having any legal effect on any cause of action for damages under the law of any state (including statutes, regulations, and common law)”

The overall thrust of the Hill article is that this is a change in the law and in current practice. In fact, whether state court lawsuits alleging that prescription drugs or medical devices are dangerous and defective are preempted by the Food Drug and Cosmetics Act (FDCA) is an issue on which courts are currently very divided. The pendulum has swung a bit towards preemption in the wake of the FDA’s issuing a preamble to its new rule on drug labelling in 2006. (see page 38 for the Preamble).

In a nutshell, the FDA declared its opinion that such state court lawsuits are preempted. The FDA has been making such arguments for several years, more or less since the Bush administration took office, mostly by intervening and filing briefs in individual state court lawsuits. This marked a change in FDA policy, and was apparently initiated by former FDA general counsel Daniel Troy, now a partner at Sidley Austin, a law firm that represents drug and device companies.

Public Citizen release an excellent analysis of why the FDA’s Preamble is wrong, both as a matter of law and as a matter of policy.

The Hill’s article momentarily appears to admit that this is not a change in the law, but a clarification:

“Democrats are not trying to roll back federal preemption, the committee spokeswoman said. “We are not attempting to change the status quo on preemption,” she said. Instead, the Democrats want to forestall the expansion of federal preemption into new areas of drug and device law.

But by attributing this to Democrats only, the article refuses to analyze whether in fact federal preemption is a recent change in how courts address these cases, or whether it is the norm which “the Democrats” and “trial lawyers” are now trying to change. It is true that there has been a greater trend towards courts finding preemption — but there has also been a countertrend of courts refusing to find such cases preempted. (e.g. Kelly v. Wyeth, and Perry v. Novartis)

And then the article goes on to say:

“The pharmaceutical and device makers contend that the change in the law could grant state courts the authority to override FDA decisions about the safety and efficacy of their products or about warnings on the products’ labels.” [emphasis added]

By characterizing this as a “change in the law,” rather than saying, for example “pharmaceutical and device makers contend that this is a change in the law,” the article seems to accept the premise that it is in fact a change in the law.

But, the semantics of the article aside, the ‘trend’ towards federal preemption comes amidst justifiable skepticism about whether the FDA is adequately protecting unsafe drugs. This concern has been renewed in recent weeks as the heart attack risks of the diabetes drug Avandia have come to light.

Some of the worst risks and dangers of prescription drugs only come to light years after the drug has been approved. The FDA has shown itself unwilling to do enough to take dangerous drugs off the market. Recall that Vioxx was withdrawn voluntarily by Merck, not because of any FDA order. With the FDA proving itself unwilling to even force drug companies to complete the post-approval studies that they often promise to do, can we rely on the FDA to police drugs once they are on the market?

It is this very question that has led to the numerous bills in Congress to strengthen the FDA’s ongoing oversight of drugs, such as by separating the functions and divisions within FDA that approve new drugs and that police drugs already on the market. But in the absence of adequate ongoing oversight by the FDA, lawsuits play a vital role — in bringing the dangerousness of drugs to light, in forcing manufacturers to revise the labelling of their drugs or even take them off the market, and in compensating people who’ve been injured by dangerous drugs. The FDA’s and the pharmaceutical industry’s arguments that the FDA preempts these cases amounts to a “do-nothing” system — the FDA won’t do anything, and the Courts can’t do anything.

A recent article in the Journal of the American Medical Association addressed the role that litigation plays in highlighting safety issues: “The Role of Litigation in Defining Drug Risks, Aaron S. Kesselheim, MD, JD; Jerry Avorn, MD, JAMA. 2007;297:308-311.”

Whenever the climate in Congress and the Administration shifts towards a refusal to regulate corporate behavior, states begin to step in to fill the gap and protect public health and safety. Preemption is being pushed by big business and its allies in Congress and the Administration to undermine these efforts, not just in prescription drugs and medical devices, but in food safety, banking and financial services, privacy and countless other arenas.