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A bad idea: implied preemption of state law requirements for drug labels

Should drug manufacturers, assuming they meet all the labeling requirements imposed by the FDA, be subject to liability for failing to meet more extensive or different labeling requirments imposed by the states?

This article in the NEJM ($), criticizing the FDA's new labeling regulations, buries its most important paragraph deep in the middle of the piece:

The most troubling aspect of the FDA's new plan, however, has nothing to do with providing information to prescribers. In an unusual move after the end of a five-year period of comments on the initial rule, the agency used the passage of the new labeling regulations to quietly add a new section to its preamble that will make it extremely difficult for anyone to bring legal action against a drug manufacturer for harm caused by one of its products.

Whether you find this troubling or not will depend on what you think about the trustworthiness of the FDA and drug manufacturers, the appropriateness of private lawsuits in areas subject to extensive government regulation, and the relative role of state and federal law.

For years, the pharmaceutical industry had sought to pass legislation that would prohibit litigation over adverse effects as long as the medication was approved by the FDA; Congress has consistently rejected this idea. But after the comment period for the new labeling regulation had closed, language was added to the final rule stating that any FDA-approved label, "whether it be in the old or new format, preempts . . . decisions of a court of law for purposes of product liability litigation."

Drug manufacturers would love for Congress to explicitly preempt state laws governing drug labeling, but so far, Congress has chosen not to do so. There's nothing that explicitly prevents states from passing drug labeling laws that impose more extensive requirements on drug manufacturers than imposed by the FDA under the federal Food, Drug, and Cosmetic Act.

Usually when an industry wants federal preemption of state laws, but can't convince the Congress to go along, the industry relies on the doctrine of implied preemption to argue that courts should refuse to enforce state laws anyway. Their argument is that when Congress legislates extensively about a given subject, it has implicitly exercised its power to preempt state law. State legislation on the same subject, even if it doesn't actually conflict with federal requirements, would alter the federal regulatory regime in ways that Congress would never have intended.

This doctrine leaves the preemption decision to the courts. But federal agencies do influence the final decisions about implied preemption, and that's why this new language from the FDA is important. When courts are presented with the argument that federal law implicitly preempts state law, they will often grant some deference to the interpretation of that federal law by the agencies charged with implementing it. For example, if the FDA interprets the Food, Drug, and Cosmetic Act to preempt state labeling requirements, it's more likely that a court will find that state law is preempted. That's why this part of the article is misleading:

Beginning at the end of this month, the new regulations would preempt nearly all action by patients in state courts against drug manufacturers for unanticipated injuries resulting from the use of their products. This immunity would apply even if a company failed to warn prescribers or patients adequately about a known risk, unless a patient could prove that the company intentionally committed fraud — a very hard test to meet.

The FDA's opinion about preemption isn't itself legally binding, but it does make it more likely that the courts will go along with drug manufacturers' preemption arguments.

Is any of this a good thing? There's a strong case to be made that in the absence of any state law to the contrary, a state jury shouldn't be able to hold a drug manufacturer liable for a "failure to warn" in a case where the manufacturer complied with FDA labeling requirements. The FDA does rely on clinical trial data to determine what warnings are appropriate. Its judgments shouldn't be routinely discarded by lay juries.

However, things are different when a state passes a specific law requiring warnings in addition to those imposed by the FDA. Contrary to what the FDA suggests, a drug's "safety" isn't something objectively inherent in the drug, and that can be objectively determined in scientific studies. Does a 1 in 5 chance of constipation make a drug unsafe? A 1 in 300 chance of a heart attack? Although the statistical likelihood of adverse side effects can be objectively measured, the safety of a drug is in the eye of the beholder. There's no reason why the FDA's decision that some risks are insignificant enough to be left off a warning label should prevent states from requiring that these risks be disclosed anyway. At least, not until the Congress decides to explicitly preempt state laws that require this additional disclosure.

The FDA argues that "State-law attempts to impose additional warnings can lead to labeling that does not accurately portray a product’s risks, thereby potentially discouraging safe and effective use of approved products or encouraging inappropriate use and undermining the objectives of the act." But this just amounts to an assertion that what's "appropriate," "safe," and "effective" is exclusively a matter for the FDA to decide -- and Congress hasn't explicitly given it this authority.

Implied preemption arguments should be approached skeptically, especially in cases where Congress has considered and declined to exercise its power to expressly preempt state law. The FDA's arguments for preemption should be treated even more skeptically, since they essentially restate the position of the drug manufacturers that has not succeeded in Congress.

The new regulations are here: www.fda.gov/OHRMS/DOCKETS/98fr/06-545.pdf.

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