We did a short post on December 14, 2006, noting Professor Richard Nagareda’s new article, “FDA Preemption: When Tort Law Meets the Administrative State,” in the first issue of the new Journal of Tort Law. We agree with some parts, and disagree with others, of the article. But here’s a suggestion implicit in the article that practitioners might want to consider.

Nagareda notes that some prescription drugs are approved by the FDA and never again the subject of public FDA activity; the FDA, for example, never convenes an Advisory Panel to consider some aspect of the drug’s safety. Other drugs — Nagareda uses SSRI antidepressants as an example — are both approved and then later the subject of public activity and pronouncements by the FDA. In the case of SSRI antidepressants, the FDA repeatedly convened Advisory Panels during the 1990s, and filed amicus curiae briefs since 2000, all concluding that this class of antidepressants did not cause adult patients to develop suicidal thinking or behavior.

Compare two hypothetical lawsuits: One involves a drug that was approved in 1990, and never again considered publicly by the FDA. The plaintiff claims to have ingested the drug and been injured in 2000, and pleads that the manufacturer should have warned of a certain risk associated with use of the drug.

The second case involves a drug that was approved in 1990, and the FDA
repeatedly thereafter — up through, say, 2005 — publicly stated that the
manufacturer should not warn of a certain risk. Again, the plaintiff claims to have ingested the drug and been injured in 2000, pleading that the manufacturer should have given the warning that the FDA repeatedly considered and rejected in public.

Given what we do for a living, it’s no surprise that we think the manufacturer should win in both of those situations. Whether or not the FDA is convening Advisory Panels and filing amicus briefs, the Agency is always privately evaluating data about risks and deciding what warnings are appropriate, and society is surely better served by having an expert agency assess risks and mandate warnings than having juries — after-the-fact, and in cases involving injured plaintiffs — make those decisions.

But Nagareda suggests that the second hypothetical case may be stronger than the first. When the FDA has publicly expressly considered and rejected a request to give a certain warning as of the year 2000, judges might more easily find that the manufacturer was forbidden to give that warning (and thus rule in favor of preemption).

If that’s true, it has two implications. First, drug companies should try to
create preemption precedents in cases that resemble the second hypothetical — where the FDA has repeatedly, and publicly, considered and rejected warnings proposed after the time the drug was originally approved. After establishing those “easier” precedents, manufacturers should move on to what Nagareda implicitly views as the harder cases — drug approval followed by public silence. (The cases Nagareda expressly identifies may not be his only preferred cases for manufacturers. We can imagine cases, for example, where a manufacturer privately asked the FDA to allow a specific warning, and the FDA forbade giving the warning. Nagareda might view that case, too, as a particularly attractive candidate for finding preemption.)

Second, if Nagareda’s right, then industry has lucked out. By sheer
coincidence, the drug preemption cases that are currently closest to appellate resolution — Colacicco and McNellis in the Third Circuit — involve SSRI antidepressants and thus present, according to Nagareda, the more compelling case for preemption.

Time will tell.