A new lawsuit was filed in our favorite Judicial Hellhole, Madison County, Illinois, alleging that a pharmaceutical company failed to warn that African-Americans face an elevated risk of certain dermatological side-effects from Tegretol. At this point it’s merely a complaint. Anyone with a word processor and a check can file one, especially in Madison County.

The racial-ethnic issue is already built into Tegretol’s label, which explicitly warns that Asians possess certain genes that might make them more susceptible to certain dermatological side effects. Apparently, plaintiffs believe that the science shows that African-Americans also face heightened risks from Tegretol, that the company knew it, and that the company should have added a warning regarding African-Americans to the labels. Interestingly, the label currently says specifically that the problematic gene “is largely absent in individuals not of Asian origin (e.g., Caucasians, African-Americans, Hispanics, and Native Americans).” Given that language, this case might be ripe for the sort of preemption defense that survives Wyeth v. Levine.

Even putting preemption aside, there is a question of how much increased risk would warrant a warning. Doubling? Shouldn’t some rigor be present? Racial-ethnic categories are blunt instruments for getting at what seems to be the real issue reported in the labels, genetic susceptibility. It’s been said for a while that the pharmaceutical business is evolving from broad-based drugs to narrowly targeted medicines that match people with a defined genetic profile. Perhaps variations of a drug will be developed for specific genes. If products will be designed for people with certain genetics, there will be warnings and contraindications for people with certain genes. Tegretol is just one example. There are other drugs that warn about side effects for people with certain genes. Similarly, the Plavix label warns of diminished effectiveness in “poor metabolizers.” Of course, such warnings are helpful only if patients or their doctors know whether the patients have the genes in question. That means genetic testing and that isn’t cheap. And it’s probably not covered by insurance.

The other side of the coin is that some drugs will be effective only or especially for certain groups. For those drugs, we might see targeted DTC advertising, and such advertising will itself become the target of plaintiff lawyers. There have been several product liability cases where plaintiffs have sought to introduce a defendant’s internal marketing documents to prove that the company targeted subgroups based on gender, age, socioeconomic, or racial-ethnic segmentation. Such an allegation is, in a sense, almost always true. Sane marketing requires some degree of segmentation and targeting. The department store magnate John Wanamaker once said that half of the dollars he spent on advertising were wasted — he just didn’t know which half. Companies conduct a lot of market research to figure out where and how to spend their advertising dollars. Marketing documents typically talk about spending “against” certain groups. It can sound vaguely aggressive, even militaristic.

In one tobacco case, the plaintiff lawyer argued in his opening statement that tobacco companies “divided the races” (true – to the extent that some marketing documents contained standard market segment analyses), and argued in his closing that cigarettes should no more be legal than separate drinking fountains for whites and African-Americans. This oratory was perplexing, because there wasn’t even an allegation that racial targeting had anything to do with why any of the plaintiffs used the product. The allusion to civil rights issues was meant to provoke jury anger, even to the point of jury nullification. (How do we know this? The same plaintiff lawyer had made exactly the same closing argument in a different case several years before and then wrote a book about it, explaining his aims.)

For race to show up on a label — or in a complaint — how good a proxy should race have to be for genes? A pair of bioethicists recently wrote that “[m]edicine should not be color blind, but it also should not be too quick to use race as a proxy for genes. Government has a strong interest in approving the use of race only when it is supported by robust scientific studies, not simply minimal ones.” The science is evolving. Actually, it’s exploding. What we think today is very different from what we thought just five years ago, and what we think today will probably seem wrong-headed five years from now. In the meantime, the popular culture (including your average juror) is fascinated by genetics. This week’s Sports Illustrated has an article on genetics and sports, and it left us hopelessly confused by the whole nature vs nurture thing. (We suspect nature and nurture conspired to ensure that the authors of this blog will always be slow, weak, and uncoordinated.) Ever hear of epigenetics? Did you know Lamarck (he of the giraffes-got-long-necks-because-they-kept-stretching for food theory) is making a comeback? Geneticist Francis Collins says that we can go a little too far in attributing diseases to genes: “associations often made between race and disease only occasionally have anything to do with DNA [and] most diseases are not single-locus genetic diseases and often are quite complex, involving many genetic loci as well as environmental factors.”

As Judge Posner said (in a quote we wheel out at the drop of a hat) “law lags science; it does not lead it.” Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319 (7th Cir. 1996). Before judges permit plaintiffs to argue for heightened warnings regarding race, ethnicity, or genetics, the science had better be well-laid out, fully satisfying Daubert, Frye, or whatever standard applies. Plaintiffs should be required to make a clear case for what the warning should say exactly, and should be required to provide testimony from prescribers that that exact warning would have changed their prescribing decision. If plaintiffs want to talk about ethnic marketing, they must first show that the prescriber was materially influenced by such marketing.

As it stands, we cannot predict what will happen with the Tegretol complaint. We cannot say whether it will survive Twombly-Iqbal, Daubert, or Learned Intermediary. And in terms of the larger issue of what will happen with labels and litigation for future drugs with future genetic dimensions, we can predict even less. Except that we can predict that plaintiffs will be aggressive and much will depend on the extent to which courts act as gatekeepers.