On Tuesday, the Supreme Court declined to review a California court’s decision that a plaintiff could sue generic drug companies on certain failure-to-warn claims. If you’ve been following the Supreme Court’s drug-labeling-preemption decisions over the last 5 or 6 years, you might find this news a little surprising at first glance. After all, as I explained in a blog post about a year ago, state failure-to-warn claims are generally preempted by federal law for generic drugs. But, once you dig into the facts of the California case – Teva Pharmaceuticals v. Superior Court – the outcome isn’t all that surprising, and it highlights some of the nuances of when state failure-to-warn-claims are, and are not, preempted in the generic drug context.

So what happened in this case?

Olga Pikerie, the plaintiff, took the generic drug alendronate sodium (brand name: Fosamax), which is indicated for the treatment and prevention of osteoporosis. It turns out that alendronate sodium is associated with a risk of atypical femur fractures, and, unfortunately, Ms. Pikerie suffered a femur fracture in April 2011, after taking the drug from 2006-2011.

After suffering the fracture, Ms. Pikerie sued the manufacturers of generic alendronate sodium on two grounds. The first is that they failed to update the generic drug labeling to match the brand name drug labeling. This distinguishes Ms. Pikerie’s claim from the failure-to-warn claims at issue in Pliva v. Mensing, in which the plaintiff argued that the generic labeling should have been updated independently of the brand name labeling. Because Ms. Pikerie’s claim is consistent with federal law – and the requirement that generic drug labeling be the “same” as the brand name drug’s labeling – the California court concluded that, unlike the claims at issue in Pliva, this claim is not preempted. And this conclusion is consistent with what many (although not all) other courts have said—the California court cites at least 8 other cases in which courts reached the same conclusion based on similar facts and claims.

Ms. Pikerie’s second argument is that the generic drug companies should have sent “Dear Doctor” letters to health care professionals to communicate the risk of femur fractures. The generic companies argued that they couldn’t have sent “Dear Doctor” letters, because the brand name company didn’t send such letters. But, again, the California court disagreed. It noted that the generic companies couldn’t have sent “Dear Doctor” letters that were inconsistent with the brand name drug’s labeling—but that’s not what Ms. Pikerie is saying the companies ought to have done. Her argument is that they should have sent letters that communicated the risk of femur fractures consistent with the warnings in the brand name drug labeling.

All of this is to say that I think the California court was correct to distinguish this case from Pliva v. Mensing. It seems right to conclude that Ms. Pikerie’s claims are not preempted by the Federal Food, Drug, and Cosmetic Act. But note that the California court is saying only that Ms. Pikerie’s claims aren’t preempted by federal law—not that she necessarily wins her lawsuit. And I think there’s any interesting policy question as to whether she should win, at least with respect to her first claim. The brand name labeling was updated in March of 2010, and January of 2011, to add information about the risk of femure fractures, and each time, the generic labeling was updated 6 weeks later. In other words, Ms. Pikerie’s claim was that the generic labeling wasn’t updated quickly enough. FDA doesn’t say precisely how quickly the generic drug’s labeling must be updated, just that it should be done “at the very earliest time possible.” But six weeks seems like a relatively timely update to the generic drug’s labeling, all things considered. At the very least, this isn’t the kind of egregious delay that has sometimes occurred—for example, in a similar case in the Sixth Circuit, a generic company failed to update its drug’s labeling to match the brand name drug for at least 3 years. So I will be interested to see what happens with this case, and what, if anything, the courts make of the 6-week “delay” between the brand name and generic labeling changes.