Bioethics Blogs

The Nuances of Preemption in the Generic Drug Context

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.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.