Marcus v. Forest Pharmaceuticals, Inc.
779 F.3d 34
| 1st Cir. | 2015Background
- Plaintiffs (the Marcuses) bought Lexapro for their adolescent son and allege the FDA‑approved label omitted material efficacy information, causing consumers to overestimate the drug's effectiveness. They sued under California consumer protection statutes (CLRA, FAL, UCL).
- Forest is the brand‑name manufacturer; Lexapro's sNDA for adolescent major depressive disorder was approved by the FDA in March 2009 on the basis of one positive Lexapro study plus extrapolation from a Celexa study; two other studies failed to show efficacy. The FDA expressly found the approved label "not false or misleading in any particular."
- Plaintiffs contend certain study results were manipulated or marginal, and they seek an injunction requiring Forest to stop marketing Lexapro with the current label and to seek a revised label from the FDA.
- Forest moved to dismiss asserting federal preemption under the FDCA (and alternatively California's safe‑harbor doctrine); the district court dismissed on safe‑harbor grounds. The First Circuit affirmed, holding plaintiffs' label‑content claims are impliedly preempted.
- The central legal question was whether Forest could have unilaterally altered its FDA‑approved label to satisfy the state‑law duty plaintiffs assert (i.e., whether the Changes Being Effected (CBE) process would have permitted the change). The court found the change plaintiffs sought was based on information known to the FDA at approval and thus not actionable via CBE.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether California consumer‑protection law can require Forest to change the FDA‑approved label | Marcus: state law can require disclosure of omitted efficacy information; label is misleading and should be corrected | Forest: state law cannot impose a duty that would force a change to an FDA‑approved label absent FDA approval; federal law preempts | Held: Preempted — plaintiffs seek a label change Forest could not make independently under federal law (CBE not available) |
| Whether Wyeth v. Levine allows state‑law claims here | Marcus: Wyeth permits state claims because brand manufacturers may use CBE to strengthen labels | Forest: Wyeth is inapposite because the requested change is not based on "newly acquired information" and thus CBE does not apply | Held: Wyeth does not save plaintiffs because CBE requires "newly acquired information," which plaintiffs do not plausibly allege |
| Whether PLIVA (Mensing) supports preemption | Marcus: PLIVA limited to generics; inapplicable to brand manufacturer | Forest: PLIVA principles on impossibility apply — state law cannot require a manufacturer to effect a label change federal law forbids | Held: PLIVA’s impossibility analysis controls: the relevant question is whether the manufacturer could independently do under federal law what state law requires; here it could not |
| Whether plaintiffs alleged "newly acquired information" to invoke CBE | Marcus: some post‑approval articles and re‑analyses support alleged deficiencies | Forest: the articles do not present new data revealing different risks/effectiveness; core complaints concern information FDA already knew | Held: Plaintiffs did not plausibly allege newly acquired information; the label change they seek would require prior FDA approval and is therefore preempted |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (brand manufacturer may in some cases use CBE to add warnings without prior FDA approval)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (state‑law requirements that would force a manufacturer to change an FDA‑mandated label are preempted when the manufacturer cannot unilaterally comply)
- Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (impossibility preemption; a party is not required to stop selling to avoid conflict between state and federal law)
- Cel‑Tech Commc'ns, Inc. v. Los Angeles Cellular Tel. Co., 20 Cal. 4th 163 (framework for California "safe harbor" doctrine under UCL)