Rodney Guilbeau v. Pfizer Inc.
880 F.3d 304
7th Cir.2018Background
- Depo-Testosterone (Depo-T) is an FDA-approved testosterone injection; its ANDA was approved in 1979 and it later became the reference listed drug (RLD) for its product class.
- Plaintiffs in MDL 2545 allege failure-to-warn claims under state law, claiming Depo-T increased cardiovascular risk and that manufacturers failed to add adequate warnings to the label.
- The district court dismissed failure-to-warn claims against ANDA-approved products (including Depo-T) as preempted under federal law, finding ANDA holders cannot unilaterally use the FDA’s changes-being-effected (CBE) regulation to add warnings.
- Plaintiffs argued Depo-T’s RLD status (and its pre-1984 approval history) permits unilateral CBE changes because an RLD must match only itself, so Mensing should not apply.
- The Seventh Circuit affirmed: Mensing’s rule (CBE unavailable to ANDA holders) controls regardless of RLD status or Depo-T’s unusual approval timeline; discovery requests about historical FDA communications were also properly denied.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether ANDA holders that are RLDs may unilaterally add or strengthen warnings using the CBE regulation | Depo-T (plaintiffs): RLD status means Pfizer need only match itself, so it can use CBE to add warnings; Mensing should not bar an RLD-ANDA holder, especially one approved pre-1984 | Pfizer (defendants): Mensing controls; ANDA status, not RLD status, determines access to CBE — no ANDA holder may unilaterally add warnings | Court: Mensing applies; no ANDA holder (including RLD ANDAs like Depo-T) may use CBE to add/strengthen warnings; state failure-to-warn claims are preempted |
| Whether plaintiffs were entitled to further discovery into FDA–manufacturer communications about Depo-T labeling | Plaintiffs: Historical FDA correspondence may show the FDA allowed CBE uses or an authoritative interpretation that defeats preemption | Defendants: Historical letters don’t show FDA-authoritative legal interpretation permitting CBE for WARNINGS; FOIA and public record suffice | Court: No abuse of discretion in denying further discovery; plaintiffs lacked a plausible source showing FDA had adopted an authoritative pre-Mensing position enabling CBE use for warning additions |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (brand-name NDA-holder could use CBE to add warnings; no preemption)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (ANDA holders cannot unilaterally use CBE to add warnings; state-law failure-to-warn claims preempted)
- In re Darvocet, Darvon, & Propoxyphene Prods. Liab. Litig., 756 F.3d 917 (6th Cir. 2014) (RLD status does not alter ANDA-holder obligations; Mensing applied)
- Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013) (discussion of state-law liability distinct from federal labeling duties)
- Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013) (clarifying Mensing’s preemption framework)