Dolin v. GlaxoSmithKline LLC
901 F.3d 803
7th Cir.2018Background
- Stewart Dolin (57) was prescribed Paxil (brand paroxetine) in 2010 but received a generic paroxetine from another manufacturer; six days later he committed suicide and paroxetine was in his system.
- GSK manufactured brand-name Paxil and controlled the FDA-approved label from 1992–2014; generic makers must mirror brand labeling under Hatch‑Waxman.
- In 2006 GSK added a paroxetine-specific warning (via CBE) about increased suicide attempts in adults, but the FDA in 2007 ordered a uniform SSRI class-wide warning limiting risk language to patients ≤24 and disallowing the paroxetine‑specific adult warning.
- GSK asked the FDA multiple times in 2007 to retain the paroxetine‑specific warning; the FDA rejected those attempts and required verbatim class-wide language.
- Dolin sued GSK in Illinois state court alleging negligent omission of an adult‑suicidality warning; case removed to federal court; jury returned a $3 million verdict for plaintiff.
- On appeal the Seventh Circuit held Dolin’s state‑law failure‑to‑warn claim is conflict‑preempted because GSK could not have lawfully added the adult‑suicidality warning (CBE) after the FDA’s 2007 rejection and had no qualifying newly acquired information after 2007.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether GSK could be held liable under Illinois law for failing to warn when the decedent took a generic made by another company | Dolin: The harm flowed from the allegedly incomplete brand label; only GSK could change the label, so GSK owes a duty despite the drug taken being generic | GSK: No duty to a patient who consumed a drug it did not manufacture; state law cannot impose label‑changing duties that federal law forbids | Court did not decide duty question (preemption dispositive) |
| Whether federal law (Supremacy Clause) preempts Dolin’s state‑law failure‑to‑warn claim | Dolin: GSK could have unilaterally added the warning via CBE or could have sought further FDA reconsideration | GSK: FDA affirmatively rejected the paroxetine‑specific adult warning in 2007; CBE was not available and no newly acquired information after 2007 justified a CBE | Held: Preempted — clear evidence FDA would have rejected the adult‑suicidality warning; GSK lacked newly acquired information after 2007 to invoke CBE; claim dismissed |
| Whether there was clear‑evidence that the FDA would have rejected the proposed label change (Levine standard) | Dolin: Rejection was limited or procedural; a meeting or different proposal placement might have succeeded | GSK: Multiple documented rejections and class‑wide ordering show clear evidence FDA would deny the change | Held: As a matter of law, FDA’s 2007 action and repeated denials are clear evidence of rejection; no reasonable jury could find otherwise |
| Whether GSK had newly acquired information after 2007 sufficient to invoke the CBE exception | Dolin: Additional analyses/publications show new data or re‑analyses linking paroxetine to adult suicidality | GSK: Data and re‑analyses relied on were already submitted or not new; plaintiff’s cited article rehashed 2006 analysis | Held: No newly acquired information after 2007 shown; CBE unavailable; preemption stands |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (2009) (state‑law failure‑to‑warn claims not preempted unless manufacturer shows clear evidence FDA would have rejected label change)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (federal law preempts state duties that generics cannot satisfy because they must match brand labeling)
- Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013) (design‑defect claims preempted where federal requirements made compliance with state law impossible)
- Mason v. SmithKline Beecham Corp., 596 F.3d 387 (7th Cir. 2010) (discussing Levine factors and FDA review history in Paxil context)
- Guilbeau v. Pfizer, Inc., 880 F.3d 304 (7th Cir. 2018) (preemption is a legal question for courts to decide)
- In re Celexa & Lexapro Mktg. & Sales Practices Litig., 779 F.3d 34 (1st Cir. 2015) (plaintiffs must allege label deficiency that could have been corrected via CBE)
- In re Fosamax Prod. Liab. Litig., 852 F.3d 268 (3d Cir. 2017) (discussion of factual vs. legal questions in Levine preemption analysis)