Dolin v. SmithKline Beecham Corp.
2014 U.S. Dist. LEXIS 26219
N.D. Ill.2014Background
- Dolin sues GSK and Mylan in a wrongful death action; GSK moves for summary judgment and Mylan seeks dismissal.
- Mr. Dolin was prescribed Paxil (paroxetine) but ingested a generic paroxetine made by Mylan; paroxetine positive in autopsy.
- The complaint alleges akathisia from SSRIs contributed to suicide; the label at the time did not warn about adult suicidality.
- GSK allegedly knew of increased adult suicidality risk and concealed or mishandled data; Mylan allegedly knew and continued selling generic without informing the medical community.
- Hatch-Waxman Act governs generic approvals, allowing design/warning label control by the brand manufacturer; this creates tension with Illinois tort law.
- Plaintiff asserts various common-law negligence, negligent misrepresentation, and product liability theories against both defendants; GSK seeks to avoid liability since it did not manufacture the ingested pill, while Mylan seeks federal preemption.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether GSK owed a duty to Dolin despite not manufacturing the ingested pill. | Dolin argues GSK’s design/warning duty applies to all paroxetine users. | GSK contends no duty to Dolin since he did not ingest Paxil. | GSK owed a duty based on design/warning responsibilities; duty found. |
| Whether Dolin’s claims are properly framed as common-law negligence or products liability. | Claims can be grounded in negligence with product-related elements. | Arguments framed as product liability are inappropriate since GSK didn’t manufacture the pill. | Claims survive as common-law negligence/negligent misrepresentation; not defeated as product liability. |
| Whether the negligent misrepresentation claim requires intent to induce and reliance via learned intermediaries. | Misrepresentations were intended to be relied upon by physicians and patients. | Intention to induce Dolin is lacking; reliance via learned intermediaries is insufficient. | Claim viable; intent and reliance via learned intermediaries supported. |
| Whether strict product liability attaches given Hatch-Waxman separation of design/warning from manufacturing. | Brand design/warning can be considered the product causing injury; strict liability may apply. | Hatch-Waxman prohibits extending strict liability to cover injuries from generics; policy reasons. | GSK’s strict liability claim dismissed; cannot hold brand manufacturer strictly liable for injuries from generics. |
| Whether Mylan’s warnings/design updates are preempted by federal law, and whether Dear Doctor letters could defeat preemption. | Mylan should be liable for updated warnings absent labeling changes. | Bartlett/Mensing preclude such claims; Dear Doctor letters would be labeling changes and are preempted. | Mylan preemption issues resolved in favor of preemption; Dear Doctor letter theory rejected. |
Key Cases Cited
- Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S.Ct. 2466 (U.S. 2013) (preemption governs warnings when generic cannot change label)
- Pliva, Inc. v. Mensing, 131 S.Ct. 2567 (U.S. 2011) (generic labeling preemption for warnings)
- Wyeth, Inc. v. Levine, 555 U.S. 555 (U.S. 2009) (name-brand labeling decisions not preempted)
- Foster v. American Home Products Corp., 29 F.3d 165 (4th Cir. 1994) (no duty to consumers of another manufacturer’s product)
- Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir. 2011) (duty issues in brand vs. generic context)
- Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009) (preemption on design-defect claims for generic warnings)
- Bartlett (Mutual Pharmaceutical Co., Inc. v. Bartlett), 133 S. Ct. 2466 (U.S. 2013) (central preemption holding for generic drugs)
- Calles v. Scripto-Tokai Corp., 224 Ill.2d 247 (2007) (negligence product liability framework in Illinois)