514 F.Supp.3d 418
D. Conn.2021Background
- Infant Tylea Hundley was born at ~26 weeks, spent 48 days in the NICU, and died of necrotizing enterocolitis (NEC) after being fed formulas at Yale New Haven Hospital that contained cow milk.
- Plaintiff (administrator of estate) sued Mead Johnson and Abbott under the Connecticut Product Liability Act (CPLA) alleging: failure to warn, strict design-defect (cow-milk ingredient), misrepresentation, and breach of warranty.
- Defendants moved to dismiss, arguing (inter alia) state-law claims are preempted by the Infant Formula Act (IFA), warnings obligations depend on the learned intermediary doctrine, and many claims lack plausible or particularized allegations.
- Court permitted limited discovery and certified (or will seek to certify) the key question whether the learned intermediary doctrine applies to these infant-formula warnings to the Connecticut Supreme Court; related dismissal motions denied without prejudice pending that certification.
- Court held (1) design-defect claim based on cow-milk ingredient survives dismissal (preemption is a close question requiring factual development); (2) failure-to-warn analysis deferred pending learned-intermediary certification; (3) misrepresentation and express/implied warranty claims dismissed for inadequate specificity and lack of pleaded reliance, despite leave to amend.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether learned intermediary doctrine applies to warnings for infant formula (who must be warned: physicians or parents) | Ferry: doctrine does not apply; defendants owed parents direct warnings about NEC risk | Defendants: doctrine applies; duty runs to treating physicians, not parents | Court: important unsettled question under Conn. law — will certify to CT Supreme Court; related dismissal denied without prejudice and limited discovery ordered |
| Whether state-law design-defect claim (cow-milk ingredient) is preempted by federal IFA (impossibility preemption) | Ferry: IFA requires notification, not pre-approval; manufacturers could comply with state law; no impossibility | Defendants: substituting cow milk is a "major change" requiring FDA notification/processing; cannot unilaterally reformulate so state law is preempted | Court: preemption is a close question; cannot resolve on Rule 12(b)(6) without factual development (market practice, whether change is a "major change," FDA process) — dismissal denied |
| Whether plaintiff plausibly pleaded design defect and causation (cow-milk caused NEC/death) | Ferry: cites studies showing human milk protective and bovine milk increases NEC risk; alleges temporal link and increased risk | Defendants: prematurity itself is predominant NEC risk; short exposures and other factors undermine causation | Court: pleaded facts and cited literature suffice at pleading stage to state plausible design-defect claim and plausible causation |
| Whether misrepresentation and breach-of-warranty claims are adequately pleaded (specificity, reliance, notice) | Ferry: defendants marketed formulas as safe/beneficial for premature infants; identifies website/materials to support warranties/misrepresentations | Defendants: allegations are vague, lack particularized false statements, scienter, or that parents/doctors relied; no notice for implied-warranty claim | Court: misrepresentation and express/implied-warranty claims dismissed for failure to plead with Rule 9(b) particularity or to allege reliance/notice; plaintiff granted leave to amend but existing submissions did not cure pleading defects |
Key Cases Cited
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (establishes pleading plausibility standard)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (complaint must state a plausible claim)
- Mut. Pharm. Co. v. Bartlett, 570 U.S. 472 (2013) (impossibility preemption can bar state-law claims when federal law forbids the conduct state law would require)
- Wyeth v. Levine, 555 U.S. 555 (2009) (preemption analysis: no preemption where manufacturer could have strengthened label under FDA regime)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (generic drug-label claims preempted where federal law barred unilateral label changes)
- Bifolck v. Philip Morris, 324 Conn. 402 (2016) (CPLA elements and consumer-expectation vs. risk-utility design-defect tests)
- Vitanza v. Upjohn Co., 257 Conn. 365 (2001) (learned intermediary doctrine applied to pharmaceuticals and similar medical products)
- Yates v. Ortho-McNeil-Janssen Pharm., Inc., 808 F.3d 281 (6th Cir. 2015) (framework for analyzing impossibility preemption post-Levine)
- Marentette v. Abbott Labs., Inc., 886 F.3d 112 (2d Cir. 2018) (distinguishing regulatory schemes when assessing preemption)