13 F. Supp. 3d 730
W.D. Ky.2014Background
- Plaintiffs (Vanden Bosch, Hogue, Rice) sue Bayer over alleged injuries from the Mirena IUD (levonorgestrel): interstitial cystitis (Vanden Bosch) and birth defects in Rice (mother Hogue used Mirena). Plaintiffs assert negligence, strict liability (design/manufacture/failure to warn), warranty, fraud, consumer-protection, and punitive damages claims.
- Procedural posture: Bayer moved to dismiss under Fed. R. Civ. P. 12(b)(6) and to strike portions of the complaint under Rule 12(f). Kentucky substantive law applied.
- Key factual allegations: Vanden Bosch alleged immediate urinary symptoms after insertion and removal within 11 days; Hogue alleged pregnancy while using Mirena leading to Rice’s chromosomal abnormality; plaintiffs allege Bayer misrepresented safety through brochures/ads and omitted risks.
- Statute-of-limitations issue: Kentucky has a one-year limitations period for products-liability claims; Indiana’s period is two years. Court applied Kentucky law and borrowing statute analysis, concluding Kentucky’s one-year period controls where applicable.
- The court dismissed many claims for failure to plead facts (design/manufacture/manufacturing-defect/failure-to-test as independent claim) or for lack of cognizable injury (Hogue’s tort claims based on pregnancy), but left several claims to proceed for specified plaintiffs.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Statute of limitations for Vanden Bosch’s products-liability claims | Borrow Kentucky’s statute to Indiana (or apply Indiana two-year) because insertion may have occurred in Indiana | Kentucky one-year period applies; Vanden Bosch’s injuries and device insertion alleged in Kentucky; suit is time-barred | Dismissed: Vanden Bosch’s products-liability claims time-barred under Kentucky one-year rule |
| Cognizable injury for Hogue (pregnancy while using Mirena) | Pregnancy and attendant burdens (medical visits, stress, child’s defects) constitute legally cognizable injury | Kentucky law forecloses recovery where the asserted injury is birth of a child or pregnancy-related—wrongful birth/ conception claims limited; child’s life not cognizable injury | Dismissed: Hogue’s tort claims (negligence, strict liability, fraud) for lack of legally cognizable injury |
| Adequacy of pleading for design/manufacture/manufacturing-defect claims (Rice) | Complaint alleges Mirena is defective in design/manufacture and lists harms and regulatory violations; enough to survive | Allegations are formulaic legal conclusions lacking specific factual allegations about how product or plaintiffs’ devices were defective | Dismissed: Rice’s design and manufacturing defect and negligent design/manufacture theories (but negligence related to marketing/distribution remains) |
| Fraud-based claims and failure-to-warn/failure-to-test | Fraud/omission claims grounded in brochures/ads and omissions around time of insertion; failure-to-test recognized under KY Product Liability Act | Fraud allegations lack particularity; KY does not recognize independent failure-to-test claim (should be subsumed by failure-to-warn) | Fraud claims (misrepresentation, concealment, deceit) survive for Vanden Bosch and Rice (pleaded with sufficient particularity); failure-to-test as independent claim dismissed and subsumed into failure-to-warn |
| Breach of warranty and consumer protection claims (privity) | Express warranties via ads/pamphlets intended for consumers create exception to privity; thus express warranty and KCPA claims viable | Warranty and KCPA generally require buyer-seller privity; plaintiffs did not purchase directly from Bayer | Express warranty claim (seventh) and KCPA claim (twelfth) survive based on alleged express warranties to consumers; implied warranty and other warranty-based nonconforming representation claim dismissed for lack of privity or redundancy |
| Punitive damages pleaded as standalone cause of action | Plaintiffs sought punitive damages | Punitive damages are a remedy, not an independent cause of action | Moot/Withdrawn: Plaintiffs withdrew standalone punitive-damages count; court treated motion as denied as moot |
| Motion to strike "Federal Requirements" allegations | Allegations of multiple federal violations are vague and immaterial and should be stricken | Allegations bear on duty, breach, and defect and are relevant to claims | Denied: court refused to strike the section; allegations remain |
Key Cases Cited
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (pleading standard requires factual content permitting reasonable inference of liability)
- Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) (complaint must state plausible claim beyond labels and conclusions)
- Grubbs ex rel. Grubbs v. Barbourville Family Health Ctr., P.S.C., 120 S.W.3d 682 (Ky. 2003) (parents cannot recover for a legally cognizable injury based solely on birth of a child with congenital defects in wrongful-birth/wrongful-conception context)
- Radcliff Homes, Inc. v. Jackson, 766 S.W.2d 63 (Ky. Ct. App. 1989) (elements required for strict products liability under Kentucky law)
- Schork v. Huber, 648 S.W.2d 861 (Ky. 1983) (wrongful birth/conception claims are a matter for the legislature)
- United Parcel Service Co. v. Rickert, 996 S.W.2d 464 (Ky. 1999) (fraud elements require proof of injury and reliance)
