234 F.Supp.3d 873
W.D. Ky.2017Background
- Plaintiff Estate of Jerry DeMoss (and Cynthia DeMoss) sued Eli Lilly after Mr. DeMoss died of a massive cerebral hemorrhage following use of the prescription antiplatelet drug Effient (prasugrel). DeMoss took Effient beginning April 2014 and died July 19, 2014.
- Effient was FDA‑approved in 2009 based on TRITON‑TIMI 38 clinical trial data showing greater ischemic protection than clopidogrel (Plavix) but a significantly increased risk of bleeding, including fatal bleeding.
- Plaintiffs allege Lilly promoted Effient without adequately disclosing the heightened bleeding risk, the absence of any reversal agent, and suppressed safety concerns (including removal of an FDA panelist who questioned safety).
- Plaintiffs asserted claims for strict products liability (design, manufacturing, failure to warn), negligence (design, manufacturing, failure to warn), breach of implied warranty, negligent misrepresentation, Kentucky Consumer Protection Act (KCPA) violations, and loss of consortium.
- Lilly moved to dismiss under Fed. R. Civ. P. 8(a), 9(b), and 12(b)(6), arguing deficient pleading and legal defenses (including Comment k / prescription drug exception and lack of privity for warranty/KCPA claims).
- The court denied dismissal of strict liability and negligence claims based on design defect and failure to warn, dismissed manufacturing‑defect, negligent‑manufacture, breach of implied warranty, negligent misrepresentation, and KCPA claims without prejudice, and preserved loss of consortium.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Strict‑liability design defect (Comment k) | Effient’s design was unreasonably dangerous because it caused higher bleeding risk and lacked a reversal agent; DeMoss died from that risk. | FDA approval and public benefit trigger Comment k protection, insulating Lilly from design defect liability. | Denied dismissal — court declines to apply Comment k at pleading stage because the inquiry is fact‑dependent and Plaintiffs pleaded facts sufficient to state a plausible design defect claim. |
| Strict‑liability manufacturing defect | Effient was defectively manufactured and thus unreasonably dangerous. | Plaintiffs plead only boilerplate; no specific manufacturing defect or deviation from specs alleged. | Granted dismissal without prejudice — complaint lacks factual allegations identifying a manufacturing defect. |
| Failure to warn (strict liability & negligence) | Lilly failed to warn prescribing physicians/DeMoss about known or knowable life‑threatening bleeding risks and lack of reversal, and inadequate testing made warnings insufficient. | Arguments that allegations are conclusory/insufficient under Iqbal/Twombly. | Denied dismissal — allegations that warnings were inadequate and caused DeMoss’s death are sufficient at this stage. |
| Negligent misrepresentation | Promotional materials misrepresented Effient’s safety/benefit profile to DeMoss and clinicians. | Either not an appropriate theory for product advertising or not pleaded with required specificity under Rule 9(b). | Dismissed without prejudice — Kentucky requires an affirmative false statement and heightened specificity; plaintiffs allege omissions rather than affirmative misrepresentations. |
| Breach of implied warranty / KCPA | Lilly made direct representations in labeling/marketing that created express warranties and so privity exception applies. | No privity; DeMoss did not purchase drug from Lilly; implied warranty and KCPA require privity absent a valid express warranty to the consumer. | Dismissed without prejudice — complaint fails to plead privity or qualifying express warranties for the privity exception. |
Key Cases Cited
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (pleading must state a plausible claim and more than conclusory statements)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (plausibility pleading standard for complaints)
- Prather v. Abbott Labs., 960 F. Supp. 2d 700 (W.D. Ky. 2013) (application of Restatement comment k and prescription‑drug products‑liability principles)
- Bosch v. Bayer Healthcare Pharms., Inc., 13 F. Supp. 3d 730 (W.D. Ky. 2014) (discussion of strict liability, negligence, and privity in pharmaceutical cases)
- Giddings & Lewis, Inc. v. Industrial Risk Insurers, 348 S.W.3d 729 (Ky. 2011) (Kentucky recognition of negligent‑misrepresentation theory in product sale context; need for affirmative misstatement)