Schedin v. Ortho-McNeil-Janssen Pharmaceuticals, Inc.
808 F. Supp. 2d 1125
D. Minnesota2011Background
- Schedin sustained bilateral Achilles tendon ruptures after eight days on Levaquin, leading to a failure-to-warn claim against Ortho-McNeil.
- Label warnings existed since 1997 with a 2001 update for elderly patients and concurrent corticosteroid use.
- Beecher, Schedin’s prescribing physician, read an older label but did not read the 2001 update before prescribing; he later changed prescribing habits.
- Jury awarded Schedin compensatory $700,000 and punitive $1,115,000 on the failure-to-warn claim; consumer fraud claim favored Ortho-McNeil.
- Ortho-McNeil sought a new trial and JMOL arguing weight of evidence and evidentiary/closing-argument errors; Mensing-based preemption was invoked.
- Court held brand-name Wyeth/Mensing framework applies; denied new trial and JMOL on pre-emption and evidentiary grounds.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Pre-emption framework governs failure-to-warn claims | Schedin argues Wyeth/Mensing control; brand-name not pre-empted. | Ortho-McNeil urges Mensing impossibility pre-emption for brand-name under pre-2007 regime. | Brand-name Wyeth framework applies; pre-emption not established. |
| Whether verdict on failure-to-warn is against the weight of the evidence | Evidence supports inadequate warning and causation. | Jury's verdict not against the weight of the evidence. | No miscarriage of justice; verdict sustained. |
| Whether evidentiary rulings required a new trial | Admission of post-2005 labeling, foreign regulatory action, and AERs prejudiced trial. | Rulings were proper and properly limited. | No reversible error; no new trial warranted. |
| Whether punitive damages were properly supported | Evidence showed deliberate disregard and allowed damages as a consequence of liability. | Punitive damages improper given underlying issues. | Punitive damages upheld; not clearly improper. |
| Whether pre-emption bars data about comparative toxicity | Comparative toxicity data should have been in label. | Label changes precluded by regulations. | Pre-emption not satisfied; no JMOL. |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (U.S. 2009) (brand-name pre-emption framework; heightened duty to warn)
- Mensing v. Pliva, 131 S. Ct. 2567 (U.S. 2011) (impossibility pre-emption for generic drugs; distinct for brand-name)
- Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (U.S. 2001) (fraud-on-the-FDA pre-emption framework)
- Campbell v. State Farm Mut. Auto. Ins. Co., 538 U.S. 408 (U.S. 2003) (punitive damages evidence and passion/prejudice limits)
- Crosby v. Nat. Foreign Trade Council, 530 U.S. 363 (U.S. 2000) (implied pre-emption framework and federal-state balance)