Schedin v. Ortho-McNeil-Janssen Pharmaceuticals, Inc.
2012 U.S. App. LEXIS 24640
8th Cir.2012Background
- Schedin, elderly, prescribed Levaquin with a corticosteroid in 2005, suffered Achilles tendon ruptures.
- Levaquin’s 2001 warning stated tendon risks, especially with corticosteroids in the elderly; FDA later made this language mandatory in 2004.
- OMJP’s package insert, PDR presence, and communications to physicians formed the warning framework.
- Dr. Beecher, the prescriber, did not read the 2001 warning; OMJP failed to personally convey it.
- OMJP’s communications included limited direct warnings from sales reps and lack of Dear Doctor letters; a 2008 FDA letter criticized Levaquin labeling.
- Jury found OMJP primarily liable for compensatory damages and punitive damages were awarded; district court denied JMOL/new trial, appellate review follows.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Was OMJP’s communication of the 2001 warning to the physician adequate? | Schedin argues warnings to Beecher were insufficient to inform him of the 2001 risk. | OMJP contends the warning was adequately conveyed via the package insert and PDR; altering delivery did not create liability. | No JMOL/new trial required; jury could find inadequate communication under the circumstances. |
| Did causation support recovery given learned intermediary doctrine? | Schedin must show the warning would have changed Beecher’s prescribing decision. | OMJP argues Beecher’s prescribing decisions were not shown to be influenced by the warnings. | Causation present; evidence supported that proper warning could have changed prescribing. |
| Should punitive damages survive under Minnesota law? | OMJP deliberately disregarded safety by downplaying tendon risks and manipulating information. | Warning efforts and published warnings showed a lack of deliberate disregard. | The district court erred in denying JMOL on punitive damages; punitive damages reversed. |
| Was the 2008 FDA warning letter properly admitted? | The letter admissible for corroboration; possible pre-injury knowledge supported by the record. |
Key Cases Cited
- Mulder v. Parke Davis & Co., 181 N.W.2d 882 (Minn. 1970) (learned intermediary doctrine and duty to warn physicians)
- Erickson ex rel. Bunker v. American Honda Motor Co., 455 N.W.2d 74 (Minn. Ct. App. 1990) (establishes causation framework in failure-to-warn contexts)
- Sterling Drug, Inc. v. Yarrow, 408 F.2d 978 (8th Cir. 1969) (duty to warn requires full communication of dangers)
- Balder v. Haley, 399 N.W.2d 77 (Minn. 1987) (duty to warn and standards for culpability)
- J. W. Enters., Inc. v. Economy Sales, Inc., 486 N.W.2d 179 (Minn. Ct. App. 1992) (warnings read and heeded; reading not necessary to bar recovery)
- Thomlison v. City of Omaha, 63 F.3d 786 (8th Cir. 1995) (harmless error standard for JMOL on some claims)