Ortho-McNeil-Janssen Pharmaceuticals, Inc. v. State
2014 Ark. 124
| Ark. | 2014Background
- Risperdal (risperidone) developed by Janssen; FDA approved Risperdal in 1994 and it was portrayed as a breakthrough among antipsychotics.
- In 2000, FDA requested data on weight gain and diabetes; in 2003 FDA required a class warning for diabetes and asked for a Dear Doctor Letter (DDL).
- Janssen issued the November 10, 2003 DDL with a diabetes hyperglycemia warning; FDA later issued a Warning Letter in April 2004 criticizing the DHCP letter as misleading.
- Janssen issued corrective letters in 2004 and the DDMAC closed the matter in October 2004; afterward, Arkansas filed suit in 2007 alleging MFFCA and DTPA violations based on labeling and the DDL, focusing on 238,874 prescriptions and 4,569 DDL distributions in Arkansas from 2002–2006.
- After a 12-day trial, the jury found Janssen liable under MFFCA and DTPA; penalties were imposed, prompting Janssen to appeal on multiple grounds.
- The Arkansas Supreme Court reversed and remanded in part: MFFCA claim dismissed; DTPA claim reversed and remanded for reconsideration.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| MFFCA liability interpretation under §20-77-902(8)(B). | Janssen contends the circuit court misread (A)-(B) and overbroadly applied §20-77-902(8)(B). | State argues (8)(B) covers information required by federal/state law and provider agreements. | Statute read as a single provision; MFFCA claim dismissed as Janssen not a healthcare facility under the act. |
| Admissibility of the DDMAC Warning Letter under Rule 803(8)(iv). | DTPA relies on the Warning Letter; argues it is admissible as a public-records item. | Letter should be admitted as part of an ongoing regulatory process or routine records. | Warning Letter excluded as inadmissible under Rule 803(8)(iv) due to being a special-investigation finding and highly prejudicial; DTPA remanded. |
| Impact of DDMAC actions on remaining DTPA claims. | (Not stated separately in ruling) | (Not stated separately in ruling) | Court remanded the DTPA claim; did not resolve further issues after partial reversal. |
Key Cases Cited
- McCorkle Farms, Inc. v. Thompson, 84 S.W.3d 884 (Ark. App. 2002) (admissibility under Rule 803(8)(iv) for state board reports; special investigations excluded)
- Archer-Daniels-Midland Co. v. Beadles Enterprises, Inc., 238 S.W.3d 79 (Ark. 2006) (FDA letters admissible as public records to prove regulatory actions)
- Omni Holding & Development Corp. v. 3D.SA., Inc., 156 S.W.3d 228 (Ark. 2004) (FAA inspection reports admissible as public records; routine vs. special investigations analyzed)