Ortho-McNeil-Janssen Pharmaceuticals, Inc. v. State

2014 Ark. 124, 432 S.W.3d 563, 2014 WL 1096040, 2014 Ark. LEXIS 188
CourtSupreme Court of Arkansas
DecidedMarch 20, 2014
DocketCV-12-1058
StatusPublished
Cited by21 cases

This text of 2014 Ark. 124 (Ortho-McNeil-Janssen Pharmaceuticals, Inc. v. State) is published on Counsel Stack Legal Research, covering Supreme Court of Arkansas primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Ortho-McNeil-Janssen Pharmaceuticals, Inc. v. State, 2014 Ark. 124, 432 S.W.3d 563, 2014 WL 1096040, 2014 Ark. LEXIS 188 (Ark. 2014).

Opinions

KAREN R. BAKER, Justice.

|,This appeal stems from litigation regarding Risperdal (risperidone). Risper-dal is a second-generation, or atypical, an-tipsychotic medication developed in 1993 by the appellants, Ortho-McNeil-Janssen Pharmaceuticals, Inc. f/k/a Janssen Phar-maceutica, Inc. and/or Janssen, LP, and Johnson & Johnson (“Janssen”). Risper-dal is considered to be highly beneficial in treating schizophrenia patients and allowing them to return to more productive lives.

Risperdal was approved by the Food and Drug Administration (“FDA”) and put on the market in 1994.1 The development of Risperdal and other second-generation antipsychotics was a tremendous breakthrough for this arena. The first-generation ^antipsychotics were riddled with side effects, including severe neuroleptic effects, similar to Parkinson’s disease. The State’s expert, psychiatrist Dr. William Wirshing, compared the introduction of Risperdal to the advent of the antibiotic penicillin in the 1950s and labeled Risper-dal as a “godsend.” Further, Wirshing testified that second-generation antipsy-chotics are among the most powerful disease modifiers in all of modern medicine and that psychiatrists felt it was a “miracle drug” because it did not have the serious side effects of first-generation antipsychot-ics.

In 2000, the FDA requested that all drug manufacturers of second-generation antipsychotics provide any information that the companies had regarding weight gain and diabetes associated with the anti-psychotics. Janssen responded in August 2000, but the FDA did not take action until September 2003. In September 2003, the FDA notified Janssen and all other drug manufacturers producing second-generation antipsychotics to add a class warning to their labels about diabetes. Janssen did not agree with the FDA’s assessment that all second-generation antipsychotics required the same warning and corresponded with the FDA regarding modification of its label. In addition to the class warning, the FDA required all second-generation antipsychotic-drug manufacturers to send a letter to all health-care providers nationwide (referred to in the pharmaceutical industry as a “Dear Doctor Letter” (“DDL”)) to advise of the label change.

On November 10, 2003, Janssen sent its DDL stating that the FDA had requested all manufacturers of second-generation an-tipsychotics, including Risperdal, to include a class-warning label regarding hyperglycemia and diabetes mellitus in their product labeling and to ^enclose updated prescribing information for Risperdal. The November 10, 2003 DDL included the diabetes class-warning label and additional statements regarding Risperdal. The DDL stated in pertinent part:

November 10, 2003
Dear Healthcare Provider,
The Food and Drug Administration (FDA) has requested all manufacturers of atypical antipsychotics to include a warning regarding hyperglycemia and diabetes mellitus in their product labeling. In addition to Janssen, the FDA made this request to the following manufacturers:
AstraZeneca — Seroquel® (quetiapine)
Bristol-Myers Squibb — Ability™ (aripi-prazole)
Eli Lilly and Company — Zyprexa® (olanzapine)
Novartis — Clozaril® (clozapine)
Pfizer — Geo don® (ziprasidone)
In an effort to keep you updated with the most current product information available for the management of your patients, enclosed please find updated prescribing information for RISPER-DAL®(risperidone).
Hyperglycemia-related adverse events have infrequently been reported in patients receiving RISPERDAL. Although confirmatory research is still needed, a body of evidence from published peer-reviewed epidemiology research suggests that RISPERDAL is not associated with an increased risk of diabetes when compared to untreated patients or patients treated with conventional anti-psychotics. Evidence also suggests that RISPERDAL is associated with a lower risk of diabetes than some other studied atypical antipsychotics.
For additional information about RIS-PERDAL or any other Janssen product, please call 1-800-JANSSEN (526-7736) from 9AM to 5PM EST, Monday through Friday.
Sincerely,
Ramy Mahmoud, MD
Vice President CNS Medical Affairs
Janssen Pharmaeeutica, Inc.

I/The DDL cited eight references in support of its position.

On April 19, 2004, in response to Jans-sen’s November 10, 2003 DDL, the FDA’s Division of Drug Marketing, Advertising and Communications (“DDMAC”) sent a “DDMAC Warning Letter” (hereinafter “Warning Letter”) to Janssen, directing Janssen to cease dissemination of any promotional materials contained in the information in the DDL and to also submit a plan of action to disseminate accurate and complete information. The “Warning Letter” stated in pertinent part:

WARNING LETTER
The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed a “Dear Healthcare Provider” (DHCP) Letter for Risper-dal®(risperidone) disseminated by Jans-sen Pharmaeeutica, Inc. on November 10, 2003. DDMAC has concluded that the DHCP letter is false or misleading in violation of Sections 502(a) and 201(n)of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. 352(a) and 321(n)), because it fails to disclose the addition of information relating to hyperglycemia and diabetes mellitus to the approved product labeling (PI), minimizes the risk of hyperglycemia-related adverse events, which in extreme cases is associated with serious adverse events including ketoacidosis, hyperosmolar coma, and death, fails to recommend regular glucose control monitoring to identify diabetes mellitus as soon as possible, and misleadingly claims that Ris-perdal is safer than other atypical anti-psychotics.

Athough Janssen disagreed with the DDMAC’s position and asserted that scientific evidence supported its 2003 DDL, Janssen followed the DDMAC’s directive and sent a corrective letter with information about Risperdal, relating to hyperglycemia and diabetes, to the recipients of its DDL letter.2 On July 21, 2004, Janssen sent a corrective letter to |5health-care providers. The corrective letter, titled “IMPORTANT CORRECTION OF DRUG INFORMATION,” stated in part as follows:

The Food and Drug Administration’s (FDA) Division of Drug, Marketing, Advertising, and Communications (DDMAC) has asked us to contact you because Janssen Pharmaeeutica Products, L.P. recently received a Warning Letter concerning the promotion of Ris-perdal ® (risperidone). This letter provides important corrective information about Risperdal relating to hyperglycemia and Diabetes Mellitus.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Bio Gen LLC v. Sarah Huckabee Sanders
142 F.4th 591 (Eighth Circuit, 2025)
HAYES v. NORTHEAST OKLAHOMA ELECTRIC COOPERATIVE
2022 OK CIV APP 20 (Court of Civil Appeals of Oklahoma, 2021)
Roderick Talley v. State of Arkansas
2020 Ark. App. 461 (Court of Appeals of Arkansas, 2020)
Schnarr v. State
561 S.W.3d 308 (Supreme Court of Arkansas, 2018)
Jefferson Cnty. Election Comm'n v. Wilkins ex rel. Jefferson Cnty.
547 S.W.3d 58 (Supreme Court of Arkansas, 2018)
Ark. Game & Fish Comm'n v. Gerard
541 S.W.3d 422 (Supreme Court of Arkansas, 2018)
Johnson v. State
538 S.W.3d 819 (Supreme Court of Arkansas, 2018)
Earls v. Arkansas Department of Human Services
2017 Ark. 171 (Supreme Court of Arkansas, 2017)
City of North Little Rock v. Pfeifer
2017 Ark. 113 (Supreme Court of Arkansas, 2017)
Pritchett v. Spicer
2017 Ark. 82 (Supreme Court of Arkansas, 2017)
Haile v. Johnston
2016 Ark. 52 (Supreme Court of Arkansas, 2016)
Ortho-McNeil-Janssen Pharm. Inc.2
2014 Ark. 126 (Supreme Court of Arkansas, 2014)
Ortho-McNeil-Janssen Pharmaceuticals, Inc. v. State
2014 Ark. 124 (Supreme Court of Arkansas, 2014)

Cite This Page — Counsel Stack

Bluebook (online)
2014 Ark. 124, 432 S.W.3d 563, 2014 WL 1096040, 2014 Ark. LEXIS 188, Counsel Stack Legal Research, https://law.counselstack.com/opinion/ortho-mcneil-janssen-pharmaceuticals-inc-v-state-ark-2014.