Ortho-Mcneil-Janssen Pharms., Inc. v. State
| Citation | 432 S.W.3d 563,2014 Ark. 124 |
| Decision Date | 24 April 2014 |
| Docket Number | No. CV–12–1058.,CV–12–1058. |
| Parties | ORTHO–McNEIL–JANSSEN PHARMACEUTICALS, INC. f/k/a Janssen Pharmaceutica, Inc., and/or Janssen, LP; and Johnson & Johnson, Inc., Appellants v. STATE of Arkansas, Appellee. |
| Court | Supreme Court of Arkansas |
OPINION TEXT STARTS HERE
O'Melveny & Myers, LLP, by: Charles C. Lifland (California), Stephen D. Brody and Walter Dellinger (Washington DC); Drinker Biddle & Reath LLP, by: Thomas F. Campion (New Jersey), Edward M. Posner, Gregg W. Mackuse (Pennsylvania); and Friday, Eldredge & Clark, LLP, by: James M. Simpson, Laura H. Smith, Robert S. Shafer, and Martin A. Kasten, for appellants.
Dustin McDaniel, Att'y Gen., by: Bradford J. Phelps, Chief Deputy Att'y Gen.; Kellogg, Huber, Hansen, Todd, Evans & Figel, PLLC, by: David C. Frederick, Derek T. Ho, and Caitlin S. Hall; and Bailey Perrin Bailey PLLC, by: Fletcher V. Trammell, Robert W. Cowan, Justin C. Jenson, and Elizabeth W. Dwyer, for appellee.
Mitchell, Williams, Selig, Gates & Woodyard, P.L.L.C., by: Sherry P. Bartley and Brian A. Pipkin, for amicus curiae Arkansas State Chamber of Commerce in support of appellants.
Richard A. Samp, Washington Legal Foundation; and Brett D. Watson, PLLC, by: Brett D. Watson, for amici curiae Washington Legal Foundation and Allied Educational Foundation in support of appellees.
Branch, Thompson, Warmath & Dale, P.A., by: Robert F. Thompson; and Michael J. Gottlieb, for amicus curiae 65 Arkansas Legislators in support of appellees.
Quattlebaum, Grooms, Tull & Burrow, PLLC, by: Steven W. Quattlebaum and E.B. Chiles, IV; and Arnold & Porter, LLP, by: Robert N. Weiner, Jeffrey L. Handwerker, and Sarah M. Harris, for amicus curiae Pharmaceutical Research and Manufacturers of America in support of appellants.
Hon. Alan Wilson, Att'y Gen., Robert Cook, Solicitor General, J. Emory Smith, Deputy Solicitor General, South Carolina; and Gordon Caruth & Virden, PLC, by: Edward Allen Gordon, for amici curiae states South Carolina, Alaska, Arizona, California, Colorado, Connecticut, Delaware, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, Nebraska, New Mexico, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Utah, Vermont, and Washington in support of appellees.
Massey & Gail, LLP, by: Jonathan S. Massey; and Health Law Associates, by: Charles R. Hicks, for amicus curiae former FDA Commissioner Dr. Donald Kennedy.
Scott L. Nelson and Allison M. Zieve, Public Citizen Litigation Group; Lavey & Burnett, by: John L. Burnett; and Annabelle Imber Tuck for amicus curiae Public Citizen, Inc., in support of appellee.
This appeal stems from litigation regarding Risperdal (risperidone). Risperdal is a second-generation, or atypical, antipsychotic medication developed in 1993 by the appellants, Ortho–McNeil–Janssen Pharmaceuticals, Inc. f/k/a Janssen Pharmaceutica, Inc. and/or Janssen, LP, and Johnson & Johnson (“Janssen”). Risperdal 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 Risperdal as a “godsend.” Further, Wirshing testified that second-generation antipsychotics 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 antipsychotics.
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 antipsychotics. 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 antipsychotics, 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:
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—AbilifyTM (aripiprazole)
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 RISPERDAL®(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 associatedwith an increased risk of diabetes when compared to untreated patients or patients treated with conventional antipsychotics. Evidence also suggests that RISPERDAL is associated with a lower risk of diabetes than some other studied atypical antipsychotics.
For additional information about RISPERDAL 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 Pharmaceutica, Inc.
The DDL cited eight references in support of its position.
On April 19, 2004, in response to Janssen'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 Risperdal® (risperidone) disseminated by Janssen Pharmaceutica, 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 Risperdal is safer than other atypical antipsychotics.
Although 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 health-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 Pharmaceutica Products, L.P. recently received a Warning Letter concerning the promotion of Risperdal ® (risperidone). This letter provides important corrective information about Risperdal relating to hyperglycemia and Diabetes Mellitus.
The Warning Letter concludes that Janssen disseminated a Risperdal Dear Health Care Provider (DHCP) dated November 10, 2003 that omitted material information about Risperdal, minimized potentially fatal risks, and made misleading claims suggesting superior safety to other atypical antipsychotics without adequate substantiation, in violation of the Federal Food, Drug and Cosmetic Act [“FDCA”].
Specifically, the Warning Letter stated that the DHCP letter omitted important information regarding hyperglycemia and diabetes, including the potential consequences and the recommendation of regular glucose control monitoring that was added to the approved product labeling for Risperdal; minimized the potentially fatal risks of hyperglycemia-related adverse events such as...
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