United States District Court, D. Massachusetts
In re: CELEXA AND LEXAPRO MARKETING AND SALES PRACTICES LITIGATION.
Forest Pharmaceuticals, Inc. and Forest Laboratories, Inc., Civil Action No. 10-10154-NMG. THIS DOCUMENT RELATES TO: Scott A. Wilcox
MEMORANDUM & ORDER
NATHANIEL M. GORTON, District Judge.
This case arises out of the marketing and sales of the anti-depressant drug Celexa by defendants Forest Laboratories, Inc. and Forest Pharmaceuticals, Inc. ("defendants" or, collectively, "Forest"). Plaintiff Scott Wilcox ("plaintiff" or "Wilcox") alleges that defendants violated the California Unfair Competition Law ("UCL"), Cal. Bus. & Prof. Code §§ 17200-17209, and the California False Advertising Law ("FAL"), Cal. Bus. & Prof. Code §§ 17500-17509, by making "fraudulent, false, unlawful and misleading representations that [Celexa] was safe and effective for minor children." Plaintiff alleges that such misrepresentations were material to the decision of a physician to prescribe Celexa to plaintiff's minor son. He also alleges that he was personally deceived by such representations.
A. Celexa and Lexapro
Celexa and Lexapro are closely-related selective serotonin reuptake inhibitor ("SSRI") antidepressants. Forest obtained the approval of the federal Food and Drug Administration ("FDA") to market Celexa (citalopram) for adult use in 1998. It has been available in generic form in the United States since 2004. The FDA approved the marketing of Lexapro (escitalopram) for adult use in the United States in 2002.
By law, prescription drugs must be distributed with an FDA-approved label which includes information about the drug's approved uses. See 21 C.F.R. §§ 201.15, 201.50-58. In 1998, the FDA-approved label for Celexa stated that "Safety and effectiveness in pediatric patients has not been established."
In 2001, the results of two double-blind, placebo-controlled pediatric efficacy studies of Celexa were disseminated to high level executives of Forest. "Celexa Study 18", which was sponsored by Forest, produced positive results supporting the conclusion that Celexa was more effective than a placebo in treating depression in children and adolescents, whereas the "Lundbeck Study" produced negative results that did not support that conclusion.
Forest submitted the results of the two Celexa studies to the FDA in 2002 as part of its application for approval to market Celexa for the treatment of pediatric depression. The FDA denied the application on the basis that Forest had only submitted one positive study of efficacy in the pediatric population when at least two were required. The FDA informed Forest that it would consider a subsequent positive study of Lexapro sufficient to support marketing both Celexa and Lexapro for pediatric use.
In June, 2004, Forest issued a press release announcing the results of the negative Lundbeck study. The FDA thereafter changed its requirements for labeling of antidepressants and ordered manufacturers to add information about pediatric efficacy studies to the labels of their drugs. The revised label for Celexa, which was approved by the FDA in February, 2005, stated that
Safety and effectiveness in the pediatric population have not been established.... Two placebo-controlled trials in 407 pediatric patients with MDD have been conducted with Celexa, and the data were not sufficient to support a claim for use in pediatric patients. Anyone considering the use of Celexa in a child or adolescent must balance the potential risks with the clinical need.
In 2009, the FDA approved the marketing of Lexapro to treat depression in adolescent patients aged 12 to 17 years. The FDA based its approval on the positive Celexa Study 18 and a positive study on the use of Lexapro to treat adolescent depression. Forest never applied for FDA approval to market Celexa for pediatric use.
B. Use of Celexa and Citalopram by Plaintiff's Minor Son
Wilcox's son, Robert "Woody" Wilcox ("Woody") was first prescribed Celexa in July, 2003 when he was twelve years old. Woody took, and Wilcox paid for, Celexa for six years before he switched to generic citalopram in 2009.
Woody was initially prescribed Celexa by Dr. David Ritvo ("Dr. Ritvo"). Dr. Ritvo had been practicing for about 25 years at the time. He is board-certified in psychiatry and has a sub-specialty in child and adolescent psychology. About 40% of his patients at a given time were children or adolescents and he prescribed Celexa to hundreds of children.
Dr. Ritvo testified that he assessed Woody prior to prescribing Celexa in 2003 and determined that he had symptoms of obsessive-compulsive disorder ("OCD"), attention deficit disorder ("ADD"), depression and anxiety. He initially prescribed Celexa because it was his understanding at the time that Celexa was less likely than other SSRIs to cause gastro-intestinal side effects. He testified that he did not know if he knew at the time whether Celexa had been approved by the FDA for pediatric use.
Dr. Ritvo reported that Woody's mood appeared to improve after starting on Celexa but Dr. Ritvo nevertheless decided to stop prescribing Celexa and to prescribe Zoloft, a different SSRI, in the fall of 2003 to see if it would do more to address Woody's OCD symptoms. However, Dr. Ritvo stopped prescribing Zoloft and resumed prescribing Celexa based upon his conclusion that Celexa was more effective in treating Woody's various symptoms. He testified that, at the very least, he found Celexa effective in treating Woody's depression and anxiety. In 2004, he decided to switch Woody to generic citalopram in order to save plaintiff money.
Dr. Ritvo stopped treating Woody in March, 2006 and Woody's pediatrician, Dr. Arthur Law ("Dr. Law"), continued to prescribe citalopram. Dr. Law's treatment notes indicate that he prescribed citalopram for Woody at the request of Wilcox.
In August, 2007, Woody began treatment with Dr. Michael Schwab ("Dr. Schwab"), who had been practicing psychiatry for 34 years. Dr. Schwab continued to prescribe citalopram for Woody until he ceased to treat him in March, 2009, when Woody was 18 years old. He testified that he continued to prescribe Celexa because it was "effective" and because Woody was experiencing very few symptoms of the conditions for which it was prescribed.
Plaintiff retained Dr. Peter Breggin to review and opine upon the records of Woody's treatment with Celexa by Dr. Ritvo. Dr. Breggin is a licensed psychiatrist who has practiced in the field since 1968 and has published several articles on the adverse effects of SSRIs, including Celexa. He concluded that Celexa was not effective based upon the fact that Dr. Ritvo increased the dose numerous times and suggested a possible link between Woody's violent nightmares and symptoms of mania or bipolar disorder and his treatment with Celexa.
Wilcox testified in his deposition that Woody's anxiety and depression improved somewhat while he was taking Celexa and citalopram under the care of Dr. Ritvo. He testified that Celexa was not effective in treating Woody's symptoms of OCD, however, and that the symptoms of depression and anxiety continued under Dr. Schwab. Wilcox attributes any improvements to the cognitive therapy that Woody received from a different physician during that period. He does not recall, however, whether he told either Dr. Schwab or Dr. Ritvo that they needed to try something else because Celexa wasn't working. He also acknowledged that he relied entirely upon the doctors to determine whether any improvement was attributable to Celexa or citalopram.
All told, Wilcox purchased Celexa for Woody between July, 2003 and November, 2004 and spent $660.88 in insurance co-payments. He bought generic citalopram between November, 2004 and June, 2010 and spent $831.34 in insurance co-payments.
C. Exposure of Woody's Treating Physicians to Alleged Misrepresentations
Dr. Ritvo received a sales call from a representative of Forest in June, 2000. The notes from the call mention that Dr. Ritvo "specialized in children" and that the caller "went thru entire celexa pres (sic)." On the following day, Forest sent a letter that said
Thank you for your recent inquiry regarding Celexa off-label uses including treatment of obsessivecompulsive disorder (OCD) and use in the pediatric population.... The safety and effectiveness of Celexa in the treatment of depressed children and adolescents have not been established in controlled clinical trials. Systematic studies in this population are currently in progress.... There are a number of published reports describing the use of citalopram to treat patients between 6 and 17 years of age with psychiatric conditions other than depression [including OCD and panic disorder].
In August, 2000, Dr. Ritvo went to a "dine-and-dash" sponsored by Forest at which Celexa was discussed.
According to the notes of sales representatives of Forest, Dr. Schwab was also invited to the dine-and-dash in August, 2000 and to a major league baseball game in October, 2000. In 2011, a sales representative reported that Dr. Schwab thought that a Celexa-related program at the Mandarin Hotel was "awesome" and that ...