Sidney Hillman Health Center of Rochester v. Abbott Laboratories & AbbVie Inc.

192 F. Supp. 3d 963, 2016 U.S. Dist. LEXIS 84662, 2016 WL 3538808
CourtDistrict Court, N.D. Illinois
DecidedJune 29, 2016
DocketNo. 13 C 5865
StatusPublished
Cited by7 cases

This text of 192 F. Supp. 3d 963 (Sidney Hillman Health Center of Rochester v. Abbott Laboratories & AbbVie Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Sidney Hillman Health Center of Rochester v. Abbott Laboratories & AbbVie Inc., 192 F. Supp. 3d 963, 2016 U.S. Dist. LEXIS 84662, 2016 WL 3538808 (N.D. Ill. 2016).

Opinion

OPINION AND ORDER

SARA L. ELLIS, United States District Judge

Sidney Hillman Health Center of Rochester (“Hillman”) and Teamsters Health Services and Insurance Plan Local 404 (“Local 404,” and collectively with Hillman, the “Funds”) are multi-employer benefit plans and health services funds that provide health benefits, including prescription drug coverage, to their members. The Funds seek to represent a nationwide class of such third-party purchasers or third-party payors (“TPPs”) who from 1998 to 2012 reimbursed and paid all or some of the purchase price for Depakote, a drug developed and initially marketed by Abbott Laboratories and later by AbbVie, Inc. (collectively, “Abbott”), for indications not approved' by the Food and Drug Administration (the “FDA”).1 The Funds also seek to represent subclasses of TPPs in New York and Massachusetts. The Funds bring claims for violation of the Racketeer Influenced and Corrupt Organizations Act (“RICO”), 18 U.S.C. § 1962(c), conspiracy to violate RICO, 18 U.S.C. § 1962(d), violation of the New York deceptive business practices act, N.Y. Gen. Bus. Law § 349, and unjust enrichment under New York and Massachusetts law.2 Abbott has moved to dismiss the amended class action complaint. Because the Funds have not adequately alleged proximate cause under RICO, the Court dismisses the RICO claims. With the dismissal of the federal claims, the Court declines to address the state law claims, deferring consideration of Abbott’s arguments on these issues until thé Funds have adequately alleged a basis for the Court’s subject matter jurisdiction.

BACKGROUND3

Since 1983, the FDA has approved De-pakote (divalproex sodium), which is sold and marketed by Abbott, for the treatment of epileptic seizures, acute manic or mixed [965]*965episodes associated with bipolar disorder, certain absence seizures for adults and children over ten years old, and adult migraine prevention and prophylaxis. The FDA has not approved Depakote for the treatment of dementia, including agitation associated with dementia, bipolar depression, schizophrenia, attention deficit hyperactivity disorder (“ADHD”), narcotic drug withdrawal, or any other uses.

Nonetheless, Abbott has marketed De-pakote for such unapproved “off-label” uses. To do so, it has used intermediary marketing firms, allegedly independent entities, paid physician spokespeople, as well as its own internal sales divisions. These efforts resulted in dramatically increased sales of Depakote, reaching $1.5 billion in 2007.

Abbott established and controlled three enterprises to promote off-label Depakote uses. First is what the Funds have termed the “CENE Enterprisé,” comprised of Abbott, associated physicians, the Council for Excellence in Neuroscience Education (“CENE”), and ACCESS Medical Group (“ACCESS”). CENE—a purportedly independent continuing education medical group with undisclosed ties to Abbott— disseminated materials and sponsored we-binars and meetings on off-label Depakote uses. CENE ■ also. retained “faculty” and “council” physician members to promote Depakote for off-label uses. ACCESS aided CENE by creating continuing education materials, including slide show presentations for use by doctors in Abbott’s speakers’ bureau. The second—the so-called “PharmaCare Enterprise”—included Abbott, its sales representatives, and PharmaCare Strategies,' Inc. (“Pharma-Care Strategies”), a market development firm that trained Abbott employees to successfully promote Depakote for off-label uses. PharmaCare Strategies conducted its training off-site rather than at Abbott’s headquarters. The third enterprise, the “ABcomm Enterprise,” tunneled kickbacks to physicians to increase Depakote prescriptions. The ABcomm Enterprise included physicians and other medical professionals, Abbott, and ABcomm, Inc: (“ABcomm"), a medical continuing education provider that created training materials and provided live activities. Abbott controlled and participated in each of these enterprises with the goal of increasing the amount of off-label Depakote prescriptions purchased by the TPPs.

Through these three enterprises, Abbott sponsored dinners and other programs where a physician would speak on off-label Depakote uses. Abbott directly or indirectly compensated the speaker, also paying for the meals of those physicians attending the dinners. Abbott funded physicians’ studies of Depakote, which served as a backdoor way of increasing Depakote prescriptions. Abbott also funded the development of clinical practice guidelines for De-pakote that mandated its use as a first-line of defense for dementia and long-term agitation and sundown syndrome in patients suffering from dementia. The guidelines did not disclose Abbott’s financial support, instead purporting to be independent. Similarly, Abbott issued supplements to medical journals disguised as peer-written articles free from' pharmaceutical manufacturer influence that promoted Depakote’s use for off-label indications.

In addition to working with these outside entities and physicians to promote off-label uses of Depakote, Abbott also had internal mechanisms in place to drive such sales. This included providing incentive packages to sales representatives based on their success in marketing Depakote. Abbott promoted standardized messaging among its sales representatives, providing them with scripts on how to sell physicians on prescribing Depakote for off-label uses. Abbott then had monthly contests for each [966]*966district sales area, rewarding sales representatives for their delivery of the scripted messages. To optimize its targets, Abbott accessed and analyzed prescription data from Health Market Science, Inc. Abbott encouraged its sales representatives to discuss the lower cost of Depakote and its higher likelihood of reimbursement when compared to other medications such .as Lamictal, an anticonvulsant used for maintenance treatment of bipolar I disorder (for which Depakote is not indicated). Abbott also instructed sales representatives to encourage physicians to use rapid loading or increased doses of Depakote in them patients, despite warning labels and other dosing instructions. Abbott blurred the lines between bipolar mania and agitation associated with dementia to make its sales appear legitimate, used data that did not relate directly to Depakote, and promoted Depakote directly to patients and caregivers at support group meetings. But because Abbott wanted to conceal its off-label marketing, it instructed its sales representatives not to place their call.notes— i.e., their summaries of sales calls with physicians—concerning off-label uses of Depakote into its computer system and instructed them to indicate discussions of ,on-label diagnoses instead.

Abbott marketed Depakote for off-label uses despite having no reliable evidence of its safety or efficacy for the .treatment of these off-label conditions and, in some cases, having evidence that it was actually ineffective or unsafe for those conditions. For example, a study suspended in March 1999 for safety reasons “failed to show that Depakote was effective in treating the signs and symptoms of mania in elderly dementia patients.” Doe. '92 ¶ 60.

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Cite This Page — Counsel Stack

Bluebook (online)
192 F. Supp. 3d 963, 2016 U.S. Dist. LEXIS 84662, 2016 WL 3538808, Counsel Stack Legal Research, https://law.counselstack.com/opinion/sidney-hillman-health-center-of-rochester-v-abbott-laboratories-abbvie-ilnd-2016.