United States v. Infomedics, Inc.

847 F. Supp. 2d 256, 2012 WL 826889, 2012 U.S. Dist. LEXIS 32300
CourtDistrict Court, D. Massachusetts
DecidedMarch 12, 2012
DocketCivil Action No. 08-11775-NMG
StatusPublished
Cited by2 cases

This text of 847 F. Supp. 2d 256 (United States v. Infomedics, Inc.) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States v. Infomedics, Inc., 847 F. Supp. 2d 256, 2012 WL 826889, 2012 U.S. Dist. LEXIS 32300 (D. Mass. 2012).

Opinion

MEMORANDUM & ORDER

GORTON, District Judge.

Arlene Tessitore (“Relator”) brings this qui tarn action on behalf of the United States, 22 individual states and the District of Columbia against defendants Infomedics, Inc. (“Infomedics”), Glaxosmithkline PLC and Glaxosmithkline LLC (together, “GSK”) under the federal False Claims Act (“FCA”), 31 U.S.C. § 3729(a)(1), (a)(2) and (a)(3), and various state FCAs.

The suit arises from the defendants’ marketing of the drug paroxetine hydrochloride, sold in the United States under the trade names Paxil and Paxil CR (“Paxil”). Before the Court are two motions to dismiss: one of GSK and one of Infomedics.

I. Background

GSK is one of the world’s largest pharmaceutical manufacturers. Among its arsenal of prescription drug products is Paxil, an antidepressant used to treat several depression and anxiety-related disorders. In the late-1990s, GSK hired Infomedics, a pharmaceutical marketing company, to assist in the marketing and promoting of Paxil. Relator, a former employee of Infomedics between late 1999 and early 2002, was involved in those marketing efforts.

Paxil was first approved by the United States Food and Drug Administration (“FDA”) in 1992 for treatment of Major Depressive Disorder and has subsequently been FDA-approved as treatment for several other indications. Most germane to the instant action, Paxil was approved by the FDA as treatment for Social Anxiety Disorder (“SAD”) in May, 1999. Paxil was the first drug to be approved for such treatment.

Prior to obtaining FDA approval, GSK allegedly launched The Initiative for Social Anxiety Assessment and Care Program (“ISAAC program”). The ISAAC program purported to be a study into social phobias but Relator contends it was, in fact, a marketing mechanism to encourage physicians, through monetary incentives, to prescribe Paxil as treatment for SAD. GSK hired Infomedics to administer the ISAAC program and serve as a general intermediary with consumers.

Relator contends that, pursuant to the ISAAC program, GSK hosted a series of continuing education classes for physicians in which Paxil was promoted as treatment for SAD and attending physicians were provided with GSK-devised diagnostic [259]*259tools. The physicians would subsequently use those diagnostic tools to screen their patients for social anxiety symptoms. Physicians would then instruct any positively screened patients to participate in the study of social phobias by calling a toll-free number and answering symptom-related questions. For each patient who called to complete the survey, physicians “received compensation” paid by GSK, although Relator does not specify the nature of that compensation.

According to the complaint, the ISAAC program dispensed with the continuing education classes after the FDA approved Paxil as treatment for SAD, and GSK sales representatives began directly recruiting physicians. Thereafter, for each patient who completed the telephonic survey, physicians were paid $100, with a maximum of up to $1,000 per physician. The Relator estimates that 1) 1,500 physicians participated in ISAAC (because it was GSK’s “goal” to enroll that number), 2) more than 12,000 patients participated in the program and 3) the ISAAC program generated $150 million in increased Paxil sales for GSK.

Also after obtaining FDA approval, GSK allegedly advertised Paxil as treatment for SAD on television and in print. Included within the advertisements were “800" telephone numbers (“Paxil 800 numbers”) for consumers to call and request more information about Paxil. Relator contends that the Paxil 800 numbers included automated promotional statements about Paxil, provided SAD screening tests for consumers to self-diagnose and allowed consumers to leave their contacts in order to receive labeling information, but did not, contrary to recommended industry practice, provide consumers with an alternate phone number or method to report adverse experiences associated with their Paxil use.

According to the complaint, Infomedics hosted the Paxil 800 numbers and received the calls from consumers. A voice message left by a consumer seeking further information was recorded into a database and later transcribed by InfoMedics call center operators. That database generated mailing labels that Infomedics used to send callers Paxil brochures and drug inserts.

Relator states that she acted as a Call Center Supervisor and Business Analyst for the Paxil Marketing Program between late 1999 and early 2002. She alleges that, during that period of time, consumers would leave messages reporting serious adverse experiences with Paxil, including, but not limited to, birth defects and suicidal behavior. Because certain calls were shocking and disturbing, call center representatives would often play the messages on speaker phone for other call center representatives to hear.

Nonetheless, the call center representatives were allegedly instructed by their supervisors at Infomedics not to transcribe or forward the adverse event calls to GSK. When Relator herself twice asked supervisors, once verbally and once by e-mail, whether the serious adverse event calls should be transcribed and reported to GSK, she was informed that they should not be and that GSK did not want to receive any such reports.

Relator states that the Paxil 8Ó0 numbers generated over 100,000 calls into the InfoMedics call center. She further estimates that 7,000 of those calls reported adverse events. Her latter estimate is based upon a statistic from the Consumer Healthcare Product Association that, on average, 7% of calls received into a company’s 800 number relate to adverse drug reactions. Relator contends that Infomedics never transcribed or forwarded those adverse events to GSK and that, in turn, [260]*260the adverse events were never reported to the FDA.

According to Relator, the concealment of adverse events was not limited to Paxil’s marketing for SAD but also occurred with respect to other Paxil marketing campaigns administered by Infomedics. Specifically, she states that she was an analyst of Infomedics’ “Brand Accelerator Program” which allegedly allowed Infomedics’ clients to use positive feedback from patient surveys while intentionally avoiding the collection and reporting of adverse events. GSK launched a Paxil Brand Accelerator program in mid-2002, after Relator had left Infomedics. Relator states, “upon information and belief’, that the Paxil Brand Accelerator program prohibited the reporting and recording of adverse events.

Eventually, Relator contends, the FDA required GSK to include warnings regarding a risk of suicidal ideation and. birth defects associated with Paxil. Specifically, she states that in June, 2003, the FDA issued a public safety alert regarding a possible link between Paxil use and increased suicidal ideation in children and adolescents. After confirming the risk, the FDA purportedly required GSK to place a black box safety warning on its Paxil label and then, in 2006, to amend that label to include young adults. Meanwhile, Relator states, in December, 2005, the FDA released a public health advisory reporting that it was increasing Paxil’s “pregnancy category risk profile”.

Relator’s qui tam

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Related

United States ex rel. Garcia v. Novartis AG
91 F. Supp. 3d 87 (D. Massachusetts, 2015)
United States v. Merck & Co.
44 F. Supp. 3d 581 (E.D. Pennsylvania, 2014)

Cite This Page — Counsel Stack

Bluebook (online)
847 F. Supp. 2d 256, 2012 WL 826889, 2012 U.S. Dist. LEXIS 32300, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-v-infomedics-inc-mad-2012.