Medical Mutual v. Abbvie Inc.

159 F. Supp. 3d 898
CourtDistrict Court, N.D. Illinois
DecidedFebruary 5, 2016
DocketNo. 14 C 1748; MDL No. 2545; No. 14 C 8857
StatusPublished
Cited by10 cases

This text of 159 F. Supp. 3d 898 (Medical Mutual v. 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
Medical Mutual v. Abbvie Inc., 159 F. Supp. 3d 898 (N.D. Ill. 2016).

Opinion

[902]*902MEMORANDUM OPINION AND ORDER (CORRECTED)

MATTHEW F. KENNELLY, District Judge:

Defendants in this MDL proceeding are manufacturers, sellers, and promoters of testosterone replacement therapy drugs (TRTs). Nearly all of the plaintiffs have brought lawsuits claiming personal injuries they claim were caused by TRTs. The Court has already ruled on a motion to dismiss many of those personal injury claims. See In re Testosterone Replacement Therapy Products Liab. Litig. (“In Re TRT”), No. 14 C 1748, 2014 WL 7365872 (N.D.Ill. Dec. 23, 2014) (denying motions to dismiss as to personal injury fraud, misrepresentation, and failure-to-warn claims).

In the case now before the Court, plaintiff Medical Mutual of Ohio (MMO), an Ohio mutual insurance company, purports to represent a class of third-party payors (TPPs) who allege that they suffered economic injuries when — as the result of defendants’ fraudulent marketing schemes— they made reimbursement payments for medically inappropriate TRT prescriptions. In its complaint, MMO sorts the twenty-three named defendants into seven separate groups: (1) Solvay S.A., Solvay America, Inc., Solvay Pharmaceuticals, Inc., Un-imed Pharmaceuticals, LLC, Besins Inc., Besins Healthcare, S.A., Abbott Products, Inc., AbbVie Inc., and Abbott Laboratories (collectively, AbbVie or AbbVie defendants); (2) Auxilium Pharmaceuticals, Inc. (Auxilium); (3) GlaxoSmithKline LLC (GSK); (4) Oscient Pharmaceuticals Corp. (Oscient); (5) Eli Lilly and Company, Lilly USA, Inc., Aerux Commercial Pty Ltd., Acrux DDS Pty Ltd. (collectively, Lilly or Lilly defendants); (6) Actavis pic, Actavis Pharma, Inc., Actavis, Inc., Watson Pharmaceuticals, Inc., Watson Laboratories, Inc., Anda, Inc. (collectively, Actavis or [903]*903Aetavis defendants); and (7) Endo Pharmaceuticals, Inc. (Endo).

MMO alleges that defendants participated in a fraudulent marketing scheme that mischaracterized TRT drugs as a safe and effective treatment for various “off label” conditions. As a result, MMO and other TPPs allegedly paid for numerous off-label TRT prescriptions that were unnecessary and unsafe for their insureds and for which they would have never paid but for defendants’ fraudulent scheme. In its complaint, MMO asserts claims for mail and wire fraud in violation of the federal RICO Act, 18 U.S.C. § 1962(c), as well as for conspiracy to violate the Act, 18 U.S.C. § 1962(d), against AbbVie, Auxilium, Lilly, Aetavis, and Endo (the RICO defendants). MMO also asserts claims against AbbVie, Auxilium, Lilly, Aetavis, and Endo under the consumer protection statutes of all fifty states and the insurance fraud statutes of the states in which they are headquartered. In addition, MMO asserts claims against “all defendants” for common law fraud, negligent misrepresentation, and unjust enrichment. Plaintiff has already amended its complaint twice: one substantive amendment in response to defendants’ motion to dismiss and a technical, non-substantive amendment. All defendants except Besins Inc., Besins Healthcare, S.A., and Oscient have moved to dismiss this second amended complaint for lack of standing and for failure to state a claim.1 Solvay, S.A. and Solvay America, Inc. have also moved to dismiss for lack of personal jurisdiction. For the reasons stated below, the Court grants defendants’ motion in part and denies it in part.

Background

The Court takes the following facts from the allegations in plaintiffs 434-page complaint, which describes a number of nationwide schemes orchestrated by defendants with the intention to boost TRT sales by deceiving patients, primary care physicians, and TPPs about the drugs’ safety and efficacy for treating certain conditions. The United States Food and Drug Administration (FDA) has approved TRT drugs for the treatment of a single rare condition, called “classical hypogonadism,” which is characterized by insufficient secretion of the testosterone necessary for the body to perform normal functions. Though the FDA has not approved TRT drugs for the treatment of conditions other than classical hypogonadism, plaintiff alleges that defendants have marketed the drugs as being safe and effective for the treatment of other “off label” conditions and symptoms, such as erectile dysfunction, diabetes, AIDS, cancer, depression, and obesity. Defendant’s off-label marketing scheme allegedly included a “disease awareness” campaign that promoted the existence of a false disease, called “Andro-pause” or “Low T,” which they had invented and for which they claimed TRT drugs were a safe and effective treatment.

According to plaintiff, however, off-label TRT drug use — for “Low T” or otherwise — is neither safe nor effective. Plaintiff asserts that no competent medical evidence demonstrates that TRT drugs are effective at treating off-label conditions but that medical evidence does show that off-label TRT use is associated with increased incidence of adverse cardiovascular events, including myocardial infarction (heart at[904]*904tack), stroke, pulmonary embolism, and other thromboembolic (blood clotting) adverse events. As one doctor allegedly commented regarding TRT drugs’ effectiveness, for the millions of patients that' do not have truly low testosterone levels, TRT drugs are “in the same category as snake oil.” Compl. ¶ 21. In addition, plaintiff alleges that the safety risks are particularly high for aging men, who are most likely to experience symptoms of “Low T” and at whom defendants’ marketing scheme was primarily aimed. According to plaintiff, in certain patient populations, “TRT drugs may increase the incidence of adverse events and death by over 500%.” Id. ¶ 93. Though increased off-label marketing coincided with an “astronomical spike” in TRT drug prescriptions and sales, those sales have begun to decrease, despite “continued rampant promotion,” in response to recent revelations of the drugs’ safety risks. Id. ¶¶ 18-20.

Plaintiff alleges that defendants’ own research put them in a position to be aware of the risks TRT use poses. For example, in 2009, a safety review board halted a study of frail and aging men using Testim (Auxilium’s TRT drug) after 23 of 106 patients in the Testim group suffered adverse cardiovascular events, compared to 5 of the 103 placebo group patients.

Plaintiff asserts that despite defendants’ alleged knowledge (or obligation to know) of their products’ dangers and ineffectiveness, defendants targeted TPPs, physicians, and consumers with fraudulent marketing schemes that affirmatively promoted the drugs’ safety and effectiveness for off-label use and actively concealed unfavorable evidence. According to plaintiff, each group of RICO defendants engaged in respective marketing schemes by forming four “complementary and mutually reinforcing” fraudulent enterprises: a TPP “formulary access” enterprise, which targeted TPPs directly; “peer selling” and “publication” enterprises, which targeted prescribing physicians; and a “direet-to-consume” enterprise, which targeted consumers. Id. ¶¶ 140-144. Totaling the alleged enterprises formed by AbbVie, Aux-ilium, Lilly, Actavis, and Endo, plaintiff asserts the existence of twenty complementary and mutually reinforcing fraudulent marketing enterprises.

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Bluebook (online)
159 F. Supp. 3d 898, Counsel Stack Legal Research, https://law.counselstack.com/opinion/medical-mutual-v-abbvie-inc-ilnd-2016.