In re Testosterone Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial Proceedings, 14 C 1748
| Decision Date | 23 December 2014 |
| Docket Number | No. 14 C 1748,14 C 1748 |
| Court | U.S. District Court — Northern District of Illinois |
| Parties | In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings |
This multidistrict litigation (MDL) proceeding consists of, at this point, around 700 individual lawsuits that have been consolidated in this Court for coordinated pretrial proceedings. Each of the lawsuits includes claims for injuries allegedly caused by defendants' testosterone replacement therapy (TRT) drugs.
Before the creation of the MDL proceeding, a significant number of TRT cases were already pending in this district and had been assigned to the undersigned judge for pretrial supervision. The Court determined to consider motions to dismiss in the first few dozen cases that were filed and stayed the filing of responses to the complaints in all cases filed thereafter. On June 4, 2014, the defendants, AbbVie, Inc. and Abbott Laboratories, Inc. (AbbVie), Endo Pharmaceuticals, Inc. (Endo), Auxilium Pharmaceuticals, Inc. (Auxilium), and Lilly USA, Inc. and Eli Lilly and Company (Lilly), jointly moved to dismiss thirty-nine of the complaints under Federal Rule of Civil Procedure 12(b)(6). Endo, Auxilium, and Lilly also separately moved to dismiss the claims against them.
For purposes of the motion to dismiss, the Court accepts as true the followingfacts alleged in plaintiffs' complaints. See, e.g., Fortres Grand Corp. v. Warner Bros. Ent'mt Inc., 763 F.3d 696, 700 (7th Cir. 2014). Defendants are manufacturers, sellers, and promoters of TRT drugs, which the Court will refer to as TRTs. TRTs are drugs approved by the U.S. Food and Drug Administration (FDA) for the treatment of abnormally low testosterone in men, a condition known as hypogonadism. 1st Am. Compl. ¶ 29.1 All of the TRTs at issue in this litigation are administered in the form of a topical cream, gel, or patch. Id. ¶ 65.
Plaintiffs allege that defendants fraudulently promoted the drugs for off-label uses and failed to warn plaintiffs and their physicians of potentially dangerous side effects. All of the plaintiffs used AndroGel, manufactured by defendants AbbVie, Inc. and Abbott Laboratories, Inc. Three of the thirty-nine plaintiffs also used a drug manufactured by one of the other defendants. Natale Cataudella used Fortesta, which is manufactured by Endo. Loran Parker used Testim, manufactured by Auxilium. And Frank Lau used Axiron, manufactured by Lilly. Plaintiffs claim that defendants' drugs caused injuries, including blood clots (deep vein thrombosis and pulmonary embolism), heart attacks (myocardial infarctions), and strokes.
Plaintiffs contend that defendants sought to convince men who did not have hypogonadism "that they suffered from a non-existent and unrecognized medical condition called 'Low T', which was a term for low testosterone." Id. ¶ 35. Defendants conducted a "national disease awareness media blitz," which was designed to convince men that "normal and common conditions associated with normal aging could becaused by low testosterone levels." Id. ¶¶ 35-39. According to plaintiffs, TRTs were promoted as a "lifestyle drug" for off-label uses that were not approved by the FDA, including for treatment of erectile dysfunction, osteoporosis, depression, fatigue, and obesity. Id. ¶¶ 47, 49, 63, 92.
Plaintiffs make allegations about each defendant's off-label marketing schemes. Plaintiffs allege that AbbVie intentionally misrepresented information about AndroGel's uses and side effects. Starting in 2000, plaintiffs allege that AbbVie's marketing strategy "has been to aggressively market and sell their products by misleading potential users and their physicians about the prevalence and symptoms of low testosterone and by failing to protect users from serious dangers that Defendants knew or should have known to result from use of its products." Id. ¶ 89. AbbVie promoted the drug to physicians and healthcare providers "as a product approved and indicated for the treatment of age-related declines in testosterone levels and age-related symptoms," even though the company knew the drug was not approved for those uses. Id. ¶¶ 50, 53. AbbVie operated an unbranded website called "IsItLowT.com," which features an interactive quiz that allows men to determine if they exhibit symptoms of "Low T." Id. ¶ 7. In fact, AbbVie was admonished as a result of its promotional efforts in 2000, when the FDA warned that "claims and representation[s] that suggest that AndroGel is indicated for men with 'age associated' hypogonadism or 'andropause' are misleading." Id. ¶ 34.
For its part, Lilly's advertisements "suggested that various symptoms often associated with other conditions may be caused by low testosterone." Lau 1st Am. Compl. ¶ 46. Lilly "encouraged men to discuss testosterone replacement therapy withtheir doctors if they experienced any of the 'symptoms' of low testosterone." Id. Lilly announced in a 2010 press release "that symptoms associated with 'Low T' include 'erectile dysfunction and decreased sexual desire, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics and osteoporosis.'" Id. ¶ 60.
Auxilium also engaged in a marketing campaign "for the purpose of increasing and promoting 'off-label' prescriptions for the Testim product." Parker 1st Am. Compl. ¶ 44. Auxilium initiated a "Low Testosterone Therapy With Testim" campaign, and it recruited a professional golfer to provide an endorsement that he had been "successfully" treated for "Low T." Id. ¶¶ 48-53. Like AbbVie, Auxilium's website included a questionnaire to promote the product—the "ADAM questionnaire," short for "Androgen Deficiency in Adult Males." Id. ¶¶ 56-59. This questionnaire "screened for age-related signs and symptoms," even though the drugs were not approved to treat such symptoms. Id. ¶ 58. According to Parker, Auxilium's marketing "was knowingly false, inaccurate, deceptive, and misleading with respect to the information offered," because Auxilium "willfully sought to conflate the diagnosis of hypogonadism with the diagnosis of 'Low T' or age-related declines in testosterone levels or age-related symptoms in men." Id.
Endo also embraced the "Low T" moniker. Cataudella 1st Am. Compl. ¶ 42. Endo disseminated advertisements encouraging men to see their doctors about symptoms including "'reduced sexual drive (libido) and activity,' 'difficulty in achieving or maintaining an erection,' feeling 'tired, fatigued, or notic[ing] a loss of energy,' depressed mood, 'lost body hair or . . . less of a need to shave,' 'decrease in strength or muscle mass,' or osteoporosis." Id. ¶ 47. Endo also stated in a 2011 press release thatthe symptoms of "Low T" include "'erectile dysfunction and decreased sexual desire.'" Id. ¶ 63. Like the other defendants, Endo operated a website, www.GetTestedForLowT.com, which encouraged men "to complete a quiz to see if they are 'eligible for a free testosterone test to measure [their] testosterone levels.'" Id. ¶ 48. Endo provided free blood testing to men as long as state law did not prohibit the testing. Id. ¶ 54.
Plaintiffs cite a number of studies that purport to show that TRTs increase users' risks for cardiac events, stroke, pulmonary embolisms, and blood clotting. 1st Am. Compl. ¶¶ 105-08. According to the plaintiffs, TRT drugs increase hematocrit, the proportion of total blood volume that is comprised of red blood cells, and estradiol, the primary female sex hormone. Increases in hematocrit and estradiol, they allege, can result in blood clots, strokes, and other cardiovascular events. Id. ¶¶ 66-81.
Plaintiffs allege that defendants "purposefully downplayed, understated and outright ignored the health hazards and risks associated with using" TRTs. Id. ¶ 93; Lau 1st Am. Compl. ¶ 103; Cataudella 1st Am. Compl. ¶ 107; Parker 1st Am. Compl. ¶ 126. Plaintiffs contend that the prescribing information and medication guides for AndroGel, Fortesta, Testim, and Axiron do not adequately warn about potentially dangerous side effects. Specifically, they fail to instruct patients to tell their healthcare providers about traits that increase the risk of blood clotting, and they fail to instruct patients and physicians to screen for preexisting conditions that increase the risk of clotting and heart disease. 1st Am. Compl. ¶¶ 97, 100. The prescribing information and medication guides also fail to instruct physicians to evaluate patients' hematocrit and estradiollevels. Id. ¶ 99, 102.
To support the contention that defendants' warnings were insufficient, plaintiffs refer to a June 19, 2014 announcement by the FDA that it was requiring TRT manufacturers to update their labels to include a general warning about the risks of venous thromboembolism, including deep vein thrombosis and pulmonary embolism. Id. ¶ 110.
Each plaintiff alleges that he was injured as a result of taking testosterone replacement therapy. Each also states that he would not have taken defendants' drugs or would have monitored for side effects had he known of the risks. Plaintiffs assert claims for: (1) strict products liability based on failure to warn; (2) negligence; (3) breach of implied warranty; (4) breach of express warranty; and (5) fraud. Some also assert claims for design defect, negligent misrepresentation, and loss of consortium. See, e.g., 1st Am. Compl. ¶¶ 188-206. Two complaints also include a wrongful death or survival action because the plaintiff is now deceased. See LaRoche 1st Am. Compl. ¶¶ 194-200; Lueck 1st Am. Compl. ¶¶ 167-75.
Defendants have collectively moved to dismiss the complaints. Defendants Endo, Lilly, and Auxilium have also separately moved to dismiss the claims against them. Because the allegations against each of the defendants are nearly identical, the Court will not address...
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