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In re Testosterone Replacement Therapy Products Liability Litigation

United States District Court, N.D. Illinois, Eastern Division

November 3, 2017

In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings
Auxilium Pharmaceuticals, Inc., Case No. 15 C 3941 This document applies to all s and to Holtsclaw



         Auxilium Pharmaceuticals, Inc. is one of a number of defendants in this multidistrict litigation (MDL) proceeding that manufacturers and sells testosterone replacement therapy (TRT) drugs. The Court selected two of the cases involving Auxilium for "bellwether" trials, but only one of those case survived Auxilium's motions for summary judgment. See In re: Testosterone Replacement Therapy Prod. Liab. Litig. Coordinated Pretrial Proceedings (Auxilium Summary Judgment Ruling), No. 14 C 1748, 2017 WL 4772759, at *9 (N.D. Ill. Oct. 23, 2017).

         Steven Holtsclaw, the plaintiff in the remaining bellwether case, alleges that he suffered a heart attack as a result of using Auxilium's TRT drug Testim. He contends that Auxilium improperly marketed and promoted the drug as being safe and effective for treating symptoms of aging that are also associated with declining testosterone levels in the blood. According to Holtsclaw, Testim and other TRT drugs have been proven to be safe and effective only for the treatment of "classical hypogonadism, " a disorder characterized by abnormally low testosterone levels resulting from some other specified condition, such as a genetic disease or injury to the testicles. Holtsclaw also contends that Auxilium failed to provide adequate warnings of the cardiovascular risk Testim posed to users of the drug.

         Both Auxilium and Holtsclaw have filed motions in limine in advance of the bellwether trial in which they seek to exclude certain evidence.[1] The Court has already addressed a number of similar issues in its ruling on motions in limine filed in the bellwether cases involving AbbVie Inc., another defendant in this proceeding. See In re Testosterone Replacement Therapy Prod. Liab. Litig. Coordinated Pretrial Proceedings (AbbVie MIL Ruling), No. 14 C 1748, 2017 WL 2313201 (N.D. Ill. May 29, 2017). In this opinion, the Court assumes familiarity with that ruling and other rulings issued in the bellwether cases involving AbbVie and Auxilium.

         A. Evidence Auxilium has moved to exclude

         1. Marketing and promotional materials not seen or relied upon by Holtsclaw or his physician

         Auxilium has moved to exclude as irrelevant evidence of specific marketing or promotional materials to the extent Holtsclaw cannot show that he or his physician viewed the specific materials or relied upon them in deciding to take or prescribe Testim. It is undisputed that Holtsclaw does not recall viewing any promotional materials for Testim or other TRT drugs prior to using the drug. Auxilium also emphasizes that there is no evidence that Holtsclaw's physician, Dr. Dean McLaughlin, relied on any particular promotional material from Auxilium when deciding to prescribe the drug, and he specifically denied having received any misleading communications or materials from the company.

         The Court has already determined, in denying Auxilium's motion for summary judgment, that a reasonable jury could infer that Dr. McLaughlin relied on representations from Auxilium in making his prescribing decision and that "Auxilium's marketing material-at least the material that predates Holtsclaw's use of Testim- therefore is, in general, relevant." Auxilium Summary Judgment Ruling, 2017 WL 4772759, at *9. The Court also ruled previously, and repeats here, that even if a manufacturer's marketing material played no direct role in causing a plaintiff to take a TRT drug, the material may still be relevant "on the question of [the manufacturer's] knowledge that its marketing was misleading or its intent to create an off-label market." AbbVie MIL Ruling, 2017 WL 2313201, at *2.

         Auxilium's marketing material is likely to be relevant in this case for similar reasons. At some point, as the Court noted previously, Rule 403 may require exclusion of certain marketing evidence based on cumulativeness or danger of unfair prejudice. Id. And because there is no evidence in this case that Holtsclaw viewed any Testim or TRT marketing material, the probative value of evidence concerning Auxilium's direct-to-consumer marketing material may be more limited than the evidence about material aimed at physicians. Thus only a limited amount of evidence of that sort may be admitted before the Rule 403 balance favors exclusion. The extent to which such evidence is admissible will have to be determined during the trial.

         2. Evidence related to other pharmaceutical manufacturers

         Auxilium has moved to exclude evidence concerning promotional activities of other TRT manufacturers, citing the Court's prior determination that evidence regarding other manufacturers has the "potential for confusion or unfair prejudice, " because the different products have different marketing and regulatory histories and because the plaintiffs have access to information about the defendants in this MDL that each individual defendant might not have about each other. AbbVie MIL Ruling, 2017 WL 2313201, at *3. In response to Auxilium's motion, Holtsclaw has agreed not to introduce evidence of marketing material from other manufacturers, and Auxilium has therefore withdrawn its motion.

         3. Testim sales figures

         Auxilium moves to exclude evidence of the sales (i.e., revenue) figures for Testim, arguing that it is irrelevant and misleading, especially when not accompanied by evidence of the various economic and market factors that affect the price of a prescription drug and a manufacturer's ability to profit from drug sales. Holtsclaw responds that the evidence is relevant on the issue of motive; the relationship between Auxilium's promotion of Testim and the drug's sales, he argues, suggests a motive for Auxilium's alleged off-label marketing campaign. With respect to whether the sales figures are potentially misleading, Holtsclaw notes that Auxilium only sold one product for most of its existence. Thus evidence of Auxilium's profits would not be misleading, according to Holtsclaw, because those profits would almost exclusively be profits earned from Testim sales, as opposed to sales of other products. But although that argument supports the admission of evidence concerning Auxilium's profits, it is not responsive to the concern raised about the potential for sales figures to mislead. Holtsclaw does not address, for example, Auxilium's contention that evidence of sales figures is misleading without a discussion of the costs of producing Testim. The Court concludes that evidence of profits derived from Testim is relevant and admissible, but evidence of sales figures is excluded under Rule 403.

         4. References to the presence, absence, or identify of a corporate representative

         Auxilium moves to preclude Holtsclaw from making reference to Auxilium's corporate representative at trial and, in particular, commenting on whether a corporate representative is present or absent. Holtsclaw responds that "the presence or absence of a party at trial is a matter of fact that the jury is entitled to know." Pls.' Resp. to Auxilium's Mots. at 12. But he does not explain how an Auxilium representative's absence or presence at trial "has any tendency to make a fact more or less probable than it [otherwise] would be" or how that fact would be "of consequence in determining the action." Fed.R.Evid. 401. The Court finds this irrelevant and grants Auxilium's motion.

         5. Regional sales strategies

         Auxilium has moved to exclude evidence of internal regional sales strategies that were not used in Tennessee, where Holtsclaw lived, visited his physician, and used Testim. Specifically, Auxilium seeks exclusion of evidence regarding a sales strategy known as the "Turnips initiative, " which Auxilium says was developed by a regional sales manager from Texas and was not used in Tennessee or in connection with any communications between Auxilium and Dr. McLaughlin. In response to this motion, Holtsclaw has agreed not to introduce evidence in his case regarding the Turnips initiative, and Auxilium has therefore withdrawn its motion on this matter.

         6. Evidence related to an FDA division's 2008 requirement to evaluate cardiovascular risk for the class of drugs indicated to treat diabetes

         Auxilium moves to prohibit Holtsclaw from offering testimony and argument about a letter the FDA's Division of Metabolism and Endocrinology (DMEP) sent to Auxilium in November 2008. In the letter, DMEP notified Auxilium that it was requiring manufacturers of a class of new anti-diabetic drugs to demonstrate that the therapy would not result in an unacceptable increase in cardiovascular risk. Auxilium concedes that it had submitted an application for Testim as a drug that could treat diabetes but notes that the last clinical study under the application ended over two years before DMEP sent its letter to Auxilium. That clinical study, Auxilium explains, did not show that Testim effectively treated diabetes, and Auxilium abandoned its attempt to obtain approval for Testim to treat diabetes. Auxilium maintains that FDA's Division of Reproductive and Urologic ...

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