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In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings

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

January 6, 2018

In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings This document applies to all cases and to Nolte
AbbVie, Inc. et al., Case No. 14 C 8135



         Plaintiff Robert Nolte has sued defendants AbbVie, Inc. and Abbott Laboratories (collectively, AbbVie), alleging that AbbVie's testosterone replacement therapy (TRT) drug AndroGel caused him to suffer a pulmonary embolism-a sudden blockage of a blood vessel in the lungs. Nolte asserts that AbbVie misleadingly marketed AndroGel as being safe and effective for the treatment of age-related hypogonadism, that is, low testosterone levels in the blood, and accompanying signs and symptoms, brought about by the normal male aging process. He also asserts that AbbVie failed to adequately warn that AndroGel use could cause venous thromboembolic (VTE) injuries, such as a pulmonary embolism or deep-vein thrombosis.

         Nolte's is the fourth "bellwether" case in this multidistrict litigation proceeding to go to trial. The Court issued rulings on motions in limine in advance of each of the first three trials, two of which also involved AbbVie as a defendant. See In re Testosterone Replacement Therapy Prod. Liab. Litig. Coordinated Pretrial Proceedings (Holtsclaw MIL Ruling), No. 14 C 1748, 2017 WL 5029601 (N.D. Ill. Nov. 3, 2017) (rulings on motions in limine in case brought against defendant Auxilium Pharmaceuticals, Inc.); In re Testosterone Replacement Therapy Prod. Liab. Litig. Coordinated Pretrial Proceedings (Prior AbbVie MIL Rulings), No. 14 C 1748, 2017 WL 2313201 (N.D. Ill. May 29, 2017) (rulings on motions in limine in two cases brought against AbbVie). Both sides have asked the Court to adopt its prior rulings in this case, and the Court does so, except as discussed below.

         This case also presents certain new issues. Each plaintiff in the prior bellwether cases, for example, alleged that TRT caused him to suffer a cardiovascular injury (heart attack or stroke). Nolte's case thus will be the first one involving an alleged VTE injury to be tried. In light of the alleged injury and other issues specific to Nolte's case, the parties have moved to exclude additional items of evidence that were not addressed in prior rulings. The Court assumes familiarity with those rulings for purposes of this opinion.

         A. Evidence Nolte has moved to exclude

         1. 2014 Public Citizen letter and response from the FDA

         Nolte has moved to exclude evidence of a 2014 letter sent by the advocacy group Public Citizen to the FDA, as well as the FDA's response to that letter. In the letter, Public Citizen asked the FDA to require additional warnings about the increased risk of cardiovascular injuries associated with TRT use. In prior cases, the Court determined that the letter and the FDA's response denying Public Citizen's request were relevant and admissible on the issue of whether TRT causes cardiovascular injuries. Nolte contends that the evidence is irrelevant in this case because Nolte does not allege that he suffered any cardiovascular injury. AbbVie agrees that the Public Citizen letter and the response from the FDA are irrelevant; it asks the Court to exclude all evidence relating to the purported cardiovascular risks associated with TRT use, a request the Court will discuss later in this order. Nolte's motion concerning the Public Citizen letter and the FDA's response is unopposed, and the Court grants the motion.

         2. History of alcohol use and alcohol-induced pancreatitis

         The remainder of Nolte's motions in limine concern aspects of his medical history that AbbVie's expert witnesses might opine to be risk factors for a pulmonary embolism or for hypogonadism. Nolte contends that there is insufficient evidence linking those medical conditions to the pulmonary embolism he suffered or to his hypogonadism diagnosis, and he maintains that any probative value of testimony about those conditions is substantially outweighed by the risk of unfair prejudice to him. AbbVie charges that Nolte's effort to exclude the testimony of AbbVie's experts is effectively a belated Daubert challenge. Just as the Court permitted Nolte's expert, Dr. Rinder, to consider multiple sources of evidence to establish causation based upon the "totality of the evidence, " AbbVie argues that the Court should allow AbbVie's experts to testify broadly about potential risk factors, including those that have weaker support in the scientific literature or a weaker connection to Nolte's case than other factors.

         The Court believes that both parties' comparisons to prior Daubert rulings are misplaced. Nolte, for example, faults AbbVie's experts for failing to establish that certain purported risk factors were "substantial contributing factors" in causing his injury. It is true that Nolte has to establish that AndroGel was a substantial contributing factor to his injury to satisfy the causation element of his claims, and thus the admissibility of his experts' testimony on causation depends, in part, on whether the testimony satisfies that standard. See Schultz v. Akzo Nobel Paints, LLC, 721 F.3d 426, 433 (7th Cir. 2013) (considering state law's "substantial factor" standard for causation in determining admissibility of expert witness' causation testimony). But AbbVie does not carry the same burden to establish conclusively that any one factor caused Nolte's injury, and thus an opinion from one its experts that some factor may have contributed to the injury could be relevant and admissible.

         At the same time, AbbVie unduly emphasizes the fact that the Court permitted Dr. Rinder and other experts to testify about causation opinions based on a "totality of the evidence" method. It is true that the Court found it permissible for experts in this case to base their causation opinions on sources of evidence, like animal studies and in vitro studies, that might be insufficient on their own to establish causation. See In re Testosterone Replacement Therapy Prod. Liab. Litig. Coordinated Pretrial Proceedings, No. 14 C 1748, 2017 WL 1833173, at *14 (N.D. Ill. May 8, 2017) (experts may "rely on such studies as part of a much broader set of evidence"). In permitting the testimony, the Court concluded that a "totality of the evidence" method-including consideration of evidentiary sources with varying degrees of strength and quality-may be a reliable basis for a relevant causation opinion. It is a separate question whether the probative value of certain evidence relied upon by an expert is substantially outweighed by its potential for unfair prejudice. If an expert's discussion of animal studies, for example, carried a significant risk of jury confusion or unfair prejudice to AbbVie in a particular case, the expert's testimony about those studies might be inadmissible even if it otherwise satisfied Daubert's admissibility criteria. See Fed. R. Evid. 403 ("The court may exclude [even] relevant evidence if its probative value is substantially outweighed by a danger of . . . unfair prejudice [or] misleading the jury[.]"). And if a defense expert's testimony about a particular risk factor is not tied to evidence that the plaintiff actually had that risk factor, the testimony likely would be irrelevant or at least would be subject to exclusion under Rule 403.

         Nolte contends that testimony about his history of alcohol use presents a danger of unfair prejudice against him that substantially outweighs the testimony's probative value. Medical records indicate that in 2008, Nolte was diagnosed with an acute episode of alcohol-related pancreatitis. Medical records also reflect Nolte's apparent report that he later resumed alcohol use and drank scotch on a daily or almost-daily basis at one or more points in time. The Court has previously remarked on the potential for evidence of alcohol use to prejudice a party unfairly by placing him in a negative light before the jury. See Prior AbbVie MIL Rulings, 2017 WL 2313201, at *11.

         AbbVie first maintains that Nolte's history of alcohol use is relevant because alcohol abuse is a potential risk factor for a pulmonary embolism. But AbbVie's expert, Dr. Kenneth Bauer, opined only that alcohol use was a potential risk factor for a pulmonary embolism and cited no scientific support for that claim. Thus evidence of Nolte's alcohol use has limited probative value in this context and is substantially outweighed by the risk of unfair prejudice.

         AbbVie also maintains that Nolte's history of alcohol use is relevant because it explains why he might have discontinued his anticoagulation medication prior to the pulmonary embolism at issue in this case.[1] Drinking alcohol while taking anticoagulation medication can increase one's risk of bleeding, but there is no evidence that Nolte decided to stop taking the medication because he was concerned the interaction with alcohol. Any argument of that kind would be based on rank speculation, and thus the probative value of the evidence is also substantially outweighed by the danger of unfair prejudice in this context as well.

         AbbVie also suggests that Nolte's alcohol use, rather than his pulmonary embolism, might be the cause of a subdural hematoma (bleeding in the brain) that he suffered in 2014. But AbbVie presents no evidence to support this assertion; it is speculative. Therefore the history of alcohol use also has limited probative value in this context, which again is far outweighed by the risk of unfair prejudice.

         Evidence of Nolte's alcohol use arguably has greater probative value on the issue of the underlying cause of his low testosterone level at the time he was prescribed AndroGel. AbbVie's expert, Dr. Mohit Khera, states that a history of alcohol abuse is associated with classical hypogonadism, that is, hypogonadism caused by a specific medical condition rather than the normal male aging process. AbbVie contends that Nolte's blood testosterone level dropped because of alcohol abuse. It cites the aforementioned episode of acute, alcohol-related pancreatitis, before which Nolte's testosterone level was in a normal range, and a testosterone measurement several years later that showed a significantly lower, below-normal level. AbbVie also cites, among other things, statements in Nolte's medical records reflecting his report that he resumed the use of alcohol at some point after his pancreatitis episode-including one report that he was drinking a double scotch at dinnertime six times per week. This evidence, it appears, forms the basis for Dr. Khera's statement that "it is not unreasonable to assume that Mr. Nolte may have had toxic damage from alcohol to his testicles due to his extensive drinking history." Khera Rep., Ex. 10 to Pl.'s Mot., at 4.

         The AndroGel warning label states that the drug is indicated to treat hypogonadism resulting from testicular failure due to toxic damage from alcohol. Given Nolte's allegations that AbbVie promoted AndroGel "off label, " the underlying cause of Nolte's hypogonadism is potentially a significant issue. That said, Dr. Khera does not actually opine that Nolte's low testosterone level was caused by alcohol abuse. His statement, quoted above, is hedged in several ways: he says only that it is "not unreasonable" to "assume" that Nolte "may" have damaged his testicles by abusing alcohol. Id. Neither Dr. Khera nor any other witness ultimately concludes that Nolte had testicular failure resulting from alcohol-induced damage. Indeed, Dr. Khera states in his report that Nolte's medical records "do not identify a specific cause or 'classical' etiology for his hypogonadism, " and his conclusion is that Nolte's hypogonadism "was 'non-classical' or idiopathic [that is, without an identifiable cause] and would now be recognized as AOH [adult-onset hypogonadism]." Id. Dr. Khera's own conclusion that Nolte likely had non-classical hypogonadism limits the probative value of his statement regarding the potential effects of Nolte's alcohol use. The probative value of evidence concerning Nolte's alcohol use vis-à-vis the indicated uses of AndroGel is further limited by the fact that Nolte's treating physician did not diagnose him with hypogonadism caused by alcohol use and thus does not appear to have understood he was prescribing AndroGel "on label."

         All of that said, the Court believes that given the significance of the on-label/off-label issue in this case, Dr. Khera's testimony on this point as set forth in his expert report is relevant, and its probative value is not substantially outweighed by the danger of unfair prejudice posed by admission of evidence regarding Nolte's alcohol use. The Court therefore overrules Nolte's objection to this evidence. But this does not give AbbVie free rein to overstate the significance of this evidence or to characterize it in an unfairly pejorative way. First, Dr. Khera's testimony on the point is and will be constrained by his report and the way he characterizes the evidence there. Second, AbbVie's counsel and witnesses may not characterize Nolte's alcohol use in the pejorative way counsel did in its written submission and at the pretrial conference-one example being statement to the effect that Nolte "poisoned his pancreas."[2] Third, the manner in which AbbVie's counsel argues the point will be limited by the way Dr. Khera has hedged his opinion. Given these limitations, AbbVie's counsel would be well-advised to seek advance guidance from the Court in order to avoid the potential for a mistrial. Finally, as the Court has ruled, AbbVie may not attempt to suggest or elicit testimony regarding a link between Nolte's alcohol use and his pulmonary embolism, his discontinuance of anticoagulant medication, or his subdural hematoma.

         3. History of smoking tobacco

         Evidence of tobacco use, like evidence of alcohol use, carries a risk of unfair prejudice. AbbVie contends that Nolte's history of smoking tobacco is relevant because it may have played a role in causing his pulmonary embolism. As with alcohol use, however, Dr. Bauer opined only that tobacco use was a potential risk factor for a pulmonary embolism. He also conceded during his deposition that "tobacco is actually somewhat controversial, although oftentimes people regard it as a risk factor[] in VTE." Bauer Dep., Ex. 8 to Pl.'s Mot., at 221:3-6. And he did not address whether it was significant that Nolte quit smoking cigarettes three years prior to the pulmonary embolism at ...

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