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In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings

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

May 5, 2018

In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings This document applies to all cases and to Myers
v.
AbbVie, Inc. et al., Case No. 15 C 1085

          CASE MANAGEMENT ORDER NO. 116 (RULINGS ON MOTIONS IN LIMINE IN MYERS V. ABBVIE INC. ET AL., CASE NO. 15 C 1085)

          MATTHEW F. KENNELLY UNITED STATES DISTRICT JUDGE

         Arthur Myers has sued AbbVie Inc. and Abbott Laboratories Inc. (AbbVie), alleging that its testosterone replacement therapy (TRT) drug, AndroGel, caused him to suffer pulmonary emboli in February 2008. Pulmonary emboli are sudden blockages of blood vessels in the lungs. Myers asserts that AbbVie marketed AndroGel in a misleading manner by representing that it is safe and effective for treating age-related hypogonadism-low levels of testosterone in the blood, and related symptoms, arising out of the normal male aging process. Myers also asserts that AbbVie failed to adequately warn that AndroGel could cause venous thromboembolic (VTE) injuries, like pulmonary embolism or deep-vein thrombosis.

         Myers's case is the fifth "bellwether" case in this multidistrict litigation proceeding to go to trial. The Court has issued rulings on motions in limine in each of the prior cases, including in three where AbbVie was a defendant. See In re Testosterone Replacement Therapy Prod. Liab. Litig. Coordinated Pretrial Proceedings, No. 14 C 1748, 2017 WL 5029601 (N.D. Ill. Nov. 3, 2017) (Holtsclaw MIL Ruling); In re Testosterone Replacement Therapy Prod. Liab. Litig. Coordinated Pretrial Proceedings, No. 14 C 1748, 2017 WL 2313201 (N.D. Ill. May 29, 2017) (Prior AbbVie MIL Rulings); In re Testosterone Replacement Therapy Prod. Liab. Litig. Coordinated Pretrial Proceedings, No. 14 C 1748, MDL No. 2545, 2018 WL 305503 (N.D. Ill. Jan. 6, 2018) (Nolte MIL Ruling); In re Testosterone Replacement Therapy Prod. Liab. Litig. Coordinated Pretrial Proceedings, No. 14 C 1748, 2018 WL 1316724 (N.D. Ill. Mar. 14, 2018) (Mitchell II MIL Ruling).

         At the pretrial conference on May 2, 2018, the Court adopted certain prior rulings that Myers and AbbVie sought to reaffirm. The parties have also moved to exclude additional items of evidence, and the Court rules on those motions as follows.

         A. Evidence AbbVie has moved to exclude

         1. Evidence of AbbVie's knowledge and conduct after February 2008

         AbbVie contends that whether it "knew or reasonably should have known of the risk of VTE injury must be judged by the information available in February 2008, " when Myers had his pulmonary emboli (PE). Defs.' Mot. at 3. Accordingly, AbbVie seeks to exclude evidence relating to the 2014 VTE label change, evidence relating to the 2015 label changes, and other post-February 2008 documents and testimony. AbbVie acknowledges that the Court has denied similar motions in previous bellwether trials, including in Nolte, a VTE case where, as here, Arizona law governed the substantive claims. But AbbVie contends that differences in Myers's case justify departures from those rulings.

         First, AbbVie argues that although there was a strict liability design defect claim in Nolte, there is no such claim in Myers's case. Myers effectively confirmed this at the May 2, 2018 pretrial conference but argued that he has brought information defect claims arising in both negligence and strict liability. For reasons stated on the record at the pretrial conference, the Court agrees. Unlike for a strict liability design defect claim, Myers cannot introduce post-February 2008 evidence to prove AbbVie's knowledge and conduct for purposes of his information defect claims, except to the extent that evidence bears on AbbVie's knowledge as of February 2008. See Powers v. Taser Int'l, Inc., 217 Ariz. 398, 404, 174 P.3d 777, 783 (Ct. App. Ariz. 2007) (stating that even for strict liability information defect claims, information regarding what "was known or knowable" to manufacturers is measured "at the time of manufacture and distribution"). Nevertheless, as discussed below, the evidence that AbbVie seeks to exclude is admissible for other purposes.

         Second, AbbVie argues that an Arizona product liability statute, A.R.S. § 12-686, requires the Court to exclude post-February 2008 labeling evidence. See Defs.' Mot. at 3-6. AbbVie cites one case for the proposition that federal courts apply A.R.S. § 12-686, even though the statute sets forth evidentiary rules. See Walton v. Bridgestone / Firestone Inc., No. CV-05-3027-PHX-ROS, 2009 WL 2778441, at *8-9 (D. Ariz. Jan. 16, 2009). The Court is inclined to disagree; it is settled law that the Federal Rules of Evidence govern in federal court, even in diversity cases where the substantive rule of decision is supplied by state law. See, e.g., Schrott v. Bristol-Myers Squibb Co., 403 F.3d 940, 943 (7th Cir. 2005). But even assuming federal courts apply A.R.S. § 12-686, the statute does not bar the labeling evidence. Arizona courts have construed A.R.S. § 12-686 to operate in the same manner for post-sale remedial measures as Arizona Rule of Evidence 407-which is identical to its federal counterpart-operates for post-injury remedial measures. See Readenour v. Marion Power Shovel, 149 Ariz. 442, 446, 719 P.2d 1058, 1062 (1986). This Court has previously held that Rule 407's exclusion of subsequent remedial measures does not extend to FDA-mandated label changes. Prior AbbVie MIL Ruling, 2017 WL 2313201, at *2. Under Readenour, the result is the same under A.R.S. § 12-686.

         Having addressed AbbVie's threshold arguments for excluding post-February 2008 evidence of knowledge and conduct, the Court considers its remaining arguments.

         i. 2014 VTE label change (and related discussions)

         AbbVie seeks to exclude evidence regarding the 2014 VTE label change pursuant to Rules 401 and 403. AbbVie acknowledges the Court's prior ruling that post-injury label changes "can be relevant on the question of what a prescribing physician would have done if the drug's label had been different." See Defs.' Mot. at 3 (quoting Nolte MIL Ruling, 2018 WL 305503, at *8). But AbbVie contends that the 2014 VTE label changes are irrelevant for this purpose in Myers's case because his prescribing physician, Dr. Michaela Tong, testified that the subsequent labeling "would have had no impact on her prescription decision in 2007." Defs.' Mot. at 4. In response, Myers cites Dr. Tong's testimony that had she been told in 2007 of AndroGel's potential to increase the risk of heart attacks and strokes, particularly in patients who had underlying risk factors, she would have discussed this information with Myers. Although this testimony, strictly speaking, concerns the 2015 label changes, it indicates that the point is not as clear-cut as AbbVie contends.

         Separately, the Court has ruled in prior bellwether trials that subsequent label changes are relevant on the issue of causation to the extent they reflect the FDA's views on AndroGel's ability to cause heart attacks. Prior AbbVie MIL Rulings, 2017 WL 2313201, at *2. The same logic extends to VTE causation. AbbVie, however, contends that evidence regarding the 2014 VTE label change is irrelevant for this purpose because, it contends, this evidence shows that the FDA actually "lacked a belief that AndroGel caused VTEs." Defs.' Mot. at 4. AbbVie points to the fact that the FDA "initially propos[ed] language that suggested a causal link between testosterone therapy and VTEs, " but later removed the causation language and "approved a labeling change that did not include any causation warning at all." Defs.' Mot. at 4. AbbVie also cites a document from May 2014 in which the FDA indicated that a "direct causality link" between testosterone replacement therapy and VTE could not be made at the time. Defs.' Mot. at 4. Although this may reflect uncertainty on the FDA's part, the FDA nevertheless insisted upon adding information about VTE risk to the label. Thus the label change does, in fact, bear on the causation question. The Court is not persuaded that the probative value of the evidence would be substantially outweighed by the risk of wasting time or of "confus[ing] the jury about the date by which AbbVie's conduct must be judged." Defs.' Mot. at 5.

         ii. 2015 label changes (and related discussions)

         AbbVie seeks to exclude evidence regarding the 2015 label changes pursuant to Rules 402 and 403. First, based on Dr. Tong's testimony discussed above, AbbVie argues that this evidence is irrelevant regarding whether Dr. Tong would have changed her prescribing practices had AndroGel's label been different. When asked about the 2015 label, however, Dr. Tong stated that she would have discussed with Myers the information in the label about an increased risk for strokes. Because a thromboembolism can cause a stroke, and because a reasonable jury could credit Dr. Tong's testimony that she would have had a different discussion with Myers had the label contained different information, evidence regarding the 2015 label changes is relevant and admissible to how Dr. Tong might have changed her prescribing practices.

         With respect to the FDA's views on causation, AbbVie seeks to exclude evidence regarding "the removal of 'idiopathic' in the secondary hypogonadism paragraph." Defs.' Mot. at 5. The Court denies AbbVie's motion in this regard because according to AbbVie's endocrinology expert, Myers had a form of idiopathic hypogonadism. AbbVie also seeks to exclude "an addition to 'Limitations of use' stating that 'Safety and efficacy of AndroGel 1% in men with 'age-related hypogonadism' (also referred to as 'late-onset hypogonadism') have not been established.'" Defs.' Mot. at 5. AbbVie argues that this evidence is irrelevant because "this is not an 'age-related hypogonadism' case." Id. at 6. AbbVie, for example, states that Myers began taking AndroGel when he was 37 and had his PE when he was 42. Id. at 5-6. Furthermore, according to AbbVie, there is no evidence that Myers's testosterone was low because of his age, yet there is evidence- including Myers's comorbid conditions-that Myers's doctors did not prescribe AndroGel for age-related hypogonadism.

         The Court disagrees with AbbVie's analysis. As discussed when the Court found this evidence admissible in Nolte, the prior label contained a warning about AndroGel's efficacy in patients over 65 as compared to younger patients, whereas the 2015 label stated that "safety and efficacy had not been established at all in men with age-related hypogonadism, regardless of age." Nolte MIL Ruling, 2018 WL 305503, at *8 (emphasis added). AbbVie has presented no evidence that Myers was too young to have age-related hypogonadism or that the 2015 label was not directed toward men under a certain age. Additionally, as Myers notes, his doctor prescribed AndroGel to treat symptoms typically associated with aging: fatigue and problems with libido. Finally, as the Court understands Myers's argument, his hypogonadism would be considered non-classical even if comorbid conditions like morbid obesity caused his low testosterone levels. And in connection with the 2015 label changes, the FDA told AbbVie that the indication for "all approved testosterone replacement therapies [should] be limited to classical hypogonadism." Pl.'s Opp. at 6-7 (emphasis added). Because Myers took AndroGel for a non-indicated purpose, the FDA's position on VTE causation vis-à-vis the 2015 label changes is relevant. And its probative value would not be substantially outweighed by its claimed potential to confuse the jury about the appropriate time frame in which to judge AbbVie's conduct. The time frame can be, and is appropriately, dealt with via the Court's instructions to the jury.[1]

         c. Other post-February 2008 evidence of AbbVie's knowledge and conduct

         AbbVie has moved to exclude of documents on Myers's exhibit list that post-date February 2008. Defs.' Mot. at 6. In its motion, AbbVie discusses three specific documents: a June 2015 advertisement for AndroGel 1.62%, a 2012 e-mail discussing the "Glueck" article, and comments AbbVie made in 2010 about AndroGel sales materials. The Court has previously ruled that sales and marketing materials relate to plaintiffs' contentions regarding off-label marketing and are "generally admissible to show AbbVie's intent, motivation, and knowledge with respect to marketing." See, e.g., Prior AbbVie MIL Rulings, 2017 WL 2313201, at *5. This ruling applies with equal force in Myers's case. Separately, AbbVie's commentary on the post-February 2008 Glueck article relates to a retrospective analysis of VTE risk signals that AbbVie conducted. That analysis included information from 2003 to 2008. AbbVie's commentary on the Glueck article is therefore relevant regarding whether AbbVie "should ...


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