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In re Testosterone Replacement Therapy Products Liability Litigation

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

December 30, 2019

In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings
Actavis, Inc., No. 15 C 4292 This document applies to Martin



         Plaintiffs in this multidistrict litigation (MDL) proceeding allege that they suffered either arterial cardiovascular injuries or injuries related to blood clots in the veins (venous thromboembolisms) as a result of taking prescription testosterone replacement therapy (TRT) drugs. Defendants Actavis, Inc., Actavis Pharma, Inc., and Actavis Laboratories UT, Inc. (collectively, Actavis) manufacture or sell Androderm, one of the TRT products at issue in this litigation.[1] Plaintiff Brad Martin alleges that his use of Androderm from October 2012 to May 2013 caused him to suffer a myocardial infarction (heart attack) in May 2013. He asserts claims against Actavis under Minnesota law for design defect; failure to warn; negligence; breach of express warranty; breach of implied warranty of merchantability; negligent misrepresentation; fraudulent misrepresentation; redhibition; consumer protection (specifically, violation of the Minnesota False Statement in Advertising Act (MFSAA), Minn. Stat. § 325F.67, and the Minnesota Deceptive Trade Practices Act (MDPTA), Minn. Stat. § 325D.44(13)); unjust enrichment; and punitive damages.

         In 2018, based on proposals from Actavis and the Plaintiffs' Steering Committee, the Court selected Martin's case as the first Actavis bellwether trial case. Before trial, Actavis moved to exclude the testimony of several of Martin's expert witnesses under Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). Actavis also moved for summary judgment on the ground that Martin's failure to warn, design defect, and so-called "off-label promotion" claims are preempted by federal law. Finally, Actavis contended that all of Martin's claims fail under Minnesota law, which the parties agree applies. The motions were fully briefed in June 2018, but in July 2018, the Court terminated them as moot due to the execution of a Master Settlement Agreement covering cases involving Actavis. In August 2019, Martin informed the Court that he has elected not to settle his claims. Thus Actavis's Daubert and summary judgment motions are again before the Court.

         For the following reasons, the Court denies Actavis's motion for summary judgment based on federal preemption; denies Actavis's motion to exclude Martin's expert testimony concerning general and specific causation; and terminates as moot Actavis's motion to exclude the expert testimony of Robert Johnson. The Court grants Actavis's motion for summary judgment on Martin's claims for breach of implied warranty of merchantability, negligent misrepresentation, unjust enrichment, redhibition, and violation of the MFSAA; reserves judgment on Actavis's motion for summary judgment on claims against Actavis, Inc.; and denies Actavis's motion in all other respects.


         The Court has ruled on motions raising similar issues in cases brought against AbbVie and Auxilium, other defendants in this MDL, concerning their TRT drugs AndroGel and Testim. See In re Testosterone Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial Proceedings, No. 14 C 1748, MDL No. 2545, 2018 WL 4030585 (N.D. Ill. Aug. 23, 2018) ("CMO 133"); In re Testosterone Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial Proceedings, No. 14 C 1748, MDL No. 2545, 2018 WL 4030586 (N.D. Ill. Aug. 23, 2018) ("CMO 132"); In re Testosterone Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial Proceedings, No. 14 C 1748, MDL No. 2545, 2017 WL 4772759 (N.D. Ill. Oct. 23, 2017) ("CMO 76"); In re Testosterone Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial Proceedings, No. 14 C 1748, MDL No. 2545, 2017 WL 1836443 (N.D. Ill. May 8, 2017) ("CMO 48"); In re Testosterone Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial Proceedings, No. 14 C 1748, MDL No. 2545, 2017 WL 1836435 (N.D. Ill. May 8, 2017) ("CMO 47"); In re Testosterone Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial Proceedings, No. 14 C 1748, MDL No. 2545, 2017 WL 1833173 (N.D. Ill. May 8, 2017) ("CMO 46"). The Court assumes familiarity with those orders but discusses them as necessary throughout this order. In addition, the Court takes the following factual background from Martin's and Actavis's briefs and exhibits. For summary judgment purposes, where facts are in dispute, the Court recounts them in the light most favorable to Martin, the non-moving party.

         A. Hypogonadism

         Male hypogonadism is an endocrine disorder characterized by abnormally low levels of testosterone in the blood. "Classical" hypogonadism falls into two categories: "primary" and "secondary." Primary hypogonadism is the failure of testicles to produce adequate levels of testosterone, and it is caused by medical conditions such as Klinefelter syndrome and physical injuries to the testicles. Secondary hypogonadism results from a disorder of the pituitary gland or the hypothalamus. In adult males, hypogonadism may be accompanied by signs and symptoms including reduced libido, fatigue, infertility, depressed mood, and reduced muscle mass.

         It is normal for testosterone levels to decline in men as they age. An age-related decline in testosterone is not "classical" hypogonadism and is generally not considered to be a medical condition that requires treatment. Like other plaintiffs in this proceeding, Martin contends that Actavis (along with other TRT manufacturers) created a fictitious condition called "age-related hypogonadism"-also referred to as "andropause" or "Low T"-and improperly marketed Androderm for the treatment of that supposed condition. Martin maintains that Androderm has never been proven safe or effective for that use. He also argues that Androderm does not provide significant relief for the symptoms of aging and that it increases the risk of cardiovascular injuries such as heart attacks.

         B. Regulatory history of Androderm

         The Food and Drug Administration (FDA) has approved numerous testosterone products to treat classical hypogonadism. In 1981, it issued a Class Labeling Guideline for androgens, a group of hormones that includes testosterone. See Expert Report of Dr. Peggy Pence ("Pence Report"), Ex. 2 to Martin Opp. to Actavis Mot. for Summ. J. Based on Federal Preemption ("Martin Preemption Opp."), ¶ 147. The Class Labeling Guideline was intended to promote consistency in labeling of drugs in the same class. See Id. ¶ 149. Among other things, it defined the FDA-approved uses for androgens. See Id. ¶ 150.

         Androderm is a testosterone transdermal system, meaning a patch that delivers testosterone to the body through the skin. The FDA approved Androderm in September 1995 for the treatment of male hypogonadism. The initial approval was for a 2.5 milligram strength. Between September 1995 and October 2011, the FDA approved supplemental new drug applications for Androderm in several different strengths. The FDA approved a new label in October 2011 to reflect the new strengths, but neither Martin nor Actavis contends that the label change is relevant to this case. In April 2012, the FDA approved a new label to account for the discontinuation of old strengths. Actavis says that between September 1995 and April 2012, the Androderm label followed the Class Labeling Guideline. Martin contends that during that time, the label "was not identical to the class labeling." Martin Resp. to Actavis Local Rule 56.1 Stat. ¶ 39. But he does not identify which portions of the Androderm label were different or explain why the differences are relevant. The Court, therefore, assumes that the differences, if any, are not material to this case.

         The April 2012 label was in effect when Martin was prescribed and used Androderm. Actavis points out that the label referenced signs and symptoms of hypogonadism, as follows:

Signs/symptoms associated with male hypogonadism include erectile dysfunction and decreased sexual desire, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics, and osteoporosis.

See Actavis Mot. for Summ. J. Based on Federal Preemption ("Actavis Preemption Mot.") at 4 (quoting April 2012 Androderm Label, Ex. 9 to Actavis Mot. for Summ. J. Based on State Law ("Actavis Mot. for Summ. J."), Full Prescribing Information § 12.1).

         The FDA has, at various times, considered requiring TRT manufacturers and sellers, including Actavis, to warn about the risk of cardiovascular injuries that might accompany TRT use. The regulatory history is recounted in detail in the Court's prior orders. See, e.g., CMO 76, 2017 WL 4772759, at *3-4; CMO 47, 2017 WL 18366435, at *1-4. In May 2015, the FDA required Actavis to add the following warning to the Warnings and Precautions section of the Full Prescribing Information in the Androderm label:

5.4 Cardiovascular Risk
Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE) such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or continue to use ANDRODERM.

         May 2015 Androderm Label, Ex. 10 to Actavis Mot. for Summ. J., Full Prescribing Information § 5.4; see Actavis Preemption Mot. at 4, 9. The FDA also required Actavis to add the following language to the Limitations of Use section of the Full Prescribing Information: "Safety and efficacy of ANDRODERM in men with 'age-related hypogonadism' (also referred to as 'late-onset hypogonadism') have not been established." May 2015 Androderm Label, Full Prescribing Information § 1; see Actavis Preemption Mot. at 9. The "Highlights of Prescribing Information" section of the May 2015 Androderm label cross-references the FDA-mandated changes. Martin contends that Actavis should have made similar changes to the Full Prescribing Information before he was prescribed Androderm in October 2012.

         C. Martin's use of Androderm

         Martin was a Minnesota resident at all times relevant to this dispute. Before he began taking Androderm in October 2012, he suffered from various health problems. According to medical records from 2006, for example, Martin had hyperlipidemia (a high concentration of fats or lipids in the blood), hypercholesterolemia (high cholesterol), hypertension (high blood pressure), and elevated blood sugar. He took medications for some of these conditions, but the parties dispute the extent to which Martin managed them. Martin concedes that he is a former smoker and a recovering alcoholic. He also acknowledges that some of his close family members have had cardiovascular problems: his father had an angioplasty to clear clogged arteries in his heart; his mother had coronary artery bypass surgery; and one of his brothers had a stroke.

         Martin testified during his deposition that beginning in 2011 or 2012, he felt "fatigued all the time." Dep. of Brad Martin ("Martin Dep."), Ex. 3 to Martin Summ. J. Opp., at 135:19-136:8. Martin's medical records indicate that he discussed the fatigue with his primary care physician, Dr. Stephen Firestone, during an annual physical in August 2012. See Martin St. Cloud VA Health System Records ("Martin Medical Records"), Ex. 2 to Martin Summ. J. Opp., at 000148-49. On October 15, 2012, Amy Hopkins-the nurse that worked with Dr. Firestone-spoke with Martin about his fatigue and a new medication he had started. See Id. at 000141. According to Ms. Hopkins's notes in the records, Martin told her, "I don't feel like I should. I still have no energy, no motivation to do things. I don't feel depressed. I just feel fatigued all the time. I was wondering if it could be related to my testosterone level?" Id. Ms. Hopkins's notes also state, in relevant part: "[V]eteran requesting testosterone level check. Plan: Will consult with PCP Firestone on above. Will return call to veteran with further orders or instructions." Id. at 000143.

         On October 16, 2012, Ms. Hopkins wrote in Martin's medical records, "Consulted PCP Firestone. Chart reviewed. PCP orders: ok to check testosterone level, will supplement if necessary . . . . Veteran notified by phone . . . . Veteran is agreeable to have his testosterone level checked." Id. Martin had his testosterone level checked on October 19, 2012. The test showed that his level was in the "low end of [the] normal range." Id. at 000122. Ms. Hopkins reported the result to Martin and noted in his chart:

Veteran reports "I have been doing some research on my own, trying to weigh the benefits versus risk of supplementing testosterone levels. All I really could find is the risk for prostate cancer, really."
Today's lab results reviewed with veteran.
Testosterone 345 10/19/2012
Veteran inquires if Dr. Firestone would consider trialing supplementation, even though his result is low end of normal range. Verbalizes understanding of risks.
Plan: Discussed with PCP Firestone. PCP orders: ok to trial low dose testosterone 2mg patch. Recheck level in 1-2 months.
Veteran notified of above, and is agreeable with plan. Will schedule lab only appt in 1-2 months, to recheck testosterone level and effects.


         Dr. Firestone prescribed Androderm to Martin on October 19, 2012, and Martin filled his first prescription that day. Approximately one month later, on November 15, 2012, Martin visited Ms. Hopkins for a follow-up appointment. According to the records of that visit, Martin "report[ed] compliance with testosterone patches," stated that his "energy level [was] so much better," reported improvements in his libido, and "denie[d] any side effects or concerns with . . . use/application" of Androderm. Id. at 000121. Ms. Hopkins noted, "Therapeutic medication regimen, effective r/t management of testosterone level, libido and fatigue. Plan: Veteran would like to continue with testosterone patches at this time. Offers no further concerns or questions. . . . Will update PCP of above." Id. Martin refilled Androderm prescriptions in November 2012, December 2012, February 2013, and April 2013. On May 25, 2013, when Martin was 52 years old, he had a heart attack. It is undisputed that Dr. Firestone is deceased and has not given a deposition in this action.


         Summary judgment is appropriate if the moving party "shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(a). There is a genuine issue of material fact, and summary judgment is precluded, "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). When ruling on a motion for summary judgment, a court views the record in the light most favorable to the non-moving party and draws all reasonable inferences in that party's favor. Id. at 255; see also Driveline Sys., LLC v. Arctic Cat, Inc., 936 F.3d 576, 579 (7th Cir. 2019). "The court does not assess the credibility of witnesses, choose between competing reasonable inferences, or balance the relative weight of conflicting evidence." Driveline Sys., 936 F.3d at 579 (internal quotation marks omitted).

         A. Preemption

         Actavis contends that Martin's failure to warn, design defect, and so-called "off-label promotion" claims are preempted by federal law. As discussed below, the Court disagrees.

         1. Failure to warn

         Federal preemption "occurs when a state law is invalidated because it conflicts with a federal law." Mason v. SmithKline Beecham Corp., 596 F.3d 387, 390 (7th Cir. 2010). Courts have identified three forms of preemption: (1) express preemption, which occurs when Congress clearly declares its intent to preempt state law; (2) implied preemption, which occurs when the structure and purpose of federal law demonstrates Congress's intent to preempt state law; and (3) conflict preemption, which occurs when there is "an actual conflict between state and federal law such that it is impossible for a person to obey both." Dolin v. GlaxoSmithKline LLC, 901 F.3d 803, 811 (7th Cir. 2018) (internal quotation marks omitted); see also Mason, 596 F.3d at 390. Actavis relies on conflict preemption; it contends that Martin's failure to warn claims are preempted because it would be impossible to comply with both FDA labeling requirements and state-law duties on which the claims are premised.

         The Supreme Court has held that state-law failure to warn claims concerning prescription drugs are preempted only where there is "clear evidence" that the FDA would have rejected the proposed label change. Wyeth v. Levine, 555 U.S. 555, 571-72 (2009); see Dolin, 901 F.3d at 812. The Court explained that typically, "a manufacturer may only change a drug label after the FDA approves a supplemental application." Wyeth, 555 U.S. at 568. But the FDA's "changes being effected" (CBE) regulation makes an exception; it "permits a manufacturer to make certain changes to its label before receiving the agency's approval." Id. The CBE regulation, for example, allows a manufacturer to "add or strengthen a contraindication, warning, precaution, or adverse reaction" without waiting for the FDA to approve the change. Id. (citing 21 C.F.R. § 314.70(c)(6)(iii)(A)). This type of change must "reflect newly acquired information" and be supported by "reasonable evidence of a causal association with [the] drug." 21 C.F.R. § 314.70(c)(6)(iii)(A); 21 C.F.R. § 201.57(c)(6)(i).

         Applying the standard set forth in Wyeth to failure to warn claims asserted previously in this MDL, this Court determined that the record lacked "clear evidence" that the FDA would have rejected efforts by AbbVie and Auxilium to add warnings about cardiovascular risk to their TRT drug labels. See CMO 76, 2017 WL 4772759, at *10-11; CMO 47, 2017 WL 1836435, at *7-11. Subsequently-and after Actavis's summary judgment and Daubert motions were fully briefed-the Supreme Court clarified the meaning of "clear evidence" under Wyeth. It held that "clear evidence" means "evidence that shows the court that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug's label to include that warning." Merck Sharp & Dohme Corp. v. Albrecht, 139 S.Ct. 1668, 1672 (2019). The Supreme Court also stated that "the only agency actions that can determine the answer to the pre-emption question . . . are agency actions taken pursuant to the FDA's congressionally delegated authority," such as "notice-and-comment rulemaking setting forth labeling standards" or "formally rejecting a warning label that would have been adequate under state law." Id. at 1679. And it held that the question of preemption "is a legal one for the judge, not a jury," to decide. Id.

         The regulatory history for Androderm is similar in all material respects to that of AbbVie and Auxilium's TRT drugs. Actavis advances several arguments that it contends support a different result in Martin's case, but none is persuasive.

         a. Changes to the Highlights section of a label

         First, Actavis argues that it would have been legally impossible to use the CBE process to make the label changes Martin contends were necessary: adding warnings, similar to those the FDA required in May 2015, concerning (1) increased cardiovascular risk and (2) lack of proven safety and efficacy for treating age-related hypogonadism. Actavis's theory is that if it had tried to add these warnings to the Full Prescribing Information, it would have had to add them to the Highlights section as well. But changes to the Highlights section, Actavis points out, cannot be made through the CBE process; rather, they require FDA pre-approval. See 21 C.F.R. § 314.70(b)(2)(v)(C) (with several exceptions that are inapplicable here, "any change to the information required by § 201.57(a) of this chapter"-i.e. the Highlights section-"require[es] supplement submission and approval prior to distribution of the product made using the change"). In other words, Actavis argues that "if a change to [the] Full Prescribing Information section requires a corresponding change to Highlights, the Full Prescribing Information section also cannot be changed independently." Actavis Preemption Mot. at 8. According to Actavis, this principle applies in Martin's case-even though Martin never alleged that Actavis should have made changes to the Highlights section- because the Highlights section cross-references the FDA-mandated changes to the Full Prescribing Information.

         Actavis is correct that the Highlights section of the label and the Full Prescribing Information must contain many of the same categories of information, including "indications and usage," "dosage and administration," and "warnings and precautions." Compare 21 C.F.R. § 201.57(a)(6), (7), (10) with Id. § 201.57(c)(2), (3), (6). But the Highlights section does not contain all of the information that appears in the Full Prescribing Information. See Id. § 201.57(a)(1) (providing that the Highlights section must state, "These highlights do not include all the information needed to use [the drug] safely and effectively. See full prescribing information for [the drug]."); see also Id. § 201.57(a)(6) (the Highlights section must reference "[m]ajor limitations of use" (emphasis added)); id. § 201.57(a)(10) (the Highlights section must provide "[a] concise summary of the most clinically significant information required under" the warnings and precautions section of the Full Prescribing Information, "including information that would affect decisions about whether to prescribe a drug . . . ." (emphasis added)). Actavis's argument thus appears to be that when changes to the Full Prescribing Information are so critical that they must also appear, in some form, in the Highlights section, the FDA prohibits manufacturers from using the CBE process to change the Full Prescribing Information.

         Actavis cites no case law that supports its theory, and the Court concludes that it is misguided. Actavis, for example, does not cite any authority providing that the Highlights section and the Full Prescribing Information must be changed simultaneously. The relevant regulation, moreover, appears to contemplate a temporal gap between "major" label changes and corresponding updates to the Highlights section. See 21 C.F.R. § 201.57(a)(5) (Highlights section must contain a "list of the section(s) of the full prescribing information . . . that contain(s) substantive labeling changes that have been approved by FDA or authorized under § 314.70(c)(6)" and must contain "the date . . . on which the change was incorporated in labeling" (emphasis added)). The Court thus sees no reason why a drug manufacturer could not first make a change to the Full Prescribing Information using the CBE process and later seek FDA approval to make a corresponding change to the Highlights section if the FDA determines that a corresponding change is required.

         Actavis's theory is also problematic because it would severely limit the scope of the CBE process. The CBE provision at issue does reiterate that changes to the Highlights section cannot be made without FDA pre-approval. See 21 C.F.R. § 314.70(c)(6)(iii) (citing 21 C.F.R. § 314.70(b)(2)(v)(C)). But that same CBE provision expressly permits a manufacturer to change the label "to reflect newly acquired information . . . to accomplish" several purposes-including to "add or strengthen a contraindication, warning, precaution, or adverse reaction" for which there is reasonable evidence of a causal association, "add or strengthen a statement about drug abuse," "add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product," and "delete false, misleading, or unsupported indications for use or claims for effectiveness." 21 C.F.R. § 314.70(c)(6)(iii)(A)-(D).

         These purposes directly implicate consumer safety. One could argue that almost any change made to accomplish these purposes concerns a "major" limitation of use or adds "information that would affect" a prescribing decision-and as noted, such a change must be referenced in the Highlights section. 21 C.F.R. §§ 201.57(a)(6), (a)(10). Under Actavis's logic, a drug manufacturer would not be able to use the CBE process to make this kind of change. This would mean that the CBE process would be available only for minor label changes that are inconsequential for safety and efficacy. But the plain language of the CBE provision at issue suggests the opposite, not least because it permits a manufacturer to add or strengthen a contraindication or warning. See 21 C.F.R. § 314.70(c)(6)(iii)(A). The case law, too, indicates that the CBE process has broader applicability. In Wyeth, for example, the Supreme Court determined that "the CBE regulation permitted" a drug manufacturer to warn about "the risk of gangrene from IV-push injection" of the drug "before receiving the FDA's approval." 555 U.S. at 571. That warning was hardly inconsequential.

         For these reasons, and absent controlling authority providing otherwise, the Court declines to adopt a statutory interpretation that would prevent drug manufacturers from making significant safety- and efficacy-related label changes using the CBE process. See Gracia v. Sessions, 873 F.3d 553, 557 (7th Cir. 2017) ("Canons of statutory construction discourage an interpretation that would render a statute meaningless . . . ."); Scherr v. Marriott Int'l, Inc., 703 F.3d 1069, 1078 (7th Cir. 2013) (declining to "construe regulations in such a way as to render other provisions of the regulations meaningless or ...

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