In re Testosterone Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial Proceedings

430 F.Supp.3d 516

IN RE TESTOSTERONE REPLACEMENT THERAPY PRODUCTS LIABILITY LITIGATION COORDINATED PRETRIAL PROCEEDINGS

(This document applies to Martin v. Actavis, Inc.)

Case No. 14 C 1748

MDL No. 2545

Case No. 15 C 4292

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

Signed December 30, 2019

CASE MANAGEMENT ORDER NO. 166

(Memorandum Opinion and Order on Actavis, Inc.'s motion to exclude expert testimony and motions for summary judgment in Martin v. Actavis, Inc. , Case No. 15 C 4292)

MATTHEW F. KENNELLY, District Judge:

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, 113 S.Ct. 2786, 125 L.Ed.2d 469 (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.

Background

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 1836435, 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

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