Martin v. Actavis, Inc. (In re Testosterone Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial Proceedings)
| Decision Date | 02 August 2020 |
| Docket Number | Case No. 14 C 1748,MDL No. 2545 |
| Parties | In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings (This document applies to Martin v. Actavis, Inc., Case No. 15 C 4292) |
| Court | U.S. District Court — Northern District of Illinois |
(Memorandum Opinion and Order on Actavis, Inc.'s motion to exclude the testimony of Plaintiff's expert Joshua Sharlin, Ph.D. in Martin v. Actavis, Inc., Case No. 15 C 4292)
In this multidistrict litigation (MDL) proceeding, Plaintiff Brad Martin alleges that he suffered a myocardial infarction (heart attack) as a result of taking Androderm, a prescription testosterone replacement therapy (TRT) drug manufactured or sold by Defendants Actavis, Inc., Actavis Pharma, Inc., and Actavis Laboratories UT, Inc. (collectively, Actavis). In August 2019, Martin informed the Court that he has elected not to settle his claims under the Master Settlement Agreement covering cases involving Actavis. In December 2019, the Court denied Actavis's motion to exclude expert testimony concerning general and specific causation; denied Actavis's motion for summary judgment based on federal preemption; and granted in part and denied in part Actavis's motion for summary judgment on Martin's state law claims. See In re Testosterone Replacement Therapy Prods. Liability Litig. Coordinated Pretrial Proceedings, 430 F. Supp. 3d 516 (N.D. Ill. 2019) (CMO 166).
In January 2020, the Court granted Martin's motion to substitute a new expert witness—Dr. Joshua Sharlin—for Dr. Peggy Pence, who had been serving as Martin's Food and Drug Administration (FDA) regulatory expert, and whose opinions Actavis did not move to exclude. Actavis now moves to exclude a number of opinions that Dr. Sharlin offers. The Court addresses Actavis's motion in this decision.
The Court assumes familiarity with its prior orders in the MDL but discusses them as necessary here.
Dr. Pence has provided expert reports, deposition testimony, and trial testimony for plaintiffs in this MDL whose cases were selected for bellwether trials. Her expertise includes ensuring that prescription drugs are researched, developed, labeled, and marketed in compliance with FDA requirements. In Martin's case, Dr. Pence submitted an expert report and provided deposition testimony. Among other things, she opined that Actavis should have added a cardiovascular (CV) risk warning to the Androderm label by 2007 and that the warning should have been similar to the one that the FDA required Actavis to add in May 2015. She also opined that Actavis marketed Androderm for the treatment of age-related hypogonadism, an off-label use, despite that it knew or should have known about the CV risk and that the safety and efficacy of the off-label use have not been established.
In November 2019, for reasons that are irrelevant here, Dr. Pence told Martin that she could not serve as his FDA regulatory expert at trial. As noted, the Court granted Martin's motion to substitute Dr. Sharlin. Dr. Sharlin then submitted an expert report. He "adopt[ed] Dr. Pence's report, including her conclusions" but explained that he "independently reached [his] own conclusions." Actavis's Mot. to Exclude the Testimony of Pl.'s Expert Joshua Sharlin, Ph.D., Ex. 2 (Sharlin Report) [129-2] ¶ 192.Like Dr. Pence, Dr. Sharlin opines that Actavis should have added a CV risk warning to the Androderm label before the FDA required it to do so in May 2015. According to Dr. Sharlin, Actavis should have added the warning by 2011. Dr. Sharlin also opines that Actavis promoted Androderm for the treatment of age-related hypogonadism. Actavis challenges these and other opinions under Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).
Before filing its Daubert motion, Actavis moved to strike Dr. Sharlin's expert report. The Court granted the motion in part following a hearing on February 14, 2020. It excluded Dr. Sharlin's opinions about the total number of CV-related events for TRT drugs allegedly extracted from the FDA's adverse event reporting system (FAERS) database using targeted search terms. The Court determined that those opinions went "significantly beyond" what Dr. Pence previously disclosed in her expert report and deposition testimony and that Martin's failure to disclose the opinions was not substantially justified or harmless. Actavis Reply in Supp. of Mot. to Exclude, Ex. 1 (Feb. 14, 2020 Hr'g Tr.) [148-1] at 6:4-7, 7:2-14 (). The excluded material, the Court explained, is referenced in "the first two bullet points on page 6 of Actavis' motion to strike." Id. at 7:15-17. Those bullet points are reproduced here:
Actavis Mot. to Strike [108], at 6. The Court denied Actavis's motion to strike in all other respects. Actavis took Dr. Sharlin's deposition in February 2020. In May 2020, Actavis moved to strike changes in the errata sheet attached to the deposition transcript. The Court denied the motion, and neither side has indicated that the contents of the errata sheet are relevant to the present Daubert dispute.
Federal Rule of Evidence 702 and the principles set forth in Daubert govern the admissibility of expert testimony. "In Daubert, the Supreme Court interpreted Rule 702 to require the district court to act as an evidentiary gatekeeper, ensuring that an expert's testimony rests on a reliable foundation and is relevant to the task at hand." Gopalratnam v. Hewlett-Packard Co., 877 F.3d 771, 778 (7th Cir. 2017) (internal quotation marks omitted). To this end, the district court must engage in what is essentially a three-step analysis: it must determine whether (1) the expert is qualified; (2) the reasoning or methodology underlying the expert's testimony is reliable; and (3) the testimony is relevant, meaning likely to assist the trier of fact to understand the evidence or to determine a fact in issue. Id. at 779 (citing Myers v. Ill. Cent. R.R. Co., 629 F.3d 639, 644 (7th Cir. 2010)). The expert's testimony is admissible only if all three hurdles are cleared.
The district court's role as gatekeeper is meant to ensure that an expert "employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field." Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999). In exercising its gatekeeping role, a court does not ask whether the expert "is qualifiedin general," but rather whether he is qualified "to answer a specific question." Gayton v. McCoy, 593 F.3d 610, 617 (7th Cir. 2010) (quoting Berry v. City of Detroit, 25 F.3d 1342, 1351 (6th Cir. 1994)). Further, a court should focus on the expert's "principles and methodology" rather than on his conclusions, Daubert, 509 U.S. at 595, or the "factual underpinnings" of those conclusions. Walker v. Soo Line R.R. Co., 208 F.3d 581, 586 (7th Cir. 2000). That said, an opinion must be connected to the existing data by more than an expert's "ipse dixit." Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997). An opinion may be inadmissible if there is "too great an analytical gap between the data and the opinion proffered." Id. An opinion must also "fit the issue to which the expert is testifying and be tied to the facts of the case." Owens v. Auxilium Pharm., Inc., 895 F.3d 971, 973 (7th Cir. 2018) (internal quotation marks omitted).
1. Qualifications
Actavis moves to exclude Dr. Sharlin's opinion that "[b]ased on clinical trials, [FAERS] reports, and research studies conducted by others, Actavis should have warned about major adverse cardiovascular events (MACE) associated with Androderm by 2011." Actavis Mem. in Supp. of Mot. to Exclude (Actavis Br.) [128] at 2 (citing Mot. to Exclude, Ex. 1 (Sharlin Dep.) [129-1] at 147:15-23, 148:5-16). Actavis argues that Dr. Sharlin is not qualified to offer this opinion because he "is not an expert in epidemiology, pharmacology, or medicine"; "has no experience with [TRT] drugs or the condition or treatment of hypogonadism"; and repeatedly insisted during his deposition that he is offering opinions only on "regulatory compliance." Actavis Br. at 1. Without this professional experience, Actavis contends, Dr. Sharlin cannot properly "evaluateavailable scientific evidence or draw any conclusions from such data" about whether there is reasonable evidence of a causal association between adverse CV events and Androderm use. Id. at 3-4.
Actavis is incorrect to fault Dr. Sharlin for his lack of experience in epidemiology, pharmacology, and, medicine. In this MDL, the Court has ruled that an FDA regulatory expert can rely on a causation expert's scientific opinions to reach conclusions about what a pharmaceutical company should have done when confronted with scientific evidence. See, e.g., In re Testosterone Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial Proceedings, No. 14 C 1748, 2017 WL 1836443, at *14 (N.D. Ill. May 8, 2017) (CMO 48) (determining that it was appropriate for FDA regulatory expert, Dr. David Kessler, "to rely on the testimony of plaintiffs'...
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