Davis v. Actavis, Inc. (In re Testosterone Replacement Therapy Prods. Liab. Litig.)
| Docket Number | MDL 2545,14 C 1748 |
| Decision Date | 01 November 2023 |
| Parties | In re Testosterone Replacement Therapy Products Liability Litigation v. Actavis, Inc., Case No. 17 C 3775 This document applies to Davis |
| Court | U.S. District Court — Northern District of Illinois |
CASE MANAGEMENT ORDER NO. 196 (ORDER ON PLAINTIFFS' MOTION TO EXCLUDE EXPERT TESTIMONY DEFENDANTS' MOTION TO EXCLUDE EXPERT TESTIMONY, AND DEFENDANTS' MOTION FOR SUMMARY JUDGMENT IN DAVIS V ACTAVIS, INC., CASE NO. 17 C 3775)
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 Androderm, one of the TRT products at issue in this litigation. Before the Court are the plaintiffs' motion to exclude expert testimony and Actavis's motions to exclude expert testimony and for summary judgment in Davis v. Actavis Inc. Douglas Davis and his wife, Laura Davis, allege the Douglas's use of Androderm caused the stroke that he suffered in August 2015.
The plaintiffs have moved under Federal Rule of Evidence 702 to exclude the testimony of expert witness Dr. Alan Segal. Actavis has moved to exclude the testimony of the plaintiffs' causation witnesses, Dr. Hossein Ardehali and Dr. Ronald Ziman. Actavis also has moved for summary judgment on all of the plaintiffs' remaining claims. For the following reasons, the Court denies both parties' motions to exclude. The Court grants summary judgment in favor of Actavis on the plaintiffs' express and implied breach of warranty, negligent misrepresentation, fraud, unjust enrichment, and consumer protection claims but otherwise denies Actavis's motion for summary judgment.
The Court assumes familiarity with the background as set out in its prior case management orders and therefore discusses only those details relevant to the motions at issue. The facts are undisputed except where otherwise stated.
Douglas Davis first received testosterone replacement therapy in injectable form between 2013 and 2015. He stopped taking the testosterone injections in May 2015. Davis then began seeing a new physician, Dr. Frank Avey, who ordered a new round of testing of Davis's testosterone level. On July 17, 2015, Dr. Avey noted that the testing showed that Davis's testosterone level was low. Dr. Avey then prescribed him Androderm, which supplies testosterone via a patch placed on the skin. Davis began using the Androderm patches on July 22, 2015. Davis says that when he received his Androderm prescription, it came with prescribing information last updated in 2013; as a result, it did not include an FDA-mandated cardiovascular risk warning. As of the date Dr. Avey prescribed Androderm to Davis, the FDA recently had ordered Actavis to include a warning about the drug's cardiovascular risks including the risk of stroke. Actavis revised Androderm's package insert to include the warning in May 2015. The parties dispute whether Dr. Avey was aware of this warning when he prescribed Androderm to Davis in July 2015. On August 14, 2015, after approximately 23 days of Androderm use, Davis suffered an ischemic stroke.
The plaintiffs filed suit in May 2017 asserting claims under Florida law for design defect, failure to warn, negligent misrepresentation, fraud, breach of implied and express warranty, redhibition, consumer protection, unjust enrichment, and punitive damages. Laura Davis asserted a claim for loss of consortium. In support of their claims, the plaintiffs rely on the testimony of medical experts Dr. Ardehali and Dr. Ziman that Androderm was a substantial cause of Davis's stroke. They also rely on the testimony of Dr. Joshua Sharlin, a regulatory expert, regarding Actavis's failure to respond to warning signs that Androderm was dangerous and its "off-label" marketing of Androderm. Dr. Sharlin's report states that the FDA approved Androderm only for treatment of "classical hypogonadism" but that Actavis marketed the drug as a blanket solution for low testosterone and certain associated symptoms regardless of the cause. See Sharlin Expert Rep. at 33-56. Actavis relies on testimony of its medical expert, Dr. Alan Segal, that the cause of Davis's stroke was unknown and that the stroke was not the result of his Androderm usage.
In April 2020, Actavis moved for summary judgment on the plaintiffs' failure to warn theory of liability. Actavis argued that it updated Androderm's label to include a stroke warning approximately two months before Dr. Avey prescribed Androderm to Davis and that it had no duty under Florida law to provide warnings in some manner apart from the product's FDA-approved package insert. The Court denied Actavis's motion, concluding that "[i]f the Florida Supreme Court were asked whether a prescription drug manufacturer's duty to warn is invariably limited to providing a warning via the package insert, there is reason to believe it would . . . answer in the negative-at least in the situation where, as in this case, regulatory authorities have recently mandated a change in the package insert's warnings." In re Testosterone Replacement Therapy Prod. Liab. Litig. Coordinated Pretrial Proc., No. 14 C 1748, 2020 WL 6487327, at *9 (N.D. Ill. Nov. 4, 2020) (hereinafter CMO 179).
Douglas Davis passed away on September 19, 2023. No motion for substitution of his estate or other appropriate representative has been filed as of the date this order is being entered.
The parties agree that Florida law governs the plaintiffs' claims. Under Florida law, a plaintiff must show that the defendant's conduct was "'a substantial factor in bringing about' the plaintiff's injury," although it need not be "the exclusive or even the primary cause." Ruiz v. Tenet Hialeah Healthsystem, Inc., 260 So.3d 977, 982 (Fla. 2018) (quoting Gooding v. Univ. Hosp. Bldg., 445 So.2d 1015, 1018 (Fla. 1984)). The plaintiffs' experts have provided both "general causation" and "specific causation" opinions. General causation concerns whether the product at issue had the capacity to cause the type of injury alleged, and specific causation deals with whether the product in fact caused the plaintiff's injury. See C.W. ex rel. Wood v. Textron, Inc., 807 F.3d 827, 831 (7th Cir. 2015).
The Court has assessed the general causation opinions of Dr. Ardehali and Dr. Ziman in detail in other cases in this MDL and has admitted those opinions. See In re Testosterone Replacement Therapy Prod. Liab. Litig. Coordinated Pretrial Proc., No. 14 C 1748, 2017 WL 1833173, at *2 (N.D. Ill. May 8, 2017) (hereinafter CMO 46); In re Testosterone Replacement Therapy Prod. Liab. Litig. Coordinated Pretrial Proc., No. 14 C 1748, 2018 WL 4030585 (N.D. Ill. Aug. 23, 2018); In re Testosterone Replacement Therapy Prod. Liab. Litig. Coordinated Pretrial Proc., 430 F.Supp.3d 516, 533 (N.D. Ill. 2019). Actavis advances two reasons why the Court should not do so in this case. First, Actavis argues that this Court has mistakenly employed a "weight of the evidence" approach to expert testimony rather than the "scientific method standard" that Actavis says is required by Federal Rule of Evidence 702 and the Supreme Court's decision in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). In Actavis's view, the expert testimony at issue is inadmissible under the "scientific method standard" because the "plaintiffs' experts have no scientifically recognized data demonstrating a reliable association between TRT and ischemic stroke." Actavis Mot. to Exclude at 7. Second, Actavis contends that the experts' general causation testimony must be excluded because they have no data "demonstrating an ischemic stroke can be caused by 23 days [sic] use of Androderm." Id.
Rule 702 requires a court to evaluate "(1) the proffered expert's qualifications; (2) the reliability of the expert's methodology; and (3) the relevance of the expert's testimony." Gopalratnam v. Hewlett-Packard Co., 877 F.3d 771, 779 (7th Cir. 2017). Actavis's argument focuses on the reliability of the experts' general causation opinions. To determine the reliability of expert testimony, Rule 702 directs courts to consider whether an expert's opinion is "based on sufficient facts or data," whether the opinion is "the product of reliable principles and methods," and whether that methodology has been "reliably applied . . . to the facts of the case." Fed.R.Evid. 702(b)-(d). The Seventh Circuit has explained that "reliability is determined on a case-by-case basis." C.W. ex rel. Wood, 807 F.3d at 835. The Supreme Court has "provide[d] several guideposts for determining reliability" including "(1) whether the scientific theory has been or can be tested; (2) whether the theory has been subjected to peer-review and/or academic publication; (3) whether the theory has a known rate of error; and (4) whether the theory is generally accepted in the relevant scientific community." Id. But this list "is neither exhaustive nor mandatory." Id. Among other things, a district court may determine that an expert opinion is unreliable if there is "too great an analytical gap between the data and the opinion proffered." Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997).
Actavis repeatedly asserts that "Rule 702 and Daubert require that expert testimony be evaluated to make sure it is grounded in the procedures and methods of science," the Court should "apply the...
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