Juliana A. Bunting as Personal Representative of the Estate of Kenneth F. Bunting v. AbbVie Inc.

CourtDistrict Court, N.D. Illinois
DecidedFebruary 7, 2023
Docket1:15-cv-09699
StatusUnknown

This text of Juliana A. Bunting as Personal Representative of the Estate of Kenneth F. Bunting v. AbbVie Inc. (Juliana A. Bunting as Personal Representative of the Estate of Kenneth F. Bunting v. AbbVie Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Juliana A. Bunting as Personal Representative of the Estate of Kenneth F. Bunting v. AbbVie Inc., (N.D. Ill. 2023).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ILLINOIS EASTERN DIVISION

In re Testosterone Replacement ) Therapy Products Liability Litigation ) Case No. 14 C 1748 ) MDL No. 2545 ) (This document applies to ) Bunting v. AbbVie Inc., Case No. 15 C 9699) )

CASE MANAGEMENT ORDER NO. 192 (Order on AbbVie's motion for summary judgment in Bunting v. AbbVie Inc., No. 15 C 9699)

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 AbbVie Inc., AbbVie Products LLC, Abbott Laboratories, Inc., and Unimed Pharmaceuticals, Inc (collectively, AbbVie) manufacture AndroGel, one of the TRT products at issue in this litigation. Juliana Bunting, who is suing in the dual capacity of personal representative of the estate of her late husband, Kenneth Bunting and on her own behalf, alleges that Kenneth Bunting's use of AndroGel in 2013 and 2014 caused his death from a heart attack in April 2014.1 The plaintiffs assert wrongful death and survival claims of strict liability, negligence, negligent misrepresentation, breach of warranty, and redhibition, as well as other claims.

1 Where necessary to avoid confusion, the Court will refer to Juliana Bunting and Kenneth Bunting by their first names and the estate of Kenneth Bunting as "the Estate." AbbVie has moved for summary judgment on all of the plaintiffs' claims. For the following reasons, the Court denies AbbVie's motion for summary judgment on Juliana's wrongful death claim as it relates to the strict liability failure to warn, negligent failure to warn, strict liability design defect, fraud, negligent representation, and consumer

protection claims. The Court otherwise grants the motion for summary judgment. Background

The Court assumes familiarity with the background as set out in its prior case management orders and therefore discusses only those details uniquely relevant to the plaintiffs' claims. The Court recounts the following facts from the parties' Local Rule 56.1 statements, exhibits, and summary judgment briefing. The facts are undisputed except where otherwise stated. A. Kenneth's medical history Kenneth suffered from diffuse coronary artery disease, diabetes, hypertension, high cholesterol, and obstructive sleep apnea. He began using prescription testosterone injections in 1999 and first met with Dr. Karl Kochendorfer on December 23, 2010. During that visit, Kenneth asked Dr. Kochendorfer about continuing his injectable TRT prescription. Dr. Kochendorfer testified during his deposition that he believes he discussed the cardiovascular risks of TRT with Kenneth in 2010, stating: In my first note at the very bottom of the note in the assessment and plan, I documented that we discussed [Kenneth]'s testosterone, taking of that. I counseled [Kenneth] on it. Typically for me and what I recall from med school and others that there may be an increased [cardiovascular] risk, and I tried to counsel him about that potential, even during that first visit, that was—I made one line in the note about the discussion of testosterone replacement.

I believe that I shared with [Kenneth] there might be cardiovascular risk while taking testosterone or the potential of it. I believe I did discuss possible cardiovascular risk with [Kenneth] at [the December 23, 2010] visit.

Pls.' LR 56.1 Stat., Ex. A, Kochendorfer Dep. Tr. ("Kochendorfer Dep."), at 22:8– 16, 23:1–3, 98:2–3 (dkt. no. 53-2). Dr. Kochendorfer continued Kenneth's injectable TRT prescription until May 2012, when Kenneth switched to a testosterone patch called Androderm. After using Androderm for several months and seeing a commercial for AndroGel, Kenneth emailed Dr. Kochendorfer in November 2012 to ask about switching to AndroGel. Kenneth and Dr. Kochendorfer discussed switching to AndroGel during their December 2, 2012 appointment. Dr. Kochendorfer stated that he "[felt] like [his] discussion about risks happened in [the December 2010] visit" and that he did not recall discussing the specific risks of AndroGel with Kenneth during the December 2012 appointment. Kochendorfer Dep. at 66:24–67:4. When asked if he had prescribed AndroGel for Kenneth, Dr. Kochendorfer answered that he did not see an order for AndroGel in his note of the appointment, which usually includes any orders he places. He also testified that he does not prescribe AndroGel very often and that he did not know if he had ever initiated an AndroGel prescription himself. Kenneth's prescription records, however, indicate that Kenneth filled a prescription for AndroGel in January and May 2013 that listed Dr. Kochendorfer as the prescriber. After reviewing those records, Dr. Kochendorfer stated that it appeared he had written an AndroGel prescription for Kenneth. Dr. Kochendorfer moved to a different medical practice in December 2012 and had no communications with Kenneth after their December 2, 2012 appointment. He transferred Kenneth's care to Dr. Aaron Gray, who met with Kenneth for the first time on March 18, 2013. Dr. Gray's records from that appointment note that Kenneth had low testosterone and had used "Androderm in [the] past but switched to cheaper AndroGel." Pls.' LR 56.1 Stat., Ex. E at 1 (dkt. no. 53-6). Dr. Gray treated Kenneth and continued

his AndroGel prescription until April 2014, when Kenneth died after suffering a heart attack. B. Dr. Kochendorfer's knowledge During his deposition, Dr. Kochendorfer also testified about his own knowledge of the risks of TRT when he discussed the treatment with Kenneth in December 2010. He stated: I believe I was under the impression that testosterone replacement might increase myocardial or cardiovascular events or risks. I believe that was something that I might have been taught either in med school or by other teachers in residency or picked up in some other way in grand rounds or lectures or—or other means, and so I do believe it was a consideration of mine in that first visit.

Kochendorfer Dep. at 94:8–15. He testified that he did not know "specifically where [he] would have learned that information" and that "[i]n addition to other educational forums [and] training," he relied on a software application named Epocrates as "a quick easy reference" in clinical care regarding the risks and benefits of the treatments he prescribes. Id. at 94:17–19, 95:22–96:3. He stated that he did not recall reading AndroGel's medication label itself or seeing any advertising for AndroGel. Additionally, Dr. Kochendorfer testified that even if information about the risks of TRT may not have been on Epocrates when he met with Kenneth, he did "feel like [he] was taught or was aware of potential cardiovascular risk." Id. at 96:22–24. Later in the deposition, he explained that the source of his knowledge of the risks of TRT in 2011 and 2012 would have been either "[his] training or taking into account [that] increased levels of lipids or hemoglobin or hematocrit, you know, might be a predisposition to a cardiovascular event." Id. at 98:23–99:2. In contrast, Dr. Kochendorfer stated that he did not recall a 2015 memorandum

from the Food and Drug Administration (FDA) indicating that "the agency had become aware that manufacturers were promoting [TRT] off-label for men who had low- testosterone due to aging or other conditions." Id. at 102:2–5. Nor did he know that in 2018 the FDA informed AbbVie and other manufacturers that it "had become aware of clinically meaningful increases of blood pressure associated with taking testosterone." Id. at 106:9–11.

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Juliana A. Bunting as Personal Representative of the Estate of Kenneth F. Bunting v. AbbVie Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/juliana-a-bunting-as-personal-representative-of-the-estate-of-kenneth-f-ilnd-2023.