Butler v. Juno Therapeutics, Inc.

• Decision Date: 27 May 2021
• Docket Number: CIVIL ACTION NO. H-18-898
• Citation: 541 F.Supp.3d 774
• Parties: Lisa Gayle BUTLER and David A. Holland, individually and as personal representatives of the Estate of Maty Gayle Holland, Deceased, Plaintiffs, v. JUNO THERAPEUTICS, INC., Defendant.
• Court: U.S. District Court — Southern District of Texas

541 F.Supp.3d 774

Lisa Gayle BUTLER and David A. Holland, individually and as personal representatives of the Estate of Maty Gayle Holland, Deceased, Plaintiffs,

v.JUNO THERAPEUTICS, INC., Defendant.

CIVIL ACTION NO. H-18-898

United States District Court, S.D. Texas, Houston Division.

Signed May 27, 2021

W. Mark Lanier, Christopher Lee Gadoury, The Lanier Law Firm PC, Houston, TX, Randall B. Richards, Law Office of Randy Richards, Boerne, TX, for Plaintiffs.

John Laurens Wilkes, Christopher Henry Domingo, Jones Day, Houston, TX, Elizabeth J. Marino, Jose A. Isasi, II, Kathryn L. Dore, Pro Hac Vice, Kristina K. Cercone, Pro Hac Vice, Jones Day, Chicago, IL, Steven N. Geise, Pro Hac Vice, Jones Day, San Diego, CA, for Defendant.

MEMORANDUM AND OPINION

Lee H. Rosenthal, Chief United States District Judge

When medicine fails to save a young life, and instead even shortens it, what damages claims arise under state law, and how should a court respond? Maty Holland died in 2016, at age 19, after battling leukemia

off and on for six years. When, after remission, her leukemia returned and did not respond to conventional treatments, Holland and her parents agreed to have her participate in a clinical trial of a drug manufactured by Juno Therapeutics. Holland died one week after receiving the experimental drug. Holland's parents, Lisa Butler and David Holland, individually and as representatives of her estate, sued Juno, seeking damages for wrongful death, strict liability, fraud, negligence, gross negligence, and breach of warranty. (Docket Entry No. 76 at ¶¶ 101–33).

After discovery, Juno moved for summary judgment, the plaintiffs responded, and Juno replied. (Docket Entry No. 100, 114, 126, 130).¹ Based on the motion, the response, the voluminous record, and the applicable law, the court grants the motion and enters final judgment by separate order. The reasons are explained below.

I. Background

A. Factual and Procedural Background

Many of the facts are undisputed. Chimeric Antigen Receptor T-cell (CAR-T) therapy is a developing treatment for advanced blood cancers

. The therapy genetically modifies a patient's white blood cells to target cancer cells. (Docket Entry No. 104-26 at 1 (Exh. 59) (sealed)). The goal is to improve the patient's condition to the point of tolerating a bone marrow or stem-cell transplant, which may ultimately cure the disease and prolong the patient's healthy life. (Docket Entry No. 104-27 at 37:4–38:6 (Exh. 79) (sealed)).

In 2007, the Memorial Sloan-Kettering Cancer Center submitted to the Food and Drug Administration an Investigational New Drug Application for a product known as "1928z CAR T cells." (Docket Entry No. 110-4 at 16).² With the FDA's approval, Memorial Sloan-Kettering began a Phase 1 clinical trial for 1928z in 2010. (Id. ). Memorial Sloan-Kettering made changes to the manufacturing process for 1928z to create JCAR015, another CAR T-cell treatment. (Docket Entry No. 101-2 at 12 (Exh. 12); Docket Entry No. 104-9 at 20 (sealed); Docket Entry No. 116-1 at 11–13 (sealed); Docket Entry No. 116-3 at 10–11 (sealed)).

In 2013, Memorial Sloan-Kettering, the Fred Hutchinson Cancer Research Center, the Seattle Children's Research Institute, and affiliated medical scientists founded Juno, with the goal of developing CAR-T therapy drugs. (Docket Entry Nos. 110-1, 110-2). Memorial Sloan-Kettering provided Juno a license to develop and market JCAR015. (Docket Entry No. 110-4 at 44).

In July 2014, Juno asked to meet with the FDA to discuss starting a Phase 2 clinical trial of JCAR015. (Docket Entry No. 117-1 at 4 (sealed)). Juno submitted premeeting materials in August 2014, and the FDA provided its preliminary responses in September. (Id. ; Docket Entry No. 116-4 (sealed)). Representatives of Juno and the FDA met a few days later, discussed multiple issues, and set follow-up plans. (Docket Entry No. 117-1 (sealed)). One issue was whether Juno's proposed changes to the manufacturing process for JCAR015 made that drug so different from 1928z that Juno would need to do a Phase 1 clinical trial on JCAR015 before the planned Phase 2 trial.

In December 2014, the FDA stated that more data was needed on the comparability between JCAR015 and 1928z. The FDA recommended that Juno "collect data from a limited number of subjects prior to initiation of a pivotal study to demonstrate comparability between the [Memorial Sloan-Kettering 1928z] and Juno manufacturing process and final products." (Docket Entry No. 117-2 at 3 (sealed)).

In January 2015, Elizabeth Smith, Juno's senior vice-president for regulatory affairs, spoke with Dr. Peter Bross and Dr. Kristen Baird of the FDA about how to gather comparability data for JCAR015.

Smith summarized their discussion in a note stating, in relevant part, that Dr. Baird was concerned that "the changes [Juno was] making to the process at [Memorial Sloan-Kettering] were intended to make the product [(JCAR015)] superior/equivalent and that by making a ‘superior’ product, that the better binding or in vivo expansion could make it more toxic and safety would be an important consideration in the first few patients." (Docket Entry No. 117-3 at 2 (sealed)). Smith responded that "the changes ... were not intended to make the product better, but were intended to address availability of reagents ... and create better controls for a more consistent manufacturing process." (Id. ; see Docket Entry No. 123-6 at 23–31 (sealed)). Smith also stated that, to gather comparability data, Juno would enroll patients for the Phase 2 trial, conduct an interim comparability analysis while that trial was pending, and submit the interim data to the FDA. (Id. ). Dr. Bross and Dr. Baird stated that while Juno's proposal was "reasonable," they remained "concerned about the potential for a different safety profile with the new process." (Id. ). However, "if [Juno] [was] able to convince the product reviewers that [JCAR015] and [1928z] are comparable, there will be less concern from the clinical reviewer perspective." (Id. ).

On June 30, 2015, Juno submitted an Investigational New Drug Application for JCAR015. (Docket Entry No. 104-15 (Exh. 26) (sealed); Docket Entry No. 104-21 (sealed)). The short title for Juno's proposed Phase 2 clinical trial was the "Rocket Study." (Docket Entry No. 104-15 at 27 (Exh. 26) (sealed)).³ Juno's application included: (i) the interim results of the Phase 1 clinical trial of 1928z, (Id. at 26–27); (ii) pretrial comparability data for JCAR015 and 1928z (not the results of Juno's proposed interim comparability analysis), (Docket Entry Nos. 104-22 (sealed), 104-23 (sealed), 104-24 (sealed)); (iii) the protocol for the Rocket Study; (iv) an Investigator's Brochure; (v) a template informed-consent form; and (vi) other required information, (Docket Entry No. 104-21 (sealed)).

Juno proposed running a "safety and efficacy analysis" on the first ten patients with morphologic disease⁴ treated with JCAR015. (Docket Entry No. 104-15 at 26–27 (Exh. 26) (sealed)). That data would be the basis for an interim comparability analysis. (Id. at 27; Docket Entry No. 104-27 at 8–9 (Exh. 66) (sealed); Docket Entry No. 1104-9 at 99–100 (sealed)).

On July 23, 2015, Argaw Takele of the FDA emailed Bentley Moyer, Juno's senior director of regulatory affairs, asking where "the information about the comparability bridging, clinical study data supporting the product changes" could be found in the JCAR015 Investigational New Drug Application. (Docket Entry No. 117-4 at 4 (sealed)). Moyer responded that the data would be forthcoming as part of the interim analysis conducted partway through the Phase 2 trial. (Id. at 2).

On July 29, 2015, Dr. Baird approved Juno's proposed interim study for comparability data. (Docket Entry No. 104-15 (Exh. 27) (sealed); Docket Entry No. 118-1 (sealed)).

The next day, Juanita Williams-Gould of the FDA notified Moyer that the agency had approved Juno's Application and that the Rocket Study could proceed. (Docket Entry No. 104-14 (Exh. 21) (sealed)).

In October 2015, Juno entered into a Clinical Study Agreement with the MD Anderson Cancer Center. (Docket Entry No. 121-1 (sealed)). Juno agreed to pay MD Anderson $38,090.00 in startup costs, along with other costs related to the Study. (Id. at 22–23). Juno would pay MD Anderson, not any individual doctor. (Id. at 20, 24). Juno and MD Anderson anticipated enrolling eight to ten patients in the Rocket Study by September 2016. (Id. at 2). Juno entered into similar agreements with other hospitals around the same time.

Dr. William Wierda of MD Anderson was the principal investigator of the Rocket Study at that hospital. (Id. at 2, 18–19; Docket Entry No. 104-8 (Exh. 9) (sealed)). He and his team were responsible for enrolling patients in the Study, obtaining their informed consent, and conducting and supervising the Study. (Docket Entry No. 104-8 (Exh. 9) (sealed); Docket Entry No. 104-27 at 81:3–22 (Exh. 83) (sealed)). Dr. Wierda appointed Dr. Michael Rytting as a subinvestigator, authorizing him to obtain informed consent from potential subjects in the Study. (Docket Entry No. 104-8 at 6 (Exh. 9) (sealed); Docket Entry No. 104-27 at 81:23–82:24 (Exh. 83) (sealed)).

In December 2015, a routine checkup by Maty Holland's pediatric oncologist revealed that her acute lymphoblastic leukemia

, which had gone into remission in 2014, had returned. (Docket Entry No. 104-12 (Exh. 17) (sealed); Docket Entry No. 104-14 (Exh. 20) (sealed)). Subsequent chemotherapy was unsuccessful. By May 2016, Holland's cancer had progressed to the point that she was ineligible for a stem-cell transplant and further chemotherapy was unlikely to help. (Docket Entry No. 104-27 at 107–09 (Exh. 76) (sealed); Docket Entry No. 104-26 at 107–08 (Exh. 63) (sealed)). Holland's pediatric oncologist referred her to the MD Anderson Cancer Center to explore treatment options. (Docket Entry No. 104-27 at 105–06 (Exh. 76) (sealed)). At that stage, her condition was considered...