United States District Court, S.D. Texas, Houston Division
LISA GAYLE BUTLER and DAVID A. HOLLAND, individually and as personal Representatives of the ESTATE OF MATY GAYLE HOLLAND, deceased. Plaintiffs,
JUNO THERAPEUTICS, INC. Defendant.
MEMORANDUM AND ORDER
Rosenthal, Chief United States District Judge.
Gayle Holland died in 2016, at age 19. She had battled
leukemia off and on for six years before she died. She died
less than two months after starting to participate in a
clinical trial of a drug for FDA approval. (Docket Entry No.
41). After her death, Holland's parents, Lisa Gayle
Butler and David A. Holland, individually and as estate
representatives, sued the drug manufacturer, Juno
Therapeutics, Inc., in March 2018. (Docket Entry No. 1). In
October, the plaintiffs filed an amended complaint, and Juno
moved to dismiss. (Docket Entry Nos. 41, 43). The plaintiffs
responded, Juno replied, and the parties supplemented their
briefs on the plaintiffs' fraud allegations and on
Juno's learned-intermediary doctrine defense. (Docket
Entry Nos. 46, 48, 56-60, 62-1). The court heard oral
argument on the motion to dismiss.
on the pleadings; the motion, response, and reply; the
supplemental briefing; counsels' arguments at the motion
hearing; and the applicable law, the court denies the motion
to dismiss. (Docket Entry No. 43). The reasons for this
decision are detailed below.
2010, Holland, then 13-years old, was diagnosed with acute
lymphoblastic leukemia. (Docket Entry No. 41 at ¶ 49).
Conventional chemotherapy led to remission by the time she
entered high school, but the cancer returned during her
freshman year of college. (Id. at ¶¶ 49-
50). Chemotherapy initially seemed to work, but further
rounds did not lead to remission. (Id. at ¶
50). In May 2016, Holland, then 19-years old, joined
Juno's Phase II JCAR015 ROCKET Trial. (Id. at
¶¶ 52, 57). In June, a week after her first
infusion of the trial drug, JCAR015, Holland died.
(Id. at ¶¶ 76, 80).
The FDA Approval Process
Food and Drug Administration must approve New Drug
Applications before a manufacturer may market a drug. 21
U.S.C. § 355(b)(1). The FDA requires three clinical
trial phases to show that the drug is efficacious and safe,
consistent with the Food, Drug and Cosmetic Act of 1938
before a manufacturer can submit a New Drug Application.
Id. § 355(i), (b)(1).
studies “determine the metabolism and pharmacologic
actions of the drug in humans, the side effects associated
with increasing doses, and . . . early evidence on
effectiveness.” 21 C.F.R. § 312.21(a). Phase II
studies “include controlled clinical studies
conducted to evaluate the effectiveness of the drug for a
particular indication or indications in patients with the
disease or condition under study and to determine the common
short-term side effects and risks associated with the
drug.” Id. § 312.21(b). Phase III studies
involve “expanded controlled and uncontrolled trials .
. . . performed after preliminary evidence suggesting
effectiveness of the drug has been obtained.”
Id. at § 312.21(c). They give new data on the
drug's efficacy and safety and help inform physician
sponsors must submit an Investigational New Drug Application
to the FDA to begin a clinical trial. 21 U.S.C. §
355(i); 21 C.F.R. § 312.20. Sponsors must select medical
investigators for the trial and ensure that the
investigations are conducted properly and that the “FDA
and all participating investigators are promptly informed of
significant new adverse effects or risks with respect to the
drug.” Id. § 312.50. If the three-phase
clinical trial is successful in showing the drug's safety
and efficacy, the sponsor may file a New Drug Application
that specifies the conditions the drug will treat and in what
dose. (See Docket Entry No. 41 at ¶¶
19-23); see 21 U.S.C. § 355(b)(1); 21 C.F.R.
an investigation or clinical trials begin, a sponsor must
provide “each participating clinical investigator an
investigator brochure, ” 21 C.F.R. § 312.55(a),
containing “[a] brief description of the drug substance
and the formulation, ” “[a] summary of the
pharmacological and toxicological effects of the drug in
animals and, to the extent known, in humans, ”
“[a] summary of the pharmacokinetics and biological
disposition of the drug in animals and, if known, in humans,
” “[a] summary of information relating to safety
and effectiveness in humans obtained from prior clinical
studies, ” and “[a] description of possible risks
and side effects to be anticipated on the basis of prior
experience with the drug under investigation or with related
drugs, and of precautions or special monitoring to be done as
part of the investigational use of the drug.” 21 C.F.R.
§ 312.23(a)(5). The sponsor has an ongoing
responsibility to “keep each participating investigator
informed of new observations discovered by or reported to the
sponsor on the drug, particularly with respect to adverse
effects and safe use. . . . Important safety information is
required to be relayed to investigators.” Id.
new drugs on people, even people with few options, is fraught
with ethical issues. Those are amplified when the patient is
young. The regulations address the ethical concerns by
requiring informed consent after the risks are properly
disclosed. “[N]o investigator may involve a human being
as a subject in research . . . unless the investigator has
obtained the legally effective informed consent of the
subject or the subject's legally authorized
representative.” Id. § 50.20. Disclosures
required for legally effective informed consent include,
among other things, “[a] description of any reasonably
foreseeable risks or discomforts to the subject” and,
“[f]or research involving more than minimal risk . . .
and an explanation as to whether any medical treatments are
available if injury occurs and, if so, what they consist of,
or where further information may be obtained.”
Id. § 50.25(a)(2), (6).
critical issue in this case is whether Juno adequately
disclosed the risks to Holland to satisfy the requirements
for legally sufficient informed consent. Another issue is
whether the fact that Juno paid the JCAR015 ROCKET Trial
investigator to conduct the Trial vitiates the
learned-intermediary doctrine. These and other issues raised
by the motion to dismiss and response are analyzed below.
Juno Therapeutics and JCAR015
Therapeutics develops biopharmaceutical “cellular
immunotherapies” for treating cancer. (Docket Entry No.
41 at ¶ 1). Juno specializes in treatments that collect,
modify, and use a patient's own T cells to treat that
patient's cancer. (Id.). The most advanced of
these treatments is CAR-T therapy. (Id.).
sponsors clinical trials to test its products.
(Id.). Juno has three “CD19 Product
Candidates, JCAR014, JCAR015, and JCAR017. All “use a
chimeric antigen receptor” or “CAR” to
target the CD19 protein found on the surface of the malignant
white blood cells that cause B-cell leukemia and lymphoma.
(Id.). The CAR-T therapy using these products begins
with leukapheresis, or harvesting of the patient's own
white blood cells. (Id. at ¶ 15). Once
harvested, the T cells are “selected and activated,
” and “gene sequences for the CAR construct are
transferred into the T cell DNA using a viral vector.”
(Id.). This process creates receptors on the T-cell
surface that, once infused back into the patient's body,
allow the T cells to recognize and attack the CD19 protein on
the cancer cells. (Id. at ¶ 14). The number of
modified cells is then expanded to the proper dose.
(Id. at ¶ 15). The patient receives
chemotherapy to deplete the existing T cells and allow the
modified cells to grow. (Id. at ¶ 16). The last
step is to infuse the patient with the genetically engineered
T cells. (Id. at ¶ 17).
has not yet approved any of Juno's CD19 product
candidates. None of its CD19 products has made it past a
Phase II clinical trial. (Id. at ¶ 2).
competes with other biotech companies to enroll patients in
clinical drug trials so that it can be the first to the
market with a CAR-T immunotherapy that makes it through the
FDA approval process. (Id. at ¶ 3). Juno used a
“fast to market strategy” for JCAR015 and
designated the JCAR015 Phase II trial as a “ROCKET
Trial.” (Id.). In its 2015 Annual Report, Juno
stated that it planned to seek regulatory approval for
JCAR015 as early as 2017. (Id.). The Annual Report
warned of delay if Juno had trouble enrolling patients in its
clinical trials and identified the treatment-related side
effects as a possible barrier to enrollment. (Id. at
¶¶ 4, 5).
January 2007, the Memorial Sloan Kettering Cancer Center in
New York sponsored an Investigational New Drug Application
for Juno's JCAR015. (Id. at ¶ 31). The
Phase I clinical trial began in January 2010 and was expected
to end in January 2017. Early results showed that JCAR015 had
serious risks. (Id. at ¶¶ 31-33). In its
2015 Annual Report, Juno acknowledged side effects ranging
from “minor reactions to death, ” including
severe neurotoxicity severe cytokine release
syndrome. (Id. at ¶¶ 6, 33). Both
neurotoxicity and severe cytokine release syndrome require
“ICU level care” and can be fatal. (Id.
at ¶¶ 28, 35).
placed the JCAR015 ROCKET Trial on hold after two patients
died in 2014. (Id. at ¶ 36). The FDA removed
the hold after Juno made several changes to the Phase I
protocol. (Id.) According to Juno's 2015 Annual
Report, 52% of the patients in the Trial with acute
lympoblastic leukemia suffered from either severe cytokine
release syndrome or severe neurotoxicity. (Id. at
¶ 38). In the “morphologic patient
population” of the patients with more than 5%
lymphoblasts in their bone marrow, 84% suffered from either
severe cytokine release syndrome or severe neurotoxicity.
(Id. at ¶ 39). Juno stated in 2015 that besides
the severe cytokine release syndrome or severe neurotoxicity,
“JCAR015 has been generally well tolerated.”
(Id. at ¶ 41).
provided its ROCKET Trial investigators with both an
Investigator's Brochure and a sample informed consent
form. Both were required, and both were intended, to explain
the risks and side effects associated with JCAR015.
(Id. at ¶ 26). The ROCKET Trial's informed
consent form listed as “common” side effects
those occurring in more than 20% of patients. But the form
did not list either neurotoxicity or severe cytokine release
syndrome among the common side effects. (Id. at
¶ 40). Even though the Phase I Trial was not scheduled
to end until January 2017, Juno advanced to a Phase II trial
on August 21, 2015. (Id. at ¶ 42). Juno stated
in its 2015 Annual Report that the ROCKET Trial “could
support accelerated U.S. regulatory approval as early as
Juno drug in clinical trials, JCAR014, was similar enough to
JCAR015 for Juno to cite data from the JCAR014 trials in
analyzing the JCAR015 Trials, including the ROCKET Trial.
(Id. at ¶¶ 43, 47). JCAR014 and JCAR015
require the same chemotherapy treatments before the infusions
and target the same CD19 proteins. (Id. at ¶
44). JCAR014 caused severe cytokine release syndrome in 23%
of acute lymphoblastic leukemia patients and severe
neurotoxicity in 50% of those patients. (Id. at
¶ 45). Six patients, including 3 acute lymphoblastic
leukemia patients, died from those two side effects during
the JCAR014 trial. (Id. at ¶ 46). The
plaintiffs point out that Juno's 2015 Annual Report
showed that 11 of the 20 patients in the JCAR014 trial who
received the cyclophosphamide and fludarabine drug
combination experienced severe cytokine release syndrome or
severe neurotoxicity; 35% experienced severe neurotoxicity.
(Id. at ¶ 48). None of the 12 patients who
received only cyclophosphamide experienced severe cytokine
release syndrome, and only 17% of those patients experienced
severe neurotoxicity. (Id.).
acknowledged the potentially deadly side effects of its CD19
product candidates, including JCAR015, in various media. Its
2015 Annual Report explained that the “use of our
product candidates could be associated with side effects or
adverse events which can vary in severity from minor
reactions to death and in frequency from infrequent to
prevalent.” (Id. at ¶¶ 6, 27). The
Annual Report stated that Juno had “seen severe
neurotoxicity . . . in some cases leading to death, in a
number of patients . . . using each of JCAR015, JCAR017, and
JCAR014.” (Id. at ¶ 27 (emphasis
omitted)). In a different lawsuit brought under the federal
securities laws, Juno acknowledged in a pleading that
“Car-T therapy can have serious and deadly side
effects, including severe neurotoxicity that can damage the
brain and cause cerebral edemas and death.”
(Id. at ¶ 28 (emphasis omitted)). The
plaintiffs allege that “Juno's knowledge of such
risks is also evidenced by various papers and presentations
that it, its officers, employees, agents, and researchers
working on its clinical trials, published in various
publications or presented to various conferences and
meetings.” (Id. at ¶ 29).
July 2016, Juno's clinical tests for its CAR-T therapy
drugs used a chemotherapy drug cocktail of cyclophosphamide
and fludarabine. (Id. at ¶ 16). After three
patients died in July 2016, Juno stopped using that drug
Holland's Involvement in the JCAR015 ROCKET
regular oncologist suggested that CAR-T immunotherapy might
be a treatment option after her lymphoblast levels fell below
0.1% after several rounds of chemotherapy. (Id. at
¶¶ 50-51). Holland was referred to a pediatric
oncologist at the M.D. Anderson Cancer Center, Dr. Michael E.
Rytting. Holland and her parents met with Dr. Rytting to
discuss CAR-T options in May 2016. (Id. at
¶¶ 51-52). Dr. Rytting told them that Holland could
be a candidate for Juno's Phase II JCAR015 ROCKET Trial.
(Id. at ¶ 52).
William Wierda was the Study Chair for the ROCKET Trial at
M.D. Anderson and the investigator responsible for
administering the treatments to participants, including
Holland. (Id. at ¶ 53). The plaintiffs
emphasize that “[t]here were no alternative drugs for
Dr. Wierda to choose from for the ROCKET Trial” and
that he could prescribe only JCAR015 for that Trial.
(Id.). Juno paid Dr. Wierda for serving as the
investigator for the JCAR015 ROCKET Trial at M.D. Anderson.
The informed consent form disclosed Dr. Wierda's
financial relationship with Juno as “significant”
and the plaintiffs allege that Dr. Wierda “was not a
prescribing physician.” (Id.). Dr. Wierda also
received compensation for consulting and research for other
drug companies, including two of Juno's CAR-T
M.D. Anderson leukemia team, which included Dr. Wierda,
reviewed Holland's case in May 2016. (Id. at
¶ 54). The team approved her participation in the
JCAR015 ROCKET Trial on May 10. (Id.). On May 16,
2016, Holland and her mother met with Dr. Wierda to discuss
the ROCKET Trial. (Id. at ¶ 55). Dr. Wierda
explained that Holland was eligible for the Trial and noted
the successful remission rates of CAR-T immunotherapy trials.
(Id.). The plaintiffs allege that “Dr. Wierda
did not discuss any risks or side effects to participants in
the ROCKET Trial during this meeting.” (Id.).
Dr. Wierda did explain the prescreening process and answered
other questions. (Id.).
and her mother then met with Virginia Bayer, the lead
clinical research nurse for the ROCKET Trial at M.D.
Anderson. (Id. at ¶ 56). Dr. Wierda was not
present. (Id. at ¶ 58). Bayer reported to Dr.
Wierda and was responsible for “guiding participants
through the informed consent process, collecting data for the
trial, managing the clinical and operational aspects of the
clinical trial protocol, ensuring that participants [met]
protocol goals, and providing information to both
participants and . . . Dr. Wierda.” (Id.).
Bayer explained the informed consent form to Holland and her
mother during this meeting, and Holland signed
(Id. at ¶ 57). The plaintiffs allege that
Holland was not given a copy of the form, signed or blank.
They also allege that neither Bayer nor the content of the
consent form revealed “the significant known risks to
patients in the ROCKET Trial of suffering from severe
neurotoxicity, severe cytokine release syndrome, or cerebral
edema, leading to death, after their infusion with
regulations require clinical trial sponsors to inform
participants of reasonably known risks through investigators,
such as Dr. Wierda. The FDA does not approve any informed
consent forms. Instead, the investigators' or
sponsor's institutional review boards must approve the
forms used in a clinical trial. (Id. at ¶ 60
n.38). The plaintiffs do not allege what institutional review
board approved the consent form Holland signed or who
comprised that board.
provided its investigators with information on the JCAR015
ROCKET Trial risks in its Investigator's Brochure.
(Id. at ¶ 60). The FDA requires an
Investigator's Brochure to include “pharmacological
and toxicological effects of the drug in animals and, to the
extent known, in humans, ” as well as information on
the possible risks, side effects, and safety of the drug
being tested. (Id. at ¶ 24 (citing 21 C.F.R.
§§ 312.25(a)(5), 312.55)). Juno released the most
recent version of the ROCKET Trial Investigator's
Brochure on October 27, 2015. (Id. at ¶ 60).
Neither Holland nor her family was given a copy of the
Brochure before Holland agreed to participate in the Trial.
in the ROCKET Trial informed consent form disclosed the known
risks of severe neurotoxicity or severe cytokine release
syndrome. The form stated that it listed “commonly
occurring side effects” and “rare but serious
side effects.” (Id. at ¶ 61). Juno
defined “common” side effects as those occurring
in more than 20% of patients. (Id. at ¶ 40).
Data from the JCAR014 trials had shown that 20% of patients
suffered from severe cytokine release syndrome and 35%
suffered from severe neurotoxicity. (Id. at ¶
48). The plaintiffs allege that because Juno used
“JCAR014 trial data to provide insight[s]” into
CAR therapy, that data is also relevant to the JCAR015 ROCKET
Trial. (Id. at ¶ 43). The plaintiffs allege
that Juno should have specifically and prominently listed
severe neurotoxicity and severe cytokine release syndrome as
“common” side effects of JCAR015. (Id.
at ¶ 61).
informed consent form stated that JCAR015 was an in early
study phase and that the side effects were not well known.
(Id. at ¶ 62). According to the plaintiffs, the
form had no information about the patients who had died soon
after their infusions, including deaths from severe
neurotoxicity or severe cytokine release syndrome.
(Id.). Nor did the form disclose the increased risk
of these severe side effects in “morphologic”
patients, or the increased risk among patients receiving the
cyclophosphamide and fludarabine drug combination.
(Id. at ¶¶ 64-65). The form also did not
disclose that Holland fit into both categories. (See
Id. at ¶ 75). The form did not explain what medical
treatments might be options in the event of side effects or
other injury, as required for studies with more than a
minimal risk. (Id. at ¶ 66). Juno did disclose
information about these known side effects, risks, and deaths
in its annual reports and other literature and presentations,
but provided none of those to Dr. Wierda's team to give
to potential patients. (Id. at ¶ 62).
signed the informed consent form. She spent the next four
days completing pre-screening, testing, and having her white
blood cells harvested for modification in a lab.
(Id. at ¶ 57, 59). Shortly after Holland signed
the informed consent form in May 2016, the first JCAR015
ROCKET Trial patient died from severe cytokine release
syndrome and severe neurotoxicity. (Id. at ¶
68). Eleven days later, Juno published a press release about
the JCAR015 ROCKET Trial's successful findings.
(Id. at ¶ 69). The press release did not
mention the recent death or any of the deaths from Phase I.
2016, Bayer contacted Holland and her family to tell them
that a “new safety concern” had arisen and that
the JCAR015 ROCKET Trial was on hold until patients could
review a new informed consent form. (Id. at ¶
71). Bayer explained that Dr. Wierda would provide more
details, but that Holland and others whose T cells were
already harvested would be permitted to continue the Trial
“once the new informed consent form was ready.”
15, Dr. Wierda met with Holland and her mother and told them
that a patient had recently died from a high fever and
cerebral edema within 24 hours of receiving the JCAR015 Trial
infusion. (Id. at ¶ 72). Dr. Wierda explained
that the cerebral edema could have been reversed if the
patient had immediately received steroids, which did not
occur because the patient had a high fever that could have
led to T-cell suppression. (Id.). Dr. Wierda
explained that a new informed consent form with the recent
deaths was not available. (Id.). He assured Holland
and her family that Holland would do fine continuing the
Trial. He also made clear that if she developed a high fever,
he would administer steroids promptly. (Id.).
did not update the Investigator's Brochure after the May
2016 death and before Holland's JCAR015 infusion.
(Id. at ¶ 74). Holland did not receive an
updated informed consent. (Id.). According to the
plaintiffs, Dr. Wierda's information was wrong and
“creat[ed] the false impression that the deadly side
effects were reversible.” (Id.). The
plaintiffs allege that Dr. Wierda's assurances
“play[ed] a significant role in [Holland] initially
agreeing to participate in the ROCKET Trial [and] . . . in
preventing [Holland] from declining to continue in the trial
following the May death.” (Id.).
continued the prescreening and testing on June 15, 2016.
(Id. at ¶ 75). The tests showed high
lymphoblast levels, placing her in the high-risk category for
developing severe neurotoxicity or severe cytokine release
syndrome. (Id.). Neither she nor her family were
given this information. (Id.). The next day, Holland
started the preconditioning chemotherapy at M.D. Anderson,
receiving the cyclophosphamide and fludarabine drug
combination. (Id. at ¶ 76). On June 23, she
received the infusion of genetically modified CAR-T cells.
(Id. at ¶ 77). On June 27, she developed a
fever of 103.5 degrees, and the next day she developed severe
neurotoxicity. (Id.). On June 29, Dr. Wierda told
Holland's parents that neurotoxicity is common and
reversible, but, that afternoon, Holland began having
continuous seizures and was moved to the intensive care unit.
(Id. at ¶ 78).
30, one week after the infusion, nurses informed
Holland's parents that she had developed cerebral edema.
(Id. at ¶ 79). A CAT scan showed it to be
irreversible. (Id.). Dr. Wierda told Holland's
parents that he thought the edema was caused by the addition
of fludarabine to the chemotherapy. (Id.).
Holland's ventilator was turned off and she died the same
day. (Id. at ¶ 80). Her death certificate
stated the cause of death as severe cerebral edema, status
epilepticus, and cytokine release syndrome. (Id.)
JCAR015 ROCKET Trial patient died the same week.
(Id. at ¶ 82). On July 7, Juno publicly
announced the three deaths since May, including
Holland's. (Id.). Juno also corrected
misstatements about the number of deaths stated in previously
filed SEC documents. (Id.). The FDA again put the
Trial on hold. It removed the hold once Juno removed the
fludarabine from the chemotherapy treatments and prepared a
new informed consent form. (Id.).
November 2016, two more JCAR015 ROCKET Trial patients died.
(Id. at ¶ 83). This time, Juno voluntarily put
the Trial on hold, pending an investigation. Juno terminated
all JCAR015 Trials in March 2017. (Id.). At least
seven patients had died during the JCAR015 Phase I and II
Trials, and at least six patients had died during the JCAR014
Trials. (Id.). Of the JCAR015 ROCKET Trial Phase II
participants, 52% suffered severe neurotoxicity and 21%
suffered severe cytokine release syndrome. (Id. at
issued its investigation's findings in 2017 that the
severe cytokine release syndrome and severe neurotoxicity
experienced in the JCAR015 ROCKET Trial were caused by
“early and rapid modified CAR-T cell expansion”
combined with a rise in interleukin-15 levels. (Id.
at ¶ 85). The report stated that at least one
patient-specific factor contributed to the deaths from these
side effects. (Id. at ¶ 86). Patients with
certain gene signatures were reported to experience greater
toxicity, “including all five patients who died.”
(Id.). The plaintiffs allege that the report was
“botched, ” pointing out that Holland did not
have this gene signature and that at least seven
participants, not five, had died during the Phase I and Phase
II JCAR015 Trials. (Id.).
plaintiffs allege that had Holland or her parents known of
the risks of the JCAR015 ROCKET Trial, she would not have
participated. (Id. at ¶ 87). They assert that
Juno did not give Holland the opportunity to give legally
effective informed consent. (Id.).
plaintiffs assert seven claims against Juno in the amended
complaint: (1) wrongful death and survival under Texas Civil
Practice and Remedies Code §§ 71.002, 71.021; (2)
strict products liability; (3) fraud and fraudulent
concealment; (4) negligence; (5) negligent marketing; (6)
negligent misrepresentation; and (7) breach of warranty. The
plaintiffs have voluntarily dismissed their previously
asserted design-defect claims. (Docket Entry No. 58).
seven claims are based on the theory that Juno knew of the
risks and side effects and failed to disclose them to Holland
and her parents. (Id. at ¶¶ 91, 95, 97,
102-06). The plaintiffs allege that had Holland known about
the high rates of severe neurotoxicity and severe cytokine
release syndrome, she would not have participated in the
JCAR015 ROCKET Trial and “would not have died from
severe neurotoxicity and severe cytokine release
syndrome.” (Id. at ¶¶ 91, 95, 97).
They allege that Juno had a duty to use reasonable care in
disclosing the known risks and effects of JCAR015 and that
Juno breached that duty by failing to disclose or to warn.
(Id. at ¶¶ 102-04). They argue that the
applicable standard of care required compliance with FDA
regulations that plaintiffs allege Juno did not meet because
of its deficient informed consent and risk disclosures.
(Id.). The plaintiffs further allege that Juno
negligently misrepresented JCAR015's known fatal side
effects and risks, providing false information about the
risks of participating in the JCAR015 ROCKET Trial.
(Id. at ¶ 105). Finally, they allege that the
informed consent form expressly affirmed the safety of
receiving JCAR015 in the ROCKET Trial, and that Holland and
her parents relied on these statements in agreeing to
participate. They allege that Juno breached its duty of care
by failing to disclose the ROCKET Trial's dangers.
(Id. at ¶ 106).
moves to dismiss the plaintiffs' amended complaint for
failure to state a plausible claim. (Docket Entry No. 43).
Each argument and response is considered below.
The Legal Standard
12(b)(6) requires dismissal if a plaintiff fails “to
state a claim upon which relief can be granted.”
Fed.R.Civ.P. 12(b)(6). Rule 12(b)(6) must be read in
conjunction with Rule 8's requirement of a “short
and plain statement of the claim showing that the pleader is
entitled to relief.” Fed.R.Civ.P. 8(a)(2). A complaint
must contain “only enough facts to state a claim to
relief that is plausible on its face.” Bell Atl.
Corp. v. Twombly, 550 U.S. 544, 570 (2007). Rule 8
“does not require ‘detailed factual
allegations,' but it demands more than an unadorned,
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting
Twombly, 550 U.S. at 555). “A claim has facial
plausibility when the plaintiff pleads factual content that
allows the court to draw the reasonable inference that the
defendant is liable for the misconduct alleged.”
Id. (citing Twombly, 550 U.S. at 556).
“The plausibility standard is not akin to a
‘probability requirement,' but it asks for more
than a sheer possibility that a defendant has acted
unlawfully.” Id. (citing Twombly, 550
U.S. at 556).
withstand a Rule 12(b)(6) motion, a “complaint must
allege ‘more than labels and conclusions, '”
and “a formulaic recitation of the elements of a cause
of action will not do.” Norris v. Hearst Tr.,
500 F.3d 454, 464 (5th Cir. 2007) (quoting Twombly,
550 U.S. at 555). “Nor does a complaint suffice if it
tenders ‘naked assertion[s]' devoid of
‘further factual enhancement.'”
Iqbal, 556 U.S. at 678 (alteration in original)
(quoting Twombly, 550 U.S. at 557). “[A]
complaint ‘does not need detailed factual
allegations,' but must provide the plaintiff's
grounds for entitlement to relief-including factual
allegations that when assumed to be true ‘raise a right
to relief above the speculative level.'”
Cuvillier v. Taylor, 503 F.3d 397, 401 (5th Cir.
2007) (quoting Twombly, 550 U.S. at 555).
“Conversely, when the allegations in a complaint,
however true, could not raise a claim of entitlement to
relief, this basic deficiency should be exposed at the point
of minimum expenditure of time and money by the parties and
the court.” Id. (quotation marks and
considering a motion to dismiss under Rule 12(b)(6), “a
district court must limit itself to the contents of the
pleadings, including attachments.” Collins v.
Morgan Stanley Dean Witter, 224 F.3d 496, 498 (5th Cir.
2000). Documents “attache[d] to a motion to dismiss are
considered part of the pleadings, if they are referred to in
the plaintiff's complaint and are central to [the]
claim.” Id. at 498-99 (quoting Venture
Assocs. Corp. v. Zenith Data Sys. Corp., 987 F.2d 429,
431 (7th Cir. 1993)). The court may also “take judicial
notice of matters of public record.” Norris,
500 F.3d at 461 n.9.
plaintiff's complaint fails to state a claim, the court
should generally give the plaintiff a chance to amend under
Rule 15(a) before dismissing the action with prejudice,
unless it is clear that to do so would be futile. See
Carroll v. Fort James Corp., 470 F.3d 1171, 1175 (5th
Cir. 2006) (“[Rule 15(a)] evinces a bias in favor of
granting leave to amend.” (quotation omitted));
Great Plains Tr. Co. v. Morgan Stanley Dean Witter &
Co., 313 F.3d 305, 329 (5th Cir. 2002)
(“[D]istrict courts often afford plaintiffs at least
one opportunity to cure pleading deficiencies before
dismissing a case, unless it is clear that the defects are
incurable or the plaintiffs advise the court that they are
unwilling or unable to amend in a manner that will avoid
dismissal.”). A court may deny a motion to amend as
futile if an amended complaint would fail to state a claim
upon which relief could be granted. Pervasive Software
Inc. v. Lexware GmbH & Co., 688 F.3d 214, 232 (5th
Cir. 2012). Whether to grant or deny leave to amend “is
entrusted to the sound discretion of the district
claim and the sufficiency of the pleading are analyzed below.
plaintiffs' amended complaint asserts defective-design
claims against Juno. (Docket Entry No. 41 at ¶¶
96-100, 103; see Id. at ¶¶ 91, 95). The
plaintiffs have informed the court that they are nonsuiting
“their design defect claims, including claims related
to the ROCKET Trial protocol.” (Docket Entry No. 58).