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Butler v. Juno Therapeutics, Inc.

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

June 21, 2019

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.

          MEMORANDUM AND ORDER

          Lee H. Rosenthal, Chief United States District Judge.

         Maty 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.

         Based 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.

         I. Background

         In 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).

         A. The FDA Approval Process

         The 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).

         Phase I 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 labeling. Id.

         Clinical-trial 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. §§ 314.50(d)(5).

         Before 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. § 312.55(b).

         Testing 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).

         One 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.

         B. Juno Therapeutics and JCAR015

         Juno 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.).

         Juno 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).

         The FDA 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).

         Juno 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).

         In 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.[1] (Id. at ¶¶ 6, 33). Both neurotoxicity and severe cytokine release syndrome require “ICU level care” and can be fatal. (Id. at ¶¶ 28, 35).

         The FDA 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).

         Juno 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 2017.” (Id.).

         Another 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.).

         Juno 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).

         Until 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 combination. (Id.).

         C. Holland's Involvement in the JCAR015 ROCKET Trial

         Holland's 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).

         Dr. 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 competitors. (Id.).

         The 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.).

         Holland 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 it.[2] (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 JCAR015.” (Id.).

         Federal 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.

         Juno 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. (Id.).

         Nothing 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).

         The 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).

         Holland 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. (Id.).

         In June 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.” (Id.).

         On June 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.).

         Juno 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.).

         Holland 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).

         On June 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.)

         Another 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.).

         In 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 ¶ 84).

         Juno 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.).

         The 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.).

         E. The Claims

         The 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).

         These 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).

         Juno 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.

         II. The Legal Standard

         Rule 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, the-defendant-unlawfully-harmed-me accusation.” 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).

         To 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 alteration omitted).

         In 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.

         When a 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 court.” Id.

         Each claim and the sufficiency of the pleading are analyzed below.

         III. Design Defect

         The 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). The ...


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