Spedale v. Constellation Pharmaceutical Incorporated

• Court: District Court, D. Arizona
• Decided: August 16, 2019
• Docket: 2:17-cv-00109
• Status: Unknown

Opinion

1 WO 2 3 4 5 6 IN THE UNITED STATES DISTRICT COURT 7 FOR THE DISTRICT OF ARIZONA

9 Iris Spedale and Daniel Spedale, No. CV-17-00109-PHX-JJT

10 Plaintiffs, ORDER

11 v.

12 Constellation Pharmaceuticals Inc.,

13 Defendant. 14 15 The Court now considers Defendant Constellation Pharmaceuticals, Inc.’s Motion 16 to Exclude Expert Testimony of Dr. James P. Sutton (Doc. 55, MTE), Motion for Summary 17 Judgment (Doc. 56, MSJ), and Objections to Portions of Dr. James P. Sutton’s Declaration 18 (See Doc. 68, Reply to MTE Opp’n; Doc. 69, Reply to MSJ Opp’n), as well as Plaintiffs’ 19 Motion for Leave to Respond to Defendant’s Objections (Doc. 71, MFL) and Motion to 20 Strike the Affidavit of Dr. Robert Sims (Doc. 63, MSJ Opp’n). For the reasons set forth 21 below, the Court grants in part and denies in part Defendant’s Motion to Exclude, grants 22 in part and denies in part Defendant’s Motion for Summary Judgment, and grants 23 Plaintiffs’ Motion to Strike.1 Additionally, the Court overrules Defendant’s Objections and 24 denies Plaintiffs’ Motion for Leave as moot.2

25 1 Defendant has requested oral argument with respect to its Motion to Exclude and Motion for Summary Judgment. The Court denies Defendant’s request because the issues have 26 been fully briefed and oral argument will not aid the Court’s decision. See Fed. R. Civ. P. 78(b) (court may decide motions without oral hearings); LRCiv. 7.2(f) (same). 27 2 On January 9, 2019, Defendant filed its Reply to Plaintiffs’ Opposition to Motion to Exclude and Reply to Plaintiffs’ Opposition to Motion for Summary Judgment. (Reply to 28 MTE Opp’n; Reply to MSJ Opp’n.) In both filings, Defendant objects to paragraphs 13, 15, 16–25, 36–38, 41, 43, 49, 50–52, 57, 61– 72, 75–91, 95–96, and 99–100 of Dr. Sutton’s 1 I. FACTUAL BACKGROUND 2 Defendant is a Massachusetts corporation and developer and manufacturer of 3 pharmaceuticals. (Doc. 64, Pls.’ Statement of Add’l Facts & Resp. to Def.’s Statement of 4 Facts, (“PSOAF”)3 ¶ 20.) Defendant conducts business, including sponsoring clinical trials, 5 in Arizona, where Plaintiffs Iris Spedale and Daniel Spedale reside and the events giving 6 rise to this suit occurred. (Doc. 59-11, Ex. K, Clinical Trial Agreement Between 7 Constellation & Mayo Clinic Arizona (“CTA”) at 2; MSJ Opp’n at 2.) 8 A. Ms. Spedale’s Health 9 Ms. Spedale was first diagnosed with multiple myeloma in May 2009, at the age of 10 sixty-six. (Doc. 64-1, Ex. 1, Spedale Medical Records I (“Spedale MR I”) at 11.) 11 Ms. Spedale sought treatment from Dr. Rafael Fonseca, M.D., at Mayo Clinic. (Doc. 57, 12 Def.’s Statement of Facts in Supp. of MSJ (“DSOF”) ¶ 3; PSOAF ¶ 5; Doc. 64, PSOAF & 13 Resp. to DSOF (“PSOF”)4 ¶ 3.) At the time of her diagnosis, Ms. Spedale had no prior 14 history of psychological problems; however, while using dexamethasone (a steroid) as part 15 of her cancer treatment regimen, she experienced “steroid-induced mania syndrome.” 16 (Doc. 59-15, Ex. O, Daniel Spedale Dep. (“Mr. Spedale Dep.”) at 8; PSOAF ¶ 9; Spedale 17 MR I at 27.) In September 2009, Dr. Robert Bright, a Mayo psychiatrist, prescribed 18 Zyprexa Zydis (“olanzapine”) to Ms. Spedale to “help restore a normal sleep/wake cycle” 19 and “provide mood stabilization.” (Spedale MR I at 27.) By her October 2009 follow-up, 20 Ms. Spedale’s mood and sleep cycle had improved significantly. (Id. at 29.) One month 21 later, Ms. Spedale underwent a successful stem-cell transplant, leaving her cancer in 22 remission for three years. (Id. at 35; see Doc. 64-2, Ex. 2, Spedale Medical Records II 23 (“Spedale MR II”) at 75–76.) Ms. Spedale was treated for cancer twice more: once in 2013,

24 Declaration (identical copies attached to Plaintiffs’ Statement of Additional Facts and Response to Defendant’s Statement of Facts (Doc. 64-17, Ex. 16, Decl. of Dr. James P. 25 Sutton, M.D.) and Opposition to Motion to Exclude (Doc. 65-3, Ex. 3, Decl. of Dr. James P. Sutton, M.D.)). (See Reply to MTE Opp’n at 2–4; Reply to MSJ Opp’n at 2–3.) On 26 January 16, 2019, Plaintiffs filed their Motion for Leave. (MFL.) Because the Court does not rely on Dr. Sutton’s Declaration in deciding Defendant’s summary judgment motion, 27 the Court denies both Defendant’s Objections and Plaintiff’s Motion for Leave as moot. 3 “PSOAF” refers to the first section of Doc. 64, Plaintiffs’ Statement of Additional Facts. 28 4 “PSOF” refers to the second section of Doc. 64, Plaintiffs’ Response to Defendant’s Statement of Facts. 1 and again in 2014, though each time with a lower dose of dexamethasone. (See Spedale 2 MR II at 73 (Dr. Fonseca’s “Final Report” of Aug. 19, 2013 visit, detailing treatment plan); 3 id. at 59 (Dr. Fonseca’s “Final Report” of Oct. 21, 2014 visit, detailing treatment plan).) 4 B. CPI-0610 5 1. Development of CPI-0610 6 On June 5, 2013, Defendant submitted an Investigational New Drug (“IND”) 7 Application to the FDA for its study drug, CPI-0610, a type of BET inhibitor. (DSOF ¶ 5; 8 PSOF ¶ 5.) The International Conference on Harmonisation (“ICH”) guidelines detail the 9 types of studies required to support an IND application, as well as the sequence in which 10 those studies should be performed. (DSOF ¶ 6; PSOF ¶ 6.) The guidelines applicable to 11 pre-clinical safety testing for oncology drugs are known as ICH S9.5 (Jacobson-Kram 12 Report at 4.) Defendant’s regulatory expert, Dr. Jacobson-Kram,6 has explained the 13 necessity of distinct guidelines with respect to oncology drugs: “[I]nitial doses in phase 1 14 studies with healthy volunteers generally are below a level that causes a pharmacological 15 effect. When treating oncology patients with advanced disease, it is desirable that patients 16 are initially dosed at levels that have pharmacological effects.” (Id.) 17 a. Potential Issues with Neurotoxicity 18 In his report, Plaintiff’s expert, neurologist Dr. James P. Sutton, suggests that 19 Defendant failed to perform adequate preclinical safety testing for neurotoxicity on CPI- 20 0610. (See Doc. 55-2, Ex. A, Dr. James P. Sutton’s Expert Report (“Sutton Report”) at 9– 21 5 ICH S9 states: “[a]n assessment of the pharmaceutical’s effect on vital organ functions 22 (including cardiovascular, respiratory and central nervous systems) should be available before the initiation of clinical studies; such parameters could be included in general 23 toxicology studies. Detailed clinical observations following dosing and appropriate electrocardiographic measurements in non-rodents are generally considered sufficient. 24 Conducting stand-alone safety pharmacology studies to support studies in patients with advanced cancer is not called for. In cases where specific concerns have been identified 25 that could put patients at significant additional risks in clinical trials, appropriate safety pharmacology studies described in ICH S7A and/or S7B should be considered. In the 26 absence of a specific risk, such studies will not be called for to support clinical trials or for marketing.” (Doc. 59-7, Ex. G, David Jacobson-Kram, Ph.D., DABT Expert Report 27 (“Jacobson-Kram Report”) at 5.) 6 Defendant has retained Dr. Jacobson-Kram to provide an expert opinion on the regulatory 28 submissions process for drug development, including the federal guidelines and regulations governing preclinical testing. (Jacobson-Kram Report at 3.) 1 10.) Dr. Jacobson-Kram disagrees. (See generally Jacobson-Kram Report.) Dr. Jacobson- 2 Kram currently works as a pharmaceutical consultant specializing in non-clinical safety 3 assessment. (Id at 3.) Dr. Jacobson-Kram served as head of toxicology in the FDA’s Office 4 of New Drugs for 11 years, and vice president of a contract testing laboratory for 15 years. 5 (Id.) 6 According to Dr. Jacobson-Kram, Defendant adhered to ICH S9: “[n]o specific 7 safety concerns were identified that would have led to additional studies described in ICH 8 S9.” (Id. at 5.) In both rodent and dog studies, “[n]o change in behavioral patterns were 9 observed that might suggest neurological effects.”7 (Id.; see id. at 5–7.) Nothing in these 10 preclinical studies indicated a risk for neurotoxicity—i.e., that CPI-0610 affected the 11 “normal stereotypical behavior of experimental animals and no histopathology of the 12 central nervous system was seen.” (Id. at 8.) Dr. Jacobson-Kram opines: (1) Defendant 13 performed all preclinical studies required by ICH S9; (2) the FDA agreed that the study 14 was safe to proceed since they had declined to issue a clinical hold; and (3) Defendant’s 15 preclinical package is standard in the industry and consistent with regulatory guidelines. 16 (Id. at 9.) 17 2. 0610-03 Study 18 On June 28, 2013, the FDA approved Defendant’s IND Application for CPI-0610. 19 (Doc. 59-9, Ex. I, IND Approval at 2.) Defendant and Mayo entered into a Clinical Trial 20 Agreement (“CTA”), agreeing that Defendant would support, and Mayo would conduct, a 21 clinical trial entitled, “A Phase 1 Study of CPI-0610, a Small Molecule Inhibitor of BET 22 Proteins, in Patients with Previously Treated Multiple Myeloma.”8 (CTA at 2.) The CTA 23 defines the relationship between Defendant and Mayo, respectively, Sponsor and 24 Institution, as that of “independent contractor.” (DSOF ¶ 17; PSOF ¶ 17.) The CTA 25 identifies Dr. P. Leif Bergsagel, M.D., as Principal Investigator,9 “responsible for the

26 7 Based on her CPI-0610 dose, Ms. Spedale’s exposures were most closely mimicked at a steady state in the rat 20mg/kg dose group, which showed no significant clinical signs. (Id. 27 at 6.) And Ms. Spedale’s exposures were most closely mimicked at a steady state in the dog 4mg/kg dose group, which showed no significant behavioral changes. (Id. at 7.) 28 8 The Court refers to the “Phase 1 Study of CPI-0610” as the “0610-03 Study.” 9 Under 21 C.F.R. § 312.60, an investigator “is responsible for ensuring that an 1 direction of the Trial in accordance with applicable [Mayo] policies and Applicable Law.” 2 (CTA at 2.) 3 Enrollment for the 0610-03 Study began in September 2013. (DSOF ¶¶ 1, 37; PSOF 4 ¶¶ 1, 37.) By its conclusion, 138 patients were evaluated across three trial sites (all Phase 5 1 studies), at doses of 6mg to 400mg once per day and 85mg to 110mg twice per day. 6 (DSOF ¶ 38; PSOF ¶ 38.) Of the 138 total patients, 30 patients had multiple myeloma. 7 (DSOF ¶ 38; PSOF ¶ 38.) Ms. Spedale, the 25th patient with multiple myeloma, enrolled 8 at the Arizona trial site (Mayo) on December 1, 2015. (DSOF ¶¶ 1, 39; PSOF ¶¶ 1, 39.) At 9 Mayo, Ms. Spedale was the last of 5 patients with multiple myeloma evaluated at the 10 150mg dose. (DSOF ¶ 39; PSOF ¶ 39.) Prior to Ms. Spedale’s enrollment, two trial sites 11 reported adverse events—Massachusetts General Hospital (“MGH”) and The Ohio State 12 University Cancer Center (“OSU”).10 (DSOF ¶ 41; PSOF ¶ 41.) Ms. Spedale discussed her 13 enrollment with Dr. Fonseca, as well as Dr. Bergsagel and Charanjit (J.R.) Singh, Mayo’s 14 clinical research coordinator. (DSOF ¶¶ 31–33, 36; PSOF ¶¶ 31–33.) Mr. Singh went over 15 each section of the Informed Consent Document (“ICF”) with Ms. Spedale before she 16 signed it. (Doc. 59-24, Ex. X, Charanjit (J.R.) Singh Dep. (“Singh Dep.”) at 54–55; PSOF 17 ¶ 35.) Plaintiffs and Defendant disagree as to whether Ms. Spedale was fully aware of the 18 experimental nature of the 0610-03 Study when she signed the ICF.11 (See DSOF ¶ 35; 19 PSOF ¶ 35 (“Ms. Spedale’s deposition testimony is questionable, as her condition may 20 affect her memory and responses. For this reason, her deposition was terminated early.”);

21 investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and 22 welfare of subjects under the investigator’s care; and for the control of drugs under investigation.” (See DSOF ¶ 18; PSOF ¶ 18.) The study sponsor must select qualified 23 investigators, provide appropriate information, and ensure that the investigation is properly monitored and adheres to the IND. (DSOF ¶ 19 (citing 21 C.F.R. § 312.50); PSOF ¶ 19.) 24 10 At MGH, a leukemia patient presented with “confusion,” which later resolved (MGH’s principal investigator deemed the patient’s confusion unrelated to the study drug). (DSOF 25 ¶ 41; PSOF ¶ 41.) At OSU, a lymphoma patient also presented with confusion, which fully resolved within forty minutes. (DSOF ¶ 41; PSOF ¶ 41.) OSU’s principal investigator 26 concluded the patient’s confusion was related to the study drug, but unexpected. (DSOF ¶ 41; PSOF ¶ 41.) 27 11 Dr. Sutton’s Report adds color to Plaintiffs’ claim that Ms. Spedale perceived CPI-0610 as a “therapeutic alternative to two approved medications with known safety and efficacy 28 profiles.” (Dr. Sutton’s Report at 11.) “There is nothing in the medical record to suggest that Ms. Spedale had an alternative motivation . . . such as altruism or curiosity.” (Id.) 1 see also PSOF ¶ 44 (“Mr. Singh would not have been aware of the information that 2 [Defendant] omitted from the protocol.”).) 3 3. ICF 4 Federal regulations require all clinical trials to be approved by an IRB independent 5 of the sponsor. See 45 C.F.R. § 46.107 (defining the composition of an IRB); see also 21 6 C.F.R § 56.111 (defining criteria for IRB approval of research); (Doc. 59-12, Ex. L, Italo 7 Biaggioni, M.D. Expert Report (“Biaggioni Report”) at 3–4).12 Mayo’s internal IRB acted 8 as the “IRB of record” for the 0610-03 Study and reviewed the study’s protocol, including 9 its scientific merit and associated risks. (DSOF ¶¶ 22, 47; Biaggioni Report at 4; PSOF 10 ¶¶ 22, 47.) Mayo’s IRB was tasked with ensuring the ICF accurately reflected the study’s 11 risks, contained important safety-related information, and was written in a manner 12 comprehensible to the target population. (Biaggioni Report at 5–6.) Per the CTA, Mayo 13 was to obtain written informed consent from each trial subject according to protocol 14 approved by the FDA and Mayo’s IRB. (CTA at 2, 5.) Dr. Bergsagel testified that he 15 reviewed the proposed ICF and submitted it to the IRB for approval. (DSOF ¶ 25; PSOF ¶ 16 25.) Plaintiffs, however, claim that “the IRB and investigators were not fully informed of 17 all the risks,” resulting in an allegedly deficient ICF. (PSOF ¶ 47.) 18 The ICF explains: 19 The main purpose of this study is to determine the highest dose of CPI-0610 that can be given without causing severe side 20 effects. This is a Phase 1 study, which means that CPI-0610 is in very early stages of testing in humans. Future studies may 21 then test whether or not CPI-0610 is useful against different types of cancer. CPI-0610 is experimental, which means that it 22 is not approved by the [FDA] or other regulatory agencies around the world to treat cancer or for any other disease. 23 24 (DSOF ¶ 48; PSOF ¶ 48; Doc. 59-1, Research Participant Consent & Privacy Authorization 25 Form (“ICF”) at 4.) Next, the ICF lists five research questions: 26 27

28 12 Dr. Biaggioni’s Report is also attached to the Motion to Exclude. (See Doc. 55-1, Ex. F, Italo Biaggioni, M.D. Expert Report.) 1  What is the highest dose of CPI-0610 that can be administered to multiple myeloma patients without causing 2 severe side effects? 3  What are the side effects of CPI-0610? 4  How much CPI-0610 is in the bloodstream at specific times after taking it, and how rapidly does the body get rid of CPI- 5 0610? 6  What are the effects of CPI-0610 on the expression of certain genes, both in normal blood cells and multiple 7 myeloma cells? 8  Will CPI-0610 help reduce the amount of multiple myeloma in patients’ bodies? 9 10 (DSOF ¶ 49; PSOF ¶ 49.) The section addressing “possible risks or discomforts” associated 11 with the study explains that “risks and discomforts related to CPI-0610 are not well 12 known,” and explains findings associated with CPI-0610 animal studies, as well as other 13 potential medical issues. (DSOF ¶ 50; see ICF at 14–17.) The section addressing “possible 14 benefits” of participation states: 15 There may or may not be medical benefit to you. Other people may benefit from the information that is learned in this study. 16 This is a study to help develop a new therapy for others with a similar condition. 17 18 (ICF at 17; see DSOF ¶ 50.) 19 4. Ms. Spedale’s Participation in the 0610-03 Study 20 On November 17, 2015, Dr. Fonseca noted Ms. Spedale’s cancer had reappeared in 21 diagnostic tests, and it was time to consider “the next line of treatment in her situation.” 22 (DSOF ¶ 27; PSOF ¶ 27.) He wrote, “[t]he logical next step would be the use of 23 carfilzomib,” but “[a]nother possibility would be . . . participat[ion] in one of our clinical 24 trials.” (DSOF ¶ 27; PSOF ¶ 27.) Dr. Fonseca further stated that he had already 25 communicated with Mayo’s study coordinators and was in the process of determining 26 Ms. Spedale’s eligibility. (DSOF ¶ 27; PSOF ¶ 27.) On November 23, 2015, Mr. Singh 27 wrote to Plaintiffs, “[Dr. Fonseca] would recommend to first try the study drug (BET 28 inhibitor). . . . Let me know if you want to pursue the trial.” (Doc. 59-17, Ex. Q, Nov. 23, 1 2015 email exchange between Daniel Spedale and J.R. Singh at 2; see DSOF ¶ 29; PSOF 2 ¶ 29.) Mr. Spedale responded affirmatively. (See DSOF ¶ 30; PSOF ¶ 30.) 3 On December 10, 2015, Ms. Spedale began the 0610-03 Study’s fourteen-day 4 regimen. (DSOF ¶ 2; PSOF ¶ 2.) On December 29, 2015, Ms. Spedale exhibited mild forms 5 of grade 1 mania, which rapidly worsened to grade 3. (DSOF ¶ 3; PSOF ¶ 3.) Ms. Spedale 6 continued to experience manic symptoms into 2017, attributing them to CPI-0610.13 7 (DSOF ¶ 4; PSOF ¶ 4.) 8 II. PROCEDURAL BACKGROUND 9 Plaintiffs filed this case on January 13, 2017. (Doc. 1, Compl.) Plaintiffs allege that 10 prior to the 0610-03 Study, Ms. Spedale was “rational,” “able to perform her usual duties 11 and provide comfort, society and support to her family.” (Id. ¶ 41.) In October 2016, after 12 attempting a complex care plan that included live-in aides and regular fly-in visits from her 13 son and sister, Ms. Spedale “was placed in an assisted living facility, out of concerns for 14 her own safety and security as a result of her mental state.” (Id. ¶¶ 44, 47.) Estranged from 15 his wife,14 Mr. Spedale suffered nerve damage and subsequently underwent back surgery 16 and received multiple spine injections. (Id. ¶¶ 48, 50.) Currently, Mr. Spedale resides in an 17 elder-care facility to receive “assistance with his ongoing physical needs.” (Id. ¶ 51.) 18 Plaintiffs make four claims. The first three are based on the theory that Defendant 19 knew or should have known of certain neurological risks associated with CPI-0610. First, 20 Plaintiffs allege Defendant negligently drafted the ICF, failing to adequately disclose CPI- 21 0610’s risks. (Id. ¶¶ 58–73.) Second, Plaintiffs allege Defendant intentionally, recklessly, 22 and/or negligently enrolled Ms. Spedale in the 0610-03 Study without obtaining her full 23 informed consent. (Id. ¶¶ 74–81.) Third, Plaintiffs allege Defendant is strictly liable for 24 failing to provide adequate warnings with respect to CPI-0610, designing an unreasonably 25 13 Plaintiffs dispute Defendant’s claim that Ms. Spedale has “returned to her normal self.” 26 (DSOF ¶ 4; PSOF ¶ 4.) “On the contrary, Ms. Spedale’s mental condition has never recovered to her pre-clinical trial status.” (PSOF ¶ 4; see PSOAF ¶¶ 75–81.) 27 14 As her paranoia worsened, Ms. Spedale obtained a protective order against Mr. Spedale, requiring him to leave their residence and move into a third-story walk-up apartment. 28 Frequently climbing up and down stairs allegedly caused his nerve damage. (Compl. ¶¶ 35, 48.) 1 dangerous product, and inadequately testing the product. (Id. ¶¶ 82–88.) Fourth, Plaintiffs 2 allege Defendant caused Mr. Spedale to suffer the loss of his wife’s companionship, 3 services, and society. (Id. ¶¶ 89–90.) Plaintiffs also seek punitive damages. (Id. ¶ 91.) 4 Defendant now seeks summary judgment on all causes of action. 5 III. MOTION TO STRIKE 6 Plaintiffs move to strike the Affidavit of Dr. Robert Sims because “it fails to state 7 that it is made under penalty of perjury” as required by 28 U.S.C. § 1746. (MSJ Opp’n at 8 4; see Doc. 55-3, Ex. G, Aff. of Dr. Robert Sims (“Aff. I”); Doc. 59-8, Ex. H, Aff. of Dr. 9 Sims (“Aff. II”) (identical filing).) The Court agrees. Although the Affidavit is signed, it 10 fails to substantially comply with § 1746, which requires that any affidavit state “under 11 penalty of perjury that the foregoing is true and correct.” § 1746; see Schroeder v. 12 McDonald, 55 F.3d 454, 460 n.10 (9th Cir. 1995) (stating pleading substantially complied 13 with § 1746 when plaintiff stated under penalty of perjury that contents were true and 14 correct); Kersting v. United States, 865 F. Supp. 669, 676 (D. Haw. 1994) (“As long as an 15 unsworn declaration contains the phrase ‘under penalty of perjury’ and states that the 16 document is true, the verification requirements of 28 U.S.C. § 1746 are satisfied.”). Here, 17 the Affidavit states: “The foregoing statements made by me are true and correct to the best 18 of my knowledge. I am aware that if the foregoing are willfully false, I am subject to 19 punishment.” (Aff. I at 4; Aff. II at 5.) Because the Affidavit makes only one of the two 20 required assertions, the Court grants Plaintiffs’ Motion to Strike. 21 IV. MOTION TO EXCLUDE 22 A. Legal Standard 23 Rule 702 provides: 24 A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an 25 opinion or otherwise if: 26 (a) the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence 27 or to determine a fact in issue; 28 (b) the testimony is based on sufficient facts or data; 1 (c) the testimony is the product of reliable principles and methods; and 2 (d) the expert has reliably applied the principles and methods 3 to the facts of the case. 4 Fed. R. Evid. 702. Under Rule 702, the trial court acts as “gatekeeper,” ensuring proffered 5 scientific testimony meets certain standards of relevance and reliability before admission. 6 Daubert v. Merrell Dow Pharm., Inc. (“Daubert I”), 509 U.S. 579, 590–95 (1993). 7 1. Reliability 8 An expert opinion is reliable if based on proper methods and procedures rather than 9 “subjective belief or unsupported speculation.” Id. at 590. The test for reliability “‘is not 10 the correctness of the expert’s conclusions but the soundness of his methodology.’” Stilwell 11 v. Smith & Nephew, Inc., 482 F.3d 1187, 1192 (9th Cir. 2007) (quoting Daubert v. Merrell 12 Dow Pharm., Inc. (“Daubert II”), 43 F.3d 1311, 1318 (9th Cir. 1995)). Alternative or 13 opposing opinions or tests do not “preclude the admission of the expert’s testimony—they 14 go to the weight, not the admissibility.” Kennedy v. Collagen Corp., 161 F.3d 1226, 1231 15 (9th Cir. 1998). The same is true of “[d]isputes as to the strength of [an expert’s] 16 credentials, faults in his use of [a particular] methodology, or lack of textual authority for 17 his opinion . . . .” Id. (quotation omitted). 18 The proffering party must demonstrate expert testimony’s admissibility by a 19 preponderance of the evidence. Daubert I, 509 U.S. at 592 n.10. The district court considers 20 four factors to determine whether the testimony will assist the trier of fact: “(i) whether the 21 expert is qualified; (ii) whether the subject matter of the testimony is proper for the jury’s 22 consideration; (iii) whether the testimony conforms to a generally accepted explanatory 23 theory; and (iv) whether the probative value of the testimony outweighs its prejudicial 24 effect.” Scott v. Ross, 140 F.3d 1275, 1285–86 (9th Cir. 1998) (citations omitted). Whether 25 an expert seeks to “testify about matters growing naturally and directly out of research they 26 have conducted independent of the litigation, or whether they have developed their 27 opinions expressly for the purpose of testifying” is highly significant. Daubert II, 43 F.3d 28 at 1317. If the proposed testimony is not based on independent research, the court may rely 1 on “other objective, verifiable evidence that the testimony is based on ‘scientifically valid 2 principles.’” Id. at 1317–18. Ultimately, “judges are entitled to broad discretion when 3 discharging their gatekeeping function.” United States v. Hankey, 203 F.3d 1160, 1168 (9th 4 Cir. 2000) (citing Kumho Tire Co. v. Carmichael, 562 U.S. 137, 149–153 (1999)). 5 2. Relevance 6 The district court must exclude proffered scientific evidence unless it is “convinced 7 that it speaks clearly and directly to an issue in dispute in the case, and that it will not 8 mislead the jury.” Cloud v. Pfizer Inc., 198 F. Supp. 2d 1118, 1130 (D. Ariz. 2001) (citing 9 Daubert II, 43 F.3d at 1321). The district court “assessing a professor of expert scientific 10 testimony . . . should also be mindful of other applicable rules,” including Federal Rule of 11 Evidence 403, which allows “exclusion of relevant evidence ‘if its probative value is 12 substantially outweighed by the danger of unfair prejudice, confusion of issues, or 13 misleading the jury. . . .’” Daubert I, 509 U.S. at 595 (citing Fed. R. Evid. 403). 14 B. Dr. Sutton’s Opinions 15 Dr. Sutton offers ten opinions: (1) Defendant negligently advanced CPI-0610 from 16 animal studies to human clinical trials;15 (2) Ms. Spedale “suffered severe and irreversible 17 brain injury as the direct result of exposure to a toxic dose of CPI-0610”;16 (3) Ms. Spedale 18 suffered mania and psychosis as a result of this toxic exposure;17 (4) Defendant “relied on 19 flawed reasoning in suggesting that the continuation of [Ms. Spedale]’s symptoms after 20 discontinuation of CPI-0610 suggests a lack of causality”; (5) Mayo never obtained Ms. 21 Spedale’s full informed consent because: (a) she may have perceived CPI-0610 to be a 22 therapeutic alternative to cancer medication; and (b) the ICF did not adequately reflect the 23 15 Dr. Sutton opines that Defendant “failed to adequately test for potential neurotoxicity in 24 violation of basic guidelines for preclinical safety testing of an investigational new drug.” (Sutton Report at 9.) Dr. Sutton further opines that Defendant did not see a need to conduct 25 further safety testing “because they chose not to look for any.” (Id. at 10.) 16 According to Dr. Sutton, “there was no event between 2011 and 2016 other than her 26 exposure to CPI-0610 . . . that would provide an alternative explanation” for Ms. Spedale’s mania and psychosis. (Sutton Report at 10.) 27 17 Dr. Sutton explains that “[f]rontal lobe white matter abnormalities of the type described in Ms. Spedale’s MRI scan are known to be linked to mania,” and “[h]istone modification 28 of the type caused by BET inhibitors such as CPI-0610 is known to play a major role in psychiatric illnesses including mania and psychosis.” (Sutton Report at 10.) 1 risks associated with CPI-0610; (6) Defendant “is culpable in the failure to obtain informed 2 consent”;18 (7) “[Defendant]’s protocol . . . failed to ensure human subject protection”; (8) 3 Defendant “was negligent in its choice of Michael Cooper as its [Chief Medical Officer]”; 4 (9) Defendant “was negligent in not keeping abreast of BET inhibitor research in a manner 5 that would allow for . . . immediate action to ensure human subject safety”;19 and (10) Ms. 6 Spedale “has suffered permanent and irreparable psychological injury.” (Sutton Report at 7 9–14.) Defendant moves to exclude Dr. Sutton’s Report and proposed testimony as his 8 opinions are insufficiently reliable under Rule 702 and Daubert I. (MTE at 2.) 9 C. Admissibility of Dr. Sutton’s Expert Opinions 10 1. Reliability 11 a. Dr. Sutton’s Qualifications 12 Dr. Sutton is a board-certified neurologist in California. (Doc. 55-2, Ex. B, James 13 P. Sutton, M.D. Dep. (“Sutton Dep.”) at 35; Sutton Report at 18.) He has been practicing 14 medicine since 1984 and currently serves as medical director of Pacific Neuroscience 15 Medical Group. (Sutton Dep. at 34; Sutton Report at 17.) The bulk of his “clinical practice 16 consists of patients with complex neuropsychiatric issues due to neurodegenerative 17 disease, many of whom have organic psychoses.”20 (Sutton Report at 2.) Dr. Sutton has 18 served as principal investigator in over one hundred trials and in that capacity, has 19 “reviewed an equal number of clinical protocols and investigative brochures, as well as 20 SUSAR21 safety reports numbering in the thousands.” (Id.; see id. at 18–26 (detailing trials 21 (beginning in 1992) in which Dr. Sutton has participated).) Dr. Sutton does not typically

22 18 He suggests that as the study’s sponsor, Defendant was responsible for monitoring the trial site’s activities and documents, including the process of obtaining a participant’s 23 informed consent. (Sutton Report at 12.) Because Defendant did not “review, discover, and request a change” in the ICF, Defendant failed to obtain full informed consent from 24 Ms. Spedale. (Id.) 19 Specifically, Defendant failed to consider the nexus between BET inhibitors and 25 neurotoxicity. (Sutton Report at 14; see also id. (“Dr. Allis’s report was not the type that a drug company studying BET inhibitors would be expected to miss. It was published in 26 Nature Neuroscience and it appears that a press release may have gone out.”).) 20 Alongside his clinical practice, Dr. Sutton has studied “preclinical safety data for well 27 over fifty investigational new drugs,” and “authored a chapter on the genetics of rare and unusual movement disorders, reviewing the relationship between genetics, cellular 28 biology, and phenotype for each disorder.” (Sutton Report at 2.) 21 Suspected Unexpected Serious Adverse Reaction (“SUSAR”). (MTE Opp’n at 3.) 1 conduct Phase 1 trials, in part, “because the type of phase one studies that would be of or 2 in neurology often require hospitalization,” and it is “simpler . . . to focus on phase two and 3 three.” (Sutton Dep. at 45.) 4 Dr. Sutton states that “[t]hrough [] education, training, experience, review of the 5 medical literature and other professional activities,” he is “familiar with the scientific, 6 medical, ethical, regulatory, and legal foundations for the conduct of human subject 7 medical research.” (Sutton Report at 2.) Importantly, Dr. Sutton testified about the protocol 8 he utilizes when enrolling a candidate in a clinical trial: 9 I would set up a visit for them to come in, go over the consent document page by page, item by item, and I highlight, 10 basically, each area, explain what it means, what the significance is. I will take time to go over the safety 11 information, explain to them that I want them to understand what it means, what it doesn’t mean, so they don’t . . . gloss 12 over it, because it is, often, I don’t want to say ‘hidden,’ but in the middle of a document that could be 25 pages. I make sure 13 they understand, see if they have questions, and then after they do that, I give them the informed consent to take home, look 14 at, discuss with whomever they may wish, and then let us know if they want to participate. 15 16 (Sutton Dep. at 41–42.) 17 Defendant argues that although Dr. Sutton is a clinical neurologist, he is unqualified 18 to offer opinions in the three general areas: (1) standard of care; (2) informed consent; and 19 (3) causation. (See MTE at 2–3.) Defendant contends that Dr. Sutton lacks “expertise in 20 clinical trial studies, BET inhibitors, oncology drugs, and the guidelines and requirements 21 . . . [of] the FDA submission process.” (Id. at 5; see id. (“Dr. Sutton has no specific 22 knowledge about other BET inhibitor trials and whether these trials conducted additional 23 neurotoxicity in the pre-clinical phase.”) Defendant also emphasizes Dr. Sutton’s lack of 24 experience with Phase 1 clinical trials, particularly trials involving oncology drugs or BET 25 inhibitors. (Id. at 6 (citing Sutton Dep. at 45, 47–48).) Finally, Defendant suggests that 26 Dr. Sutton is insufficiently familiar with federal regulations governing pre-clinical phases 27 of cancer study drugs.22 (MTE at 7.)

28 22 Defendant argues that this case mirrors Cloud, where a psychiatrist with over thirty-three years of experience was precluded from testifying because the court found his opinions 1 Plaintiffs maintain that this case does not hinge on questions involving the approval 2 process for oncological study drugs, but on whether CPI-0610 “caused neurological 3 damage, and whether [Defendant] knew or should have known that someone,” who has “a 4 history of drug-induced mania, should be in a Phase 1 trial of [CPI-0610].” (MTE Opp’n 5 at 2.) The Court agrees with Plaintiffs. 6 First, while Defendant is correct that Ms. Spedale’s participation in a Phase 1 7 clinical trial for an oncological drug triggered this lawsuit, Ms. Spedale’s neurological 8 damage is the injury at issue. (MTE at 5.) Consequently, Dr. Sutton’s lack of training in 9 oncology is not fatal to his proposed report and testimony. Indeed, Dr. Sutton has 10 significant experience in clinical trials of drugs specifically related to neurological 11 disorders, in addition to his extensive experience in reviewing clinical trial protocols, 12 investigative brochures, and SUSAR safety reports. (See Sutton Dep. at 36–37; Sutton 13 Report at 2, 18–26.) 14 Second, Defendant improperly minimizes Dr. Sutton’s familiarity with federal 15 regulations governing pre-clinical phases of cancer study drugs. Dr. Sutton testified that he 16 reviewed relevant regulations in connection with his work in this case, and included them 17 in his Report as he saw fit. (See Sutton Dep. at 57–59.) That Dr. Sutton does not explain 18 the regulations in his Report does not mean that he is unfamiliar with them. (See id. at 58; 19 MTE Opp’n at 12.) 20 b. Dr. Sutton’s Methodology 21 Defendant does not individually engage each of Dr. Sutton’s opinions, but divides 22 its Motion to Exclude into three parts: (1) “Additional Neurotoxicity Testing Should have 23 been Performed in the Preclinical Phase”; (2) “[E]xclusion criteria was inadequately 24 drafted”; and (3) “The informed consent was inaccurate.” (MTE at 10, 15, 17.) 25

26 were developed for the purpose of testifying. (MTE at 8 (citing Cloud, 198 F. Supp. 2d at 1130, 1135).) The Court disagrees. The psychiatrist offered as an expert in Cloud had little 27 experience conducting clinical trials and, most notably, did not even consider himself an expert in the relevant fields of suicidology and psychopharmacology. See id. at 1130–31. 28 Here, in addition to other relevant knowledge and training, Dr. Sutton is a practicing neurologist with decades of experience serving as a principal investigator in clinical trials. 1 (1) Additional Testing in the Preclinical Phase 2 In reaching opinions related to the need for more preclinical safety testing, 3 Defendant argues that Dr. Sutton does “not rely on any published data of specific BET 4 inhibitors that were linked to psychiatric disorders.” (Id. at 11.) Instead, Dr. Sutton applies 5 broad research principles to arrive at a very general hypothesis: “since a BET inhibitor is 6 known to affect DNA transcription, [CPI-0610] can be linked to very general and broad 7 research on epigenetic modification.” (Id.) Defendant, however, does not cite a specific 8 part of Dr. Sutton’s Report or deposition testimony promulgating such a hypothesis. (See 9 generally MTE.) Where he does opine that Ms. Spedale “suffered disabling mania and 10 psychosis” as the result of a toxic dose of CPI-0610, Dr. Sutton explains that “[h]istone 11 modification of the type caused by BET inhibitors such as CPI-0610 is known to play a 12 role in psychiatric illnesses including mania and psychosis.” (Sutton Report at 10.) Further, 13 he states that while BET inhibitors interfere with mRNA transcription, valproic acid, “one 14 of the most effective pharmacological therapies for mania,” actually increases mRNA 15 transcription in a manner opposite to BET inhibitors such as CPI-0610. (Id. at 11.) 16 Defendant next suggests that Dr. Sutton relies exclusively on an article co-written 17 by one of Defendant’s co-founders, C. David Allis (“Allis Article”), to demonstrate 18 correlation between BET inhibitors and psychiatric disorders.23 (See MTE at 13; see also 19 id. at 12 (“Dr. Sutton seeks . . . refuge for his hypothesis by relying on the Allis Article’s 20 findings.”).) Defendant argues that, like the expert in Cloud, Dr. Sutton improperly relies 21 on “the Allis Article as the sole basis for why [Defendant] should have conducted 22 additional testing, revised its protocol and its exclusion criteria.” (MTE at 13 (citing Cloud, 23 198 F. Supp. 2d at 1132).) The Court disagrees. Dr. Sutton’s Report and proposed 24 testimony are based on thirty-four medical and scientific references, as well as his 25 knowledge and experience as a clinical neurologist. (See MTE Opp’n at 12; see also 26 Dr. Sutton Report at 15–16 (listing references).) And, significantly, he does not opine about 27 23 Erica Korb, Maro Herre, Ilana Zucker-Scharff, Robert B. Darnell & C. David Allis, BET 28 protein Brd4 activates transcription in neurons and BET inhibitor Jq1 blocks memory in mice, 18 Nature Neuroscience 1464 (2015). || the IND submission process, but testified that had Defendant conducted additional 2|| preclinical testing for neurotoxicity, such testing would have enabled a more careful 3|| drafting process for both the study protocol and ICF. (Sutton Dep. at 67; see id. at 64-68.) Furthermore, Cloud is distinguishable because, in that case, the proposed expert testified || that he did not consider one of the key articles he cited in support of his ultimate conclusion to be “reliable scientific evidence.” See Cloud, 198 F. Supp. 2d at 1133. Here, Dr. Sutton is not an out-of-field practitioner relying on a single article to substantiate his opinions. 8 Finally, Defendant posits that Dr. Sutton’s lack of awareness as to other BET 9|| inhibitor studies reporting manic or psychotic episodes “undermines his own opinion and 10}| reliability as an expert.” (MTE at 13.) Dr. Sutton testified that regardless of whether other 11] BET inhibitor studies reflected such findings, his opinion about the connection between 12 || CPI-0610 and Ms. Spedale’s neurological issues would remain unmoved, in part, due to 13 || myriad unknown variables in such studies. (Sutton Dep. at 63-65.) And while Defendant appears to take issue with Dr. Sutton’s unwillingness to state that he could have predicted 15 || aparticular outcome for Ms. Spedale, according to Dr. Sutton, the issue is not “[p]redicting a bad outcome,” but rather, “not insuring the safety of the research participants who then had a bad outcome.” (/d. at 66.) The Court finds this distinction apt—Plaintiffs do not rely upon Dr. Sutton to predict specific outcomes with respect to clinical trials involving BET 19}} inhibitors. 20 (2) Inadequate Exclusion Criteria 21 Defendant takes issue with two of Dr. Sutton’s critiques of the clinical trial protocol. First, the lack of exclusion criteria for subjects who had other treatment options, and 23 || second, the lack of exclusion criteria for patients with prior or active central nervous system 24|| neurological or psychiatric illnesses. (MTE at 15; Sutton Report at 12.) In support, 25 || Defendant cites Section Four of the protocol: 26 The patients enrolled in this study will be adults (aged > 18 years) with a_ histologically or cytologically confirmed 27 diagnosis of multiple myeloma that has progressed following standard treatment, and tor whom further effective standard

-16-

1 Doc. 55-1, Ex. E, Clinical Trial Protocol at 40.) Dr. Sutton’s opinion hinges on safety; he 2 testified that although the protocol states that this study is for patients “for whom further 3 effective standard treatment is not available,” that statement is not included in the relevant 4 subsection titled, “Exclusion [C]riteria,” essentially removing that information from the 5 patient’s mind.24 (Sutton Dep. at 99; Sutton Report at 11–12.) Defendant counters that 6 Dr. Sutton’s opinion is “anecdotal and personal.” (MTE at 16.) That may be, but 7 Dr. Sutton’s reliance on his extensive clinical background and experience in this context 8 does not justify exclusion. Among other qualifications, Dr. Sutton has been practicing for 9 over thirty years and has been involved in more than 150 clinical trials. See Primiano v. 10 Cook, 598 F.3d 558, 567 (9th Cir. 2010) (admitting expert’s testimony with “sufficient 11 basis in education and experience”). 12 Second, Defendant argues that Dr. Sutton solely and improperly relies on the Allis 13 Article to opine that Defendant failed to ensure human subject protection by failing to 14 include exclusion criteria or precautionary provisions for patients with prior or active 15 central nervous system neurological or psychiatric illness. (MTE at 16.) Plaintiff does not 16 disagree with Defendant—Dr. Sutton relies on the Allis Article to reach his opinion, but 17 sufficiently explains his criteria for doing so.25 The jury may reject Dr. Sutton’s opinions; 18 it may conclude that Defendant adequately drafted the exclusion criteria. See Primiano, 19 598 F.3d at 568. But the Court cannot close the door to these “relevant opinion[s] offered

20 24 Dr. Sutton testified that “if the information is presented in a manner that [] disappears, then the question is, first of all, why, and then second of all, who then becomes 21 responsible?” (Sutton Dep. at 99.) 25 Dr. Sutton offers numerous statements in support of this opinion: 22 (1) “The information should have been known by the drug company, given that the article is based on research . . . and published by one of its founders . . . . They 23 should have thought about the possibility that there could be injury to the central nervous system. They should have made sure there was an exclusion for psychiatric 24 disorders, they should have changed the protocol.” (Sutton Dep. at 71.) (2) “I would expect any drug company doing research on bromodomain inhibitors and 25 epigenetics would be keeping abreast of the field.” (Id. at 75.) (3) Dr. Sutton testified that Ms. Spedale had a predisposition to psychosis from steroids, 26 and, as such, any reasonable protocol would have excluded her from the trial. (Id. at 76.) 27 (4) Explaining the difference between “prior” and “concurrent” in terms of the protocol’s drafting, Dr. Sutton explains that as currently written, “you would 28 absolutely enroll someone with a past history of mania on that exclusion or inclusion criteria.” (Sutton Dep. at 78.) 1 with sufficient foundation by one qualified to give it.” Id.; see also Murray v. S. Route 2 Maritime SA, 870 F.3d 915, 925 (9th Cir. 2017) (“[T]he appropriate way to discredit [an 3 expert]’s theory [is] through competing evidence and incisive cross-examination.”). 4 (3) Inadequately Drafted ICF 5 Defendant argues that Dr. Sutton lacks the necessary experience to opine about 6 drafting informed consent and/or protocols, and that where he opines that the ICF fails to 7 specify certain risks associated with CPI-0610, he does so without support. (MTE at 17.) 8 Defendant argues that its IRB expert, Dr. Biaggioni, confirmed that the ICF “complied 9 with all applicable guidelines and regulations,” and that Dr. Sutton has not claimed 10 otherwise. (Id.; Biaggioni Report at 8–9.) Yet Dr. Sutton’s opinion that Ms. Spedale’s full 11 informed consent was never obtained is not based on his understanding of the duty and/or 12 role of the IRB; it is based on his belief that Ms. Spedale should have been given certain 13 information prior to enrollment—information Defendant neglected to account for in their 14 study design. (Sutton Report at 11–12.) While Mayo’s IRB was “responsible for reviewing, 15 amending and finalizing the ICF,” Defendant was ultimately responsible for providing the 16 underlying information. (MTE at 17; Sutton Report at 11–12.) As discussed above, Dr. 17 Sutton is qualified to render these opinions. 18 2. Relevance 19 a. Proposed Opinion 5 20 While Dr. Sutton’s opinions concerning the adequacy of the ICF speak “clearly and 21 directly to an issue in dispute in the case,” his opinion that Ms. Spedale never fully 22 consented to participate in the 0610-03 Study because she may have perceived CPI-0610 23 to be a therapeutic treatment does not. Cloud, 198 F. Supp. 2d at 1130; (see Sutton Report 24 at 11 (Opinions 5(a)–(d))). The ICF sufficiently discloses the study’s experimental nature. 25 It unambiguously states that the “main purpose of the study is to determine the highest dose 26 of CPI-0610 that can be given without causing severe side effects,” and explains that 27 because the 0610-03 Study is a Phase 1 study, “CPI-0610 is in very early stages” of human 28 testing. (ICF at 4.) Additionally, the five research questions posed by the 0610-03 Study 1 all reflect the experimental nature of the trial. (See id.) Whatever its other issues may be, 2 the ICF does not portray CPI-0610 as a “therapeutic alternative” to cancer-treating 3 medications. (See ICF at 17 (“There may or may not be medical benefit to you . . . . This 4 study may help to develop a new therapy for others with a similar condition.”).) And where 5 Dr. Sutton opines that nothing in the medical record indicates other options were discussed 6 with Ms. Spedale, even if that were true, such a discussion does not fall within the scope 7 of Defendant’s role as drug manufacturer and sponsor. (Sutton Report at 12 (Opinion 8 5(d)).) Consequently, the Court excludes proposed opinions 5(a)–(d), and 5(g).26 9 The Court excludes proposed opinions 5(h) and 5(i) for similar reasons. The 0610- 10 03 Study was a dose-escalation study, which means that patients in the first group received 11 a certain dose of CPI-0610, and if no one in the group presented a dose-limiting toxicity 12 (“DLT”), each subsequent group would receive a higher dose until at least two patients 13 presented at least one DLT. (Sutton Report at 5.) The 0610-03 Study defined DLT as a 14 “Grade III or ‘Severe Adverse Event,’” or, “[s]omething medically significant but not life- 15 threatening.” (Id.) Dr. Sutton opines that the ICF does not sufficiently explain the risks 16 associated with a dose-escalation study (such as death and DLTs). (Sutton Report at 12 17 (Opinion 5(i)).) The ICF itself states otherwise. The ICF explicitly states: “[t]he dose of 18 CPI-0610 will continue to be increased until unacceptable side effects occur in patients.” 19 (ICF at 5–6.) And, whether Ms. Spedale properly read that the study involved “the risk of 20 death” is not at issue. 21 b. Proposed Opinions 4, 8, and 9 22 Defendant specifically attacks the relevance of Dr. Sutton’s opinions concerning 23 Defendant’s liability, proposed opinions 4, 8, and 9. (MTE at 18.) Without explaining why 24 Plaintiffs cannot establish liability, Defendant argues that Dr. Sutton’s opinions are 25 irrelevant because he has not spoken with any of Defendant’s employees involved with the 26 0610-03 Study. (Id.) Defendant does not cite any supporting authority indicating that such

27 26 Opinion 5(g) pertains to Ms. Spedale’s medical record: “In the notes the day of signing informed consent, there is no record of what transpired.” (Sutton Report at 12.) This 28 statement is irrelevant, particularly with respect to Defendant’s liability, since Defendant does not oversee the physician-patient relationship between Dr. Fonseca and Ms. Spedale. 1 discussions are a precondition of relevance. (See generally id.) The Court, therefore, is 2 unmoved. Proposed opinions 4 and 9 speak “clearly and directly” to the extent of 3 Defendant’s duty to participants in the 0610-03 Study, and whether Defendant’s omissions 4 were responsible for harm suffered by Plaintiffs. Cloud, 198 F. Supp. 2d at 1130. 5 However, the Court finds that proposed opinion 8, which states that Defendant “was 6 negligent in the choice of Dr. Michael Cooper as their CMO” has little to no bearing on the 7 ultimate issues in this case. (Sutton Report at 12.) In fact, admitting this scientific-adjacent 8 opinion could potentially mislead the jury to decide that if Defendant negligently selected 9 Dr. Cooper as CMO, Defendant is liable for inadequately drafting the ICF. See Daubert II, 10 43 F.3d at 1321; see also Daubert I, 509 U.S. at 595 (explaining that scientific expert 11 testimony “can be both powerful and quite misleading” because it is difficult to evaluate). 12 The Court accordingly excludes proposed opinion 8. 13 D. Conclusion 14 Although Defendant may disagree with Dr. Sutton’s conclusions, Defendant will 15 have the opportunity to offer the testimony of its own rebuttal expert and to cross-examine 16 Dr. Sutton to explore the limitations of his analysis and conclusions. Any such limitations 17 will go to the weight, not the admissibility, of Dr. Sutton’s testimony. With the exception 18 of proposed opinions 5(a)–(d), 5(g)–(i), and 8, Dr. Sutton’s opinions are admissible. The 19 Court grants in part and denies in part Defendant’s Motion to Exclude. 20 V. DEFENDANT’S MOTION FOR SUMMARY JUDGMENT 21 A. Legal Standard 22 Summary judgment is properly granted when: (1) no genuine issues of material fact 23 remain; and (2) after viewing the evidence most favorably to the non-moving party, the 24 movant is clearly entitled to prevail as a matter of law. Fed. R. Civ. P. 56(a); Celotex Corp. 25 v. Catrett, 477 U.S. 317, 322–23 (1986); Eisenberg v. Ins. Co. of N. Am., 815 F.2d 1285, 26 1288–89 (9th Cir. 1987). A fact is “material” when, under the governing substantive law, 27 it could affect the outcome of the case. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 28 1 (1986). A “genuine issue” of material fact arises if “the evidence is such that a reasonable 2 jury could return a verdict for the nonmoving party.” Id. 3 The moving party bears the initial burden of identifying the portions of the record, 4 including pleadings, depositions, answers to interrogatories, admissions, and affidavits, 5 that it believes demonstrate the absence of a genuine issue of material fact. Celotex Corp., 6 477 U.S. at 323. If the moving party meets its initial burden, the opposing party must 7 establish the existence of a genuine dispute as to any material fact. See Matsushita Elec. 8 Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 585–86 (1986). There is no issue for trial 9 unless there is sufficient evidence favoring the non-moving party. See Anderson, 477 U.S. 10 at 249. “If the evidence is merely colorable or is not significantly probative, summary 11 judgment may be granted.” Id. at 249–50 (citations omitted). A plaintiff cannot create a 12 genuine issue for trial based solely upon subjective belief. Bradley v. Harcourt, Brace & 13 Co., 104 F.3d 267, 270 (9th Cir. 1996). However, “[t]he evidence of the non-movant is to 14 be believed, and all justifiable inferences are to be drawn in his favor.” Anderson, 477 U.S. 15 at 255 (citation omitted). 16 B. Analysis 17 1. Count One: Negligence 18 Plaintiffs argue that Defendant failed to provide Mayo with adequate information 19 about CPI-0610’s risks and benefits, thereby preventing Mayo from obtaining full 20 informed consent from study participants.27 (See PSOAF ¶¶ 31, 34–35, 47–48; Compl. 21 ¶¶ 58–73.) Plaintiffs argue that Defendant knew or should have known of the risks of 22 certain adverse effects, including neurotoxicity, associated with CPI-0610 beforehand. (See 23 PSOAF ¶ 35; Compl. ¶ 59.) “‘To establish a claim for negligence, a plaintiff must 24 27 Plaintiffs also argue that Defendant “misrepresented, in the [ICF] and otherwise, that 25 [CPI-0610] was a ‘treatment’ for multiple myeloma.” (Opp’n to MSJ at 15; see PSOAF ¶¶ 44–45; PSOF ¶¶ 49–50; Compl. ¶ 65.) Defendant denies this depiction, and emphasizes 26 that the ICF “educated the enrollee that there may not be a medical benefit of taking the study drug and there [were] potential risks associated with the study drug.” (DSOF ¶ 50.) 27 The Court agrees with Defendant. As discussed above, with respect to Dr. Sutton’s proposed opinions 5(a)–(d), the ICF does not present CPI-0610 (or the 0610-03 Study) as 28 a treatment for multiple myeloma. See supra Section IV.C.2.a. The Court grants summary judgment with respect to Plaintiffs’ negligent misrepresentation claim. 1 prove . . . : (1) a duty requiring the defendant to conform to a certain standard of care; (2) a 2 breach by the defendant of that standard; (3) a causal connection between the defendant’s 3 conduct and the resulting injury; and (4) actual damages.’” Diaz v. Phx. Lubrication Serv., 4 Inc., 230 P.3d 718, 721 (Ariz. Ct. App. 2010) (quoting Gipson v. Kasey, 150 P.3d 228, 230 5 (Ariz. 2007)). “Ordinarily, summary judgment is not appropriate in negligence actions 6 because breach of the duty of reasonable care and proximate cause are fact questions for 7 the jury.” Matthews v. Greyhound Lines, Inc., 882 F. Supp. 146, 148 (D. Ariz. 1995) 8 (citation omitted)). “Nevertheless, summary judgment is appropriate where all reasonable 9 people must draw the same conclusion.” Id. (citation omitted). 10 a. Duty 11 In a clinical trial setting, Defendant argues, the sponsor’s duty does not run to the 12 participants, but to the investigators. (MSJ at 17–18.) Therefore, as the 0610-03 Study’s 13 sponsor, Defendant denies any duty to Ms. Spedale. (Id. at 18.) Plaintiffs respond that 14 Defendant acted negligently by failing to adhere to federal regulations governing clinical 15 trials. (MSJ Opp’n at 12 (citing 21 C.F.R. §§ 312.3(b), 312.50, 312.60; 45 C.F.R. 16 § 46.116).) According to Plaintiffs, federal regulations enacted for the safety of trial 17 subjects impose duties upon sponsors that flow to trial subjects. (MSJ Opp’n at 12.) 18 Plaintiffs most persuasively cite to § 312.50, which states in part: 19 Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an 20 investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted 21 in accordance with the general investigational plan and protocols contained in the IND, maintaining an effective IND 22 with respect to the investigations, and ensuring that FDA and all participating investigators are promptly informed of 23 significant new adverse effects or risks with respect to the drug. 24 (Id.) Plaintiffs argue that Defendant’s responsibility accordingly included disclosing 25 significant risks associated with CPI-0610. (See id. at 12–13); see also 21 C.F.R. § 312.55 26 (imposing duties on sponsors, distinct from those imposed on investigators, to provide 27 information required to draft proper ICFs); Butler v. Juno Therapeutics, Inc., No. H-18- 28 898, 2019 WL 2568477, at *22–23 (S.D. Tex. June 21, 2019) (explaining how 21 C.F.R. 1 §§ 312.50, 312.55 may impose duties on drug manufacturers that flow to clinical trial 2 participants). Plaintiffs cite to Zeman v. Williams, where the court determined that while 3 “the investigator has a major, if not the major, role in obtaining a properly informed 4 consent[,]” other persons, “particularly the trial’s sponsor, might also have a responsibility 5 to help assure that the investigator actually gets a properly informed consent.” No. 11- 6 10204-GAO, 2014 WL 3058298, at *3 (D. Mass July 7, 2014). “If the investigator fails to 7 inform a subject about some substantial risk because the sponsor has failed to adequately 8 inform the investigator about the risk, the sponsor may be liable in tort.” Id. The Court 9 agrees with the general principle espoused by Zeman: if the sponsor does not fulfill its duty 10 to the investigator, then, by extension, it does not fulfill its duty to the participant. See 11 Butler, 2019 WL 2568477, at *23. 12 b. Breach 13 The issue, then, is whether Defendant fulfilled its duty to Mayo’s IRB by 14 (1) conducting appropriate preclinical safety testing on CPI-0610 and (2) accurately 15 conveying necessary information to Mayo’s IRB so that the investigators could secure full 16 informed consent from participants. Dr. Sutton opines that Defendant did not fulfill its duty 17 to Ms. Spedale because it failed to “monitor the site’s activities and documents, including 18 the [informed consent] process and the ICF.” (Sutton Report at 12.) Dr. Jacobson-Kram 19 does not directly address Dr. Sutton’s opinion, only opining that Defendant “performed 20 due diligence in its preclinical safety assessment,” in part, because “[t]he preclinical 21 package that [he] reviewed is standard in the industry and consistent with the regulatory 22 guidelines.” (Jacobson-Kram Report at 9.) Based on the difference in the opinions offered 23 by Plaintiffs’ and Defendant’s respective experts on the proper standard of care, the Court 24 finds that there is a genuine dispute of material fact as to whether Defendant breached its 25 duty of care to Ms. Spedale. 26 c. Proximate Cause 27 At this juncture, the Court concludes that Plaintiffs have demonstrated that, at the 28 very least, there is a genuine dispute as to whether Defendant’s negligence caused 1 Plaintiffs’ injuries. Dr. Sutton opines that: (1) abnormalities indicated in Ms. Spedale’s 2 MRI are known to be linked to mania; (2) Ms. Spedale’s mania was temporally linked to 3 exposure to CPI-0610; and (3) BET inhibitors such as CPI-0610 cause a kind of histone 4 modification that plays a “major role” in psychiatric illnesses. (Sutton Report at 10.) While 5 Defendant argues that Plaintiffs cannot demonstrate a reasonable connection between 6 Defendant’s act or omission and Plaintiffs’ injuries, this argument is mostly premised on 7 its assertion that it owed no duty to Ms. Spedale. (See MSJ at 18 (“If there is no duty, there 8 can be no breach and it would be impossible for [Defendant]’s conduct to be the proximate 9 cause of [P]laintiffs’ injuries.”).) Because the Court finds that a duty flowed from 10 Defendant to Ms. Spedale, Defendant’s argument is moot. 11 Defendant engages the issue of causation more thoroughly in its arguments against 12 Plaintiffs’ strict liability claim. (See MSJ at 14–15.) Defendant cites its own 13 neuropsychiatric expert [Dr. Maurice Preter]’s opinion that Ms. Spedale’s “year and a half 14 of grossly disturbed sleep patterns preceding her mania, combined with anxiety, and 15 multiple courses of chemotherapy all could have caused or contributed to Ms. Spedale’s 16 mania.” (Id. at 14.) Defendant also emphasizes that Ms. Spedale was taking several 17 medications while participating in the 0610-03 Study, and one of those medications, 18 Prednisone, “is known for aggravating pre-existing psychiatric conditions.” (Id. at 15.) 19 Defendant argues that “[t]his is not a case of strict liability. This case comes down to 20 whether or not there is negligence.” (Id.) The Court agrees. Whether Defendant acted 21 negligently—namely, the issues of breach and causation—are fact questions for the jury. 22 See Matthews, 882 F. Supp. at 148. 23 That Defendant identifies potential culprits such as chemotherapy and Prednisone 24 does not mean Dr. Sutton’s opinions pertaining to proximate cause amount to “sheer 25 speculation.” (MSJ at 15.) Proximate cause may be found even where the defendant’s act 26 or omission is not the singular cause of injury. Wisener v. State, 598 P.2d 511, 513 (Ariz. 27 1979). Because Plaintiffs have raised triable issues of fact regarding breach and causation, 28 the Court denies summary judgment with respect to Plaintiffs’ negligent drafting claim. 1 2. Count Two: Informed Consent 2 “Plaintiffs alleging lack of informed consent must show two types of causation: 3 (1) the plaintiff would have declined the treatment with adequate disclosure; and (2) the 4 treatment proximately caused injury to the plaintiff.” Rice v. Brakel, 310 P.3d 16, 22 (Ariz. 5 Ct. App. 2013) (citation omitted). While expert testimony is required to demonstrate the 6 second type of causation, it is not required to demonstrate the first. Gorney v. Meaney, 150 7 P.3d 799, 804 (Ariz. Ct. App. 2007). Plaintiffs can testify themselves as to whether they 8 would have declined the treatment with adequate disclosure, and such information falls 9 within the experiential scope of the average juror. See id.; see also Adams v. Amore, 895 10 P.2d 1016, 1018 (Ariz. Ct. App. 1994) (explaining that expert testimony derives from the 11 need for “specialized knowledge”). And Dr. Sutton’s opinions concerning proximate 12 causation, discussed with respect to Plaintiff’s negligent drafting claim, apply in this 13 context as well. 14 Plaintiffs’ informed consent claim operates on the same set of facts as their negligent 15 drafting claim. (See PSOAF ¶¶ 31, 34–35, 47–48; Compl. ¶¶ 74–81.) They introduce 16 evidence that had she been fully aware of its risks, Ms. Spedale would not have participated 17 in the study. (PSOAF ¶¶ 53, 57, 58; Compl. ¶¶ 78–80.) Defendant argues that the informed 18 consent claim lacks merit for three reasons: (1) Plaintiffs concede that Ms. Spedale did not 19 read the ICF and Mayo did not inform her of its contents; (2) Defendant is not responsible 20 for Mayo’s failure to obtain informed consent because Defendant and Mayo explicitly 21 agreed that Mayo was an independent contractor; and (3) the ICF contained sufficient 22 information regarding known and unknown risks. (See MSJ at 7–10.) 23 Apart from its third reason, Defendant’s arguments primarily underscore that the 24 ICF’s sufficiency, both in its form and implementation, fell under Mayo’s purview.28 (See,

25 28 Defendant also argues that under the learned intermediary doctrine (“LID”), “a manufacturer satisfies its duty to warn end users by giving appropriate warnings to the 26 specialized class of persons who may prescribe or administer the product.” (MSJ at 9.) But, in Arizona, the LID is “less a rule of causation and more a standard for determining when 27 a drug manufacturer has satisfied its duty to warn.” Watts v. Medicis Pharm. Corp., 365 P.3d 944, 949 (Ariz. 2016) (quotation omitted). As discussed above, there is a genuine 28 dispute as to whether Defendant satisfied its duty to warn Ms. Spedale. Thus, Defendant’s LID argument does not supplement its defense against Plaintiffs’ informed consent claim. 1 e.g., id. at 7 (“[Defendant] can have no liability since obtaining the informed consent was 2 the responsibility . . . of the . . . trial site.”).) However, if Defendant breached its duty of 3 care to Ms. Spedale by failing to perform due diligence in the preclinical testing phase, the 4 ICF could also be deemed deficient for lack of material information. Because the fate of 5 Plaintiffs’ informed consent claim rises and falls with their negligent drafting claim, the 6 Court denies summary judgment with respect to Plaintiffs’ informed consent claim. 7 3. Count Three: Strict Products Liability 8 Arizona has adopted the doctrine of strict products liability as set forth in 9 Restatement (Second) of Torts § 402A. Gaston v. Hunter, 588 P.2d 326, 338 (Ariz. Ct. 10 App. 1978) . A party may be held strictly liable for selling a product in a defective condition 11 that is unreasonably dangerous to a user or consumer. Scheller v. Wilson Certified Foods, 12 Inc., 559 P.2d 1074, 1076 (Ariz. Ct. App. 1976). To establish a prima facie case of strict 13 liability, a plaintiff must show: (1) the product was in a defective condition when it left the 14 defendant’s control; (2) the defective condition made the product unreasonably dangerous; 15 and (3) the defect caused plaintiff’s injuries.29 Jimenez v. Sears, Roebuck & Co., 904 P.2d 16 861, 864 (Ariz. 1995). There are three defective conditions theories: (1) manufacturing 17 defects, (2) design defects, and (3) informational defects. Brown v. Sears, Roebuck & Co., 18 667 P.2d 750, 756 (Ariz. Ct. App. 1983). Plaintiffs allege strict liability under all three. 19 (See MSJ Opp’n at 16–18; Compl. ¶¶ 82–88.) 20 a. Manufacturing Defect 21 Section 402A’s definition of “defective condition” works best in the context of a 22 manufacturing defect: a manufacturing or assembling abnormality that yields an 23 unintended and unexpected product. Restatement (Second) of Torts § 402A cmt. g (Am. 24 Law Inst. 1975); see Brady v. Melody Homes Mfr., 589 P.2d 896, 899 (Ariz. Ct. App. 25 1978), disapproved of on other grounds by Dart v. Wiebe Mfg., Inc., 709 P.2d 876 (Ariz.

26 29 Defendant argues that since there was no “sale” within the meaning of § 402A, it cannot be held strictly liable. (See MSJ at 10–11.) This is not so. Arizona courts do not construe 27 the term “seller” so strictly: “[T]he policies which justify the application of strict products liability principles to those who manufacture and [s]ell products also apply to those who 28 manufacture and [s]upply products to consumers on an investigational basis . . . .” Gaston, 588 P.2d at 339. 1 1985). This test, sometimes called the consumer expectation test, permits strict liability 2 where a product does not perform as safely as a reasonable consumer would expect when 3 used in its reasonably intended manner. See Dart, 709 P.2d at 878–89. A plaintiff should 4 compare the injury-inducing product with other non-defective products in the same line. 5 Brady, P.2d at 899. 6 Plaintiffs argue that a jury could readily conclude that CPI-0610’s distribution was 7 not justified, either to the general population or to an individual with Ms. Spedale’s medical 8 history. (MSJ Opp’n at 18.) Precisely what sort of manufacturing defect would persuade a 9 jury to come to such a conclusion, Plaintiffs do not say. While Plaintiffs have offered 10 sufficient evidence to survive summary judgment with respect to their negligent drafting 11 and informed consent claims, both of those claims spotlight Defendant’s conduct—namely, 12 Defendant’s alleged omission of material information from the ICF. Because a strict 13 liability manufacturing defect claim necessarily concerns the product itself, Plaintiffs have 14 not met their burden to show evidence on which a reasonable jury could reasonably find 15 for them. Anderson, 477 U.S. at 252. The Court grants summary judgment with respect to 16 Plaintiffs’ manufacturing defect claim. 17 b. Design Defect 18 Arizona courts have adopted two alternate tests to establish the existence of an 19 unreasonably dangerous design defect: (1) the consumer expectation test, and (2) the 20 risk/benefit analysis. Dart, 709 P.2d at 879. The consumer expectation test applies where 21 an ordinary consumer has experience with the product and thus has a reasonable 22 expectation of how safely it should perform. See id. at 878–79. The risk/benefit analysis 23 applies where an ordinary consumer lacks experience with the product, and thus lacks a 24 reasonable expectation as to its “safe” performance. See id. Because experimental drugs 25 are beyond the ordinary consumer’s knowledge and experience, the risk/benefit analysis 26 applies. Here, the fact-finder must decide whether the benefits of the challenged design 27 outweigh any dangers inherent in the design. Dart, 709 P.2d at 879; see also Byrns v. 28 1 Riddell, 550 P.2d 1065, 1068 (Ariz. 1976) (explaining the Byrns factors used by Arizona 2 courts in the risk/benefit analysis). 3 Plaintiffs’ design defect claim is nearly indistinguishable from its manufacturing 4 defect claim. (See MSJ Opp’n at 18.) As a result, it fails for many of the same reasons. 5 Plaintiffs do not offer evidence supporting the existence of a reasonable alternative design 6 to CPI-0610 and are likely unable to do so because of the experimental stage at which Ms. 7 Spedale encountered the study drug. Alleged issues with the 0610-03 Study do not pertain 8 to CPI-0610’s design, but to the study’s design. (See, e.g., Sutton Report at 12 (Defendant’s 9 “protocol 0610-03 failed to ensure human subject protection.”).) Such arguments overlook 10 the core of a design defect claim: whether the study drug itself is unreasonably dangerous. 11 See Dart, 709 P.2d at 878–80. The Court grants summary judgment with respect to 12 Plaintiffs’ design defect claim. 13 c. Informational Defect (Failure to Warn) 14 Under Arizona law, a manufacturer has a duty to warn of dangers inherent in the 15 intended use or reasonably foreseeable use of a product. Kavanaugh v. Kavanaugh, 641 16 P.2d 258, 262 (Ariz. Ct. App. 1981). To succeed in an informational defect claim, a plaintiff 17 must prove “that the defendant did not adequately warn of a particular risk that was known 18 or knowable in light of the generally recognized and prevailing best scientific and medical 19 knowledge available at the time of manufacture and distribution.” Powers v. Taser Int’l, 20 Inc., 174 P.3d 777, 783 (Ariz. Ct. App. 2007) (quotation omitted). A seller is charged 21 “‘with knowledge of what reasonable testing would reveal.’” Id. at 784 (quoting 22 Restatement (Third) of Torts: Products Liability § 2 cmt. m (Am. Law Inst. 1997)). But 23 where the danger is obvious or known to the user, liability will not lie. Raschke v. Carrier 24 Corp., 703 P.2d 556, 559 (Ariz. Ct. App. 1985). 25 Unlike manufacturing or design defect claims, an informational defect claim 26 “relates to a failure extraneous to the product itself.” Powers, 174 P.3d at 783. An 27 informational defect claim is thus “rooted in negligence to a greater extent than 28 manufacturing or design defect theories,” because it concerns the manufacturer’s conduct 1 in a way that the other two theories do not. Id. (quotation omitted). The same issues that 2 prevent the Court from granting summary judgment with respect to Plaintiffs’ negligent 3 drafting and informed consent claims prevent the court from doing so here. If Defendant 4 did not conduct “reasonable testing” in the preclinical testing phase, it would still be 5 “charged with knowledge of what reasonable testing would [have] reveal[ed].” Id. at 784 6 (quotation omitted). And if that knowledge would have removed someone with Ms. 7 Spedale’s medical history from the participant population, Defendant is liable for the 8 resulting informational defect. The Court denies summary judgment with respect to 9 Plaintiffs’ informational defect claim. 10 4. Count Four: Loss of Consortium & Punitive Damages 11 a. Loss of Consortium 12 Loss of consortium is “a loss of capacity to exchange love, affection, society, 13 companionship, comfort, care and moral support.” Pierce v. Casas Adobes Baptist Church, 14 782 P.2d 1162, 1165 (Ariz. 1989). Because loss of consortium is a derivative claim, “all 15 elements of the underlying cause must be proven before the claim can exist.” Barnes v. 16 Outlaw, 964 P.2d 484, 487 (Ariz. 1998). Plaintiffs argue that Mr. Spedale has suffered the 17 loss of his wife’s companionship, services, and society due to Defendant’s negligence, 18 failure to obtain informed consent, and other improper conduct. (Compl. ¶ 89.) Defendant 19 does not address Mr. Spedale’s loss of consortium claim in its summary judgment motion, 20 so the Court denies summary judgment with respect to this claim.30 21 b. Punitive Damages 22 To recover punitive damages under Arizona law, “something more is required over 23 and above the mere commission of a tort.” Linthicum v. Nationwide Life Ins. Co., 723 P.2d 24 675, 679 (Ariz. 1986) (quotation omitted). A plaintiff must prove by clear and convincing 25 evidence that the defendant engaged in aggravated and outrageous conduct with an evil 26 mind. Linthicum, 723 P.2d 680–81. This is so because punitive damages “primarily further 27 30 Regardless, Defendant is not entitled to summary judgment here because Plaintiffs have 28 established a genuine dispute concerning three of the underlying tort claims: negligent drafting, informed consent, and strict liability informational defect. 1 the same objectives underlying criminal law: punishing the defendant and deterring the 2 defendant and others from future misconduct.” Gurule v. Ill. Mut. Life & Cas. Co., 734 3 P.2d 85, 86 (Ariz. 1987). The chief question, then, is motive. Volz v. Coleman Co., Inc., 4 748 P.2d 1191, 1194 (Ariz. 1987). Because defendants rarely admit to an “evil mind,” 5 improper motive is often inferred from sufficiently oppressive, outrageous, or intolerable 6 conduct. Id.; see Linthicum, 723 P.2d at 680. And Plaintiffs do not offer any evidence of 7 such conduct. (See generally PSOF; MSJ Opp’n.) The Court grants summary judgment 8 with respect to Plaintiffs’ punitive damages claim. 9 VI. CONCLUSION 10 The Court grants in part and denies in part Defendant’s Motion to Exclude. 11 (Doc. 55.) Specifically, the Court excludes proposed opinions 5(a)–(d), 5(g)–(i), and 8. The 12 Court grants in part and denies in part Defendant’s Motion for Summary Judgment. 13 (Doc. 56.) The Court grants summary judgment on Plaintiffs’ negligent misrepresentation 14 claim, but denies summary judgment on Plaintiffs’ negligent drafting and informed consent 15 claims. The Court additionally grants summary judgment on Plaintiffs’ manufacturing and 16 design defect claims, but denies summary judgment on Plaintiffs’ informational defect 17 claim. Finally, the Court denies summary judgment on Mr. Spedale’s loss of consortium 18 claim, and grants summary judgment on Plaintiffs’ punitive damages claim. 19 IT IS ORDERED granting in part and denying in part Defendant’s Motion to 20 Exclude Expert Testimony of Dr. James P. Sutton (Doc. 55). 21 IT IS FURTHER ORDERED granting in part and denying in part Defendant’s 22 Motion for Summary Judgment (Doc. 56). 23 IT IS FURTHER ORDERED denying Defendant’s Objections to Dr. James P. 24 Sutton’s Declaration as moot (Doc. 68; Doc. 69). 25 IT IS FURTHER ORDERED denying Plaintiffs’ Motion for Leave to Respond to 26 Defendant’s Objections to Dr. James P. Sutton’s Declaration as moot (Doc. 71).

27 28 1 IT IS FURTHER ORDERED granting Plaintiffs’ Motion to Strike the Affidavit 2|| of Dr. Robert Sims (Doc. 63). 3 Dated this 16th day of August, 2019. ON 4 . United StateWDistrict Judge 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

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