Judge: George F. Bird, Jr., Case: BC681477, Date: 2023-02-02 Tentative Ruling

Case Number: BC681477    Hearing Date: February 2, 2023    Dept: B

SUPERIOR COURT OF THE STATE OF CALIFORNIA

FOR THE COUNTY OF LOS ANGELES – SOUTH CENTRAL DISTRICT

I.       BACKGROUND

             Plaintiffs are Marissa Kelly and Caroline Kelly (“Plaintiffs”), individually, and as the successors in interest of their brother, decedent George M. Kelly. The Fourth Amended Complaint states that George M. Kelly, a minor, suffered from Chronic Granulomatous Disease (“CGD”) which is a disorder of the leukocyte function which left George M. Kelly imuno-compromised. (Fourth Amended Complaint (“FAC”), ¶ 20.) As a result of his condition, George M. Kelly suffered from repeated infections and was hospitalized frequently. (FAC, ¶ 22.) Defendant Dr. Joseph Church M.D. (“Defendant”) is alleged to be the physician responsible for diagnosing George M. Kelly and was George M. Kelly’s doctor “at every turn.” (FAC, ¶ 26.)

            In 2014, Bellicum, a company engaged in the manufacture, production, packaging, marketing, sale, and distribution of pharmaceutical protocols, began a study titled “Phase II Extension Study of CaspaCIDe T Cells (BPX-501) From a HLA-partially Matched Family Donor After Negative Selection of TCR ab+T Cells in Pediatric Patients Affected by Hematological Disorders.” (FAC, ¶¶ 6 footnote 2, 68.) Bellicum developed a protocol (the “Bellicum Protocol”) which was a “T-cell depleted” transplant procedure. (FAC, ¶ 25.)

            In 2014, Defendant allegedly referred George M. Kelly to Dr. Neena Kapoor M.D. who rejected George M. Kelly for a bone marrow transplant. (FAC, ¶ 27.) In 2016, Defendant again recommended speaking to Dr. Neena Kapoor M.D. about a bone marrow transplant, and she was willing to go forward with the transplant this time. (Ibid.)

            Defendant allegedly did not disclose that Dr. Neena Kapoor M.D. would use the Bellicum Protocol, which was an experimental procedure, and Plaintiffs allege the Bellicum Protocol deviates from the standard of care. (FAC, ¶ 28.) Plaintiffs allege that Defendant knew the Bellicum Protocol was outside the standard of care because George M. Kelly’s history dictated against a “T-cell depleted” transplant. (FAC, ¶ 31.) Plaintiffs allege that George M. Kelly was not a proper candidate for this transplant, and was precluded from the study absent a waiver, due to his successive infections, age, and condition of his lungs. (FAC, ¶¶ 29, 31.) Plaintiffs allege that Defendant knew that George M. Kelly did not qualify for the study and in fact knew that George M. Kelly met the criteria for exclusion from the protocol. (FAC, ¶ 123.)

            Plaintiffs allege that Defendant failed to disclose that the Bellicum Protocol was strictly experimental, that a waiver was required to allow George M. Kelly to receive the transplant, or that the Bellicum Protocol did not comply with the procedures for a Haplo transplant in the transplant community. (FAC, ¶ 30.) 

            George M. Kelly underwent three bone marrow transplants in accordance with the Bellicum Protocol and all the transplants failed. George M. Kelly died on October 30, 2016, from encephalitis, Disseminated Fungal Disease, Chronic Granulomatous Disease, and Renal Failure. (FAC, ¶ 37.) Plaintiffs allege that Defendant’s actions were a direct cause of George M. Kelly’s death. (FAC, ¶ 139.)

            The only remaining causes of action alleged against Defendant are (1) wrongful death and (2) medical negligence. (See Notice of Ruling on Demurrers/Motions to Strike, May 19, 2022.)

II.    MOTION FOR SUMMARY JUDGMENT OR, IN THE ALTERNATIVE, SUMMARY ADJUDICATION

A.    Defendant filed the Motion for Summary Judgment on November 3, 2022.

            Defendant states that he became involved in the treatment of George M. Kelly in 2000 when George M. Kelly was diagnosed and thereafter evaluated him every six months, consulted with primary care providers, and offered recommendations for ongoing or reoccurring infections. (Defendant’s Motion for Summary Judgment, p. 2:23-27.) In 2006, Defendant reached out to the National Institutes of Health (NIH) to inquire about a gene therapy study for George M. Kelly, but at the time George M. Kelly was not eligible. (Defendant’s Motion for Summary Judgment, p. 3:7-10.)

            In 2015, Defendant was noted to be suffering from chronic lung disease, fibrosis of the lung, granulomatous pneumonia, growth hormone deficiency, and irritable bowel disease. (Defendant’s Motion for Summary Judgment, p. 3:25-26.) Defendant recommended that George M. Kelly be recommended for a “haploidentical” or half-match transplant. (Defendant’s Motion for Summary Judgment, p. 3:26-28.)

            Defendant states that a meeting occurred in April of 2016, in which Defendant did not participate, and George M. Kelly’s family was provided with “extensive informed consent paperwork and agreed to the procedure.” (Defendant’s Motion for Summary Judgment, p. 4:1-5.) George M. Kelly underwent two half-match stem cell transplants in July 2016 and an additional half-match stem cell transplant on October 24, 2016. (Defendant’s Motion for Summary Judgment, p. 4:12-15.) Defendant states that George M. Kelly’s condition deteriorated quickly after the third transplant and on October 30, 2016, George M. Kelly died. (Defendant’s Motion for Summary Judgment, p. 4:15-16.)

            Defendant argues that his conduct did not fall below the standard of care. Defendant relies on the expert opinion of Dr. Jennifer M. Puck M.D. who states that the care and treatment provided by Defendant “comply with the standard of care for pediatric immunologists.” (Decl. of Dr. Jennifer M. Puck M.D., ¶ 12.) Defendant argues that a wrongful death cause of action and medical negligence cause of action both fail because Defendant complied with the standard of care and his actions were not a substantial cause of the death of George M. Kelly.

B.     Plaintiffs filed an opposition on January 20, 2023.

            Plaintiffs allege that Defendant fell below the standard of care on two occasions: (1) when Defendant referred and recommended the Bellicum Protocol when Defendant knew that George M. Kelly was not an appropriate candidate; and (2) when Defendant failed to inform George M. Kelly or his family that George M. Kelly was not a proper candidate for the Bellicum Protocol and, due to the failure to properly inform them, Defendant failed to get informed consent.

            Plaintiffs argue that expert testimony has a very limited role when a claim is based on lack of informed consent and that this raises a triable issue of material fact.

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III.       EVIDENTIARY OBJECTIONS

            Plaintiffs object to the medical records of George M. Kelly from Children’s Hospital Los Angeles, (“CHLA”) and NIH presented in support of this Motion for Summary Judgment and reviewed by Defendant’s expert witness. Plaintiffs argue that all the records are hearsay and fail to meet the business records exception because the custodians simply recited the elements of Evidence Code section 1271.

            Evidence Code section 1271 states that, “Evidence of a writing made as a record of an act, condition, or event is not made inadmissible by the hearsay rule when offered to prove the act, condition, or event if: (a) The writing was made in the regular course of a business; (b) The writing was made at or near the time of the act, condition, or event; (c) The custodian or other qualified witness testifies to its identity and the mode of its preparation;¿and (d) The sources of information and method and time of preparation were such as to indicate its trustworthiness.”

            The declaration provided authenticating the CHLA records, submitted as Exhibit C, states “The records were prepared by the personnel of the business in the ordinary course of business at or near the time of the act, condition, or event. I testify to its identity and the mode of its preparation; and the sources of information and method of time of preparation were such as to indicate its trustworthiness. The copy is a true copy of all the documents requested.” (Defendant’s Motion for Summary Judgment, Exhibit C – 10.) The declaration is executed under penalty of perjury. The Court does not find that the declaration is lacking because it parallels the required elements to meet the business record exception to hearsay.

            The declaration provided authenticating the NIH records, submitted as Exhibit E, states “This is to certify that the enclosed records released by the Health Information Management Department of the National Institutes of Health Clinical Center are a complete, accurate copy of official medical record kept in the normal course of business for the named patient below. This also certifies that it is the duty of the National Institutes of Health to keep such records.” (Defendant’s Motion for Summary Judgment, Exhibit E.) The Court does not find that the declaration is lacking because it parallels the required elements to meet the business record exception to hearsay.

            Next, Plaintiffs contest the validity of the presented medical records because Plaintiffs state they only received roughly 13,000 pages of medical records from CHLA, and Defendant presents more than 14,000 pages of medical records from CHLA to support this Motion for Summary Judgment. Plaintiffs argue that this is relevant because Defendant’s expert relied on the medical records in formulating the opinion that Defendant was not negligent. While the Court understands Plaintiffs’ concerns, Plaintiffs have been provided the medical records which Defendant’s expert alleges she used to formulate an expert opinion. Plaintiffs can view all the 14,000 plus pages to determine what Defendant’s expert bases her opinion on and the Court fails to see how Plaintiffs are prejudiced.

            Finally, Plaintiffs argue that the Court should not consider the documents on the lodged flash drive from Defendant. Defendant alleges that the flash drive contains a copy of the discovery documents already filed with the Court. Plaintiffs object because Plaintiffs were not provided the opportunity to verify that the flash drive contained exact copies of the exhibits submitted in support of the Motion for Summary Judgment and because the flash drive was lodged on December 27, 2022, which is not within the statutory 75-day deadline for filing papers in support of a motion for summary judgment. (Code Civ. Proc., § 473c, subd. (a)(2).)

            Because the Court already has copies of the exhibits in support of this Motion for Summary Judgment that were filed within the statutory deadline, the Court will not consider the documents on the flash drive.

IV.       LEGAL STANDARDS

            The purpose of a motion for summary judgment “is to provide courts with a mechanism to cut through the parties’ pleadings in order to determine whether, despite their allegations, trial is in fact necessary to resolve their dispute.”  (Aguilar v. Atl. Richfield Co. (2001) 25 Cal.4th 826, 843.)  “Code of Civil Procedure section 437c, subdivision (c), requires the trial judge to grant summary judgment if all the evidence submitted, and ‘all inferences reasonably deducible from the evidence’ and uncontradicted by other inferences or evidence, show that there is no triable issue as to any material fact and that the moving party is entitled to judgment as a matter of law.”  (Adler v. Manor Healthcare Corp. (1992) 7 Cal.App.4th 1110, 1119.)  

            “On a motion for summary judgment, the initial burden is always on the moving party to make a prima facie showing that there are no triable issues of material fact.”  (Scalf v. D. B. Log Homes, Inc. (2005) 128 Cal.App.4th 1510, 1519.)  A defendant moving for summary judgment “has met his or her burden of showing that a cause of action has no merit if the party has shown that one or more elements of the cause of action . . . cannot be established.”  (Code Civ. Proc., § 437c(p)(2).)  “Once the defendant . . . has met that burden, the burden shifts to the plaintiff . . . to show that a triable issue of one or more material facts exists as to the cause of action or a defense thereto.”  (Id.)  “If the plaintiff cannot do so, summary judgment should be granted.”  (Avivi v. Centro Medico Urgente Med. Ctr. (2008) 159 Cal.App.4th 463, 467.)  

            “When deciding whether to grant summary judgment, the court must consider all of the evidence set forth in the papers (except evidence to which the court has sustained an objection), as well as all reasonable inferences that may be drawn from that evidence, in the light most favorable to the party opposing summary judgment.”  (Avivi, supra, 159 Cal.App.4th at p. 467; see also Code Civ. Proc., § 437c, subd. (c).) 

            Under the California Code of Civil Procedure section 473c subsection (f)(1), the court may grant a motion for summary adjudication only as to “one or more causes of action within an action, one or more affirmative defenses, one or more claims for damages, or one or more issues of duty. . .”  Because Plaintiffs allege two causes of action and Defendant brings this Motion for Summary Judgment on both causes of action, the Court may grant summary adjudication separately as to each cause of action.

V.       DISCUSSION

A.    Wrongful death and medical negligence.

            To prevail on a claim for wrongful death, a plaintiff must prove (1) a wrongful act of neglect on the part of one or more persons that (2) causes (3) the death of another person. (Musgrove v. Silver (2022) 82 Cal.App.5th 694, 705 [298 Cal.Rptr.3d 582, 591, 82 Cal.App.5th 694, 705], as modified on denial of reh'g (Sept. 13, 2022), review denied (Nov. 22, 2022).) The ‘wrongful act of neglect’ is more commonly known as negligence, and a person acts negligently when they have a duty of care and subsequently breach that duty of care. (Ibid.)

            To prevail on a claim of medical negligence, a plaintiff must prove (1) the duty of the professional to use such skill, prudence, and diligence as other members of his profession commonly possess and exercise; (2) a breach of that duty; (3) a proximate causal connection between the negligent conduct and the resulting injury; and (4) actual loss or damage resulting from the professional's negligence. (Turpin v. Sortini (1982) 31 Cal.3d 220, 229–230 [182 Cal.Rptr. 337, 343, 643 P.2d 954, 960].) On both causes of action, Defendant argues that Plaintiffs fail to establish a breach of the duty of care and a causal connection between Defendant’s actions and George M. Kelly’s death.

B.     Duty of care.

            In an action alleging negligence by a medical professional, the standard of care that a doctor is held to is “… that reasonable degree of skill and learning generally possessed by others of his profession in the same locality and to the exercise of reasonable and ordinary skill in the application of that learning. Ordinarily, proof of the prevailing standard of skill and learning in the locality and proof on the question of the propriety of particular conduct by the practitioner in particular instances is not a matter of general knowledge and can only be supplied by expert testimony.” (Stephenson v. Kaiser Foundation Hospitals (1962) 203 Cal.App.2d 631, 635 [21 Cal.Rptr. 646, 649].) “[T]his duty of care applies not only to the physician’s ‘actual performance or administration of treatment,’ but also to his ‘choice’ of which courses of treatment to recommend (or not recommend) to a patient.” (Flores v. Liu (2021) 60 Cal.App.5^th 278, 290 [274 Cal.Rptr.3d 444, 453, 60 Cal.App.5^th 278, 290].) Expert testimony is regarded as conclusive “where it appears that the matter in issue is one within the knowledge of experts only and is not within the common knowledge of laymen.” (Stephenson v. Kaiser Foundation Hospitals, supra, 203 Cal.App.2d at p. 635.)

C.     Breach of the duty of care.

            Defendant presents a declaration of Jennifer M. Puck, M.D., who has been licensed to practice medicine in the state of California since 2006. (Decl. of Jennifer M. Puck, M.D., ¶ 2.) Jennifer M. Puck, M.D. states that she has experience in pediatric immunology, the same profession as Defendant, is certified by the Board of Pediatrics, and has experience with patients who suffer from immune system impairments like George M. Kelly. (Decl. of Jennifer M. Puck, M.D., ¶¶ 3, 4, 5, 6.) Jennifer M. Puck, M.D. states that she is familiar with the diagnosis and treatment of patients with severe immunodeficiency diseases, including chronic granulomatous disease. (Decl. of Jennifer M. Puck, M.D., ¶ 8.)

            Jennifer M. Puck, M.D. determined that Defendant’s acts did not fall below the standard of care and, in particular, Jennifer M. Puck, M.D. determined, “Dr. Church appropriately referred decedent to NIH and other providers at CHLA for further evaluation, treatment, and possible bone marrow transplant” and the care and treatment provided by Defendant “comply with the standard of care for pediatric immunologists.”  (Decl. of Jennifer M. Puck, M.D., ¶ 12(e).)

D.    Duty to obtain informed consent.

            When the duty to obtain informed consent is at issue, “the duty to obtain informed consent is pegged to what a ‘reasonable person’ in the patient's position would deem to be ‘material’ to her medical decision making (rather than being pegged to customs for disclosure in the profession), the decision as to what information should be disclosed is entrusted chiefly to the trier of fact, and not to medical experts.” (Flores v. Liu, supra, 60 Cal.App.5th at p. 294.) Expert testimony is only relevant to demonstrate “what additional information over and above minimal disclosures that reasonable physicians in the relevant medical community would make to their patients.” (Ibid.) The minimal disclosures include: (1) a reasonable explanation of the recommended procedures, (2) the likelihood of success of the recommended procedure, (3) the risks of accepting and rejecting the proposed procedure, and (4) the physician's personal interest that may affect his judgment. (Id. at 293.)

E.     Breach of the duty to obtain informed consent.

            Jennifer M. Puck, M.D. determines that “[Defendant] was not involved in the selection process, decision to enroll decedent in the Bellicum protocol, nor in the consent discussions regarding the Bellicum protocol. Nor did the standard of care require Dr. Church to be involved in the informed consent discussions with decedent’s parents.” (Decl. of Jennifer M. Puck, M.D., ¶ 12(f).) Because what qualifies as a necessary disclosure to achieve informed consent is not determined by expert opinion, the declaration of Jennifer M. Puck, M.D. is not persuasive. Defendant does not present any additional argument or evidence that “a ‘reasonable person’ in the patient's position” would not have expected Defendant to disclose that George M. Kelly was not a proper candidate for the Bellicum Protocol. (Flores v. Liu, supra, 60 Cal.App.5th at p. 294.)

            Defendant has failed to satisfy his burden to demonstrate that Plaintiffs cannot establish the element of breach of duty on the theory of lack of informed consent.

F.      Causation.

            Jennifer M. Puck, M.D. also determined that “no conduct on the part of Dr. Church was a substantial cause of decedent’s death.” (Decl. of Jennifer M. Puck, M.D., ¶ 13.) “… [C]ausation in actions arising from medical negligence must be proven within a reasonable medical probability based on competent expert testimony.” (Bromme v. Pavitt (1992) 5 Cal.App.4th 1487, 1504 [7 Cal.Rptr.2d 608, 618].) Because Jennifer M. Puck, M.D. has determined that the actions of Defendant were not a substantial cause of decedent’s death, Defendant has fulfilled his burden to demonstrate that an element of the causes of action alleged cannot be established. The burden now shifts to Plaintiffs to demonstrate a triable issue of material fact regarding causation.

G.    Plaintiffs’ Burden.

            Plaintiffs argue that Defendant did in fact fall below the standard of care when Defendant knew that George M. Kelly was not a proper candidate for the Bellicum Protocol, but Defendant referred George M. Kelly to participate in the Bellicum Protocol. Plaintiffs also argue that Defendant fell below the standard of care when Defendant failed to obtain informed consent.

            Plaintiffs present the expert declaration of Michael H. Tirgan, M.D., who is a board-certified internist and medical oncologist licensed to practice medicine in the state of New York. (Decl. of Michael H. Tirgan, M.D., ¶ 1.) Michael H. Tirgan, M.D. states that he is trained in bone marrow transplantation and is familiar with chronic granulomatous disease. (Decl. of Michael H. Tirgan, M.D., ¶ 6.) After determining that George M. Kelly was not a proper candidate for the Bellicum Protocol, Michael H. Tirgan, M.D. stated, “It is my opinion that a reasonable physician who was assisting the family in communicating with the Bone Marrow Transplant unit and doctors and with the NIH would have known that the patient and his family would have believed this was a material piece of information for them to evaluate in considering the protocol. It would have been important for the family to know that information in any further communications with the Bone Marrow Transplant team to consider the risks associated with the program, in light of the fact that Dr. Church had been initially informed that GMK was not an appropriate candidate. For purposes of my opinion that Dr. Church had a duty to provide this critical information to family…. Without knowing this information, any consent provided by the family was inadequate, as they did not know that their son did not meet the inclusion criteria, and in fact was specifically excluded from participating. Therefore, all treatment received as part of the Bone Marrow Transplant caused him harm.”  (Decl. of Michael H. Tirgan, M.D., ¶¶ 28, 29.)

            Plaintiffs’ expert, Michael H. Tirgan, M.D., determined that there was a duty upon Defendant to inform George M. Kelly and his family that George M. Kelly was not a proper candidate for the Bellicum Protocol and that the failure to inform the family lead to a lack of informed consent. The treatment received premised on the lack of informed consent caused George M. Kelly harm. Plaintiffs have satisfied their burden by presenting an expert opinion that Defendant’s actions did cause harm to George M. Kelly. Because both parties have provided expert opinions on causation, there is a triable issue of material fact to be determined in this matter.

            Because Plaintiffs have presented a triable issue of material fact related to causation, this Motion for Summary Judgement is DENIED.

            Because causation is an element of both causes of action for wrongful death and medical negligence, the Court cannot grant summary adjudication as to either cause of action. This Motion for Summary Adjudication is DENIED.

VI.       CONCLUSION

             This Motion for Summary Judgement is DENIED.

            This Motion for Summary Adjudication is DENIED.

Dated: January 2, 2023                                                        _________________________

                                                                                                Judge of the Superior Court