Judge: George F. Bird, Jr., Case: BC681477, Date: 2023-02-09 Tentative Ruling
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Case Number: BC681477 Hearing Date: February 9, 2023 Dept: B
SUPERIOR
COURT OF THE STATE OF CALIFORNIA
FOR
THE COUNTY OF LOS ANGELES – SOUTH CENTRAL DISTRICT
|
Plaintiffs, vs. Defendants. |
) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) |
CASE NO: [TENTATIVE] ORDER Dept. B DATE: TIME: COMPLAINT FILED: TRIAL DATE: |
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.)
In 2014, Bellicum (“Defendant”), 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” referred to as
BP-U-004 or BP-004U. (FAC, ¶¶ 6 footnote 2, 68; Defendant’s Motion for Summary
Judgment (“D-MSJ”), p. 2:5-9.) Bellicum developed a protocol (the “Bellicum
Protocol”) which was a “T-cell depleted” transplant procedure. (FAC, ¶ 25.) As
explained by Defendant, strong doses of chemotherapy are given to patients
before they undergo haemopoietic stem cell transplants. (D-MSJ, p. 2:21-24.)
T-cells are beneficial for their potential to help the immune system recover faster,
but there is an increased risk of Graft versus Host Disease (“GvHD”) which
occurs when the T-cells attack the patient’s healthy cells. (Ibid.) the
Bellicum Protocol includes the use of BPX-501 which are T-cells from a
partially-matched donor and include a gene called caspase 9 so that the T-cells
can be killed with a dose of rimiducid in the event of GvHD. (D-MSJ, p.
2-3:25-3.)
George M. Kelly underwent three bone
marrow transplants, one of which involved the use of BPX-501, 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 product,
BPX-501, was a direct cause of George M. Kelly’s death. (FAC, ¶ 139.)
The only remaining causes of action
alleged against Defendant are (1) breach of express warranty and (2) products
liability – design or manufacturing defect. (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 on November 11,
2022.
Defendant states that the purpose of
the study involving the Bellicum Protocol and BPX-501, which is the study George
M. Kelly participated in, was “to determine whether the infusion of donor cells
modified by Bellicum’s BPX-501 product was safe and effective in improving
immune reconstruction and potentially to reduce incidence and severity of acute
graft-versus-host disease (“GvHD”).” (D-MSJ, p. 1:13-16.) Defendant states that
George M. Kelly only received one infusion of BPX-501-modified donor cells
after the first transplant on August 9, 2016, and by August 11, 2016, none of
the BPX-501-modified donor cells were detected in George M. Kelly’s body.
(D-MSJ, p.1:17-21.)
Defendant states they submitted an
Initial Investigational New Drug Application to the FDA consisting of an
introductory statement, general investigation plan, the Investigator’s
Brochure, Protocols, chemistry, manufacturing, control, pharmacology, and
toxicology information in addition to previous human experience with the
investigational drug. (D-MSJ, p. 3-4:18-5.) After 30 days, the Initial
Investigational New Drug Application went into effect and the FDA continued to
monitor the study. (D-MSJ, p. 4:6-11.) The Institutional Review Board at
Children’s Hospital Los Angeles also monitored the study and reviewed the
Investigator’s Brochure, Protocols, and informed consent forms for the Bellicum
study. (D-MSJ, p. 5:2-22.)
Defendant argues that George M.
Kelly did not die from the single infusion of BPX-501-modified cells. (D-MSJ,
p. 10:23-25.) Defendant points to the Declaration of Dr. Gale to support this
argument. (D-MSJ, p. 11:1-5.) Defendant also argues that the lot of BPX-501
which was administered to George M. Kelly was subject to quality testing and
did not contain a manufacturing defect. (D-MSJ, p. 12:10-20.) Defendant demonstrates
that, with respect to pharmaceuticals, there is no strict liability for a
design defect. (D-MSJ, p. 12:24-26.) Defendant argues that their compliance
with the FDA regulations is prima facie evidence that the design and
manufacture of BPX-501 met the standard of care and was not designed
negligently. (D-MSJ, p. 14-15:25-3.) Finally, Defendant argues that the
informed consent forms clearly demonstrate that the point of the study was to
determine BPX-501’s safety and effectiveness, therefore it could not have been
represented to Plaintiffs that BPX-501 was already safe and effective. (D-MSJ, 15-16:27-4.)
B.
Plaintiffs filed an opposition on January 30,
2023.
Plaintiffs allege that their
opposition was late due to computer and technology problems. (Opposition, p.
19:1-3.) Because the court has
discretion to consider late papers, the Court will consider this late
opposition to dispose of this matter on the merits. (Cal. Rules of Court, rule
3.1300, subd. (d).)
Plaintiffs make several arguments
that Defendant’s evidence is not admissible and therefore cannot support this
Motion for Summary Judgment. Plaintiffs argue that Defendant’s entire motion
should fail because the evidence only relates to BPX-501 while the FAC alleges
that the defective product is the Bellicum Protocol. (Opposition, p. 2:14-17.) Plaintiffs
allege that Defendant has attempted to convince the court that the Bellicum
Protocol cannot be a product on two prior demurrers and the court has rejected
such arguments. (Opposition, p. 5:6-17.) Plaintiffs state that there is a triable
issue of material fact whether improper approval of George M. Kelly to
participate in the Bellicum Protocol caused George M. Kelly’s death.
(Opposition, p. 6:1-3.) Plaintiffs contend that Defendant’s argument that
BPX-501 was not present in George M. Kelly’s system as of August 11, 2016, is
unsupported and does not overcome the assertion that the Bellicum Protocol, as
a whole, caused the death of George M. Kelly. (Opposition, p. 7:11-19.)
On the manufacturing defect cause of
action, Plaintiffs argue that the Bellicum Protocol was distributed and used in
its intended manner when it was proven to be unsafe, hazardous, and defective
to George M. Kelly. (Opposition, p. 8-9:27-13.) On the design defect cause of
action, Plaintiffs argue that the application of the consumer expectation test
or the risk benefit test both allow Plaintiffs to demonstrate a design defect
in the Bellicum Protocol. (Opposition, p. 11:12-18.) On the breach of express
warranty cause of action, Plaintiffs argue that the informed consent form
failed to disclose key risks of the study including serious GvHD and death.
(Opposition, p. 15:24-27.)
C.
Defendant filed a reply on February 3,
2023.
Defendant argues that the only
product at issue here is BPX-501, not the Bellicum Protocol as a whole. Because
BPX-501 is the only product at issue, Defendant argues that Plaintiffs’
evidence is insufficient to demonstrate that BPX-501 caused the death of George
M. Kelly, that there were any manufacturing or design defects in BPX-501, and
that there were any express warranties made about BPX-501 to Plaintiffs.
III.
EVIDENTIARY
OBJECTIONS
Plaintiffs’ submit 71 evidentiary
objections to Defendant’s support for this Motion for Summary Judgment. The
Court rules as follows:
SUSTAINED:
3, 5, 6, 8, 9, 10, 11, 12, 13, 14, 15, 40, 45, 46, 48, 49, 50, 51, 52(a), 52(b),
52(i), 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70,
71
OVERRULED:
1, 2, 4, 7, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,
33, 34, 35, 36, 37, 38, 39, 41, 42, 43, 44, 47, 52(c), 52(d), 52(e), 52(f),
52(g), 52(h)
Defendant submits 111 evidentiary
objections to Plaintiffs’ evidence in opposition to this Motion for Summary
Judgment. The Court rules as follows:
SUSTAINED:
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 19, 20, 21, 22, 23,
24, 25, 26, 27, 28, 29, 30, 31. Objections to the declaration of Michael Tirgan
M.D. paragraphs 13, 14, 16, 17, 18, 19, 24, 25, 26, 30, 31, 33, 34, 36, 37, 38,
41, 42, 44, 46, 47, 48, 54, 55.
OVERRULED:
None
UNDECIDED:
Objection 18 says “BLANK”
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 Code of Civil Procedure
section 473c, subdivision (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.
Product at issue.
Defendant argues that the only
product at issue here is BPX-501. Defendant references the FAC which states,
“The defendant knew or should have known that their design and distribution of
this product, BPX-501, was harmful ….” (FAC, ¶ 12.) Plaintiffs repeat this same sentence in the
FAC at paragraph 134. Counsel for Defendant also submits a copy of Plaintiffs
responses to special interrogatories which identifies the product for the
products liability claim as BPX-501 but not the Bellicum Protocol.
(Supplemental Declaration of Matthew L. Marshall, ¶¶ 5, 6, Exhibit 36, Exhibit
37.)
Plaintiffs argue that the court
already determined that the Bellicum Protocol is a product by allowing the
claim to proceed after a demurrer was brought. This is incorrect. A demurrer
simply tests the allegations in the pleading and assumes the truth of the
matters asserted. (Olson v. Hornbrook Community Services Dist. (2019) 33
Cal.App.5th 502, 516.) Plaintiffs asserted that the Bellicum Protocol was a product
in the Complaint and thus the demurrer was overruled. The demurrer did not make
any determination as to the validity of the assertion that the Bellicum
Protocol was a product.
Based on the foregoing, the Court
finds that the product at issue is BPX-501 and not the Bellicum Protocol.
B.
Products liability for a manufacturing
defect – Defendant’s burden.
To demonstrate a cause of action for
products liability based on a manufacturing defect, a plaintiff must show 1)
the defendant manufactured, distributed, or sold the product; 2) the product
contained a manufacturing defect; and 3) the defect was a substantial factor in
harm caused to the plaintiff. (CACI 1201.) “A product has a manufacturing
defect if it ‘differs from the manufacturer's intended result or from other
ostensibly identical units of the same product line.” (Barker, supra, at
p. 429, 143 Cal.Rptr. 225, 573 P.2d 443.)” (Johnson v. United States Steel
Corp. (2015) 240 Cal.App.4th 22, 32 [192 Cal.Rptr.3d 158, 165].) A
manufacturing defect “focuses on whether the particular product involved in the
accident was manufactured in conformity with the manufacturer's design.” (Dierks
v. Mitsubishi Motors Corp. (1989) 208 Cal.App.3d 352, 355 [256 Cal.Rptr.
230, 231].)
Defendant first argues that there is
no evidence of a manufacturing defect in the BPX-501 used on George M. Kelly. It
is an undisputed material fact between the parties that “The Certificate of
Analysis for Lot Number 004-015-004-1018 indicates that the BPX-501 that was
administered in the Study to the Decedent passed all Quality Testing before it
was released for distribution.” (Undisputed Material Facts, ¶ 94.)
Defendant also argues that
Plaintiffs fail to demonstrate that any alleged defect in BPX-501 was the cause
of the harm to George M. Kelly. Defendant relies on the declaration of Dr.
Robert Gale which states, “I opine, based on the data I reviewed and
considered, to a reasonable degree of medical probability, Mr. Kelly’s death on
October 30, 2016 from disseminated fungal disease was not a result of his
participation in the Bellicum Study or the infusion of the genetically-modified
BPX-501 cells he received on August 9, 2016. Rather. it was a result of his
receiving three unsuccessful haematopoietic cell transplants. Also, my opinion
that BPX-501, the Bellicum product, did not increase his risk of fungal
infection is concordant with that of the Children’s Hospital Los Angeles
Institutional Review Board which did not consider receipt of BPX-501 to be
associated with an increased risk of infection.” (Dr. Gale Decl., ¶ 69.)
Defendant has satisfied their burden
by demonstrating that their product was of the same quality as the other units
in the product line and that BPX-501 did not cause the harm to George M. Kelly.
The burden now shifts to Plaintiffs to demonstrate a triable issue of material
fact.
C.
Products liability for a manufacturing
defect – Plaintiffs’ burden.
Plaintiffs rely on the declaration
of Dr. Tirgan which states “The defects in design and manufacturing of
Bellicum’s products was the immediate and direct cause of GMK’s death, as their
own protocol precluded him from participating in their study.” (Dr. Tirgan
Decl., ¶ 54.) An objection has been sustained to this evidence and the court
cannot consider it as support for Plaintiffs’ argument. Such a conclusion also does
not demonstrate a manufacturing defect of BPX-501. A manufacturing defect
alleges that a product differs from the intended result or from identical units
from the same line. (Johnson v. United States Steel Corp., supra,
240 Cal.App.4th at p. 32.) This statement, even if it were admissible, does not
counter the quality testing evidence presented which Plaintiffs do not dispute.
(Undisputed Material Facts, ¶ 94.)
Additionally, even if the court were
considering the Bellicum Protocol a product, Plaintiffs are not alleging that
the Bellicum Protocol is incorrectly manufactured for patients who meet the
inclusion criteria; Rather, Plaintiffs are arguing that the Bellicum Protocol
is correctly manufactured to have excluded George M. Kelly, but he was
improperly included into the Bellicum Protocol.
Finally, Plaintiffs fail to offer
evidence that BPX-501 caused the harm to George M. Kelly. Plaintiffs only offer
arguments relating to how the Bellicum Protocol lead to the death of George M.
Kelly. Because the Bellicum Protocol is not at issue here, Plaintiffs fail to
meet their burden.
Based on the foregoing, summary adjudication
is GRANTED as to the cause of action for products liability based on a
manufacturing defect.
D.
Products liability based on a design
defect – Defendant’s burden.
While some design defects warrant
strict liability, the Supreme Court of California concluded that “a drug
manufacturer's liability for a defectively designed drug should not be measured
by the standards of strict liability….” (Brown v. Superior Court (1988)
44 Cal.3d 1049, 1061 [245 Cal.Rptr. 412, 418, 751 P.2d 470, 477].) “The test of
negligent design ‘involves a balancing of the likelihood of harm to be expected
from a machine with a given design and the gravity of harm if it happens
against the burden of the precaution which would be effective to avoid the harm.’
[Citation.]” (Merrill v. Navegar, Inc. (2001) 26 Cal.4th 465, 479 [110
Cal.Rptr.2d 370, 381, 28 P.3d 116, 125].) The theory of a design defect “focuses
upon … whether the risk of danger inherent in the design outweighed the
benefits of the design.” (Dierks v. Mitsubishi Motors Corp. (1989) 208
Cal.App.3d 352, 354–355 [256 Cal.Rptr. 230, 231].) This is often referred to as
the risk-benefit test.
Defendant argues that Plaintiffs
cannot demonstrate a design defect under the risk-benefit test because
Defendant complied with the FDA statutory requirements to have the clinical
trial of BPX-501 approved. The declaration of Dr. Scripture states, “Federal
regulations require certain information and documentation to be included in
every IND. This information and documentation includes but is not limited to an
introductory statement and general investigational plan; the Investigator’s
Brochure (“IB”); the Protocol(s); chemistry, manufacturing, and control
information; pharmacology and toxicology information; and previous human
experiences with the investigational drug. See 21 CFR Sec. 312.23. These
materials were provided by Bellicum in the IND.” (Dr. Scripture Decl., p.
5:1-7.) Code of Federal Regulations section 312.23, referenced by Dr.
Scripture, details the form and content required for an IND submitted to the
FDA for a clinical investigation. Additionally, Dr. Scripture states, “Bellicum
also provided annual reports to the FDA from which the FDA continued to assess
the risk benefit profile for BPX-501 based on emerging study data.” (Dr.
Scripture Decl., p. 7:9-10.)
“Where the evidence shows no unusual
circumstances, but only the ordinary situation contemplated by the statute or
administrative rule, then ‘the minimum standard prescribed by the legislation
or regulation may be accepted by the triers of fact, or by the court as a
matter of law, as sufficient for the occasion….’ [Citations.]” (Ramirez v.
Plough, Inc. (1993) 6 Cal.4th 539, 548 [25 Cal.Rptr.2d 97, 863 P.2d 167].)
Defendant has demonstrated traditional circumstances in applying for a clinical
trial through the FDA who then assessed and continued to approve the
risk/benefit analysis for the BPX-501 clinical trial.
Defendant has satisfied their burden
by demonstrating that Plaintiffs cannot establish the risks of the design
outweighed the benefits. The burden now shifts to Plaintiffs to demonstrate a
triable issue of material fact.
E.
Products liability based on a design
defect – Plaintiffs’ burden.
Plaintiffs fail to demonstrate that
the risk of BPX-501 outweighs the benefits of the clinical trial. Plaintiffs
only address the Bellicum Protocol and fail to offer any evidence pertaining to
BPX-501. While Plaintiffs argue that Defendant failed to comply with the
Bellicum Protocol submitted to the FDA, this argument does not focus on the
risk-benefit analysis of BPX-501.
Plaintiffs argue that they can use
an alternative test called ‘the consumer expectation test’ which requires a
plaintiff to show that a product did not perform as safely as an ordinary
consumer would have expected it to perform when used. (Trejo v. Johnson
& Johnson (2017) 13 Cal.App.5th 110, 157 [220 Cal.Rptr.3d 127].)
Defendant argues that Plaintiffs cannot use the consumer expectation test. In Trejo,
the Court of Appeal expressed that “‘The critical question, in assessing the
applicability of the consumer expectation test, is not whether the product,
when considered in isolation, is beyond the ordinary knowledge of the consumer,
but whether the product, in the context of the facts and circumstances of its
failure, is one about which the ordinary consumers can form minimum safety
expectations.’ [Citation.]” (Trejo v. Johnson & Johnson, supra,
13 Cal.App.5th at p. 156.) “[W]hen the ultimate issue of design defect calls
for a careful assessment of feasibility, practicality, risk, and benefit, the
case should not be resolved simply on the basis of ordinary consumer expectations.…”
(Internal quotations omitted.) (Id. at 157.)
Here, the ordinary consumer cannot
determine the minimum safety expectations for BPX-501 in the context of the
clinical trial. The FDA is in charge of approving and monitoring clinical
trials because the safety expectations are complex and beyond what an ordinary
consumer can determine. The approvals for a clinical trial involve the careful
assessment of feasibility, practicality, risk, and benefit that the Court of
Appeal determined should prevent the application of the consumer expectation
test. (Ibid.) Based on the foregoing, Plaintiffs cannot rely on the
consumer expectation test to demonstrate a design defect in BPX-501.
Plaintiffs fail to satisfy their
burden to demonstrate a triable issue of material fact of a design defect.
Based on the foregoing, summary
adjudication is GRANTED as to the cause of action for products liability based
on a design defect.
F.
Breach of express warranty – Defendant’s
burden.
To sustain a cause of action for
breach of express warranty, a plaintiff must demonstrate (1) a seller's
statement that constitutes an affirmation of fact or promise or a description
of the goods; (2) the statement was part of the basis of the bargain; and (3)
the warranty was breached. (Weinstat v. Dentsply Internat., Inc. (2010)
180 Cal.App.4th 1213, 1227 [103 Cal.Rptr.3d 614, 626].)
Defendant argues that the
representation made to Plaintiffs through the informed consent process
demonstrated that the study was investigating the safety and effectiveness of
BPX-501 and because of this Plaintiffs cannot demonstrate a promise that
BPX-501 was safe and effective. The Declaration of Dr. Scripture states, “The
BP-U-004 Informed Consent described the two primary purposes of the Study,
which were to determine the largest dose of genetically modified T-cells that
can help to recover the immune system without causing serious GvHD (Phase 1)
and how effective the maximum tolerated dose of genetically modified T-cells is
in preventing GVHD while helping to recover the immune system. (Phase 2).” (Dr.
Scripture Decl. p. 11:13-16.) This demonstrates that the study was
investigating effectiveness of BPX-501 and the largest does of T-cells that can
be administered “without causing serious GvHD,” indicating that the current
level of safe T-cells was unknown, and the study was attempting to determine a
safe range. Defendant has presented sufficient evidence to demonstrate that
Plaintiffs will be unable to demonstrate an express warranty of safety and
efficacy of BPX-501. Plaintiffs must now demonstrate a triable issue of
material fact concerning the breach of an express warranty.
G.
Breach of an express warranty –
Plaintiffs’ burden.
Plaintiffs fail to address the
alleged representation that BPX-501 was safe and effective and instead argue
that the representations were incomplete by failing to list all of the
potential risks of the Bellicum Protocol.
Based on the foregoing, summary adjudication
is GRANTED as to the cause of action for breach of express warranty.
Because all causes of action alleged
by Plaintiffs against Defendant fail and are subject to summary adjudication,
summary judgment is GRANTED in favor of Defendant.
VI. CONCLUSION
This Motion for Summary Judgment is
GRANTED.
Dated:
Judge of the Superior
Court