Richmond v. Patel CA2/2 ( 2021 )

Filed 12/17/21 Richmond v. Patel CA2/2
NOT TO BE PUBLISHED IN THE OFFICIAL REPORTS
California Rules of Court, rule 8.1115(a), prohibits courts and parties from citing or relying on opinions
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IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA
SECOND APPELLATE DISTRICT
DIVISION TWO
MIKE RICHMOND et al., B310903
(Los Angeles County
Plaintiffs and Appellants, Super. Ct. No.
BC643147)
v.
RAVI PATEL et al.,
Defendants and Respondents.
APPEAL from a judgement of the Superior Court of Los
Angeles County, Margaret L. Oldendorf, Judge. Affirmed.
Law Offices of Ralph B. Wegis, Ralph B. Wegis and Edward
Gordon for Plaintiffs and Appellants Mike Richmond and Kellie
Richmond.
McElroy Parris Trial Lawyers and Ashley Parris for
Plaintiff and Appellant Kellie Richmond.
Cole Pedroza, Kenneth R. Pedroza, Cassidy C. Davenport;
Lebeau-Thelen, Dennis R. Thelen and Kevin Thelen for
Defendants and Respondents.
___________________________
A pathologist misdiagnosed appellant Mike Richmond’s
pancreatic tumor. Relying on the pathology report, respondent
oncologist Ravi Patel recommended chemotherapy for Richmond
with a drug regimen that is accepted in the medical community.
Richmond consented to donate blood and tissue for research. Two
years later, a second biopsy revealed that Richmond has a rare
type of cancer that should have been surgically removed, not
treated with chemotherapy. He sued his medical providers.
After a bench trial, the court gave judgment to respondents
Dr. Patel and Comprehensive Blood & Cancer Center (CBCC). It
found (1) Dr. Patel was not negligent for relying on the pathology
report or recommending chemotherapy, (2) no evidence that
Richmond was surreptitiously placed in a clinical trial to
financially benefit respondents, nor did Dr. Patel misrepresent
the diagnosis to place Richmond in a clinical trial, and (3) no
medical battery occurred because Richmond consented to a biopsy
and weighed the recommendations of Dr. Patel and other
oncologists before agreeing to chemotherapy. The record
supports the judgment. We affirm.
FACTS AND PROCEDURAL HISTORY 1
Richmond’s 2013 Diagnosis of Adenocarcinoma
After a CT scan revealed an abnormal mass on Richmond’s
pancreas and lesions on his liver, he was referred to Dr. Patel, an
1The record contains 12 volumes of reporter’s transcript,
plus appendices, from a three-week trial. Appellants’ statement
2
oncologist with 30 years of experience in his field. At his first
meeting with Richmond on March 6, 2013, Dr. Patel ordered a
biopsy. With Richmond’s consent, a radiologist performed a CT-
guided biopsy and prepared tissue samples on March 8, 2013.
The tissue samples were analyzed by Dr. Miranda, a board-
certified pathologist. In her March 12, 2013 pathology report, Dr.
Miranda’s “final diagnosis” was that Richmond’s tissue was
“consistent with infiltrating poorly differentiated
adenocarcinoma.” She did not express doubt about her diagnosis
to Dr. Patel. No immunohistochemistry (IHC) test was done
because the tissue sample was inadequate. A defense expert
testified that IHC tests are used if “there’s not evidence that it’s
adenocarcinoma.”
Adenocarcinoma is the most common form of pancreatic
cancer, comprising about 97 percent of cases. It is treated with
chemotherapy. A patient like Richmond, who presented with
stage IV metastatic adenocarcinoma, could expect to live 12 to 15
months with chemotherapy, or 6 to 12 months without
chemotherapy. The treatment exacts a toll on the body and
impacts quality of life.
By contrast, a patient diagnosed with a neuroendocrine
tumor of the pancreas is usually treated with surgery. Patients
with neuroendocrine cancer may survive for five to 10 years. Dr.
Patel did not order a special ocreotide scan that tags
of facts is barely three pages. We remind counsel that “[i]n every
appeal, ‘the appellant has the duty to fairly summarize all of the
facts in the light most favorable to the judgment,’ ” a burden that
grows with the complexity of the record. (Myers v. Trendwest
Resorts, Inc. (2009) 178 Cal.App.4th 735, 739.)
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neuroendocrine cancers because Richmond was not diagnosed
with that type of cancer.
Richmond Consents To Chemotherapy
When the parties discussed the biopsy results, Richmond
asked if surgery was an option. Dr. Patel said no, because the
pathology report showed stage IV adenocarcinoma that was also
in his liver. Dr. Patel said the only way to extend Richmond’s life
expectancy was with chemotherapy.
Dr. Patel recommended chemotherapy with two drugs,
Gemzar and Abraxane, because “this regimen was superior to
previous regimens” and “was the treatment choice of this
particular disease.” Abraxane is FDA approved for breast cancer.
The FDA-approved drug for adenocarcinoma is Folfirinox.
Dr. Patel did not tell Richmond that Abraxane was not
FDA approved for pancreatic cancer. He never intended to
mislead or deceive Richmond. Richmond’s expert, Dr. Stark,
testified that the lack of approval should have been disclosed but
agreed that “use of Abraxane for metastatic pancreatic cancer
was commonplace by early 2013 in American oncology.” Dr. Patel
testified that a Gemzar/Abraxane regimen “was not an
experimental treatment at all.” Richmond did not tell Dr. Patel
he wanted “proven treatments.”
Before deciding on a course of treatment, Richmond
obtained a second opinion from Dr. Rosen, an oncologist at
UCLA, who said Gemzar has been used for years for breast
cancer patients but was also used for pancreatic cancer and was
more effective when used with Abraxane. Dr. Rosen did not tell
Richmond that Abraxane was not specifically approved for
pancreatic cancer. He described a chemotherapy drug called 5FU
as “extremely toxic” and “harsh on your body.” Richmond felt
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comfortable with Dr. Rosen and believed what he was saying. Dr.
Rosen did not recommend additional testing of Richmond’s tissue.
Richmond obtained a third opinion from UCLA oncologist
Dr. Wainberg. Though 5FU could be more toxic, Dr. Wainberg
advocated its use for Richmond.
After weighing the opinions of the three oncologists,
Richmond consented to chemotherapy with Gemzar and
Abraxane; he reasoned that it “was pretty much the standard.
It’s what they’re using right now.” He began treatment on April
1, 2013. He had a bad reaction, experiencing swelling in his
extremities, weight gain, fatigue, nausea, and pain. He suffered
emotionally as well. Scans showed that his tumor was stable or
getting better.
Richmond Consents to Submit Specimens for Research
Richmond signed a “Consent to Participate in Collection of
Biological Sample(s) for Diagnostic Research” on March 6, 2013.
It reads: “You are being asked to participate in a research study.
The purpose of the study is to obtain periodic blood samples and
previously obtained biological specimens (i.e., tumor tissue)
which researchers will use to help them develop new ways of
diagnosing and treating your disease.” The form continues, “If
you agree to participate in this study, a blood sample will be
taken periodically at a time when you are having blood drawn. A
sample of any previously obtained biological specimen (i.e., tumor
tissue) may also be collected. . . . There should be minimal risk or
discomfort in this study. These risks would involve the normal
discomfort and complications involved in performing a blood
draw. The alternative is to decline to participate in the study.
Your participation is strict1y voluntary.”
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A CBCC executive testified that the consent was “ongoing”
and was intended to allow collection of samples “on and after”
March 6, 2013, the date it was signed. He noted that “logic”
demanded a reading that the consent was ongoing, even if the
form referred to “previously obtained” specimens. Richmond
testified that under the consent, his role was to be “a sample
donor.”
Richmond’s tissue samples were sent to CBCC’s
biorepository. A doctor examined the samples, found they lacked
useful material, and destroyed them. The tissue was not sent out
for research.
Richmond Does Not Participate In a Clinical Trial
Dr. Patel operated CBCC in Bakersfield.2 CBCC diagnoses
and treats cancer patients, providing chemotherapy, radiation
treatment, and imaging. An affiliate of CBCC is CBCC Global
Research (Global), another of Dr. Patel’s businesses. Global
conducts clinical trials for new cancer treatments, including
pancreatic cancer. The goal of clinical trials is to “make these
additional therapies available for the potential benefit of the
patient.” Patients eligible for trials are found by prescreening
CBCC’s electronic medical records.
Patients must consent to participation in a clinical trial.
The treating physician tells the patient about the trial. If the
patient is interested, information is provided about the nature
and purpose of the experiment, the discomforts and risks, and
appropriate alternatives to participation. Dr. Patel thought
Richmond might be a candidate for a UCLA clinical trial for
metastatic adenocarcinoma. Richmond’s expert, Dr. Stark, said it
2 Bakersfield Memorial Hospital purchased CBCC and
gradually took over the business from January to July 2013.
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is routine to ask new patients if they are interested in clinical
trials.
Richmond was “adamantly against” joining a clinical trial
because “I didn’t want to be a guinea pig.” Dr. Patel was aware of
Richmond’s feelings and never discussed a trial with him again.
Richmond never signed consent forms to be in a trial, so no data
about him could be transmitted to a reporting agency.
Dr. Patel testified that Richmond was “never” part of a
clinical trial, which requires sponsorship and “rigorous”
documentation. Global’s clinical trial coordinator testified that
Richmond was not enrolled in a clinical trial and no data about
him was collected. Patients are never secretly enrolled in clinical
trials. CBCC’s clinical operations manager testified that
Richmond’s medical chart did not show participation in a trial;
moreover, the drug regimen he was on “was not part of a clinical
trial.” She was “confident that he was not on a clinical trial.”
Richmond underwent regular scans and blood tests to
monitor his cancer. His medical file was reviewed before his
appointments, to see if he was healthy enough to have a
chemotherapy infusion or if he qualified for any new trials.
Richmond’s Misdiagnosis Is Discovered In 2015
By 2015, Richmond could no longer tolerate the bodily
effects of chemotherapy and decided to stop treatment. He had
already surpassed the normal life expectancy for a patient with
metastatic adenocarcinoma. Dr. Patel recommended that he go
to UCLA, where a liver biopsy was taken. It showed his tissue
had “features consistent with an adenocarcinoma” but had “more
significant” features of a neuroendocrine tumor. Tumors were
surgically removed from his liver and pancreas. A postsurgical
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biopsy definitively showed that his cancer is neuroendocrine.
Richmond was told that he had been misdiagnosed.
Testimony On the Standard of Medical Care
Defense experts testified that Dr. Patel met the medical
standard of care by relying on Dr. Miranda’s pathology report
and recommending a regimen of Gemzar and Abraxane. The
trial court found the testimony of the defense experts
“particularly credible and persuasive.”
The pathology expert, Dr. Burg, stated that Dr. Miranda
made a “final diagnosis” of adenocarcinoma. A clinician could
initiate treatment based on the pathology report. If additional
tissue had existed (it did not), it could have been stained to
determine whether the tumor originated outside of the pancreas.
Dr. Van Scoy-Mosher, a medical oncologist, testified that
Dr. Patel “had good grounds” to conclude Richmond had
adenocarcinoma based on the pathology report, and to treat him
for that diagnosis with “the only reasonable treatment option,”
chemotherapy. Gemzar and Abraxane was “the best option in
this situation” and “was accepted by the oncology community by
that time.” Dr. Rosen concurred in this treatment plan. Dr.
Stark testified that on September 3, 2013, the FDA approved
Abraxane, individually or with Gemzar, for treatment of stage IV
pancreatic cancer.
The Richmonds File Their Lawsuit
In 2016, Richmond and his wife filed suit against
respondents, Global, UCLA, Dr. Rosen, Dr. Miranda, and others.
Dr. Miranda settled before trial. Appellants dismissed their
claims against all defendants except respondents before trial.
They allege causes of action for negligence, concealment, fraud,
medical battery, and loss of consortium.
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The Trial Court’s Judgment
A three-week bench trial was held in fall of 2020. The court
issued a statement of decision on December 30, 2020. It entered
judgment for respondents.
The court found no negligence. Dr. Patel reasonably
ordered a biopsy of the pancreas and relied on the pathology
report to recommend a course of treatment. The report had a
final, unequivocal diagnosis of adenocarcinoma; Richmond did
not show that Dr. Miranda wanted to conduct more tests to
determine if the tissue specimen was a neuroendocrine tumor.
Expert testimony showed that a chemotherapy regimen of
Gemzar and Abraxane was an accepted medical treatment in
2013, not “ ‘unproven’ ” or “ ‘experimental.’ ”
The court found no concealment or fraud. Dr. Patel did not
intend to deceive Richmond about his diagnosis or treatment and
reasonably relied on the pathology report. Any claim of fraud
“was highly speculative.” Richmond did not prove with any
credible evidence that he was placed in a clinical trial; his
medical records do not reflect that he was surreptitiously placed
in a trial. He consented to the use of his blood and “ ‘previously
obtained’ ” tissue samples for “ ‘research.’ ” Taking tissue
samples from him for diagnostic purposes, two days after he
signed the consent, does not show fraud or concealment.
The court found no evidence of medical battery. Richmond
consented to a biopsy; consented to use of his tissue for research;
and consented to a Gemzar/Abraxane chemotherapy regimen on
the recommendations of Dr. Patel and Dr. Rosen. Mrs. Richmond
cannot claim loss of consortium because her husband has no
claim against respondents.
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DISCUSSION
1. There Was No Medical Battery
Richmond argues that his consent to use “previously
obtained” tissue for research did not allow use of biopsied
specimens obtained two days after he signed the consent. He
claims respondents exceeded the scope of his consent and
committed medical battery by using his tissue for research. He
writes, “the use of a later obtained biopsy for research is a
battery” and “the use of biological samples by persons other than
those specified is a battery.”
Richmond’s argument is flawed for several reasons. First,
no battery is committed by examining cancerous cells that the
patient agreed to have removed. Second, there is no substantial
evidence that Richmond’s cancer cells were used for research.
Third, his interpretation of the consent contradicts his own
testimony, wherein he identifies himself as “a sample donor.”
The existence of informed consent presents an issue of fact.
(Quintanilla v. Dunkelman (2005) 133 Cal.App.4th 95, 115.)
Richmond must “show on appeal that there is no substantial
evidence to support [the] defense verdict, and not merely that
substantial evidence would have supported a verdict in [his]
favor.” (Flores v. Liu (2021) 60 Cal.App.5th 278, 297.)
A medical battery occurs if a doctor exceeds the scope of
consent when treating a patient. The elements of the claim are
(1) a patient gave conditional consent to treatment; (2) the doctor
intentionally violated the condition while providing treatment;
and (3) the patient suffered harm as a result of the doctor’s
violation of the condition. (Piedra v. Dugan (2004) 123
Cal.App.4th 1483, 1497–1498.) “Where a doctor obtains consent
of the patient to perform one type of treatment and subsequently
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performs a substantially different treatment for which consent
was not obtained, there is a clear case of battery.” (Cobbs v.
Grant (1972) 8 Cal.3d 229, 239; Dennis v. Southard (2009) 174
Cal.App.4th 540, 544.)
Medical battery involves harm to the patient. Battery
beyond the scope of consent occurs if a doctor promises to “remove
some corns” from the patient’s feet then removes portions of
bones and maims her. (Brown v. Bleiberg (1982) 32 Cal.3d 426,
430–431, fn. 1.) Battery occurs if a patient consents to have a
small mass removed from his scrotum for testing and does not
consent to a major surgery involving his penis while under
anesthesia. (Burchell v. Faculty Physicians & Surgeons etc.
(2020) 54 Cal.App.5th 515, 519–521, 524.)3
The rationale for the consent doctrine is “to protect the
patient’s freedom to ‘exercise . . . control over [one’s] own body’ by
directing the course of medical treatment.” (Arato v. Avedon
(1993) 5 Cal.4th 1172, 1188.) This allows the patient “ ‘to accept
or reject a recommended medical procedure.’ ” (Id. at p. 1186;
Flores v. Liu, supra, 60 Cal.App.5th at pp. 292–293.) In a
supplemental brief, Richmond points to the radiologist’s notes as
proof that multiple tissue cores were taken; however, he omits to
mention that “[a]ll the tissue” was sent “for histopathology.” The
biopsy was done by “Truxtun Radiology Medical Group,” not
3 Other examples of battery are cited in Cobbs v. Grant,
supra, 8 Cal.3d at page 239, e.g., when a patient consented to a
prostate resection but was not told that his sperm ducts would be
tied off; when a patient consented to exploratory surgery but the
doctor performed a mastectomy; when a patient consented to a
hernia operation but the doctor removed her ovaries.
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respondents, so Richmond cannot claim that respondents
committed a battery on him during the biopsy procedure.
Richmond is not claiming deprivation of his right to accept
or reject a biopsy. Instead, he claims violation of a right to
exercise control over excised tissue long after the biopsy is
performed. The law does not “impose a tort duty on scientists to
investigate the consensual pedigree of each human cell sample
used in research.” (Moore v. Regents of University of California
(1990) 51 Cal.3d 120, 135.) It is undisputed that Richmond had a
suspicious pancreatic mass; he agreed to a biopsy to determine if
it was malignant. Once the tissue was removed, Richmond had
no further possessory interest in it. California law “drastically
limits any continuing interest of a patient in excised cells.” (Id.
at p. 137.) No “battery” could be committed on cancer cells
removed from Richmond by consent. He admits there is no
authority for such a novel expansion of medical battery law.
Even if battery could be committed on excised cancer cells,
Richmond’s claim assumes that his tissue was used for research.
The evidence shows Richmond’s tissue was sent to Dr. Miranda
for diagnostic purposes. There is no proof that the tissue was
ever used again. Indeed, the evidence shows that CBCC deemed
the sample inadequate and destroyed it. Assuming the tissue
was examined in the interest of scientific advancement, this
caused no harm to Richmond. Thus, the third element of a
battery claim, harm, was unproven.
Finally, even if battery could be committed on excised cells
and assuming the cells were used for research, Richmond’s
interpretation of the consent form is illogical. He signed the form
on March 6, 2013, two days before tissue samples were taken in a
biopsy. He knew any research was prospective when he
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consented to participate in “the future development of improved
diagnostic tests and treatments.” He testified that under the
consent, he agreed to be “a sample donor.” The words “previously
obtained” did not vitiate his consent to conduct research on his
tissue sample taken March 8, 2013.
2. Dr. Patel Did Not Deceive Richmond
Richmond asserts that Dr. Patel intentionally failed to
disclose that the Gemzar/Abraxane chemotherapy regimen was
not FDA approved for pancreatic cancer. Richmond testified, “I
wanted to go with whatever the current standard was for treating
my particular cancer” and asked for “approved treatments.”
From his meetings with Dr. Patel and Dr. Rosen, Richmond
understood that Abraxane and Gemzar was an approved
treatment for his diagnosis. Richmond now claims that this was
fraudulent inducement.
The trial court “carefully weighed all evidence” relating to
Richmond’s claims and found that he “failed to establish by a
preponderance of the evidence any knowledge of falsity, or intent
to deceive, on the part of Dr. Patel with regard to his diagnosis or
plaintiff’s treatment.” It found Richmond’s evidence “highly
speculative and circumstantial.” Richmond agreed to Gemzar
and Abraxane after consulting Patel and Rosen, and “this
chemotherapy regimen was not ‘unproven’ or ‘experimental’ at
the time that Mr. Richmond commenced chemotherapy.”
Viewing the record in the light most favorable to the
judgment, we conclude that substantial evidence supports the
trial court’s findings.
Richmond began chemotherapy in April 2013; the FDA
approved the Abraxane/Gemzar combination for pancreatic
cancer on September 3, 2013. Even Dr. Stark, who testified for
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Richmond, agreed that by early 2013, Abraxane was commonly
used for metastatic pancreatic cancer. Dr. Patel denied that
Richmond insisted on FDA-approved treatments. But in any
event, Abraxane was already FDA approved for breast cancer:
“Once FDA-approved, prescription drugs can be prescribed by
doctors for both FDA-approved and unapproved uses” and “courts
and the FDA have recognized the propriety and potential public
value of unapproved or off-label drug use.” (United States v.
Caronia (2d Cir. 2012) 703 F.3d 149, 153; Association of
American Physicians & Surgeons v. United States Food and Drug
Administration (6th Cir. 2021) 13 F.4th 531, 534 [federal law
“does not prohibit doctors from prescribing an FDA-approved
drug (say, a chemotherapy drug approved to treat leukemia) for
an ‘off-label’ use (say, treatment of other cancers)”].)
Richmond did not rely solely on Dr. Patel’s therapeutic
recommendation. He consulted UCLA oncologists for second and
third opinions. One advocated for the experimental drug 5FU,
which Richmond was told was “harsh” and “toxic.” No one
advocated for the use of Folfirinox, an FDA-approved drug.
The trial court found the defense experts particularly
credible; we do not reweigh credibility determinations on appeal.
They testified that the chemotherapy Richmond received was
considered the best treatment. Richmond had what he wished,
which was “the current standard was for treating my particular
cancer” that was “approved” within the medical community as
the best available oncological treatment.
Richmond cites hundreds of pages of routine medical notes
documenting his treatment. For example, he cites the treatment
center’s “Infusion Administration Notes” showing he received
infusions. He does not point to any statement in his medical
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records showing he was treated with investigational drugs. His
claim of being the subject of investigational treatment is pure
speculation. All the experts, even Dr. Stark, agreed that the
Abraxane/Gemzar regimen was widely used, accepted by the
medical community, and approved by the FDA for treatment of
metastatic pancreatic cancer in 2013. Multiple witnesses
testified that Richmond was “never” in a clinical trial, and that
his drug regimen was not the subject of a trial.
DISPOSITION
The judgment is affirmed. Appellants to bear all costs on
appeal.
NOT TO BE PUBLISHED.
LUI, P. J.
We concur:
CHAVEZ, J.
HOFFSTADT, J.
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