United States Court of Appeals
For the First Circuit
No. 09-1079
ALBERT ANAYA-BURGOS,
Plaintiff, Appellant,
v.
DR. EDUARDO M. LASALVIA-PRISCO; PHARMABLOOD, INC.,
Defendants, Appellees,
JOSÉ MURATTI-SEPÚLVEDA; DR. RUBÉN OTERO-LÓPEZ;
FÉLIX COTTO-ORTIZ; PHARMABLOOD MEDICAL CENTER, INC.,
Defendants.
APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF PUERTO RICO
[Hon. José Antonio Fusté, U.S. District Judge]
Before
Torruella, Selya, and Lipez,
Circuit Judges.
Manuel San Juan, with whom Law Offices of Manuel San Juan,
José F. Velázquez-Ortiz, and Velázquez Law Offices, PSC, were on
brief for appellant.
John E. Bergendahl, with whom Law Offices of John E.
Bergendahl, was on brief for appellees Dr. Lasalvia-Prisco and
Pharmablood, Inc.
June 9, 2010
TORRUELLA, Circuit Judge. Plaintiff-appellant Albert
Anaya-Burgos ("Anaya") filed a complaint against Dr. Eduardo
Lasalvia-Prisco ("Dr. Lasalvia") and other Defendants-appellees
alleging that the death of his wife, Juana Ramos ("Ramos"),
occurred as a result of Defendants' negligent acts and omissions by
inducing her to purchase their supposed "cancer vaccine" treatment
and forego conventional cancer treatments. The case was tried to
a jury, which found for Plaintiff, awarding $500,000 in
compensatory damages. At Defendants' motion, the court granted
them judgment as a matter of law, setting aside the jury verdict
and dismissing the complaint. For the reasons below, we overturn
the grant of judgment as a matter of law and reinstate the jury
verdict for Plaintiff.
I. Facts and Procedural History1
A. Cancer Diagnosis Treatment at Pharmablood
In April 2003, Plaintiff's wife, Ramos, was diagnosed
with breast cancer. She consulted a surgeon who recommended a
radical mastectomy. She sought a second opinion from another
surgeon in early May of 2003, who also recommended a mastectomy.
Subsequently, Ramos was referred to an oncologist, Dr. Rizek, who
examined her for the first time on May 23, 2003. While Ramos had
1
We recite the facts in the light most favorable to the jury
verdict. Granfield v. CSX Transp., Inc., 597 F.3d 474, 482 (1st
Cir. 2010) (citing Cigna Ins. Co. v. Oy Saunatec, Ltd., 241 F.3d 1,
8 (1st Cir. 2001)).
-2-
initially been diagnosed with a form of cancer called "invasive
duct carcinoma," Dr. Rizek's diagnosis was of "inflammatory breast
cancer," a type of cancer that tends to progress much faster than
Ramos's earlier diagnosis. There was expert testimony at trial to
the effect that someone diagnosed with inflammatory breast cancer
could die within six to twelve months without adequate treatment.
Dr. Rizek recommended to Ramos that she begin chemotherapy on
June 6, 2003.2 Although Ramos never began the chemotherapy
treatments, Anaya testified that Ramos agreed to proceed with
chemotherapy. According to Anaya, Ramos did not begin chemotherapy
on the scheduled date because she was never notified that she had
been approved for coverage by her insurance carrier.3
According to Anaya, Ramos had always been interested in
a "natural" lifestyle, and regularly visited individuals who
recommended various vitamin and other natural substances to her.
She continued those visits after she was diagnosed with cancer.4
At some point after visiting Dr. Rizek but before
July 10, 2003, Ramos and Anaya became aware of Dr. Lasalvia's
2
At trial, Plaintiff's expert testified that "[m]ost people
nowadays would use chemotherapy before doing a mastectomy, [but]
some people continue to use mastectomy if the tumor is too big and
to give the chemotherapy after the surgery rather than before."
3
Evidence was presented at trial that Ramos's insurer had
approved the treatments as of June 6, 2003, but no evidence was
presented that this was ever communicated to Ramos or Anaya.
4
Plaintiff's expert testified that vitamins have not been shown
to have any effect on cancer treatment.
-3-
company, Pharmablood, through a radio program. Anaya testified
that he and Ramos heard a radio program that announced that Dr.
Lasalvia, an Uruguayan doctor, had developed a new "cancer vaccine"
that was available at the San Juan Bautista Hospital.5
A Pharmablood commercial that aired in October 2003 was
introduced at trial and touted Pharmablood as a "novel alternative
to cancer patients in Puerto Rico." A "Dr. Sylvia Cucci" explained
in the commercial that the procedure was "comfortable" and
"effective" and that it was an "FDA approved protocol." A "Dr.
Rubén Otero" was also heard in the commercial explaining that
"terminal patients that were told that perhaps their life
expectancy was six months or less . . . were offered the
Pharmablood immunotherapy and . . . in 42% of the population
treated, it was noticed there was an increase, not only in life
expectancy, but also a great improvement in the quality of life
itself."
On July 10, 2003, Anaya and Ramos visited Pharmablood at
the San Juan Bautista Hospital and met Dr. Lasalvia as well as
other Pharmablood personnel. According to Anaya, Dr. Lasalvia
examined Ramos and told her that his treatment could "cure" her.
Anaya testified that after hearing this, Ramos made the decision to
5
Pharmablood had rented office space in the first floor of the
San Juan Bautista Hospital, a well-regarded hospital in Caguas,
Puerto Rico. While Pharmablood was not formally affiliated with
the Hospital, there was testimony that the set-up gave the
appearance of affiliation.
-4-
go with the Pharmablood treatment and forego other treatments.
Anaya also explained that Pharmablood personnel told him and Ramos
that their medical plan would eventually cover the treatments, but
that they first had to make payments up front.6 All told, Anaya
and Ramos paid around $10,000 out-of-pocket for the Pharmablood
treatments.
At Pharmablood, Ramos signed an informed consent form
which stated that the Pharmablood cancer vaccine's risks were
"minimal inflammation or pain in the areas of the blood extraction"
and that it was reasonable to expect up to a one-hundred percent
improvement in the survival rate of forty percent in the patients
who were administered the vaccine treatment. Ramos began
treatments with Pharmablood shortly after signing the consent form.
On June 29, 2004, after almost one year of regular
treatments with Pharmablood, Ramos was hospitalized at the Auxilio
Mutuo Cancer Center since she was having difficulty breathing.
Expert testimony at trial revealed that at this point in time her
cancer had progressed so far that all Ramos could receive was
palliative chemotherapy, to extend her life but not to attempt to
cure her. The chemotherapy failed to work; Ramos continued to
6
The jury also was shown a separate form signed by Ramos which
states that by signing she understood that the services provided by
the Pharmablood Medical Center were not currently covered by
insurance companies. However, because this case is here following
a jury verdict in Plaintiff's favor, we credit Anaya's testimony
about what he and Ramos were told by Pharmablood.
-5-
deteriorate, and eventually died on July 30, 2004, "with her lungs
full of tumors."
B. Expert Testimony at Trial
1. Breach of the Standard of Care
At trial, Anaya's expert, Dr. Cabanillas, testified that
Dr. Lasalvia's medical license had been revoked in Hawaii. Dr.
Cabanillas testified that the Pharmablood treatments were
"illegal,"7 that they were never approved by the Food and Drug
Administration ("FDA"), and that this was not mentioned in any of
the Pharmablood literature he reviewed.8 Dr. Cabanillas also
explained that the medical papers Dr. Lasalvia had written about
the Pharmablood treatment were published in what were, in his
professional opinion, very poor journals. Dr. Cabanillas went on
to criticize the studies published in these papers, stating that
the design of the studies was very poor and that there were basic
scientific reliability tests that were not performed. He stated:
"I don't know how the papers were published, not even in journals
of low quality. I wouldn't have accepted a paper like that."
7
The district judge allowed this to be put on the record but Dr.
Cabanillas did not explain further what he meant by this. It
appears that he was referring to a criminal investigation against
Pharmablood and its officers.
8
Dr. Cabanillas also testified that none of the literature
claimed that Pharmablood was a "cure" for cancer and that instead
the literature referred to it as another "tool" in the fight
against cancer.
-6-
With regard to the forty percent or greater improvement
mentioned in both the advertisement watched by the jury and the
informed consent form signed by Ramos, Dr. Cabanillas testified
that "there was, basically, no statistical analysis of the results
[in Dr. Lasalvia's studies] to be able to convince anyone that
there's a 40 percent improvement."
Dr. Cabanillas also testified regarding Ramos's medical
records from the Pharmablood Cancer Center. He testified that it
appeared that Dr. Lasalvia did not do a physical examination of
Ramos because there were no notes of such an examination in the
records, something which Dr. Cabanillas testified was surprising
because he would have expected it of a doctor. Dr. Cabanillas also
testified that as part of her treatment, Dr. Lasalvia gave Ramos
two chemotherapy drugs. However, according to Dr. Cabanillas,
those drugs were administered at such low doses that they could not
have helped to decrease Ramos's cancer, and that the particular
drug combination used was abandoned decades ago and fell below the
standard of care. Ramos was also given a third drug at
Pharmablood: Tamoxifen. According to Dr. Cabanillas's testimony,
Tamoxifen was a drug that in the past had been thought to help a
patient in Ramos's condition. However, a 2001 medical study showed
that this drug would have no effect on a patient such as Ramos and
should not have been used on her. Dr. Cabanillas testified that
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the fact that Ramos was given this drug fell below the standard of
care.
2. Causation
Dr. Cabanillas testified that none of the notations in
the Pharmablood records indicated that Ramos had rejected
traditional treatment. When asked if the Pharmablood treatment had
caused her death, Dr. Cabanillas responded that Ramos had "lost an
opportunity." Explaining further, Dr. Cabanillas testified that if
Ramos had been given a treatment that comported with the standard
of care instead of the Pharmablood treatment, she would have had a
fifty percent chance of being alive for five years or longer.9
Instead, Ramos died just over a year after beginning the
Pharmablood treatments.
C. Anaya's Testimony on Causation
Multiple times at trial, Anaya was asked whether Ramos
had rejected traditional treatments for her cancer since she failed
to start chemotherapy or get surgery as recommended by some of the
9
The jury also heard the following exchange:
Q: If she had made a decision to reject chemo, reject
surgery, and reject radiation, nothing that Dr. Lasalvia
did caused her death; correct?
A: That's correct.
(emphasis added). The district court used this exchange as a
reason for granting judgment as a matter of law in favor of the
Defendants. However, this exchange begs the question of when and
why Ramos rejected traditional forms of treatment in favor of
Pharmablood.
-8-
doctors she saw. Anaya testified unequivocally that "[Ramos] never
ruled anything out;" "she was willing to have any treatment;" "I
don't believe she rejected chemotherapy," and that she did not rule
out surgery. Anaya testified that Ramos was willing to go through
chemotherapy or surgery, but that she also wanted to explore all
her options. After discovering Pharmablood's treatment at the San
Juan Bautista Hospital and speaking with Dr. Lasalvia, however,
Anaya testified that Ramos discarded chemotherapy and surgery as
options to treat her cancer.10 Anaya testified that because of its
location on the first floor of the San Juan Bautista Hospital, the
literature in the waiting room describing the patents that were
pending for the technology, and the representations that Dr.
Lasalvia made that his treatment would "cure" Ramos's cancer, he
and his wife proceeded to pay over $10,000 to Pharmablood for their
"cancer vaccine."
10
A medical report from the time when Ramos sought medical care
for difficulty breathing was also read into evidence. In
summarizing the patient's history, the report stated that Ramos had
previously refused to be under standard care and had sought
treatment under Dr. Lasalvia. The district court made much of
these notations as evidence that Ramos had rejected traditional
forms of treatment. But this was the opinion of the doctor who
wrote the medical report, and it did not state whether the
"rejection" occurred before or after Ramos met Dr. Lasalvia or
learned of the Pharmablood "vaccine." The jury was entitled to
credit other testimony presented to the effect that Ramos had not
in fact rejected "traditional" treatment until at least after
meeting Dr. Lasalvia.
-9-
D. Procedural History
After the conclusion of Plaintiff's presentation of
evidence, Defendants moved for judgment as a matter of law,
alleging that "there was nothing that Dr. Lasalvia did to cause
[Ramos's] death" because she had "refused standard medical
treatment." The district court denied the motion and Defendants
rested their case without putting on any evidence. The case was
submitted to the jury which found for Plaintiff and awarded him
$500,000 in damages.
Subsequently, Defendants renewed their motion for
judgment as a matter of law, and this time the district court
granted it, overturning the jury verdict and concluding as a matter
of law that "Lasalvia's quackery was not the cause of Juana Ramos's
demise" and that instead "her own election of medical remedies and
the devastating nature of the disease caused her death."
II. Discussion
We review de novo the district court's grant of judgment
as a matter of law. J.R. v. Gloria, 593 F.3d 73, 78 (1st Cir.
2010). We will not approve of a district court's ruling setting
aside the jury verdict unless "the evidence was so strongly and
overwhelmingly inconsistent with the verdict that no reasonable
jury could have returned [it]." Forgie-Buccioni v. Hannaford
Bros., Inc., 413 F.3d 175, 181 (1st Cir. 2005) (internal quotation
marks omitted).
-10-
Under Puerto Rico law, to establish a prima facie case
for medical malpractice the plaintiff must show that (1) defendant
owed plaintiff a duty; (2) defendant breached that duty; and (3)
there was "a sufficient causal nexus between the breach and some
resultant harm." Martínez-Serrano v. Quality Health Servs. of
Puerto Rico, Inc., 568 F.3d 278, 285 (1st Cir. 2009).
The "adequate causation" doctrine governs in
Puerto Rico to determine legal causation
between the negligent act or omission and the
harm. According to this doctrine, not any
condition without which a result would not
have occurred is a cause, but that which would
ordinarily produce it according to experience.
Pursuant to this doctrine, the issue to be
addressed is whether the materialization of
the harm was to be expected in the normal
course of events or if, on the contrary, it
cannot be calculated.
Sepúlveda de Arrieta v. Barreto, No. RE-90-41, 1994 WL 908876 (P.R.
Dec. 23, 1994) (internal citations and quotation marks omitted).
These concepts are very similar to proximate cause, id., and like
proximate cause, "the touchstone is foreseeability: [conduct
results in] liability if, and to the extent that, a foreseeable
risk of harm materializes." Swift v. United States, 866 F.2d 507,
510 (1st Cir. 1989).
On appeal, Defendants do not contest that Dr. Lasalvia
owed a duty of care to Ramos. Dr. Lasalvia was an oncologist
practicing in rented space at the San Juan Bautista Hospital.
Ramos went to see him to care for her cancer and he represented to
her that she would receive an FDA-approved treatment that improved
-11-
the survival of forty percent of patients who took it. Even more,
according to uncontroverted testimony at trial, Dr. Lasalvia
himself told Ramos and Anaya that his treatment could "cure" her of
cancer.
There is also no question that a reasonable jury could
have found that Dr. Lasalvia breached his duty in numerous ways.
There was uncontroverted expert testimony that Dr. Lasalvia's
treatment was not FDA-approved, despite advertisements claiming
otherwise, and that the kind and quantity of drugs given to Ramos
violated the standard of care. There was also uncontroverted
expert testimony that the medical papers Dr. Lasalvia published on
the Pharmablood treatment were published in sub-standard journals
and lacked basic scientific research methodology. The jury also
heard Plaintiff's testimony that Dr. Lasalvia promised Plaintiff
and Ramos that his treatment would "cure" her.
Finally, the informed consent form could be considered a
breach of duty in and of itself. According to unrebutted expert
testimony, the form that Ramos signed only explained that the risks
involved minimal inflammation or pain in the site of the blood
extraction. In the "benefits and probabilities of success"
section, the form stated that it was reasonable to expect an
improvement in the survival rate of forty percent of the patients
who receive the Pharmablood treatment and also said that the
prolongation of life could be more than one-hundred percent of the
-12-
average person.11 Plaintiff's expert testified that these
improvement figures had no basis whatsoever.12 In addition,
Plaintiff's expert testified that contrary to standard practice in
the oncology field, the informed consent form did not reflect the
approval of any institution. See, e.g., Sepúlveda de Arrieta, 1994
WL 908876 (P.R. 1994) ("Applied to the present case, the issue to
be addressed is whether in the normal course of events [the
defendant doctor] had to foresee that the lack of pertinent
information would lead [the patient] to take a different decision
than the one she would have taken if she had been suitably
informed."); Cruz Avilés v. Bella Vista Hosp., Inc., 112 F. Supp.
2d 200, 202 (D. P.R. 2000) (finding that "under Puerto Rico law a
patient suing for lack of informed consent does not need to prove
a separate negligent act, other than the lack of informed
consent.").
Defendants urge us to affirm the district court's
reversal of the jury verdict because, based on the evidence
presented, a reasonable jury could not have concluded that
Plaintiff met his burden to show that Defendants sufficiently
caused Plaintiff's harm under Puerto Rico law. We disagree.
11
Plaintiff's expert explained that it was not clear what was
meant by this.
12
Defendants do not contest the issue of breach on appeal.
-13-
We begin at the beginning, making clear that the harm
complained of in this case was, as Plaintiff's expert testified,
the opportunity that Ramos lost because Defendants induced her to
choose the Pharmablood treatment instead of traditional methods.
In order to be found liable, that "lost opportunity" harm needed to
have been sufficiently foreseeable to Defendants. We find that
there was sufficient evidence of a causal nexus between Defendants'
multiple breaches of duty and Ramos's untimely death.
Anaya testified at trial that Ramos only decided to
forego chemotherapy and surgery after meeting Dr. Lasalvia.
Anaya's expert, Dr. Cabanillas, testified that there was no
indication in the Pharmablood records that Ramos had ruled out
chemotherapy or surgery.13 Defendants point to evidence that
allegedly contradicted that testimony. They point to the fact that
Ramos went to three different doctors after her cancer diagnosis
and did not show up for chemotherapy after an appointment had been
scheduled. They also point to a notation in a medical record which
stated that Ramos had rejected chemotherapy and other traditional
treatments. The physician who wrote those notes saw Ramos over a
13
The district court's opinion seems to suggest otherwise,
apparently referring to the Pharmablood intake form which stated
that Ramos had not taken chemotherapy and had never taken it, and
that she was "on a natural diet." At trial, Defendants attempted
to elicit testimony from Dr. Cabanillas that the hand-written
Pharmablood records stated Ramos had "refused" chemotherapy and
surgery. Nevertheless, Dr. Cabanillas testified that he did not
understand that is what the records said.
-14-
year after she began seeing Dr. Lasalvia and receiving the
Pharmablood treatments. The notation was made by the physician who
saw Ramos after she sought treatment for difficulty breathing.
Defendants are correct that there was evidence on the
record that Ramos was determined not to submit herself to
chemotherapy or surgery for her cancer. However, there was also
evidence to the contrary. Specifically, the jury heard Anaya's
testimony that Ramos had never ruled anything out until she met
with Dr. Lasalvia, and that the reason she missed the chemotherapy
appointment was because no one notified her that her insurance was
going to cover it. That testimony was uncontroverted –- the fact
that the insurance company paid for all other treatments does not
undermine Anaya's testimony –- and the jury was entitled to believe
Anaya and his expert over the other evidence.
Defendants also point to the signed informed consent form
as evidence that Ramos knowingly rejected all forms of traditional
medical treatment. The form stated that the Pharmablood treatments
were meant to be undertaken by patients for whom chemotherapy
and/or surgery had failed, was not possible, or had been rejected.
But, Anaya testified that Dr. Lasalvia told him and Ramos that his
treatment would "cure" Ramos and that she rejected other possible
treatments based on his representations. Defendants also point to
the payment form, which stated that Pharmablood treatments were not
covered by health insurance, arguing that this should have clued in
-15-
Ramos and Anaya to the fact that this was an experimental
treatment. However, Plaintiff's expert testified that he did not
see anything in Pharmablood's literature that explained that this
was an experimental treatment; indeed, the evidence presented
showed that Defendants were advertising the treatment as FDA-
approved, and that they were misleadingly operating out of the San
Juan Bautista Hospital. Anaya also testified that Pharmablood
personnel explained that the insurance coverage issues were
temporary, and that they would only have to pay up-front for a
little while, and would later be reimbursed. Furthermore, the
informed consent form itself claimed that forty percent of patients
experienced improved quality and length of life, and that some
experienced up to a one-hundred percent improvement. The jury was
entitled to credit Anaya's testimony that Defendants' statements
and (mis)representations induced Ramos to reject other treatments
in favor of Pharmablood.
We find that Plaintiff put forth sufficient evidence,
including expert testimony, from which a reasonable jury could have
concluded -- and did conclude -- that Defendants' breach of the
standard of care towards Ramos caused her untimely death by
inducing Ramos to choose the Pharmablood treatment with promises
that it would cure her. That is, a reasonable jury could have
found that due to Dr. Lasalvia's intervention and
misrepresentations about the viability of the Pharmablood treatment
-16-
and its success rate, continued "treatment" of Ramos during an
entire year in which her cancer was continually progressing, and
the failure by Defendants to investigate and/or to advise Ramos as
to the spread of her cancer, Ramos was induced to forego
traditional treatments. From the evidence presented at trial, a
reasonable jury could have found that it was foreseeable to Dr.
Lasalvia that by advertising and inducing Ramos to receive and pay
for his "cancer vaccine," Ramos would forego conventional medical
treatment. The jury could reasonably infer that Dr. Lasalvia, an
oncologist himself, was aware of the effectiveness of conventional
treatment, and the consequences of foregoing it in favor of his
"vaccine."
Defendants urge a number of other theories, all in the
guise of lack of causation. We dispose of them quickly. At trial,
Defendants attempted to elicit evidence showing that Ramos and
Anaya had gone to college and were educated, presumably in an
attempt to convince the jury that they should not have believed in
Dr. Lasalvia's "vaccine" and instead should have returned to their
other doctors. Defendants also cite a number of cases where other
courts have held that a patient's failure to return to her
physician for follow-up care can be the sole cause or contributing
cause of her injury, and thus bar or limit her right to recover
damages. Those arguments are inapposite. Defendants did not raise
the issue of comparative negligence before or during trial, and
-17-
they did not request a comparative negligence instruction, all of
which were options available under Puerto Rico law. P.R. Laws Ann.
tit. 31, § 5141. That Ramos or Plaintiff might have been negligent
in believing Dr. Lasalvia's "quackery" could have certainly been
believed by a jury, but in this case it was not. Defendants did
not request an instruction assigning comparative blame for the harm
and they have thus waived this argument. Phav v. Trueblood, Inc.,
915 F.2d 764, 769 (1st Cir. 1990).
III. Conclusion
Finding, as we do, that there was sufficient evidence for
a reasonable jury to find Defendants guilty of medical malpractice,
we reinstate the jury verdict in its entirety. We thus vacate the
district court's entry of judgment for Defendants and remand the
case to the district court to enter judgment on the jury verdict.
Vacated and Remanded. Costs in favor of the Plaintiff.
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