Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca1-09-01079/USCOURTS-ca1-09-01079-0/pdf.json

Nature of Suit Code: 362
Nature of Suit: Medical Malpractice
Cause of Action: 

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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

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 We recite the facts in the light most favorable to the jury 1

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-

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

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 At trial, Plaintiff's expert testified that "[m]ost people 2

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."

 Evidence was presented at trial that Ramos's insurer had 3

approved the treatments as of June 6, 2003, but no evidence was

presented that this was ever communicated to Ramos or Anaya.

 Plaintiff's expert testified that vitamins have not been shown 4

to have any effect on cancer treatment.

-3-

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. Although Ramos never began the chemotherapy 2

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

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 Pharmablood had rented office space in the first floor of the 5

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.

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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

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 The jury also was shown a separate form signed by Ramos which 6

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.

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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. All told, Anaya 6

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

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 The district judge allowed this to be put on the record but Dr. 7

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.

 Dr. Cabanillas also testified that none of the literature 8

claimed that Pharmablood was a "cure" for cancer and that instead

the literature referred to it as another "tool" in the fight

against cancer.

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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," that they were never approved by the Food and Drug 7

Administration ("FDA"), and that this was not mentioned in any of

the Pharmablood literature he reviewed. Dr. Cabanillas also 8

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."

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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 jury also heard the following exchange: 9

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-

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

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 A medical report from the time when Ramos sought medical care 10

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-

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. Anaya testified that because of its 10

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."

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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).

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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

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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

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 Plaintiff's expert explained that it was not clear what was 11

meant by this.

 Defendants do not contest the issue of breach on appeal. 12

-13-

average person. Plaintiff's expert testified that these 11

improvement figures had no basis whatsoever. In addition, 12

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.

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 The district court's opinion seems to suggest otherwise, 13

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-

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. Defendants point to evidence that 13

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

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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

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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 FDAapproved, 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

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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

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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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