Miriam Rivera v. The Valley Hospital, Inc. (085992/085993/085994) (Bergen County and Statewide)

SYLLABUS
This syllabus is not part of the Court’s opinion. It has been prepared by the Office
of the Clerk for the convenience of the reader. It has been neither reviewed nor
approved by the Court and may not summarize all portions of the opinion.
Mirian Rivera v. The Valley Hospital, Inc.
(A-25/26/27-21) (085992) (085993) (085994)
Argued March 15, 2022 -- Decided August 25, 2022
PIERRE-LOUIS, J., writing for a unanimous Court.
In this matter, the Court considers whether plaintiffs’ punitive damages claim
-- which requires a showing by clear and convincing evidence that the defendant
medical providers’ acts or omissions reflected actual malice or wanton and willful
disregard for their patient -- should have been dismissed.
Plaintiffs, the heirs and executor of the estate of Viviana Ruscitto, filed
complaints seeking compensatory and punitive damages on numerous counts after
Ruscitto’s death from leiomyosarcoma, a rare cancer that cannot be reliably
diagnosed preoperatively, following the hysterectomy she underwent at defendant
Valley Hospital with the use of a power morcellation device. Ruscitto sought
treatment for uterine fibroids from defendant Howard Jones, a gynecologic surgeon
at the hospital with whom Ruscitto met four times before she underwent surgery.
At their second meeting, Dr. Jones informed Ruscitto that the endometrial
biopsy conducted at their first appointment revealed noncancerous tissue, and he
discussed all treatment options. At their third appointment, Ruscitto decided to
proceed with surgical management of her fibroids. Dr. Jones advised Ruscitto that
one particular surgical option for removal of the fibroids would result in a
significantly longer recovery time and greater postoperative pain, and that the better
option was laparoscopic hysterectomy. The laparoscopic hysterectomy would be
performed with the use of a power morcellator -- a device used to cut tissue into
smaller pieces to facilitate removal. In an update letter to Ruscitto’s
endocrinologist, Dr. Jones noted he “counsel[ed] her about the risk of morcellation
including morcellation of a malignancy.”
At their fourth appointment, Ruscitto signed a consent form agreeing to a
laparoscopic hysterectomy. The form described the procedure in simple terms and
did not mention the use of a power morcellation device. Ruscitto later testified at
her deposition that Dr. Jones never mentioned the use of a power morcellator but she
conceded that Dr. Jones told her that he would “chop up” her uterus. After the
procedure, tissue from Ruscitto’s uterus revealed Stage 4 leiomyosarcoma. Ruscitto
began cancer treatment and passed away less than one year later.
1
Approximately six months before Ruscitto’s surgery, the FDA issued a Safety
Communication discouraging the use of power morcellation. The communication
“estimated that 1 in 350 women undergoing [surgery] for the treatment of fibroids is
found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes
leiomyosarcoma.” It stated that, “[i]f laparoscopic power morcellation is performed
in women with unsuspected uterine sarcoma, there is a risk that the procedure will
spread the cancerous tissue within the abdomen and pelvis, significantly worsening
the patient’s likelihood of long-term survival.” The FDA also provided specific
recommendations for health care providers, including informing patients.
Valley Hospital administrators and Dr. Jones exchanged emails about the
continued use of power morcellation. They considered factors including that
“without the morcellator these cases would be open instead of laparoscopic, which
“increases morbidity”; the fact that “the numbers at Valley” did not support the “1
sarcoma in 350 operations” number suggested by the FDA; and the role of informed
consent. A “power morcellation group” was convened to draft an informed consent
form. A form was prepared and approved by the legal department but was never
implemented or used prior to Ruscitto’s surgery.
One month after her surgery, the FDA issued an updated communication
explicitly warning against the use of power morcellators in the majority of cases.
Valley Hospital then discontinued use of the power morcellation device.
Plaintiffs brought claims against several defendants, including Dr. Jones and
the Valley Hospital administrators, and defendants sought partial summary judgment
dismissing the punitive damages claim. The trial court denied the motions, and the
Appellate Division denied leave to appeal. The Court granted leave to appeal. 248
N.J. 552 (2021); 248 N.J. 557 (2021).
HELD: As a matter of law, the evidence presented, even affording plaintiffs all
favorable inferences, does not establish that defendants’ acts or omissions were
motivated by actual malice or accompanied by wanton and willful disregard for
Ruscitto’s health and safety. A reasonable jury could not find by clear and
convincing evidence that punitive damages are warranted based on the facts of this
case, and partial summary judgment should have been granted.
1. The Punitive Damages Act (PDA) provides that “[p]unitive damages may be
awarded . . . only if plaintiff proves, by clear and convincing evidence,” both “that
the harm suffered was the result of defendant’s acts or omissions,” and that
defendant’s acts or omissions were either “actuated by actual malice” or were
“accompanied by wanton and willful disregard of persons who foreseeably might be
harmed.” N.J.S.A. 2A:15-5.15(a). The PDA explicitly states that “[t]his burden of
proof may not be satisfied by proof of any degree of negligence including gross
2
negligence.” Ibid. “Actual malice” is defined as “intentional wrongdoing in the
sense of an evil-minded act.” N.J.S.A. 2A:15-5.10. “Wanton and willful disregard”
is defined as “a deliberate act or omission with knowledge of a high degree of
probability of harm to another and reckless indifference to the consequences of such
act or omission.” Ibid. The PDA codified the common law principle that punitive
damages were limited to only exceptional cases; its purpose was to establish more
restrictive standards in awarding punitive damages. (pp. 21-24)
2. The Court explains why plaintiffs’ claims do not meet the standard for punitive
damages. First, the FDA Communication was purely advisory in nature, so the use
of the power morcellator after that communication does not constitute per se
evidence of wanton and willful disregard for Ruscitto’s safety. With regard to Dr.
Jones, nothing in the facts before the Court suggests that he acted with actual malice
or with wanton and willful disregard of Ruscitto’s health as those terms are defined
in N.J.S.A. 2A:15-5.10. Dr. Jones noted the complications that can occur with open
surgeries as opposed to non-invasive laparoscopic procedures. The FDA
Communication noted that there was less than a one percent risk that a woman
would have unsuspected uterine sarcoma, and leiomyosarcoma unfortunately cannot
be reliably diagnosed preoperatively. Dr. Jones performed the morcellation on
Ruscitto after meeting with her four times and conducting tests. As several
defendants have conceded, the facts of this case thus far present genuine issues
regarding whether defendants were negligent and deviated from accepted standards
of care. But plaintiffs cannot recover damages here by recasting their negligence
claims as wanton and willful actions based on the same alleged conduct. (pp. 24-28)
3. Plaintiffs’ punitive damages claim against the Valley Hospital defendants is even
less compelling than the claim against Dr. Jones. The numerous emails among
administrators and physicians illustrate that the Valley Hospital defendants took
proactive steps, shortly after the issuance of the FDA Communication, to respond to
the advised risks of power morcellation. Although the draft consent form was never
fully adopted and implemented, plaintiffs’ arguments regarding the lack of informed
consent for the power morcellation procedure after the FDA Communication sound
in ordinary negligence, not in actions taken with an “evil mind.” Partial summary
judgment should have been granted. The evidence proffered by the plaintiffs may
establish defendants’ negligence, but it does not constitute conduct that can be
characterized as wanton and willful. Punitive damages are available only in
exceptional cases, and this matter does not qualify as such. (pp. 28-31)
REVERSED and REMANDED to the trial court.
CHIEF JUSTICE RABNER; JUSTICES PATTERSON and SOLOMON; and
JUDGE FUENTES (temporarily assigned) join in JUSTICE PIERRE-LOUIS’s
opinion.
3
SUPREME COURT OF NEW JERSEY
A-25/26/27 September Term 2021
085992/085993/085994
Mirian Rivera, as Executrix of the
Estate of Viviana Ruscitto, et al.,
Plaintiffs-Respondents,
v.
The Valley Hospital, Inc., et al.,
Defendants-Appellants.
On appeal from the Superior Court,
Appellate Division.
Argued Decided
March 15, 2022 August 25, 2022
Rowena M. Durán argued the cause for appellants
Howard H. Jones, M.D. and Valley Physician Services,
Inc., d/b/a Valley Medical Group P.A. (Vasios, Kelly &
Strollo, attorneys; Rowena M. Durán, of counsel and on
the briefs).
William G. Theroux argued the cause for appellant Linda
Malkin (Buckley Theroux Kline & Cooley, attorneys;
William G. Theroux and Sean C. Garrett, on the briefs).
Evelyn Cadorin Farkas argued the cause for appellants
The Valley Hospital, Inc., Valley Health System, and
Audrey Meyers (Farkas & Donohue, attorneys; Evelyn
Cadorin Farkas, of counsel and on the briefs, and Eileen
M. Kavanagh, on the briefs).
1
Michael Gunzburg, a member of the New York bar,
admitted pro hac vice, argued the cause for respondent
Mirian Rivera, as Executrix of the Estate of Viviana
Ruscitto (Michael Gunzberg and Ruta, Soulios & Stratis,
attorneys; Michael Gunzberg, and Demetrios K. Stratis,
of counsel and on the briefs).
Rayna E. Kessler argued the cause for respondent
Nicholas Roche, Individually and as the Guardian of
Maximo Valentino Ruscitto-Roche (Robins Kaplan,
attorneys; Rayna E. Kessler, and Ian S. Millican, of
counsel and on the briefs).
John Zen Jackson argued the cause for amici curiae
Medical Society of New Jersey and American Medical
Association Litigation Center (Greenbaum, Rowe, Smith
& Davis, attorneys; John Zen Jackson, on the brief).
James DiGiulio argued the cause for amicus curiae New
Jersey Hospital Association (O’Toole Scrivo, attorneys;
James DiGiulio and Andrew Gimigliano, of counsel and
on the brief, and Alex Daniel and Julia E. Duffy, on the
brief).
Theodora McCormick argued the cause for amicus curiae
New Jersey Doctor-Patient Alliance (Epstein Becker &
Green, attorneys; Anthony Argiropoulos, William
Gibson, and Maximilian Cadmus, of counsel and on the
brief).
Bruce H. Nagel argued the cause for amicus curiae New
Jersey Association for Justice (Nagel Rice, attorneys;
Bruce H. Nagel, of counsel and on the brief, and Randee
M. Matloff, on the brief).
JUSTICE PIERRE-LOUIS delivered the opinion of the Court.
2
In this medical malpractice and products liability matter, the Court must
determine whether defendants’ summary judgment motions seeking dismissal
of the punitive damages claim were properly denied.
Viviana Ruscitto passed away from leiomyosarcoma, a rare cancer.
Ruscitto’s cancer was discovered after she underwent a laparoscopic
hysterectomy at The Valley Hospital with the use of a power morcellation
device -- a device used to cut uterine and fibroid tissue into smaller pieces to
facilitate removal. Roughly six months before the surgery, the U.S. Food and
Drug Administration (FDA) issued a Safety Communication warning to health
care providers about the dangers of using power morcellation for
hysterectomies because its usage could spread or “upstage” unsuspected
uterine cancer. In response to the FDA Communication, Valley Hospital
administrators and physicians collaborated in the drafting of an informed
consent form to reflect the concerns expressed in the FDA Communication.
The form was drafted and approved by the legal department in the months
following the FDA Communication but was never implemented.
Plaintiffs, the heirs and executor of Ruscitto’s estate, filed complaints
seeking compensatory and punitive damages on numerous counts. Defendants
filed motions for partial summary judgment to dismiss the punitive damages
claim. The trial court issued an order denying all defendants’ motions for
3
partial summary judgment. Defendants sought leave to appeal, which the
Appellate Division denied.
We find that under the facts of this case, partial summary judgment
should have been granted in defendants’ favor because there is no genuine
issue of material fact as to whether defendants’ acts or omissions reflected
actual malice or wanton and willful disregard for Ruscitto’s health such that
punitive damages would be appropriate in this case. Based on the facts before
the trial court on the summary judgment record, plaintiffs’ allegations have not
established by clear and convincing evidence that punitive damages may be
warranted in this case. Accordingly, we reverse the trial court’s denial of the
defendants’ motions for partial summary judgment on the punitive damages
claim.
I.
A.
We recount the following factual statements from the summary judgment
record but do not make any factual findings.
In December 2012, Viviana Ruscitto was diagnosed with uterine
fibroids. Following the birth of her son in July 2013, Ruscitto’s fibroids
became symptomatic and she subsequently experienced heavy bleeding and
anemia, prompting her to take time off from work. Ruscitto’s endocrinologist,
4
Dr. Ali Nasseri, referred her to defendant Dr. Howard Jones, a gynecologic
surgeon at Valley Hospital.
Ruscitto and Dr. Jones met for a total of four appointments before she
underwent her surgical procedure. Dr. Jones sent letters to Dr. Nasseri after
appointments with Ruscitto to update him on Ruscitto’s condition and
potential treatment.
The first appointment was on June 30, 2014, during which Dr. Jones
reviewed her medical history, performed a physical examination and
endometrial biopsy, and ordered a pelvic MRI to determine whether Ruscitto’s
fibroids were benign or raised any suspicion of cancer.
On July 14, 2014, at their second appointment, Dr. Jones reviewed with
Ruscitto her endometrial biopsy and MRI. The MRI revealed an 8-centimeter
degenerating or deteriorating fibroid, and the endometrial biopsy revealed
benign or noncancerous tissue. Dr. Jones discussed with Ruscitto all treatment
options, including hysterectomy, removal of the uterus; myomectomy, a
surgical procedure to remove fibroids; and uterine fibroid embolization, a
minimally invasive procedure that causes the fibroids to shrink. According to
Dr. Jones, a hysterectomy and uterine fibroid embolization were not realistic
options at the time because Ruscitto was considering having more children and
such procedures were incompatible with future pregnancy. Dr. Jones’s letter
5
to Dr. Nasseri noted that he discussed with Ruscitto the difficulty of a
laparoscopic myomectomy for degenerating fibroids and the correlation
between degenerating fibroids and potential leiomyosarcoma.1
The third appointment occurred on September 8, 2014. At that time,
Ruscitto decided to proceed with surgical management of her fibroids, but she
did not decide on the specific procedure. According to Dr. Jones, she was
considering either myomectomy or robotic-assisted laparoscopic hysterectomy.
Dr. Jones advised Ruscitto that myomectomy would result in a significantly
longer recovery time and greater postoperative pain, particularly because it
took Ruscitto over a month to recover from her C-section. Dr. Jones
acknowledged, however, that this procedure would preserve her uterus.
Alternatively, Dr. Jones advised Ruscitto that the better option was robotic-
assisted laparoscopic hysterectomy. In his post-appointment letter to Dr.
Nasseri, Dr. Jones noted that he “counsel[ed] her about the risk of morcellation
including morcellation of a malignancy.”
The fourth and final appointment occurred on September 17, 2014. The
purpose of this appointment was to further discuss surgical options and to
1
Uterine leiomyosarcoma is a rare cancer that is difficult to diagnose because
“uterine sarcomas are [clinically] difficult to distinguish from [noncancerous]
uterine fibroids” preoperatively. Innie Chen et al., Clinical Characteristics
Differentiating Uterine Sarcoma and Fibroids, 22 J. Soc’y Laparoscopic &
Robotic Surgeons 1,1 (2018).
6
obtain Ruscitto’s consent on a specific procedure. That day, Ruscitto signed a
consent form agreeing to a “DaVinci Assisted Laparoscopic supracervical
hysterectomy possible total hysterotomy possible laparotomy and bilateral
salpingectomy.” The form described the procedure in simple terms as the
“[l]aproscopic removal of uterus possible removal of cervix possible open
incision and both tubes.” The consent form did not mention the use of a power
morcellation device. Ruscitto later testified at her deposition that Dr. Jones
never mentioned the use of a power morcellator to her, but she conceded that
Dr. Jones told her that he would “chop up” her uterus.
Ruscitto’s surgery was scheduled for October 17, 2014. On that date,
Dr. Jones performed a hysterectomy on Ruscitto using a power morcellation
device. According to the preoperative report generated by Valley Hospital,
Ruscitto was “interviewed in the preoperative area, where consent was
confirmed.” There were no complications with the surgery.
After the procedure, a pathology report detailing Ruscitto’s post-surgery
diagnosis was generated. The report revealed that the tissue from Ruscitto’s
uterus revealed “high grade” leiomyosarcoma with an estimated tumor size of
8 centimeters. Another report further stated, “This is unfortunately
leiomyosarcoma . . . . It has all the features required for the diagnosis of a
leiomyosarcoma.”
7
Ruscitto subsequently began cancer treatment to treat her Stage 4
leiomyosarcoma. Ruscitto ultimately passed away on September 3, 2015.
B.
On April 17, 2014, approximately six months before Ruscitto’s surgery,
the FDA issued a Safety Communication titled “Laparoscopic Uterine Power
Morcellation in Hysterectomy and Myomectomy” (FDA Communication).
The purpose of the communication was to warn health care providers and the
general public of the risks involved with using power morcellation to treat
uterine fibroids. In the communication, the FDA discouraged the use of power
morcellation:
When used for hysterectomy or myomectomy in
women with uterine fibroids, laparoscopic power
morcellation poses a risk of spreading unsuspected
cancerous tissue, notably uterine sarcomas, beyond the
uterus. Health care providers and patients should
carefully consider available alternative treatment
options for symptomatic uterine fibroids. Based on
currently available information, the FDA discourages
the use of laparoscopic power morcellation during
hysterectomy or myomectomy for uterine fibroids.
....
Importantly, based on an FDA analysis of currently
available data, it is estimated that 1 in 350 women
undergoing hysterectomy or myomectomy for the
treatment of fibroids is found to have an unsuspected
uterine sarcoma, a type of uterine cancer that includes
leiomyosarcoma. If laparoscopic power morcellation is
performed in women with unsuspected uterine sarcoma,
8
there is a risk that the procedure will spread the
cancerous tissue within the abdomen and pelvis,
significantly worsening the patient’s likelihood of
long-term survival. For this reason, and because there
is no reliable method for predicting whether a woman
with fibroids may have a uterine sarcoma, the FDA
discourages the use of laparoscopic power morcellation
during hysterectomy or myomectomy for uterine
fibroids.
The FDA also provided specific recommendations for health care
providers, including informing patients that “their fibroid(s) may contain
unexpected cancerous tissue and that the laparoscopic power morcellation may
spread the cancer.”
C.
One day after the issuance of the FDA Communication, on April 18,
2014, a Valley Hospital administrator emailed both Dr. Noah Goldman, Co-
Director of the Division of Oncology at the hospital, and Dr. Jones and asked
“[d]id you see the article below on ‘power morcellations.’ Does it affect what
we do here?” Dr. Goldman responded that,
[w]hen you look at the numbers it is less than a percent
chance of having something bad happen.
Unfortunately, what people don’t understand is that
without the morcellator these cases would be open
instead of laparoscopic. This increases morbidity (i.e.
SSI) and hospital costs as people stay longer and have
increased complications. This is a reaction to a single
case, which unfortunately was a physician’s wife.
9
Our policy is to discuss this with patients and if they do
not want to take the risk, they can have their procedure
via laparotomy.
Dr. Jones later responded that “[t]he article below suggests the FDA thinks
that the number could be 1 sarcoma in 350 operations, which seems incredibly
high, especially not in line with the numbers at Valley. [Dr. Goldman’s]
absolutely right, think of the alternative to minimally invasive treatment.”
Several days later, on April 20, 2014, defendant Audrey Meyers, Chief
Executive Officer and President of Valley Hospital, emailed Dr. Goldman,
writing, “See headline story. What are we doing? Thanks.” Dr. Goldman
responded with information similar to his previous email response and added
that he and defendant Linda Malkin, the hospital’s Director of Risk
Management, were discussing proactive measures in response to the FDA
Communication:
In an effort to be proactive about this, I have contacted
Linda Malkin with regards to what we should be telling
our patients. I’d like to create some criteria for the use
of the morcellator, as well as talking points for
providers to discuss and document with the patients.
We are going to meet in the next couple weeks to flesh
this out, and then present to the OR and the OB/GYN
department for approval.
I think this will allow us to continue to use the
morcellator safely and provide minimally invasive
procedures to our patients. In the end, it will be the
patient’s decision so long as they are properly informed
10
about the potential, albeit small, risk. I am happy to
discuss this with you further at your convenience.
Sometime in April 2014, a “power morcellation group,” was convened to
draft an informed consent form to reflect the concerns expressed in the FDA
Communication. An email sent by Malkin on April 21, 2014 revealed that the
group was formed, or was in the process of being formed, within three days of
the FDA Communication.
The group was comprised of Malkin, Dr. Goldman, Dr. Ruth Schulze
(chair of the Obstetrics/Gynecology Department), Jackie Stahlmann (Quality
Assessment Coordinator), and Donna Lagasi, RN (Director of Operating Room
Services).
On May 19, 2014, Malkin emailed Dr. Goldman and attached a notice
from Ethicon, a medical device company and subsidiary of Johnson &
Johnson. In the email, Malkin advised Dr. Goldman that Ethicon had “decided
to suspend global commercialization of its Morcellation Devices until the role
of morcellation of patients with symptomatic fibroid diseases is further
redefined by FDA and the medical community.” Dr. Goldman responded,
“Just an FYI. W[e] use the Storz morcellator so this should not be an issue.”
Malkin replied, “I just wanted you to see what we are up against!” to which
Dr. Goldman responded, “Believe me. I know. The other reps are freaking
out.”
11
On May 21, 2014, Meyers emailed Malkin inquiring about the “outcome
on your discussions.” Malkin responded by informing her that
[Dr. Goldman] and I met with Jackie Stahlmann and
Donna Lagasi to review the FDA recommendations for
using the morcellator and then developed the attached
talking points that follow the FDA outline but [Dr.
Goldman] added even additional safeguards. Ruth
Schulze agrees with our approach but we will need
everyone to approve the guidelines.
This is a good device if used within the strict guidelines
and used by a skilled surgeon. Under those
circumstances, and given the patients extensive
informed consent, I am comfortable with using this
device. I welcome your thoughts and input.
By July 1, 2014, the Valley Hospital legal department approved the new
consent form titled “Laparoscopic Uterine Power Morcellation Patient
Information and Discussion Guide.” The form stated the following in the first
two paragraphs:
In accordance with the April 2014 FDA Safety
Communication regarding the use of laparoscopic
power morcellators, the Valley Hospital will provide
patients with complete information regarding the risks,
benefits and alternatives to this surgical procedure.
....
The use of laparoscopic power morcellator will not be
scheduled without this documentation.
As of August 2014, the consent form was not yet finalized because Dr.
Schulze had concerns about some of its wording. In an August 28, 2014 email,
12
Dr. Goldman stated that he believed the form should be approved as is. The
consent form, while approved by the legal department, was never implemented
or used prior to or after Ruscitto’s surgery in October 2014.
D.
On November 24, 2014, the FDA issued an updated Safety
Communication. While the April FDA Communication noted that the FDA
discouraged the used of power morcellators, the updated communication
explicitly warned against the use of power morcellators “in the majority of
women undergoing myomectomy or hysterectomy for the treatment of
fibroids.” The FDA further recommended a “black-box warning” 2 which
included the following language:
The FDA warns that uterine tissue may contain
unsuspected cancer. The use of laparoscopic power
morcellators during fibroid surgery may spread cancer,
and decrease the long-term survival of patients. This
information should be shared with patients when
considering surgery with the use of these devices.
2
FDA black box warnings “are the highest safety-related warning that
medications or medical devices can have assigned by the [FDA].” Claire
Delong & Charles V. Preuss, Black Box Warning, Nat’l Libr. of Med.,
https://www.ncbi.nlm.nih.gov/books/NBK538521/?report=reader. “These
warnings are intended to bring the consumer’s attention to the major risks” of
a drug or medical device. Ibid.13
Subsequent to the FDA’s issuance of the updated communication, on
December 24, 2014, Valley Hospital discontinued the use of the power
morcellation device.
II.
In 2017, plaintiffs Mirian Rivera (Ruscitto’s sister) as executrix of
Ruscitto’s estate and Nicholas Roche (Ruscitto’s husband) filed separate yet
related complaints3 against several defendants, including the parties to this
appeal: Dr. Jones and Valley Physician Services, Inc. (collectively, Dr.
Jones); and Meyers, Malkin, and Valley Hospital (collectively, the Valley
Hospital defendants).4 Plaintiffs sought compensatory and punitive damages
for several counts, including medical malpractice, lack of informed consent,
and products liability.
In January 2021, defendants filed separate motions for partial summary
judgment to dismiss the punitive damages claim. In April 2021, the trial court
issued an order denying all defendants’ motions for partial summary judgment.
In its statement of reasons, the court found that there was an issue of material
fact as to whether defendants’ actions or inactions were accompanied by
3
This matter was filed as two separate actions that were later consolidated.
4
Additional defendants to the action included Dr. Goldman, Karl-Storz
Endoscopy America, and other parties not involved in this appeal.
14
wanton and willful disregard for Ruscitto’s safety, which was best suited for a
jury to decide. The court reasoned that defendants’ evidence was “not so one-
sided that it must prevail as a matter of law,” and in affording plaintiffs all
favorable inferences, a reasonable jury could return a verdict for plaintiffs on
the punitive damages claim.
In May 2021, defendants filed notices of motions for leave to appeal to
the Appellate Division. The Appellate Division issued a one-page order
denying leave to appeal.
We granted defendants’ motions for leave to appeal. 248 N.J. 552(2021) (granting Dr. Jones’s motion); 248 N.J. 557 (2021) (two orders granting
leave to appeal to the Valley Hospital defendants). We also granted the
applications of the New Jersey Association for Justice, the New Jersey Doctor-
Patient Alliance, the New Jersey Hospital Association, the New Jersey Defense
Association, and the Medical Society of New Jersey and the American Medical
Association Litigation Center to participate as amici curiae.
III.
A.
Defendants collectively argue that the trial court’s denial of summary
judgment on the punitive damages claim must be reversed. Dr. Jones reasons
that plaintiffs cannot sustain the burden of proving by clear and convincing
15
evidence that he acted with actual malice or wanton and willful disregard for
Ruscitto which led to her passing. Dr. Jones argues that the totality of the
evidence, viewed in a light most favorable to plaintiffs, falls short of such a
standard. Dr. Jones asserts that at worst, a jury might conclude that his actions
constituted negligence, but a factfinder would not conclude that he acted with
actual malice towards his patient.
Similar to Dr. Jones, Malkin argues that there is no evidence suggesting
she exhibited actual malice toward Ruscitto and the trial court erred in failing
to apply the clear and convincing standard required for establishing a punitive
damages claim. Malkin also challenges the trial court’s reliance on plaintiffs’
expert report, which suggested that Malkin should have implemented a
moratorium to prevent the power morcellator from being used and should have
mandated the timely creation of an informed consent form even though the
FDA Communication did not require such action. Malkin argues that, despite
her limited authority, she provided immediate notice to the hospital
administrators when she received the FDA Communication and engaged in
meaningful discussion with the power morcellation group.
Meyers and Valley Hospital argue that their actions cannot be
considered willful if the FDA did not recall or remove power morcellators
from the marketplace. As does Dr. Jones, Meyers and Valley Hospital argue
16
that plaintiffs’ evidence poses a general negligence inquiry rather than one
involving punitive damages. Meyers and Valley Hospital also suggest that if
the punitive damages claim is not dismissed, the healthcare industry will suffer
irreparable harm because hospitals and hospital administrators would prioritize
minimizing legal exposure rather than focusing on the expansion of medical
innovation and optimization of patient care.
Several amici support defendants’ positions and emphasize the harm the
medical profession would suffer if punitive damages claims such as this are
allowed to proceed to trial. The New Jersey Doctor-Patient Alliance argues
that this Court should reverse the trial court because the Punitive Damages Act
intentionally limits punitive damages to a small number of cases for the most
egregious of circumstances and allowing such damages in routine medical
malpractice actions will have dire impacts on physicians and patient care in
New Jersey. The New Jersey Hospital Association, the New Jersey Defense
Association, the Medical Society of New Jersey, and the American Medical
Association Litigation Center all argue that plaintiffs failed to put forth
sufficient evidence upon which a jury could find that defendants acted with
actual malice or wanton and willful disregard for Ruscitto’s safety.
17
B.
Plaintiffs argue that the trial court correctly denied defendants’ motion
for summary judgment on the punitive damages issue. As to Dr. Jones,
plaintiffs assert that he acted in wanton and willful disregard of Ruscitto’s
safety. Plaintiffs contend that Dr. Jones was aware that two of three
differential diagnoses were cancer and thereby should have reasonably
suspected that Ruscitto had cancer. Plaintiffs allege that Dr. Jones never
explained power morcellation or the risks associated with the procedure to
Ruscitto and never presented her with lower-risk alternative methods as viable
options. Plaintiffs argue that the lack of informed consent supports Dr. Jones’s
reckless disregard for Ruscitto’s safety.
Plaintiffs similarly argue that Malkin acted with reckless disregard for
Ruscitto’s health and safety. Plaintiffs assert that Malkin failed in her capacity
as the Director of Risk Management because she was responsible for
expediting the implementation of appropriate policies like the informed
consent form. According to plaintiffs, Malkin abdicated her duties by enabling
Ruscitto’s death even after a previous patient suffered the same fate. Plaintiffs
claim that Malkin simply rubber-stamped the hospital administration’s
endorsement of the morcellation procedure without seeking reasonable
restrictions of its use in the form of a moratorium.
18
Plaintiffs assert that Meyers, as the President of The Valley Hospital,
should have immediately implemented a temporary moratorium, which would
have prevented the power morcellation device from being used until the timely
development and implementation of a hospital policy regarding its use and an
informed consent form. Plaintiffs also emphasize that Meyers had a
nondelegable duty to ensure the safety of all the hospital’s patients and
abdicated her responsibility by claiming that she delegated certain tasks and
responsibilities to the proper entities.
Plaintiffs argue that after the FDA Safety Communications, the Valley
Hospital defendants permitted surgeons to continue using the power
morcellation device with no restrictions, limitations, and guidance, and
without the patient’s informed consent. Based on defendants’ reckless actions,
omissions, and failures to protect patient safety, plaintiffs argue that punitive
damages are warranted.
Amicus curiae the New Jersey Association for Justice supports
plaintiffs’ position. Amicus contends that the trial court correctly denied
summary judgment on the punitive damages claims, reasoning that there is
sufficient evidence to defeat summary judgment and that a jury should
determine if punitive damages are warranted.
19
IV.
We review the grant or denial of a motion for summary judgment de
novo. Town of Kearny v. Brandt, 214 N.J. 76, 91 (2013). Rule 4:46-2(c)
provides that summary judgment should be granted when “the pleadings,
depositions, answers to interrogatories and admissions on file, together with
the affidavits, if any, show that there is no genuine issue as to any material fact
challenged and that the moving party is entitled to a judgment or order as a
matter of law.” Significantly, “[a]n issue of fact is genuine only if,
considering the burden of persuasion at trial, the evidence submitted by the
parties on the motion, together with all legitimate inferences therefrom
favoring the non-moving party, would require submission of the issue to the
trier of fact.” Ibid.“[W]hen the evidence ‘is so one-sided that one party must prevail as a
matter of law,’ the trial court “should not hesitate to grant summary
judgment.” Brill v. Guardian Life Ins. Co. of Am., 142 N.J. 520, 540 (1995)
(quoting Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 252 (1986)). “[A]
court should deny a summary judgment motion only where the party opposing
the motion has come forward with evidence that creates a ‘genuine issue as to
any material fact challenged.’” Id. at 529 (quoting R. 4:46-2(c)). A non-
moving party cannot defeat such a motion by simply pointing to any fact in
20
dispute -- such disputed issues of fact must be substantial in nature. Ibid. In
determining the existence of a genuine issue of material fact, the motion judge
must evaluate whether the presented evidentiary materials, when viewed most
favorably to the non-moving party, are sufficient to permit the jury to resolve
the alleged contested issue in favor of the non-moving party. Id. at 540.
V.
In 1995, the Legislature enacted the Punitive Damages Act (PDA),
N.J.S.A. 2A:15-5.9 to -5.17. N.J.S.A. 2A:15-5.12(a) provides that
[p]unitive damages may be awarded to the plaintiff only
if the plaintiff proves, by clear and convincing
evidence, that the harm suffered was the result of the
defendant’s acts or omissions, and such acts or
omissions were actuated by actual malice or
accompanied by a wanton and willful disregard of
persons who foreseeably might be harmed by those acts
or omissions. This burden of proof may not be satisfied
by proof of any degree of negligence including gross
negligence.
[(emphases added.)]
N.J.S.A. 2A:15-5.10 defines the critical terms encompassed in N.J.S.A.
2A:15-5.12. “Clear and convincing evidence” is defined as the “standard of
evidence which leaves no serious or substantial doubt about the correctness of
the conclusions drawn from the evidence. It is a standard which requires more
than a preponderance of evidence, but less than beyond a reasonable doubt, to
21
draw a conclusion.” N.J.S.A. 2A:15-5.10. “Actual malice” is defined as
“intentional wrongdoing in the sense of an evil-minded act.” Ibid. “Wanton
and willful disregard” is defined as “a deliberate act or omission with
knowledge of a high degree of probability of harm to another and reckless
indifference to the consequences of such act or omission.” Ibid.
The Legislature also enumerated the following four factors that “the trier
of fact shall consider” in determining whether punitive damages are to be
awarded:
(1) The likelihood, at the relevant time, that serious
harm would arise from the defendant’s conduct;
(2) The defendant’s awareness of reckless disregard of
the likelihood that the serious harm at issue would arise
from the defendant’s conduct;
(3) The conduct of the defendant upon learning that its
initial conduct would likely cause harm; and
(4) The duration of the conduct or any concealment of
it by the defendant.
[N.J.S.A 2A:15-5.12(b).]
The PDA codified common law principles underlying punitive damages,
under which punitive damages were limited “to only ‘exceptional cases . . . as
a punishment of the defendant and as a deterrent to others from following his
example.’” Pavlova v. Mint Mgmt. Corp., 375 N.J. Super. 397, 404 (App. Div.
2005) (omission in original) (quoting Di Giovanni v. Pessel, 55 N.J. 188, 190
22
(1970)). N.J.S.A. 2A:15-5.12(a) expressly provides that “the burden of proof
[in awarding punitive damages] may not be satisfied by proof of any degree of
negligence including gross negligence.” Our case law also instructs that “mere
negligence, however gross, is not enough” to warrant the awarding of punitive
damages. Pavlova, 375 N.J. Super. at 405. Accordingly, to sustain a punitive
damages claim, “[a] plaintiff must demonstrate a ‘deliberate act or omission
with knowledge of a high degree of probability of harm and reckless
indifference to consequences.’” Ibid. (quoting Berg v. Reaction Motors Div.,
37 N.J. 396, 414 (1962)).
The PDA’s legislative purpose was to establish and enforce more
restrictive standards in the awarding of punitive damages. Id. at 403 (citing
N.J.S.A. 2A:5-5.9; A. Ins. Comm. Statement to S. 1496 (L. 1995, c. 142)).
The PDA’s legislative history reveals that the “bill was intended to limit the
use and amount of punitive damages which may be awarded in a lawsuit.”
Sponsor’s Statement to S. 1496 4 (L. 1995, c. 142). The PDA thus marked a
departure from the liberal imposition of punitive damages in favor of a more
limited approach designed to more closely reflect the original purpose of such
damages:
The awarding of punitive damages was originally
intended to punish defendants for malicious or wanton
actions and to deter others from engaging in similar
activities. However, many persons believe that in
23
recent years these damages have been awarded
indiscriminately for actions that are merely careless.
This has increased the number of punitive damage
claims and contributed to the high cost of litigation.
This bill, the “Punitive Damages Act,”
establishes reasonable and fair standards with regard to
the awarding of punitive damages in civil cases.
[Ibid.]
----
VI.
Guided by those principles, we hold as a matter of law that the evidence
presented, even affording plaintiffs all favorable inferences, does not establish
that defendants’ acts or omissions were motivated by actual malice or
accompanied by wanton and willful disregard for Ruscitto’s health and safety.
A reasonable jury could not find by clear and convincing evidence that
punitive damages are warranted based on these facts.
As an initial matter, we acknowledge that the FDA Communication
warned health care professionals of the risks associated with the use of power
morcellation to treat uterine fibroids that might contain unsuspected cancer.
At the time, the FDA “estimated that 1 in 350 women undergoing
hysterectomy or myomectomy for the treatment of fibroids is found to have an
unsuspected uterine sarcoma, a type of uterine cancer that includes
leiomyosarcoma.” Simply stated, the FDA Communication advised that there
24
was roughly a 0.28 percent chance that women undergoing either a
hysterectomy or myomectomy would have undiagnosed cancer. The FDA
Communication did not call for a recall of power morcellation devices from
the marketplace or prohibit the performance of procedures with the device by
hospitals and medical professionals. As plaintiffs’ counsel acknowledged at
oral argument, the FDA has never recalled power morcellators or prohibited
procedures with the use of the device.5 Given the purely advisory nature of the
FDA Communication, any argument that seeks to treat the use of the power
morcellator after that communication as per se evidence of wanton and willful
disregard for Ruscitto’s safety falls short of meeting the clear and convincing
standard required by the PDA.
With regard to Dr. Jones, the summary judgment record revealed,
through Dr. Jones’s deposition testimony and contemporaneous letters to Dr.
Nasseri, an accounting of four appointments Dr. Jones had with Ruscitto in the
months leading up to the surgery. In those letters, Dr. Jones recounted, among
other things, his assessment of Ruscitto’s condition and the discussions he had
5
As previously noted, Ethicon voluntarily ceased commercial sale of its
power morcellators subsequent to the FDA Communication and then
voluntarily recalled the devices after the FDA’s updated communication in
November 2014. Ethicon was not the only manufacturer of power
morcellators, and the device used in this matter was manufactured by a
different company.
25
with her about the different treatment options. At the first appointment, Dr.
Jones ordered testing, an MRI and a biopsy, to try to determine whether
Ruscitto’s fibroids raised any suspicion of cancer. During the next
appointment, Dr. Jones reviewed the results with Ruscitto, explained that the
biopsy revealed noncancerous tissue, and discussed treatment options with her.
In his letter to Dr. Nasseri regarding the third appointment, Dr. Jones noted
that he “counsel[ed] [Ruscitto] about the risk of morcellation, including
morcellation of a malignancy,” i.e., cancerous tissue. Prior to the surgery,
Ruscitto signed the consent form -- and while the form did not expressly
include the words “power morcellation,” Ruscitto testified at her deposition
that Dr. Jones told her he would “chop up” her uterus during the surgery.
Although Dr. Jones’s letters and the consent form do not provide the
exact nature of the conversations between Dr. Jones and Ruscitto, they also
contain nothing suggesting the doctor acted with actual malice warranting a
jury finding by clear and convincing evidence that punitive damages are
warranted. Nothing in the facts before the Court, including Dr. Jones’s four
meetings with Ruscitto prior to the surgery, suggests that Dr. Jones acted with
actual malice towards her, which the statute defines as “intentional
wrongdoing in the sense of an evil-minded act.” ---
See N.J.S.A. 2A:15-5.10.
26
The evidence is also devoid of any indication that Dr. Jones treated
Ruscitto with wanton and willful disregard of her health. The statute defines
“wanton and willful disregard” as “a deliberate act or omission with
knowledge of a high degree of probability of harm to another and reckless
indifference to the consequences of such act or omission.” N.J.S.A. 2A:15-
5.10 (emphases added). Here, the FDA Communication noted that 1 out of
every 350 women undergoing hysterectomy or myomectomy for the treatment
of fibroids is found to have an unsuspected uterine sarcoma, and a previous
patient of Dr. Jones passed away after her cancer was upstaged by a power
morcellation procedure. Certainly, there is risk to virtually every medical
procedure. As noted in an April 2014 email, Dr. Jones agreed with Dr.
Goldman’s assessment of the increased risks and potential morbidity and
complications that can occur with open surgeries as opposed to non-invasive
laparoscopic procedures. Here, the FDA Communication noted that there was
less than a one percent risk that a woman would have unsuspected uterine
sarcoma, and leiomyosarcoma unfortunately cannot be reliably diagnosed
preoperatively. Dr. Jones performed the power morcellation procedure on
Ruscitto after meeting with her four times and conducting tests. Based on that
evidence, the wanton and willful standard that required Dr. Jones to have acted
with “knowledge of a high degree of probability of harm” and with “reckless
27
indifference to the consequences” of his actions such that punitive damages
may be awarded has not been met.
As several defendants have conceded, the facts of this case thus far
present genuine issues of fact regarding whether Dr. Jones and the Valley
Hospital defendants were negligent and deviated from accepted standards of
care. As noted quite explicitly in the PDA, however, the clear and convincing
standard of establishing actual malice or wanton and willful disregard “may
not be satisfied by proof of any degree of negligence, including gross
negligence.” N.J.S.A. 2A:15-12(a). Plaintiffs cannot recover damages here by
simply recasting their negligence claims as wanton and willful actions based
on the same alleged conduct. See Entwistle v. Draves, 102 N.J. 559, 562
(1986).
Plaintiffs’ punitive damages claim against the Valley Hospital
defendants is even less compelling than the claim against Dr. Jones. The
record reveals that the Valley Hospital defendants, within one day of the
release of the FDA Communication, began discussions regarding power
morcellation in response to the communication. The numerous emails among
Valley Hospital administrators and physicians illustrate that the Valley
Hospital defendants took proactive steps, shortly after the issuance of the FDA
Communication, to respond to the advised risks of power morcellation. Again,
28
the FDA Communication never mandated that hospitals create an informed
consent form for the morcellation procedure. The formation of a power
morcellation group to adopt an informed consent policy was a voluntary
decision by the Valley Hospital defendants in response to the concerns
expressed within the FDA Communication. That the informed consent form
was never officially implemented before discontinuation of the morcellation
procedure does not equate to defendants’ acting with actual malice or in
wanton and willful disregard of Ruscitto’s safety.
The trial court, in denying summary judgment, relied on plaintiffs’
expert report, which provided that “[t]here was no sense of urgency to
implement the patient safety elements proposed by the FDA Advisory, as a
result, the talking points, patient information, and informed consent form were
not implemented in time for [Ruscitto’s] surgery.” The report also pointed out
that, despite the absence of an informed consent form, the Valley Hospital
defendants permitted more than 37 additional patients to be put at risk without
their knowledge or consent for the morcellation procedure between the
issuance of the FDA Communication and the hospital’s discontinuation of the
procedure in December.
Again, the efforts taken by the Valley Hospital defendants illustrate that
they did not simply sit on their hands and do nothing in response to the FDA
29
Communication. And although the draft consent form was never fully adopted
and implemented, plaintiffs’ arguments regarding the lack of informed consent
for the power morcellation procedure after the FDA Communication sound in
ordinary negligence, not in actions taken with an “evil mind.” See Howard v.
UMDNJ, 172 N.J. 537, 548 (2002) (“[I]nformed consent is ‘a negligence
concept predicated on the duty of a physician to disclose to a patient
information that will enable him to “evaluate knowledgeably the options
available and the risks attendant upon each before subjecting that patient to a
course of treatment.”’” (quoting Perna v. Pirozzi, 92 N.J. 446, 459 (1983)).
The Valley Hospital defendants’ efforts simply do not demonstrate that they
were acting with a reckless disregard for Ruscitto’s health or the dangers
associated with the morcellation procedure.
Partial summary judgment should have been granted because there was
no genuine issue of material fact as to whether defendants knew that their
actions or omissions involved a high probability of harm to Ruscitto and that
their conduct evinced reckless indifference to her health. Under the facts of
this case, the evidence proffered by the plaintiffs may establish defendants’
negligence, but does not constitute conduct that can be characterized as wanton
and willful. See Pavlova, 375 N.J. Super. at 405.
30
In sum, plaintiffs have failed to articulate how the same conduct that
supports their negligence claims could lead a reasonable jury to find by clear
and convincing evidence that defendants acted with actual malice or wanton
and willful disregard for Ruscitto’s safety such that punitive damages should
be awarded.
It bears repeating that punitive damages are available only in
“exceptional cases.” --
Id. at 404. Under the facts of this case, this matter does
not qualify as such.
VII.
For the foregoing reasons, we reverse the trial court’s denial of
defendants’ partial summary judgment motion as to the punitive damages
claim and remand to the trial court for further proceedings.
CHIEF JUSTICE RABNER; JUSTICES PATTERSON and SOLOMON;
and JUDGE FUENTES (temporarily assigned) join in JUSTICE PIERRE-
LOUIS’s opinion.
31