James Donovan v. Mark I. Miller, M.D.

CourtNew Jersey Superior Court Appellate Division
DecidedMarch 12, 2024
DocketA-2194-22
StatusUnpublished

This text of James Donovan v. Mark I. Miller, M.D. (James Donovan v. Mark I. Miller, M.D.) is published on Counsel Stack Legal Research, covering New Jersey Superior Court Appellate Division primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
James Donovan v. Mark I. Miller, M.D., (N.J. Ct. App. 2024).

Opinion

NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION This opinion shall not "constitute precedent or be binding upon any court." Although it is posted on the internet, this opinion is binding only on the parties in the case and its use in other cases is limited. R. 1:36-3.

SUPERIOR COURT OF NEW JERSEY APPELLATE DIVISION DOCKET NO. A-2194-22

JAMES DONOVAN and MAUREEN BULL, his wife,

Plaintiffs-Appellants,

v.

MARK I. MILLER, M.D., PREMIER UROLOGY GROUP, LLC, THE STONE CENTER OF NEW JERSEY, LLC, and BOSTON SCIENTIFIC CORP.,

Defendants-Respondents.

Submitted February 12, 2024 – Decided March 12, 2024

Before Judges Mawla, Marczyk, and Vinci.

On appeal from the Superior Court of New Jersey, Law Division, Essex County, Docket No. L-1021-20.

Fronzuto Law Group, attorneys for appellants (Ernest Paul Fronzuto, III, of counsel; Casey Anne Cordes, on the briefs).

Vasios, Strollo & Durán, PA, attorneys for respondents Mark I. Miller, M.D. and Premier Urology Group, LLC (Rowena Marie Durán, of counsel and on the brief; Douglas McNeil Singleterry, on the brief).

PER CURIAM

Plaintiffs James Donovan and his wife Maureen Bull appeal from the trial

court's December 12, 2022 order barring their liability expert as a net opinion

and the court's February 27, 2023 order denying their cross-motion for

reconsideration.1 Plaintiff further appeals from the trial court's February 16,

2023 order granting defendants Dr. Mark Miller and Premier Urology Group

LLC's motion for summary judgment. 2

I.

Plaintiff was a patient of Dr. Miller from approximately February 2016 to

November 2018 for various urological complaints. He was eventually

diagnosed with benign prosthetic hyperplasia ("BPH").3 Following a period of

1 Because plaintiff Bull's claims are derivative of Donovan's claims, we will refer to Donovan as plaintiff for ease of reference. 2 Defendant, Boston Scientific Corp., the company that produced the device, settled. Defendant, The Stone Center of New Jersey, LLC, the facility where the procedure was performed, also settled. 3 BPH is a condition that causes a patient's prostate to grow, which may block the patient's urethra and cause symptoms that affect a patient's ability to urinate or ejaculate. Rezum Procedure, Cleveland Clinic, https://my.clevelandclinic.org/health/treatments/rezum (Nov. 8, 2023).

A-2194-22 2 conservative therapy, Dr. Miller and plaintiff discussed various treatment

options including the Rezum procedure. The Rezum procedure involves the

insertion of a device into a patient's urethra. Small needles are then deployed

through the urethra delivering steam into the enlarged areas of the prostate. The

steam is designed to destroy the prostate cells causing the enlarged areas to

shrink. Rezum Procedure, Cleveland Clinic,

https://my.clevelandclinic.org/health/treatments/rezum (Nov. 8, 2023).

In May 2018, plaintiff elected to undergo the Rezum procedure.

Following the procedure, plaintiff reported symptoms indicative of a bladder

neck contracture and obstruction of the ejaculatory ducts resulting in a loss of

the ability to ejaculate. Plaintiff's damages expert Dr. Jonathan M. Vapnek

opined these conditions were permanent.

In June 2020, plaintiff filed a complaint alleging medical malpractice and

asserting product liability claims for the injuries allegedly caused by the Rezum

procedure. At the conclusion of discovery, defendants moved to bar plaintiff's

standard of care expert Dr. Michael A. Palese.

Dr. Palese has extensive education, training, and experience in the field of

urology, including performing Rezum procedures. Defendants did not dispute

A-2194-22 3 his qualifications to render an opinion in this matter, but rather contended he

only offered net opinions in both his expert report and his deposition.

In his report, Dr. Palese concluded:

Complications following Rezum are well known and documented. However, in [plaintiff's] case, his complications were extensive and morbid including bladder neck contracture, ejaculatory duct dysfunction, anejaculation, pelvic pain and persistent lower urinary tract symptoms. The procedure described by Dr. Miller's operative summary describes three . . . water vapor treatments for a prostate measuring [thirty-eight] grams preoperatively. Long term studies on Rezum show that patients can sustain certain complications but the progression to complete ejaculatory duct obstruction, severe bladder neck contracture[,] or anejaculation are extremely rare and beyond those that can or should be reasonably expected or anticipated. . . . If properly performed, there is no conceivable way that . . . water vapor treatments for a prostate measuring [thirty-eight] grams could or should produce the extent of damage experienced by [plaintiff]. The morbid postoperative complications experienced by [plaintiff] leaves little doubt that the technique in performing the Rezum is inconsistent with what is described in the operative report and a violation of the standard of care.

At his deposition, Dr. Palese acknowledged there are various risks

associated with the Rezum procedure. Specifically, he noted the potential risks

include dysuria (pain with urination), hematuria (blood in the urine),

haematospermia (blood in the semen), urinary frequency, urinary retention,

A-2194-22 4 urinary tract infection, urosepsis, and retrograde ejaculation (semen enters the

bladder instead of emerging through the penis). Regarding plaintiff's bladder

neck contracture (a condition in which scar tissue forms in the lower part of the

bladder), Dr. Palese testified, "[i]t's a very uncommon finding and actually only

one [patient] in the initial studies . . . ever developed [the condition]." As to the

risks of anejaculation (a complete inability to ejaculate due to the complete

obstruction of the ejaculatory duct), Dr. Palese testified that "it was never

described in any of the . . . original data and I have not seen it described

anywhere else until I saw this case."

Dr. Palese explained that "no one really knows exactly why" the Rezum

procedure can cause retrograde ejaculation, but "the theory is" that it can occur

if the "energy source[,] which is the water vapor[,] gets too close to the

ejaculatory duct." He further conceded the water vapor getting too close to the

ejaculatory duct can occur even if the procedure is properly performed. He also

noted the bladder neck contracture can occur because injecting the water vapor

into the prostate can lead to inflammation and scarring, which can also occur

even when the procedure is properly executed.

During the deposition, Dr. Palese was questioned regarding how Dr. Miller

deviated from accepted standards of care:

A-2194-22 5 Q. Can you delineate for me what was done improperly in this procedure?

A. Well, what's described . . . by Dr. Miller in his deposition, this all appears to be routine, however, what's not routine is the outcome which is that the patient developed a severe bladder neck contracture, developed almost a complete obstruction of their ejaculatory duct, has postoperative prostatic pain, all these things are not typical for doing a Rezum properly. So that's the concern.

Q. Okay. So what is it about the procedure that was performed improperly that led to these complications[,] in your opinion?

A.

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