December 5, 2013
IN THE MATTER OF THE SUSPENSION OR REVOCATION OF THE LICENSE OF PARVEZ DARA, M.D., LICENSE NO. MA 33292 TO PRACTICE MEDICINE AND SURGERY IN THE STATE OF NEW JERSEY.
NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION
Argued September 16, 2013
On appeal from the Department of Law and Public Safety, Division of Consumer Affairs, New Jersey Board of Medical Examiners.
Peter L. Korn argued the cause for appellant Parvez Dara (McElroy, Deutsch, Mulvaney & Carpenter, LLP, attorneys; Mr. Korn, of counsel and on the briefs; Matthew P. Cohen, on the briefs).
Bindi Merchant, Deputy Attorney General, argued the cause for respondent New Jersey Board of Medical Examiners (John J. Hoffman, Acting Attorney General, attorney; Andrea M. Silkowitz, Assistant Attorney General, of counsel; Ms. Merchant, on the brief in A-4861-11; Siobhan B. Krier, Deputy Attorney General, on the brief in A-1110-11).
Before Judges Yannotti, Ashrafi and St. John.
Parvez Dara, M.D. appeals from the decision of the New Jersey Board of Medical Examiners (Board) revoking his medical license and ordering him to pay $30, 000 in penalties. Dara also appeals the Board's award of $372, 029.28 in fees and costs to the State. Our examination of the record satisfies us that the Board's final decisions were properly premised on facts in the record and are consonant with the applicable statutory provisions. Accordingly, we affirm.
The record discloses the following facts and procedural history leading to the administrative determinations under review.
On March 27, 2009, the Attorney General filed a complaint with the Board alleging that Dara had harmed his patients and employees by failing to implement proper infection control procedures. In the first count of the complaint, the State asserted that Dara "failed to implement adequate infection control practices" by neglecting to maintain sanitary conditions or develop proper policies and procedures, improperly handling medication and inadequately supervising staff, thereby resulting "in a risk of harm, and actual harm, to his patients." The second count alleged that Dara, despite having been on notice, repeatedly and deliberately violated Occupational Safety and Health Administration (OSHA) standards regarding toxic and hazardous substances, thus posing a danger to public health. The State sought revocation of Dara's license, as well as temporary suspension pending a final disposition.
Following a hearing of a committee of the Board on April 3, 2009, Dara's license was temporarily suspended, which was affirmed by the full Board on April 8. On April 8, we denied Dara's request to file an emergent motion. The following day, the Supreme Court denied his emergent application for a temporary stay. Dara then moved for a stay and leave to appeal at the Appellate Division, which was denied on April 22.
Having thus exhausted his emergent remedies, Dara filed an answer denying all allegations, and the matter was thereafter transferred to the Office of Administrative Law pursuant to N.J.S.A. 52:14B-1 to -15 and N.J.S.A. 52:14F-1 to -13 for adjudication as a contested case. On September 28, 2009, the State was granted leave to amend the complaint to include allegations that twenty-nine of Dara's patients had contracted Hepatitis B,  stemming from or probably linked to his practice.
After presiding over a protracted hearing between September 2010 and February 2011, the administrative law judge (ALJ) issued a lengthy written opinion and order on June 7, 2011. While finding that Dara had inadequately supervised his staff, the ALJ determined that the State failed to satisfy its burden of proof that Dara had inflicted actual harm on his patients. The ALJ recommended retroactive suspension of Dara's license, a $20, 000 fine, remuneration of State investigative costs and payment of OSHA fines. The State then filed exceptions with the Board, which heard oral argument on September 14, 2011.
On October 12, 2011, the Board issued its final decision and order, reversing the ALJ's initial decision. The Board revoked Dara's license and fined him $30, 000, having found sufficient proofs showing that Dara created an environment that risked, and actually caused, patient infections. On April 23, 2012, the Board entered a supplemental order under N.J.S.A. 45:1-25, ordering Dara to pay $328, 752.50 in investigative costs incurred by the State. Dara appeals from these two orders.
On February 24, 2009, the Ocean County Health Department (OCHD) received a report from a gastroenterologist about an unusual occurrence of Hepatitis B in two elderly, female cancer patients, who lacked the typical Hepatitis B risk factors.Robert Dosil, an administrator at Oncology Associates, also reported the cases. Although Dara first diagnosed the Hepatitis B in his patients, he failed to report at least one of the cases.
Accordingly, OCHD interviewed the two patients to determine how they had contracted Hepatitis B. OCHD then contacted the New Jersey Department of Health and Senior Services (DHSS). The agencies determined that the only identifiable risk factor at play was healthcare related, and therefore resolved to investigate the matter further. OCHD thereafter discovered two more Hepatitis B cases in elderly patients, neither of whom possessed associated risk factors. These two patients, like the gastroenterologist's infected patients, had undergone procedures at Dara's office. Investigators discerned no other commonalities.
On February 27, 2009, OCHD and DHSS sought assistance with "molecular typing of patient blood isolates" from the Center for Disease Control and Prevention (CDC). It was also decided to inspect Dara's practice as soon as possible. However, OCHD continued to conduct a widespread investigation to ascertain whether other exposure sources might explain the outbreak.
On March 3, 2009, a public health inspection team (PHIT), comprised of investigators from OCHD, DHSS, and the Board, visited Dara's Toms River facility. The investigators inspected rooms and medical waste, reviewed charts and infection control policies and procedures, and interviewed staff. A comparison of Dara's records against the CDRSS revealed a fifth infected patient.
In light of those findings, and in consultation with the CDC, the PHIT requested that Dara stop performing procedures. Dara complied and voluntarily closed the office on the same day. The local health department continued to monitor Hepatitis B cases within the county to ensure there were no other clusters outside of Dara's practice.
On March 10, 2009, investigators returned to Toms River and interviewed Dara and his staff. Except for Dara, all interviewees performed walk-through demonstrations of their delegated procedures. Consequently, the investigators discovered that staff members often failed to change their gloves after performing invasive procedures. They would then touch surfaces, syringes and other materials, thereby potentially contaminating handled items, while shifting between sterile and non-sterile procedures. Dara asserted his understanding that staff were changing their gloves as required, and maintained that he was unaware of any breaches of proper practices.
It was also discovered that Dara failed to provide policies or procedures for the proper use and storage of medications. Staff members' responses varied as to the shelf-life of medications once opened, with several staffers erroneously proclaiming that medications were fine until the manufacturer's expiration date. Moreover, with respect to medical waste, Dara did not properly decontaminate sharps containers or label them, and he failed to keep proper records regarding waste disposal.
Similarly, the office possessed neither a written infection control manual nor proper infection control policies and procedures, although the staff had, in fact, received some training. Dara's office also lacked standards regarding antiseptic use. Staffers were not trained on the use of personal protective equipment and were unsupervised when performing procedures.
For his part, Dara insisted that the substandard demonstrations did not reflect office policies, and were aberrational of how tasks were routinely performed. Had he been aware of such breaches, Dara asserted he would have stopped them and found out why they had occurred. He claimed that the staff had received bloodborne pathogen training on two separate occasions.
PHIT subsequently cautioned Dara about "significant breaches in infection control." Following the inspection, investigators continued to gather information and coordinate with Dara to resolve the problems. Barbara Montana summed up the breaches as follows:
First of all, there were no standards for infection control policies and procedures. The staff was not appropriately trained in infection control or the use of Personal Protective Equipment.
There wasn't any supervision of the staff performing these procedures. Access to catheters was not standardized. There weren't appropriate environmental controls or job assignments, so people were doing dirty procedures and clean procedures at the same time, particularly in the area of the utility room where there was blood processing and individuals drawing up medication for administration in the room next door.
There were environmental concerns, [not] thoroughly maintained sanitary conditions; the conditions in the chemotherapy room in particular; the conditions within the hood in particular as well; failure to properly handle medications and solutions appropriately; improper handling of multi-dose vials; keeping those medications out of the patient-care areas; keeping them adjacent to items that are potentially contaminated like the blood processing machine; no policies for establishing shelf life after opening of these multi-dose vials; inappropriately using bags of saline as a common source of medication for multiple patients; no labeling of syringes or prepared solutions; not adhering to aseptic techniques . . . so that staff was not engaging in inappropriate use of gloves or hand hygiene.
There was a situation where individuals were cross-contaminating items with soiled gloves that led to widespread contamination of blood within the environment. Removal of needles and syringes from sterile packages and storing those items outside of their packaging prior to the time of use, especially in an area where there was a potential for significant blood contamination adjacent to that blood analyzing machine; not using antiseptics appropriately prior to invasive procedures.
Again, not letting the alcohol dry, not letting the Betadine dry, not wiping the area with non-sterile gauze prior to performing the procedure. And . . . gauze potentially in contact with environmentally contaminated items.
Montana testified that "[e]ach of the breaches [was] significant" and had, in the past, "been associated . . . with outbreaks of diseases, bacterial and bloodborne pathogens". Since each individual breach was significant, "the totality of the situation . . . [was] egregious". Thus, Montana opined, to a reasonable degree of medical certainty, that those patients infected with Hepatitis B suffered actual harm as a result of Dara's improper practices.
The PHIT investigators were concerned for the safety of the staff and therefore contacted OSHA. They then learned that OSHA had previously inspected the Toms River facility on multiple occasions dating back to May 2002. OSHA had cited Dara for various, repeated health and safety violations, and fined him in amounts exceeding $50, 000. Accordingly, PHIT grew concerned that patients may have been exposed as early as 2002 and decided to notify those patients so that they could be tested.
Dara, hoping that corrective measures would facilitate the reopening of his practice, had hired an infection control consultant to train the staff and draft an infection control manual. PHIT again inspected Dara's office on March 23, 2009, and afterward permitted him to resume consultations and examinations only; the prohibition on invasive procedures remained.
Contemporaneous with the inspections, PHIT sustained its broad investigation to ensure there was no larger outbreak over and above Dara's practice. Investigators reviewed seventy-six regional CDRSS reports of Hepatitis B cases. They questioned Dara's patients to rule out alternative explanations, collecting information about demographics, potential exposure sources and symptoms. Consequently, investigators were able to determine the timeline of the outbreak, incubation and exposure periods, and an epidemic curve showing a significant increase of acute cases between March and May 2009.
On March 28, 2009, PHIT sent letters to Dara's patients, requesting that they be tested for Hepatitis C, Hepatitis B, and HIV. Any patients who tested positive for the Hepatitis B core antibody would then be tested for IgM, "the marker of acute infection." The acute antibody marker persists in the blood for about six months.
Of 2860 patients who were contacted, 1394 underwent testing. Of those, 103 patients were found to have markers for Hepatitis B. Thirteen had chronic Hepatitis B, nineteen had acute Hepatitis B, and sixty-eight had resolved infections. Of the thirteen chronic cases, three patients possessed lifetime risk factors. Neither those three cases nor the resolved cases were included in the CDC's subsequent molecular-typing investigation. The CDC tested only acute cases, that is, the cases from which viruses could most likely be isolated and DNA obtained.
Twenty-nine specimens were submitted to the CDC for molecular typing. Researchers successfully tested thirteen of them and discovered that each shared an identical sequence of 1900 base pairs. To the CDC, this indicated that the eleven patients were infected by the same strain of Hepatitis B and represented "a strong epidemiological link for transmission." Additionally, as the identical specimens had been obtained from acute patients, the researchers concluded that they had been infected over a period of at least one and a half years.
After examining all of the evidence, including the conditions in Dara's office and results obtained by the CDC, the PHIT investigators deduced that all specimens were part of a single outbreak. They concluded that "breaches in infection control led to the ongoing patient-to-patient transmission of Hepatitis B infection among patients undergoing invasive procedures at [Dara's] practice" over time.
Montana and Yuri Khudyakov, Ph.D., a molecular virology expert from the CDC, both testified at the hearing. Khudyakov stated that he had never before encountered, either in practice or literature, a situation where, as here, eleven specimens shared an identical sequence of 1900 base pairs. Moreover, he explained that, though genetically different, the remaining two specimens also belonged to the same "extremely rare" D-2 strain. According to Khudyakov, this was strong evidence all thirteen specimens constituted the same strain.
Montana testified that the CDC's findings supported the epidemiological findings of the investigation:
The fact that these viruses are identical completely supports what we saw . . . . [T]here was person-to-person transmission occurring within this practice, and for a period of time.
This is the same virus that is in all of these patients. And the only link between these patients is the care that they received at . . . Dara's office. So the fact that they all match and are identical completely supports what we found as a result of our [investigation], that transmission was occurring within this practice.
On the other hand, Dara posited that the cases could have been the result of reactivation,  claiming that between thirty-eight and seventy-eight percent of Hepatitis-B infected people will reactivate when subjected to chemotherapy. However, Montana controverted Dara's theory, finding that the totality of the compiled evidence did not support reactivation. William Farrer, M.D., also disputed the reactivation theory, explaining that the particular antigen marker extracted from the samples "almost always" indicates the presence of acute infection. Moreover, Farrer noted the unlikelihood that eleven patients from Dara's practice would have been infected by an identical strain years before, further militating against reactivation. Farrer also found determinative the fact that Dara's practice possessed a higher rate of infection than the rest of Ocean County.
Farrer testified as the State's expert in infectious disease and infection control. He explained how it was possible for bloodborne pathogens to pass patient-to-patient and, having reviewed the CDC molecular-typing results, opined that it was "very likely" that the eleven patients contracted Hepatitis B from the same source or each other during an ongoing time period. The comparatively higher incidence of Hepatitis B led Farrer to conclude that the outbreak originated in Dara's facility.
Dara presented his own infectious-disease expert, Leon Smith, Sr., M.D., who doubted that the breaches discovered at the Toms River office could have resulted in Hepatitis B transmission. He testified that only certain syringe types are capable of carrying the virus and noted that environmental transmission is uncommon. Smith contended that the State's witnesses were "dreaming" when they postulated that soiled gloves could have transmitted the virus, which cannot penetrate skin. He also disputed the additional hypothesized sources of transmission proffered by the State. Finally, Smith disparaged the investigators for concluding that Dara's office was the source of an outbreak without having determined the incidence of the virus strain in the community as a whole.
Dara also presented Larry Mark Weisenthal, M.D., as an expert in infectious disease as it pertains to medical oncology. Incidentally, Weisenthal was Dara's supervisor during the final year of his medical oncology fellowship. Referring to the investigation's conclusions as "farcical" and "laughable, " Weisenthal claimed that the incidence of infection here was not inconsistent with the population at large because many carriers are asymptomatic, untested or unreported. He suggested that the only appropriate control group by which to measure the infection rate at Dara's office would be patients of another area medical oncologist, and noted that no such comparison was undertaken. Weisenthal challenged much of the State's evidence and methodology, concluding the CDC test results did not constitute scientifically-reliable evidence from which investigators could properly find an outbreak.
In addition, Weisenthal, while disputing the portrayal of Dara's practices as breaches in the first place, opined that it was "utterly impossible" for the alleged breaches, separately or collectively, to have accounted for such a pattern of infections. He theorized that if an outbreak occurred in Dara's office, the only plausible explanation would be it began with an infected staff member who may have had dry, cracked hands or some other such problem that would allow her to transmit the disease to patients. The only other explanation offered by Weisenthal was that some "greedy" or "deranged" person intentionally sabotaged Dara.
Our review of an agency action is limited. See, e.g., In re Herrmann, 192 N.J. 19, 27 (2007); In re License Issued to Zahl, 186 N.J. 341, 353 (2006); In re Polk License Revocation, 90 N.J. 550, 578 (1982). We restrict our role to three inquiries:
(1)whether the agency's action violates express or implied legislative policies;
(2)whether the record contains substantial evidence to support the findings on which the agency based its action; and
(3)whether, in applying the legislative policies to the facts, the agency clearly erred in reaching a conclusion that could not reasonably have been made upon a showing of the relevant factors.
[R&R Mktg., L.L.C. v. Brown-Forman Corp., 158 N.J. 170, 175 (1999).]
"The right to practice medicine itself is granted in the interest of the public and is 'always subject to reasonable regulation in the public interest.'" Hirsch v. N.J. State Bd. of Med. Exam'rs, 252 N.J.Super. 596, 604 (App. Div. 1991) (quoting Polk, supra, 90 N.J. at 570), aff'd, 128 N.J. 160 (1992). "The Board, therefore, has the responsibility to protect the health and welfare of members of the public by assuring that all licensed practitioners are qualified, competent and honest, and to ensure that they have received adequate medical education and training." Valdes v. N.J. State Bd. of Med. Exam'rs, 205 N.J.Super. 398, 407 (App. Div. 1985)(citations and internal quotation marks omitted).
Actions of the Board are governed by the Uniform Enforcement Act (UEA), N.J.S.A. 45:1-14 to -52, and the Medical Practice Act (MPA), N.J.S.A. 45:9-1 to -19. These two acts are interpreted in pari materia. Del Tufo v. J.N., 268 N.J.Super. 291, 296 (App. Div. 1993). The Legislature, in adopting the UEA, implemented "uniform standards for license revocation, suspension and other disciplinary proceedings" by professional licensing boards, which have been given "uniform investigative and enforcement powers" to safeguard public safety. N.J.S.A. 45:1-14. Additionally, the MPA vests in the Board "broad authority to regulate the practice of medicine, " and therefore grants it "the power to promulgate rules and regulations to protect patients and licensees." Zahl, supra, 186 N.J. at 352 (citing N.J.S.A. 45:9-1 to -27).
Where a contested case is heard by an ALJ, the judge must issue an initial decision "final in form and fully dispositive of all issues in the case." N.J.A.C. 1:1-18.1(a). A recommended report and the initial decision must then be filed with the Board, as agency head, for review for adoption, rejection or modification. N.J.S.A. 52:14B-10(c). The factual findings and legal conclusions of the ALJ are not "binding upon the agency head, unless otherwise provided by statute." N.J.A.C. 1:1-18.1(c); see also In re Parlow, 192 N.J.Super. 247, 249-50 (App. Div. 1983)(finding that Civil Service Commission erred in its de novo review of ALJ's decision by considering evidence not admitted at administrative hearing).
The Board may reject or modify legal conclusions as well as fact findings unrelated to witness credibility, but must state its reasons for doing so. N.J.S.A. 52:14B-10(c); N.J.A.C. 1:1-18.6(b). However, rejection or modification of "any finding of fact as to issues of credibility of lay witness testimony" is impermissible unless the Board "first determines from a review of a record that the findings are arbitrary, capricious or unreasonable, or are not supported by sufficient, competent and credible evidence." N.J.A.C. 1:1-18.6(c); N.J.S.A. 52:14B-10(c). The Board must then specify the reasons for rejecting any findings and point to evidence supporting its new or modified findings. N.J.S.A. 52:14B-10(c); see also State, Dep't of Health v. Tegnazian, 194 N.J.Super. 435, 449-50 (App. Div. 1984)("[W]ithout such factual treatment a reviewing court is unable to weigh the agency expertise against the ALJ's opportunity to observe the witnesses in deciding whether the agency action is supported by substantial credible evidence.").
Generally, our courts have afforded "substantial deference to the actions of administrative agencies" like the Board due to the "'expertise and superior knowledge' of agencies in their specialized fields, and because agencies are executive actors." Zahl, supra, 186 N.J. at 353 (citations omitted). Although appellate review is deferential, it nevertheless "calls for careful and principled consideration of the agency record and findings." Riverside Gen. Hosp. v. N.J. Hosp. Rate Settling Comm'n, 98 N.J. 458, 468 (1985).
Where the record contains sufficient credible evidence to support an agency's conclusions, a reviewing court "must uphold those findings, even if the court believes that it would have reached a different result." Sager v. O.A. Peterson Constr., Co., 182 N.J. 156, 164 (2004). Furthermore, "[w]hen resolution of a legal question turns on factual issues within the special province of an administrative agency, those mixed questions of law and fact are to be resolved based on the agency's fact finding." Campbell v. N.J. Racing Comm'n, 169 N.J. 579, 588 (2001).
Here, the ALJ issued a comprehensive opinion following nearly twenty-five days of testimony. After agreeing with the ALJ findings on two crucial points – first, that Dara's facility was "rife with lapses in infection control due to his lack of oversight" and second, that eleven of his patients were infected with the same Hepatitis B strain – the Board ultimately rejected the ALJ's recommendations. The Board explained:
[W]e reach vastly different conclusions, as to the import of these two crucial findings. We reach these divergent results because we bring to the undertaking a scientific perspective borne from our lifetime of education and experience in medicine. We do not here overturn the credibility findings of lay witnesses. But, we have reviewed the extensive expert testimony in the record through our lens as health care providers and reach a far different conclusion on credibility of the expert testimony and scientific proofs than that reached by a trier of fact with distinctly different training and expertise. The ALJ comes from a tradition and training that causes him to analyze this matter without utilizing scientific methodology and an understanding of causality in an epidemiologic context.
Dara contends that the Board arbitrarily and capriciously rejected the findings of the ALJ, thereby reaching a conclusion that was unsupported by the evidence and violating his right to due process. Specifically, he contends that the Board: (1) did not base its findings on credible evidence in the record, as evinced by the Board's reliance on its own expertise and rejection of lay witness testimony in favor of hearsay interview summaries; and (2) punished Dara for contesting the charges. For several reasons, we disagree.
First, the Board arrived at its decision not by rejecting the lay witness testimony, but rather from its determination that the State's expert testimony was more credible than Dara's. The State's experts unquestionably possessed significant expertise in infection control, epidemiology and genetics. Additionally, Montana, an expert in infection control and epidemiology, was also a member of the PHIT and therefore observed firsthand the conditions in Dara's practice. These experts concurred that a genetically-identical strain of Hepatitis B was found among eleven of Dara's patients. This proof, combined with the conditions in Dara's office and his staff's improper procedures, supported the Board's conclusion that Dara not only exposed patients to risk of Hepatitis B infection but also caused the actual infections.
The Board reasoned that the ALJ did not place the proper weight on the expert testimony because he "clearly misperceived the import of the clinical, scientific procedures, standards, theories, statistics, essential in evaluating conflicting expert opinions." In contrast, the Board members, each of whom possessed medical expertise, credited the expert testimony as "understandable and crystal clear."
In disciplinary proceedings such as this, the evidence is "thoroughly understood by the parties involved. . . . [and] relate[s] to a profession, a specialty in which the parties, the witnesses and the members of the tribunals are all uniquely qualified and share a common expertise." In re Polk, supra, 90 N.J. at 567-68. We have previously stated that a board comprised of experts, "sitting in a quasi-judicial capacity, cannot be silent witnesses as well as judges. Their value as experts in the judging process contemplated by the statutory disciplinary proceeding, consists in the application of their special knowledge to the factual controversy appearing within the record made at the hearing." N.J. State Bd. of Optometrists v. Nemitz, 21 N.J.Super. 18, 28 (App. Div. 1952). Contrary to Dara's contentions, therefore, the Board's reliance on its own expertise was not improper.
We disagree with Dara that the Board based its conclusions on a snapshot of a single day at his practice. In addition to the expert testimony, the Board analyzed the other evidence presented. The Board expressly stated, "We do not base our finding on the condition of an unsanitary office on one day when an employee was called away unexpectedly." Rather, it looked to "the staff's representations and demonstrations of standard practice in . . . Dara's office that showed a prevalent and long standing disregard for accepted infection control standards." Specifically, the Board cited numerous breaches of infection control standards. It also found that the testimony and demonstrations by Dara's staff "corroborated that the conditions at the time of the [initial] inspection were not isolated. Many practices recognized to be standard operating procedure were caught in the 'snap shot.'"
Dara also ascribes error to the Board's reliance on hearsay evidence, specifically the PHIT's interview summaries, in place of testimony educed at the hearing. We disagree. But for limited exceptions not applicable here, administrative agency proceedings are not governed by the Rules of Evidence, including those concerning hearsay. N.J.R.E. 101(a)(3); N.J.S.A. 52:14B-10(a); see also DeBartolomeis v. Bd. of Review, 341 N.J.Super. 80, 83-84 (App. Div. 2001)("The risks of relatively free use of hearsay and other forms of evidence not sanctioned by the Rules of Evidence are mitigated by a correlative standard requiring the existence of some legally competent evidence as the foundation of every adjudicative determination made by an administrative agency."). Nonetheless, although the evidence rules do not strictly apply, "the fundamentals of fair and adequate procedure constituting due process must be observed, and cross-examination and rebuttal have been held to be basic elements of administrative hearing essential to due process." In re Application of Howard Sav. Bank, 143 N.J.Super. 1, 6-7 (App. Div. 1976).
We note that, in advance of the hearing, Dara received the interview reports and had opportunity to utilize them in preparation for cross-examination and rebuttal testimony. We also note non-hearsay testimony buttressed statements within the reports. Additionally, had the hearsay rules applied here, the interview reports would have been admissible as business records or public records. N.J.R.E. 803(c)(6), (8). Thus, we see no error in the Board's partial reliance on those exhibits.
Next, Dara argues that the Board violated due process by finding fault in retaliation for his contesting of the charges. The only evidence Dara proffers to support this serious allegation is that the Board overlooked the fact that he voluntarily closed his office to protect the public and hired an infection control specialist to train his staff. We find nothing to support Dara's charge. The Board amply explained the rationales for its adverse determination, based as it was on the Board's reasonable interpretation of substantial and credible evidence in the record.
Dara further argues that the Board applied the incorrect burden of proof on the issue of causation. Specifically, he contends that by rejecting the ALJ's conclusions, the Board "effectively redefined the burden of proof in administrative proceedings to be something less than the requisite 'preponderance of the evidence.'"
Before a physician may be sanctioned for professional dereliction, the State must make a showing of "flagrant misconduct, " that is, acts that are "so particularly egregious as to constitute misconduct in the magnitude of gross malpractice." Polk, supra, 90 N.J. at 565-66. The Court has previously determined that, "[i]n light of heightened and strict substantive standards defining professional misconduct, the preponderance of the evidence burden of proof constitutes an appropriate level of certainty to establish guilt" in medical license revocation proceedings. Id. at 566-67. The risk of confusion or error in applying this standard is low given the specialized expertise of the Board. Id. at 568.
Here, Dara contends that the Board ignored crucial gaps in the State's evidence and improperly based its conclusion on the mere possibility that the breaches in Dara's office caused the outbreak, thereby lessening the State's burden. He asserts that the Board characterized the preponderance of the evidence standard as a "medical/epidemiological standard, " which further served to lessen the burden.
The ALJ concluded that the State had "failed to demonstrate by a preponderance of the credible evidence that any of the allegedly improper procedures and techniques were more probably than not the actual means by which [Hepatitis B] was passed from actual patients to actual patients, rather than theoretically so." In other words, based on the evidence presented, the ALJ could not conclude that the Hepatitis B "'stemmed' from or was 'probably linked' to" Dara's practice. The ALJ's primary reason for rejecting the State's allegations was that alternative explanations existed that could not "be dismissed as unwarranted."
The Board disagreed with the ALJ's conclusions, believing that he improperly applied a more stringent standard than preponderance of the evidence. It explained:
The ALJ in reaching his decision, mistakenly relied on an assumption that there was no clear unequivocal connection between . . . Dara's negligence, evidenced by gross and multiple lapses in infection control standards, and the actual transmission of [Hepatitis B]. [The] ALJ . . . believes that the State must show the mode of transmission in order to support a finding that the patients were infected in [Dara's] office. This underlying assumption is for the most part the underpinning for his opinion that . . . Dara's culpability was not proved by a preponderance of the evidence. In taking this stance, we believe the ALJ demonstrated a fundamental misperception of the epidemiologic basis that we believe necessary to establish physician responsibility. In essence, he refused to appreciate scientific epidemiologic concepts of causal inference, that we accept by virtue of our training and experience. Physicians by necessity need to understand inference as they make decisions on a daily basis. We use facts, statistical associations, and probabilities that may never be 100% complete and from them we draw conclusions and make decisions. Although the ALJ correctly identifie[d] the standard of proof as the preponderance of credible evidence, at every opportunity it seems he require[d] much more. We believe that the epidemiologic findings in this matter clearly prove, by at least a preponderance of the evidence standard, that . . . Dara's practice was the source of this outbreak. [The] ALJ . . . simply applied a standard not realistic in the context of this case and one that is inappropriate in relation to an epidemiologic investigation. Instead, he applied a standard more appropriate for a proceeding requiring a burden of proof approaching clear and convincing evidence or even beyond a reasonable doubt.
The Board noted that epidemiologic investigations are not intended to "produce a direct line of evidence that ties exact action to outcome, " but rather they "deal with probabilities and provide sufficient evidence to make sound causal inferences." Moreover, in response to the ALJ's expectation that the State be able to produce concrete evidence of transmission, the Board pointed out that "a precise link or event of transmission cannot be proved long after the event." Thus, given the nature of this type of investigation, requiring such proof is a "virtually impossible burden for the State." The Board therefore concluded:
The ALJ created a standard so high that the State could never stop a licensee from practicing, even in the face of a dangerous disease outbreak such as has been demonstrated here. We clearly do not know nor do we base our findings on the exact mode and date of transmission but find that any of the lapses found to exist in [Dara's] office had the potential to cause transmission of a bloodborne pathogen. The number of significant lapses increase[s] that probability. Furthermore, the finding that . . . eleven patients contracted a genetically identical virus in circumstances where their only common exposure was . . . Dara's office leads us to find it highly probable – indeed, more probable than not – that the infection source in the disease outbreak present in this case stems from [Dara's] practice.
The Board also considered Dara's alternative explanations for the outbreak. With respect to his reactivation theory, the Board found the argument "so implausible, that it cannot be deemed probable." Rather, the Board decided it "most probable" that the virus "came from the same source, " i.e., Dara's office.
The Board also rejected the necessity of a control group under these circumstances, which is not a standard epidemiological practice during an outbreak investigation, and was infeasible, irrelevant and unnecessary. Furthermore, while acknowledging that the State could not demonstrate a precise moment of transmission that initiated the outbreak, the Board clearly explained that such proof was unnecessary. The evidence made plain that Dara's practice was replete with "multiple infection control lapses" and therefore "a fertile environment" for Hepatitis B transmission.
We likewise disagree with Dara that the Board found only a mere possibility that patients were infected under his care. Although one lapse in infection control was sufficient for a finding of potential transmission, the multiple lapses in Dara's practice "increase[d] that probability." Combining this evidence with "incontrovertible evidence" and expert testimony showing that eleven of Dara's patients were infected with a genetically identical virus, it became "certainly more probable than not" that Dara's practice not only posed a risk of infection, but that transmission actually occurred there. We conclude that the Board properly utilized the preponderance of the evidence standard to reach its conclusion.
Dara argues that the Board erred by rejecting the ALJ's dismissal of the OSHA violations in the complaint. We disagree. A board may reject an ALJ's factual findings as to lay witness credibility where it concludes the findings are arbitrary and capricious or unsupported by adequate evidence. N.J.A.C. 1:1-18.6(c).
The ALJ found Dara credible when he denied knowledge of all but one violation, and, therefore, determined that "he did not either willfully or deliberately engage in any malpractice or gross malpractice in regard to these OSHA violations." The ALJ believed it was "quite evident" that, had the Board viewed these violations outside the perspective of the Hepatitis B allegations, it would either not have charged Dara or would have imposed a minor sanction.
The Board, rejecting the ALJ's conclusions, stated:
[B]ecause . . . Dara was on notice that there were lapses in his office regarding [infection and bloodborne pathogen protocols, ] he should have been vigilant in guarding against any further infection control lapses and assuring his office staff adhered to proper protocols. We are not basing our finding on the severity of the 2002-2008 OSHA violations. Instead, we find that because he had this history of violations directly related to infection control, he should have asserted even more control over his office standards.
Instead, [Dara] demonstrated almost a decade of documented history of poor infection control training and practice, profound neglect of bloodborne pathogen prevention or a lackadaisical approach to addressing these matters despite three (3) separate warnings and substantial fines.
The Board pointed out that Dara repeatedly denied knowledge of the violations, both those found by OSHA as well as those discovered by the PHIT investigators. However, the Board found that Dara, as the sole doctor in the office, ultimately bore responsibility for the condition of his practice, the behavior of his staff, and knowledge of any breaches. Thus, the Board concluded that Dara was on notice of the lapses and repeatedly failed to correct them. He "showed no insight, even after a history of OSHA sanctions, nor recognition that his professional responsibilities as the practice owner and physician required that he oversee and ensure that safe infection control standards were in place."
Contrary to Dara's contentions, the Board amply explained its rejection of the testimony presented before the ALJ. Although Dosil may have concealed the OSHA violations from Dara, the Board found it inconceivable that Dara was unaware of the OSHA inspections and subsequent findings. At the very least, whether he was aware of the actual notices or not, the OSHA violations, several of which repeated over the course of years, clearly showed that Dara was negligent insofar as he was unaware of the appropriate standards for his practice. And, as the Board correctly pointed out, this lack of awareness resulted in the conditions which led to transmission of Hepatitis B among his patients.
The Board's analysis was clear, detailed, and based on evidence in the record. Its rejection of the lay witness testimony on which the ALJ based his decision was proper because, when the evidence was viewed in light of the Board's medical expertise, the testimony was unsupported.
Dara contends that the Board's revocation of his license was disproportionate to the charged misconduct and unsupported by the evidence. "[A]ppellate review of an agency's choice of sanction is limited." Zahl, supra, 186 N.J. at 353. A reviewing court may alter the sanction only "when necessary to bring the agency's action into conformity with its delegated authority." Polk, supra, 90 N.J. at 578. "[T]he test in reviewing administrative sanctions is 'whether such punishment is so disproportionate to the offense, in the light of all the circumstances, as to be shocking to one's sense of fairness.'" Ibid. (quoting Pell v. Bd. of Educ., 356 N.Y.S.2d 833, 841 (N.Y. 1974)).
A board may revoke a physician's license for numerous reasons, including instances where the physician has engaged in: (1) "gross negligence . . . which damaged or endangered the life, health, [or] welfare" of an individual; (2) "repeated acts of negligence"; or (3) "professional or occupational misconduct." N.J.S.A. 45:1-21(c)-(e).
Here, the Board expressed clear reasons for modifying the ALJ's penalty recommendation, noting first and foremost that it "found far more serious violations of standards of practice and violations of law than those found by the ALJ." The Board considered the mitigating circumstances, including the positive testimony of Dara's character witnesses and the fact that Dara had already suffered significant economic loss.
However, the Board's decision to revoke Dara's license was based on its findings that he was repeatedly grossly negligent by failing to correct infection control concerns or implement policies aimed at protecting his staff and patients, as well as by permitting his staff to engage in improper practices which not only created the risk of infection with bloodborne pathogens, but ultimately caused transmission of a genetically identical strain of Hepatitis B among at least eleven of Dara's patients. See N.J.S.A. 45:1-21(c), (e). These findings, in turn, were based on credible evidence in the record, as well as the Board's specialized expertise in interpreting the evidence presented.
Moreover, the Board took exception to Dara's unwillingness to accept responsibility for the circumstances in his practice, and his "total disregard for the consequences of the unsanitary conditions he allowed to exist, before his own eyes in his own office, where invasive procedures were being performed on cancer-stricken patients." The Board did not, as Dara contends, punish him for asserting his rights.
Finally, the Board did not ignore Dara's good reputation or the testimony of his character witnesses. Rather, it took those things into consideration in imposing the $30, 000 monetary penalty rather than the $500, 000 requested by the State. It also noted that it did not believe Dara willingly caused the conditions that led to transmission, and thereby permitted him to reapply for his license as early as April 2013.
Our deferential standard of review applies equally to Board disciplinary sanctions. In re Stallworth, 208 N.J. 182, 194-95 (2011). The Board's decision to revoke Dara's license was not so disproportionate to the offenses as to "shock the conscience." Polk, supra, 90 N.J. at 578. The record fully supports the penalty imposed and it is entirely appropriate in light of Dara's misconduct. Accordingly, we find no basis to substitute our judgment for that of the Board. Ibid.
Finally, Dara argues that the award of $372, 029.28 in fees and costs to the State was without sufficient evidentiary support, and that the Board failed to consider his significant financial hardship.
On September 26, 2011, the State filed an application with the Board for costs totaling $403, 665.78. On April 23, 2012, the Board issued a supplemental order on costs, nunc pro tunc November 11, 2011, awarding $372, 029.78, $31, 636.50 less than what was requested. The Board considered Dara's reputation within the medical community, as well as his considerable economic loss. Nevertheless, the Board determined that Dara should be held responsible for the State's reasonable costs in prosecuting that matter. After reviewing the parties' submissions, the Board found the State's application "sufficiently detailed to permit our conclusion that the bulk of time spent, and the overall fees sought [were] objectively reasonable."
A. Attorneys' Fees
Dara first challenges the Board's calculation and imposition of attorneys' fees. Specifically, he contends that the State's billing records were neither sufficiently specific nor contemporaneously prepared. Further, Dara objects that the State's more senior attorneys performed numerous administrative tasks, such as redacting patient identifiers, that should have been performed by more junior attorneys or paralegals. He also contends that the State's billing records were insufficiently detailed, and included numerous redundant entries for the time of one attorney assisting another lawyer at the OAL hearing.
In assessing the appropriate amount of investigative fees and costs, there must first be a developed record showing actual hours expended, "keeping in mind that actual time expended does not necessarily equate with reasonable time." Poritz v. Stang, 288 N.J.Super. 217, 221 (App. Div. 1996)(holding that the "approach to be utilized" in the context of investigative fees is analogous to the award of attorneys' fees). Next, the Board "must determine the reasonableness of the hourly rate employed[, ] . . . [which] will depend on the rate prevailing in the community for similar work." Ibid. Finally, "[a]fter multiplying the hours by the rate, the [Board] will have to assess the overall reasonableness of the costs by considering the expected return to the State and the interest to be vindicated." Id. at 222. In Rendine v. Pantzer, 141 N.J. 292, 335 (1995), the Court explained that redundant, excessive, or unnecessary hours should not be considered reasonable for purposes of fee awards.
The Board, describing Dara's case as "highly complex, " found that the State's application with respect to attorneys' fees, including time sheets and charts, "extensively documented, with limited exceptions, the time the attorneys expended in these proceedings." The Board referenced the State's "narratives reconstructing the manner in which the time billed was spent, " noting that the fact they "were not contemporaneously drafted did not diminish their value sufficiently to eliminate their consideration."
The Board further explained that the billing records "adequately detail[ed] the tasks performed and the amount of time spent on each by the DAGs" and other professionals. Thus, "especially when viewed in the context of the seriousness and scope of the action maintained against [Dara], " the Board found that the State's claims for attorneys' fees were reasonable and supported by the record.
Contrary to Dara's contentions, Rendine does not prohibit generalized billing entries. In that case, the Court, quoting the Third Circuit, explained that:
It is not necessary to know the exact number of minutes spent nor the precise activity to which each hour was devoted nor the specific attainments of each attorney. But without some fairly definite information as to the hours devoted to various general activities, e.g., pretrial discovery, settlement negotiations, and the hours spent by various classes of attorneys, e.g., senior partners, junior partners, associates, the court cannot know the nature of the services for which compensation is sought.
[Rendine, supra, 141 N.J. at 337 (quoting Lindy Bros. Builders, Inc. v. Am. Radiator & Standard Sanitary Corp., 487 F.2d 161, 167 (3d Cir. 1973).]
Entries such as "revise memorandum, " "reviewing, copying discovery, " and "reviewing documents", were sufficiently detailed to allow the Board to make a decision regarding the reasonableness of the State's request. Moreover, the Board "decline[d] to impose attorneys' fees in certain limited instances where the information provided was not sufficiently detailed so that [it] could assess the reasonableness of the tasks performed." Likewise, the award of fees for work conducted by more than one of the State's lawyers at the same time, such as appearing together at the hearings, was not unreasonable.
Finally, Dara alleges the Board improperly considered billing entries that were not contemporaneously prepared by the State. The Board explained that it permitted the State to supplement its certifications, filling in blanks in its billing records with descriptions of the work performed. It allowed the supplemental certifications "in part because the receipt of the submission did not engender delay." Additionally, public policy supported Dara bearing the costs, particularly in light of the fact that the litigation was necessitated by Dara's gross negligence. While "reliance on reconstructed records is strongly disfavored, " Szczepanski v. Newcomb Med. Ctr., 141 N.J. 346, 367-68 (1995), the Board's rationale for allowing the non-contemporaneous records was reasonable. Moreover, the fact that the Board eliminated hours that were not adequately described demonstrates that it "scrutinize[d] with meticulous care counsel's calculation of hours expended to verify the reasonableness of the hours reflected by the reconstructed records." Id. at 368.
B. Investigative Costs
Dara next contends that the Board's imposition of investigative fees was based on "an inadequate record and a legally inconsistent method of calculation, " namely the Board's use of a multiplier to establish the time spent on the investigation. The Board found that the application for investigative costs was amply supported by a certification by the supervising investigator. Moreover, the Board found:
[T]he overall amount of investigative time expended over the pendency of the matter is very reasonable for investigative services in a matter of this urgency and magnitude. There was a public health crisis due to the significant outbreak of [H]epatitis [B] in [Dara's] oncological practice. The information the investigators discerned aided the State in its effort to stem the further spread of the outbreak by identifying [Dara's] office as the source.
The Board concluded that the rates charged by the Enforcement Bureau Services were reasonable, and had been approved "many times in the past." It determined that use of the multiplier was appropriate because failing to utilize it would result in a passing of the costs to all licensees. Thus, "[c]onsidering the important state interest to be vindicated, protection of the public, (which in this case includes vulnerable cancer patients) the investigative costs imposed . . . [were] certainly reasonable."
As with attorneys' fees, when the State requests investigative costs it must provide a record of the actual hours spent on the investigation. Poritz, supra, 288 N.J.Super. at 221. Here, the supervising investigator certified that she reviewed activity logs and had personal knowledge of the case. She reviewed the records and time reports, applied the requisite multiplier, and determined the total amount owed of $15, 480.18.
C. Expert Fees and Transcript Costs
Dara next submits that the Board's finding that expert costs and transcript costs should be imposed upon him was without any legal merit and is belied by the record in this matter. We find this contention to be without sufficient merit to warrant discussion in this opinion. R. 2:11-3(e)(1)(E).
Finally, Dara argues that the Board failed to consider his financial hardship in assessing costs and fees. The Board explained that, while determining the appropriate amount of costs due, it was
mindful that [it] greatly reduced the civil penalty that could be lawfully imposed to $30, 000.00. This sum was far less than the maximum of over $500, 000.00 in penalties that could have been ordered based on the number of infection control breaches found to have occurred in [Dara's] office or the number of patients infected as a result of those breaches. In reaching a determination to impose a lower civil penalty, [the Board] took into account that [Dara] would bear the costs of the prosecution of this matter.
Moreover, the Board found Dara's "assertions of an inability to pay such costs not to be persuasive." Citing his "remarkably substantial income asserted over many years, " and noting the absence of proof with respect to his assets, the Board found Dara's contention of financial hardship "utterly unconvincing."
Although the $372, 029.28 in fees and costs is a substantial amount, it is not unreasonable under the circumstances. We find no error in the Board's award and in its decision to reject Dara's claim of financial hardship.