Summary Opinion

State of New Jersey
OFFICE OF ADMINISTRATIVE LAW

INITIAL DECISION
OAL DKT. NO. BDS 10905-99S
AGENCY DKT. NO. —

DAVID SAMSON, ATTORNEY GENERAL OF NEW JERSEY,
Complainant,
v.
LANCE L. GOOBERMAN, M.D., AND
DAVID BRADWAY, M.D.,
Respondents.
____________________________________

Douglas J. Harper, Deputy Attorney General, for complainant (David Samson, Attorney General of New Jersey, attorney)

John S. Sitzler, Esq., for respondent Lance L. Gooberman, M.D.

Michael E. Riley, Esq., and Irwin L. Lifrak, Esq., appeared for respondent David Bradway, M.D., during the hearings (Riley & Lifrak, attorneys); David Bradway, M.D., filed a pro se brief

Record Closed: June 19, 2002 Decided: November 15, 2002

BEFORE JEFF S. MASIN, ACTING CHIEF ALJ:

SUMMARY

This case has presented a number of difficult issues that require consideration of the proper role and limits of innovation and the weighing of risks and benefits of a potentially beneficial procedure. Two physicians whose prior life experiences have included serious difficulties with addiction have sought to apply their understandings of this terrible affliction and of emerging treatment possibilities to the treatment of others who need help. In doing so, Drs. Gooberman and Bradway have in some instances pushed the envelope. Dr. Gooberman, as the physician who initiated the UROD practice and taught it to Bradway, and as the overall operator of the treatment facility, no doubt bears the primary responsibility for the practice. However, Dr. Bradway is, of course, responsible for the professional decisions he made and actions he took, or failed to take.

I agree with Judge Lefelt’s thought, expressed in Murray v. State Health Benefits Commission, supra, that litigation is indeed a “poor vehicle” for determining whether alternative, innovative, non-traditional forms of medical treatment are medically sound. The litigation forum is perhaps better suited to the more traditional determination of whether practitioners have violated existing, well-understood and accepted standards of care then to a resolution of whether a controversial new form of treatment is medically acceptable. In medicine, evolving understandings of the workings of medicines, physiology and other aspects of science will often alter the perceptions and even the well-accepted understandings of what works, what does not work, what helps and what harms. What is acceptable practice today may be found to be unacceptable next week, next year. Indeed, as this decision has been in preparation, new information has emerged on such issues as replacement hormone therapy that may shake the practice of medicine in regard to issues of women’s health. This is but one example of how evolutionary medical science can be. Further, as this decision was all but completed, a new report of a randomized study comparing forms of treatment was published and offered in evidence by motion to reopen. No doubt other such studies will appear. Nevertheless, even in regard to as new a method of practice as UROD, still in its infancy despite its growth and acceptance by such organizations as ASAM, it is essential that the State, through the Board of Medical Examiners, exercise oversight over the medical profession to assure, as much as it can within the limitations of knowledge available at any given time, that the public is protected from dangerous medical practice, while at the same time, being cautious to avoid applying too stringent a control on innovation. Here, the extensive record developed leads to some conclusions that favor the work of the respondents and some that do find their work deficient when measured against appropriate standards.

I CONCLUDE that, as practiced by the respondents, UROD cannot be said to be a per se inappropriate or especially dangerous procedure. Nevertheless, as with many other medical procedures involving anesthesia and other medical procedures, some limited number of persons will unfortunately die during or shortly after the procedure, despite its relative safety and the performance of the procedure in a responsible manner. No doubt, not every decision a physician makes as to method of practice during the early stages of the practice of a new, alternative medical procedure will be either the most conservative or the most successful. Nevertheless, I CONCLUDE that in this case the respondents acted in good faith and, except for the limited exceptions noted, within the ambit of acceptable medical standards of care for both addiction medicine and anesthesiology, as well as the new and evolving method they chose to offer to a population highly in need of assistance. While there is sufficient evidence to persuasively establish a number of violations of professional and regulatory standards, I CONCLUDE that, on the whole, the practice of UROD by each doctor did not involve substantial negligence, malpractice or professional misconduct, or gross negligence, malpractice or misconduct.

I CONCLUDE that the complainant has proven both a temporal link and a causal relationship between UROD and the events that resulted in the deaths of some patients and the serious non-fatal consequences that required the hospitalization of two patients. However, the complainant has failed to prove by a preponderance of the credible evidence that the respondents’ conduct in providing UROD, or their alleged failure to act in certain ways, was substantially responsible for the deaths. I CONCLUDE that these deaths occurred either because some of the patients, acting in defiance of warnings, used cocaine after the UROD and suffered fatal arrhythmias, or, in other cases, simply could not withstand the stresses of withdrawal and suffered fatal arrhythmias, or died of aspirative pneumonia that occurred not as a result of any improper conduct by the respondents. Thus, intervening events may well have occurred in the Stavola and Beigelman cases. I further CONCLUDE that while the stress of withdrawal did prove too much for a very limited number of compromised patients, the complainant has not proven by a preponderance of the credible evidence that UROD as practiced by Drs. Gooberman and Bradway involved the use of a combination of drugs that exposed patients to any undue risk of harm so long as they were properly managed during the procedure and were appropriately discharged and, as necessary, provided with follow up support during the ongoing withdrawal process.

Based upon the discussions above, I CONCLUDE that the complainant has established by a preponderance of the credible evidence that the respondents’ practice of UROD has failed to meet several requirements of the standard of good medicine. Additionally, they have violated certain specific requirements of the regulatory code. More specifically, even though dipstick screening was available, the respondents’ failed to continue to screen patients for cocaine use. They improperly sought to have patients waive their rights to confidentiality as a part of the consent form. Dr. Gooberman failed for some indeterminate period to properly advise prospective patients that UROD was an experimental procedure, so as to properly advise them before they gave informed consent to being treated. They failed to prepare adequate records of both anesthesia and antagonist administration, as well as post-anesthesia discharge notes, as required after June 15, 1998.

Penalty

N.J.S.A. 45:1-21 permits the Board of Medical Examiners to revoke or suspend any license issued by it to a physician if the preponderance of the credible evidence establishes the physician has engaged in acts or practices that involve gross negligence, gross malpractice or gross incompetence, or repeated acts of negligence, malpractice or incompetence, or actions that constitute professional misconduct or are in violation of any act or regulation administered by the Board. In addition to such penalty or as an alternative, N.J.S.A. 45:1-22 provides that any person who violates any provision of an act or regulation administered by a professional board may receive a letter of warning, reprimand, or censure, may be assessed civil penalties and may be ordered to cease and desist from future violations or take affirmative corrective action with regard to any act or practice found unlawful. N.J.S.A. 45:1-25 provides that any person who violates any provision of an act or regulation administered by the Board shall, in addition to any other sanctions provided, be liable to a civil penalty of not more than $2,500.00 for a first offense and not more than $5,000.00 for a second and each subsequent offense. Each separate transaction shall constitute a separate offense, but “a second or subsequent offense shall not be deemed to exist unless an administrative or court order was entered in a prior, separate and independent proceeding.” In addition, in any action that is brought pursuant to the statute, the Board “may order the payment of costs for the use of the State.”

I CONCLUDE that there is no basis for the imposition of the ultimate sanction of revocation of either physician’s medical license. The extremely serious allegations regarding the employment of a purportedly unethical and medically unwarranted procedure and the charge that these respondents’ grossly negligent and/or repeatedly negligent and/or incompetent practices and misconduct caused or contributed to the deaths of seven persons and the serious illness of “dozens” of persons have not been proven by the requisite standard of proof. The suggestions and implications that they were simply grinding out ethically tainted UROD procedures and then were not seeking to reasonably assist their patients post-procedure in the attempt to stay abstinent have been demonstrated to be incorrect charges.

Despite the failure of the complainant to prove the most serious charges, clearly several violations have been established. There are obvious failures in regard to the records produced and a failure to comply with medical record requirements. The respondents were each responsible, as professionals and as supervisors, to assure that they and those under their authority properly recorded the events required to allow a complete and understandable record of the treatment rendered. It is vitally important that the records of a patient’s treatment, including and perhaps especially so those relating to surgical and anesthetic procedures, clearly indicate the drugs utilized, the method of administration, the dosage and the timing of such administration. While there is apparently no firmly established formulation for the records that identify these matters, the doctors were responsible to see that these matters were properly recorded. The failure to do so, while not shown here to have contributed to or to have disguised any negligence, nevertheless is a serious failure. Each respondent shall pay a civil penalty of $2,500 for this violation.

The attempt to publicize the procedure through the possible use of patients’ identities, even if for wholly positive reasons to alert the public that UROD was available (and no doubt also to bolster Dr. Gooberman’s, and later also Dr. Bradway’s practice), may have gotten in the way of the doctors’ responsibility to properly protect the confidentiality of their patients. The patients should never have been placed in the position of having to affirmatively opt out of possible future use of their experience, and perhaps their identity, at a time when they were quite likely not at their sharpest and no doubt under some emotional and physical strain. Again, this violation has not been shown to have had any affect upon patient care. Each physician shall pay a civil penalty of $1,500 for this offense.

While the record does not allow for a definitive determination, I strongly believe that Dr. Gooberman’s failure to advise the early patients of the “experimental” nature of UROD did not actually lead to anyone undergoing the procedure who would not have otherwise done so. Further, at some time during the four years and over 2,000 procedures, the need to refer to it as an experiment ended. Nevertheless, given the importance of fair and open dealings with patients and prospective patients, Dr. Gooberman shall pay a civil penalty of $2,500 for this offense.

Violations regarding EKGs for patients over forty and even for not continuing the use of dipsticks to screen for cocaine use are important failures. On this record, it is impossible to determine with any degree of probability that any particular patient was harmed by the failure to perform these tests; however, the failure may have increased the risk to which individuals were subjected. As such, each respondent shall be liable for a civil penalty of $2,500 for failure to use dipsticks and $2,500.00 for failure to perform EKG’s on patients over the age of 40 as a routine pre-screening device.

While in the overall scope of the charges, the charges that were sustained are limited, nevertheless, they occurred multiple times and denote a less than completely careful approach to the serious work involved. Based upon the findings and conclusions and in view of the violations of good medical practice and appropriate standards of care, I CONCLUDE that each respondent shall be suspended from practice for a period of six months. In addition, Dr. Gooberman shall pay a total of $11,500.00 in civil penalties. As the record of this case demonstrates that Dr. Bradway was previously sanctioned by the Board for serious violations of its rules and regulations, an additional penalty of $5,000.00 is imposed. Dr. Bradway shall pay a total of $14,000 in civil penalties. In addition to these sanctions, each respondent must enroll and successfully complete class(es) or course(s) designated by the Board that address issues of informed consent, patient confidentiality, screening procedures for anesthesia procedures and record keeping requirements. Further, upon the completion of their suspensions, each physician shall be placed on administrative probation for a period of two years, during which they may be subject to review of their record keeping, and should they resume UROD or any other anesthesia based procedures, their pre-procedure screening protocols.

Each physician will be equally responsible for the payment of costs of investigation. However, the bulk of the most serious charges have not been sustained. Without doubt, these charges constituted the greatly substantial elements that were the subject of the Board’s investigation and were the driving forces behind a very long and highly complex trial. I CONCLUDE that it would be manifestly unfair and inequitable for the respondents to have to pay all of the Board’s costs. Instead, the respondents shall pay one-third of the Board’s costs and attorneys fees. It is SO ORDERED. Counsel for the Board shall file affidavits with the Board regarding costs and fees and the Board will presumably make a final order regarding the allocation of costs.

I hereby FILE my initial decision with the BOARD OF MEDICAL EXAMINERS for consideration.

This recommended decision may be adopted, modified or rejected by the BOARD OF MEDICAL EXAMINERS, which by law is authorized to make a final decision in this matter. If the Board of Medical Examiners does not adopt, modify or reject this decision within forty-five (45) days and unless such time limit is otherwise extended, this recommended decision shall become a final decision in accordance with N.J.S.A. 52:14B-10.

Within thirteen (13) days from the date on which this recommended decision was mailed to the parties, any party may file written exceptions with the EXECUTIVE DIRECTOR OF THE BOARD OF MEDICAL EXAMINERS, 140 East Front Street, 2nd Floor, Trenton, New Jersey 08608, marked “Attention: Exceptions.” A copy of any exceptions must be sent to the judge and to the other parties.

DATE                                                          JEFF S. MASIN, ACTING CHIEF ALJ

Receipt Acknowledged:

DATE                                                        BOARD OF MEDICAL EXAMINERS

Mailed To Parties:

DATE                                                        OFFICE OF ADMINISTRATIVE LAW