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Delaware Board of Medical Licensure & Discipline v. Bruce Grossinger, D.O.

Citation: Not availableDocket: 53, 2019

Court: Supreme Court of Delaware; January 7, 2020; Delaware; State Supreme Court

Original Court Document: View Document

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The Delaware Board of Medical Licensure and Discipline reprimanded Dr. Bruce Grossinger for violations related to the treatment of a heroin-addicted patient, Michael. The Board upheld a hearing officer's recommendation, which found Dr. Grossinger guilty of unprofessional conduct due to inadequate documentation of the patient's substance abuse history, failure to discuss treatment risks, lack of urine testing, and incomplete treatment records. Initially, the hearing officer suggested a six-month probation, additional medical education, and a $2000 fine, but the Board reduced the penalty to a letter of reprimand. Dr. Grossinger appealed this decision to the Superior Court, which reversed all but one finding, citing issues of constitutional vagueness, the necessity of expert testimony for standards of care, and violations of due process due to the Board's reliance on extrarecord evidence. Both parties cross-appealed, with the Board contesting the Superior Court's reversal of most findings and Dr. Grossinger challenging the final finding. The Supreme Court, upon review, disagreed with the Superior Court's conclusions and reversed the decision, reaffirming the Board's original findings. The factual record was established during a two-day evidentiary hearing, where testimony from multiple witnesses, including Dr. Grossinger and his partners, was presented. Notably, the Board did not attribute Michael's death to Dr. Grossinger or his partners.

Michael's death prompted his mother to file a complaint with the Division of Professional Regulation, leading to an investigation and disciplinary proceeding. Michael had a history of pain-management treatment linked to his opiate addiction, stemming from injuries sustained in multiple motor vehicle accidents between 2008 and 2011. Following these accidents, he received treatment from Dr. Ross Ufberg, who prescribed Lyrica and Oxycodone. In March 2011, Dr. Ufberg discharged him due to inconsistencies in drug screening results. Subsequently, Michael began treatment with Dr. Damon Cary, who prescribed Roxicodone and MS Contin, both opiates, until July 2012. During this period, Michael developed an addiction to opiates, leading him to seek help from Dr. Irwin L. Lifrak in December 2013, who prescribed Suboxone for detoxification. However, Michael was discharged after one month due to a positive heroin test.

On January 29, 2014, Michael sought pain treatment at GNS, a Wilmington medical practice. He signed a pain-management agreement that mandated compliance with random drug tests and outlined consequences for violations. Dr. Steven Grossinger and Dr. Allen Silberman evaluated Michael that day. Dr. Silberman noted Michael's opiate addiction stemming from previous prescriptions and mentioned his treatment with Dr. Lifrak. Dr. Grossinger's report included the results of Michael's medical evaluations but failed to mention the reason for his Suboxone treatment. During testimony, Dr. Grossinger admitted he only learned of Michael's heroin addiction shortly before his appearance, suggesting he had not read Dr. Silberman’s report, which raised concerns regarding his awareness of Michael's medical history.

Dr. Steven Grossinger did not acquire Michael’s medical records from Dr. Lifrak, Dr. Cary, or Michael's primary care physician, Dr. Yezdani, which left him unaware of Michael's treatment compliance. Dr. Yezdani had prescribed Alprazolam and Xanax, medications that Dr. Grossinger acknowledged could influence his treatment decisions due to potential drug interactions. 

Michael received pain treatment from Dr. Brajer and Dr. Grossinger at GNS several times before his death on December 12, 2014. Initially treated about once a month, Michael was prescribed opiates like Hydrocodone and Morphine Sulfate. A critical urine drug screen scheduled for June 18, 2014, was canceled due to insurance issues, leading to Dr. Grossinger refilling Michael’s prescriptions multiple times without the necessary screening. Michael missed subsequent appointments, yet prescriptions were refilled again on November 12, 2014, despite the lack of updated screening results and missed appointments.

Michael finally attended an appointment on December 8, 2014, where he provided a urine sample, but he died from a heroin overdose four days later. GNS discharged him on December 14, 2014, unaware of his death, based on an abnormal urine sample indicating heroin use.

Following Michael's death, his mother filed a complaint, prompting an investigation that led the State to file formal complaints against Dr. Brajer, Dr. Grossinger, and Dr. Steven Grossinger for regulatory violations. The State charged Dr. Grossinger under 24 Del. C. 1731(b)(3) and (b)(11), which address unprofessional conduct related to inadequate patient record maintenance and documentation. A consolidated evidentiary hearing found all three doctors guilty of regulatory violations, but only Dr. Grossinger's findings are discussed here, as the others did not appeal.

Dr. Grossinger was found to have violated Board Regulation 18.1.1, which mandates that physicians prescribing controlled substances for pain must obtain, evaluate, and document a medical history, including a history of substance abuse. The hearing officer determined that, prior to refilling prescriptions for a patient named Michael, Dr. Grossinger reviewed his abnormal MRI and EMG results but failed to recall reviewing Michael's Prescription Monitoring Program (PMP) report. Consequently, Dr. Grossinger did not recognize Michael's past treatment with Suboxone or his history with prescribed opiates. The hearing officer highlighted that Dr. Grossinger did not request or consult Dr. Lifrak’s medical records or communicate with him about Michael’s treatment before the patient’s visit to GNS. Despite Dr. Grossinger suggesting that Dr. Lifrak should have documented Michael’s heroin addiction, he relied instead on reports from Dr. Silberman without confirming their contents. The hearing officer expressed skepticism regarding Dr. Grossinger’s credibility, noting discrepancies in his testimony about Dr. Silberman’s report, which actually mentioned Michael's "opiate addiction" and Suboxone management. Ultimately, the hearing officer concluded that a reasonable physician would have further inquired into Michael’s substance abuse history, which Dr. Grossinger failed to do.

Additionally, Dr. Grossinger was found in violation of Board Regulation 18.3, which requires practitioners to discuss the risks and benefits of controlled substances with patients. The hearing officer determined that such discussions did not occur, despite testimony from Dr. Grossinger’s expert, Dr. Staats, suggesting compliance based on statements from Dr. Grossinger and a signed consent form. The hearing officer did not find this testimony credible.

After reviewing Michael's GNS chart, it was determined that there was no documentation of a "risk and benefits" discussion between Michael and Dr. Steven Grossinger or any other healthcare provider. The hearing officer concluded that the consent form did not serve as adequate documentation for such a discussion. Notably, on April 9, 2014, Dr. Brajer switched Michael's medication from Tramadol to Hydrocodone, but the hearing officer found Dr. Brajer's claim of having had thorough discussions about risks and benefits on that date to be incredible due to the lack of supporting documentation. The officer emphasized that Dr. Grossinger, who had not met Michael, failed to adhere to Board Regulation 18.3, which mandates documentation of risk-benefit discussions. The absence of such documentation led to the conclusion that Dr. Grossinger neglected his duty to discuss these risks and benefits with Michael prior to prescribing medication.

Further, the hearing officer found Dr. Grossinger in violation of Board Regulation 18.4 for not enforcing pain-management agreements signed by Michael, which required urine testing when requested. Despite Michael signing two agreements that stipulated consequences for non-compliance, Dr. Grossinger did not enforce these provisions and refilled Michael's opiate prescriptions without conducting the necessary urine screens for five months following a canceled test. Lastly, the hearing officer identified a violation of Board Regulation 18.5, as Dr. Grossinger failed to periodically review Michael's pain treatment, which includes evaluating the necessity for continued or modified controlled substance therapy based on the patient's progress.

Dr. Grossinger was found not to have met or seen Michael, nor to have participated in planning or executing his pain treatment. Legally, the hearing officer determined that Board Regulation 18.5.1 mandates that practitioners prescribing controlled substances must conduct periodic chart reviews to assess treatment progress and decide on drug regimen modifications. Dr. Grossinger admitted he did not review relevant medical records beyond initial MRI and EMG results, instead relying on a prescriptive history from other doctors when refilling Michael's prescription. Consequently, he failed to perform the required periodic reviews.

Additionally, the hearing officer concluded Dr. Grossinger violated Board Regulation 18.7, which mandates accurate and complete record-keeping, including documentation of medical history, risk and benefit discussions, and periodic reviews. Previous violations of Regulations 18.1.1, 18.3, and 18.5 were cited as contributing to this violation of Regulation 18.7. Furthermore, Dr. Grossinger's repeated documentation failures supported a conclusion of violating 24 Del. C. 1731(b)(3), which allows for disciplinary action against practitioners for unprofessional conduct, defined as actions likely to deceive or harm the public. This conduct includes inadequate maintenance and documentation of patient records, as outlined in Board Regulation 8.1.

The hearing officer recommended that Dr. Grossinger's medical license be placed on probation for six months, require him to complete nine continuing medical education hours, and pay a $2,000 fine. After receiving the recommendations, Dr. Grossinger submitted written exceptions, which included his perspective on Michael's treatment and arguments against the severity of the penalty, as well as a claim that the State lacked expert testimony. The State objected to a letter submitted by Dr. Snyder as evidence not presented during the hearing. The Board ultimately granted the motion to strike the letter, upheld the hearing officer's legal conclusions regarding Dr. Grossinger's violations, but reduced the penalty, deeming it excessive given the case involved only one patient and Dr. Grossinger had an otherwise successful practice.

Dr. Grossinger's medical license was not placed on probation but was instead subjected to a letter of reprimand, with retained fines and continuing education requirements. He appealed this decision to the Superior Court, which reversed most of the Board's conclusions except for a finding of violation of Regulation 18.3 concerning discussions about the risks and benefits of opioid medications. The Superior Court determined that the Administrative Procedures Act (APA) did not apply to the Board, despite both parties agreeing otherwise. The court found the Board's regulations unconstitutionally vague as applied to Dr. Grossinger, stating they failed to provide adequate notice regarding prohibited conduct. Specifically, it criticized Regulation 18.1.1 for lacking clarity on the source and time period for medical records, and similarly found Regulations 18.4 and 18.5 vague regarding the frequency of urine drug screens and periodic reviews, respectively. The court held that the absence of a standard of care deprived Dr. Grossinger of due process rights, including notice and the ability to confront evidence against him. 

On appeal, the Board contested the Superior Court's findings, arguing that expert evidence was unnecessary to establish violations and that its rules were not unconstitutionally vague. It also claimed its factual findings were supported by substantial evidence. Conversely, Dr. Grossinger, in his cross-appeal, contended that the Board's determination of his failure to discuss opioid treatment risks was not backed by substantial evidence. The issues raised revolve around the necessity of expert testimony and the constitutionality of the vagueness of the Board's regulations.

The dispute centers on whether the State was obligated to present expert evidence to establish the appropriate standard of care. The Board argues that it does not need expert testimony due to its composition of both experts and laymen, alongside its specialized knowledge in medicine. Conversely, Dr. Grossinger contends that the Board's reliance on its expertise to interpret the Board Regulations under the reasonable-physician standard infringes on his due process rights to notice and confrontation of evidence.

The core issue involves the standard of care defined in the Regulations, specifically whether it requires expert evidence (a factual determination) or if it falls under the Board's legal expertise. The applicability of the Administrative Procedures Act (APA) to the Board's order is also discussed. The Superior Court initially ruled that the APA did not apply to the Board until 2017, based on a legislative amendment. However, it is clarified that the Board has been subject to APA provisions since 1984.

Given that the APA explicitly governs the Board and mandates court deference to its decisions, the Board's order is subject to substantial deference under the APA. Furthermore, it is determined that the standard of care implicit in the Board Regulations is a legal issue that does not necessitate expert evidence, as the resolution of such legal issues falls exclusively within the court's jurisdiction, rather than requiring witness testimony.

Experts are tasked with interpreting and analyzing factual evidence, but they do not testify about legal standards. Whether the standard of care under Board Regulations is a question of law or fact is critical, especially in administrative disciplinary proceedings governed by the Administrative Procedure Act (APA). Dr. Grossinger and the Superior Court view this determination as a question of fact, which is significant since findings made by the hearing officer in these proceedings are binding on the Board. The Board cannot consider additional evidence and must affirm or modify the hearing officer’s recommendations regarding conclusions of law and sanctions.

The Board contends that it is authorized to determine the standard of care without needing to hear legal arguments, as the judge’s legal knowledge is presumed adequate for guiding the jury on applicable law. Expert testimony regarding legal principles is not required because the judge’s expertise renders such testimony unnecessary.

The Division of Professional Regulation oversees various state entities, including the Board of Medical Licensure and Discipline, which operates under specific statutes. The conclusion that the standard of care in such cases is purely a question of fact is contested. While cited cases suggest that the standard of care in medical malpractice contexts is fact-specific, the standard in administrative proceedings differs significantly. In tort cases, the jury establishes the required level of care for particular situations, making it a question of fact that is tailored to specific circumstances. In contrast, administrative cases operate under a codified standard that does not change with individual facts.

An action for personal injuries and medical expenses due to alleged medical malpractice is highlighted, referencing cases such as Davis v. Maute and Campbell v. DiSabatino, which involve negligence. The Superior Court also cited Robelen Piano Co. v. Di Fonzo, a negligence case against a storekeeper. The standard of care in tort actions is defined as that of a reasonably prudent person, which must be tailored to the specific facts of each case. Regulations serve as conduct standards, with the standard of care being an implicit element of these regulations, distinct from tort cases where it is the primary governing standard determined by a jury based on the facts presented. The interpretation of regulatory standards is a legal question, not reliant on expert testimony, and is to be decided by the Board. However, in close cases, it becomes a mixed question of fact and law, warranting jury determination due to public interest in judgment. Both Dr. Grossinger and the Board acknowledge the implicit reasonable-physician standard within the regulations, although Dr. Grossinger contests its interpretation, asserting that expert testimony is necessary for its establishment. Ultimately, the interpretation of regulations is a legal matter, and their application to specific cases does not necessitate expert input, similar to how fiduciary duty breaches are assessed without legal expert testimony in court.

Delaware law governs the legal issues at hand, emphasizing that a lay hearing officer should not limit the Board's ability to make determinations regarding the standard of care for physicians based solely on specific expert testimonies. This principle aligns with the Bilski case, where a physician challenged the Board's findings due to a lack of expert testimony. The court affirmed that the absence of such testimony did not imply the Board fabricated evidence; rather, the Board's decision was backed by a substantial factual record. The Board's interpretation of its regulations and the reasonable-physician standard of care was integral to its decision-making process. Judicial review under the APA allows for deference to the Board's findings of mixed questions of fact and law, requiring consideration of the agency's specialized knowledge while maintaining that purely legal issues do not receive such deference.

Expert testimony regarding the meaning of regulations was deemed unnecessary in both the Bilski case and the current matter involving Dr. Grossinger. The court found that the absence of expert evidence concerning the level of care required by the Regulations did not infringe on Dr. Grossinger’s due process rights. He contended that the lack of expert testimony on the reasonable-physician standard of care deprived him of adequate notice and the right to confront adverse evidence. However, the court determined that the reasonable-physician standard is a legal determination, thus undermining his arguments.

Dr. Grossinger and the Superior Court claimed the Board Regulations were unconstitutionally vague due to their generality, particularly referencing Board Regulation 18.5, which lacks specificity regarding the frequency of required "periodic reviews." The court clarified that his vagueness challenge was actually facial, not as-applied, since it questions the validity of the Regulations in any context rather than just his specific case. The court emphasized that if a regulation fails to provide clear notice of its requirements, it is facially void, and clarity gained only through disciplinary proceedings does not constitute adequate notice. The concept of unconstitutional vagueness is rooted in fairness, ensuring individuals receive fair warning before facing legal consequences. The court concluded that expert testimony would only provide post-factum notice and was irrelevant to the due process challenge, ultimately rejecting Dr. Grossinger's argument regarding the Regulations' clarity.

The Regulations establish a reasonable-physician standard of care for evaluating license-holder conduct, a point not disputed by Dr. Grossinger. This objective standard is deemed sufficient for providing notice, despite the use of the term “reasonable.” Dr. Grossinger's reluctance to challenge the Regulations is acknowledged, as they are widely adopted across jurisdictions. The Superior Court emphasized that the Regulations are not vague on their face, although it did not clarify why Dr. Grossinger's challenge was limited to his specific circumstances. Importantly, the court noted that the existence of widespread use does not validate an unconstitutional regulation, asserting that due process must not be sacrificed for governmental convenience. 

For notice to be adequate, individuals must have clarity regarding prohibited conduct, and consistency is crucial. Relying on expert testimony for determining violations would lead to inconsistent standards and inadequate notice, compared to the established discretion of the Board, which comprises both licensed physicians and laypeople. The Board’s decisions may reference current clinical practice guidelines, ensuring a balanced approach that mitigates individual biases among physicians, similar to how juries operate. Overall, the Regulations are viewed as providing sufficient notice for practitioners regarding the expected standard of care.

The Board's determinations of the reasonable-physician standard of care are deemed more consistent than those made by individual experts. Dr. Grossinger's arguments regarding inadequate notice in the Regulations about documentation of substance abuse history, risk discussions of opiate medication, urine drug screening frequency, and periodic review fail. Although he and the Superior Court focus on the lack of guidance about obtaining prior treating physician records, the Regulations clearly require documentation of a patient's substance abuse history, including treatment history. Dr. Grossinger did not document Michael's substance abuse history at all, nor did his team obtain relevant treatment information from the only physician who treated Michael for addiction. Notably, Dr. Grossinger was unaware of Michael's heroin addiction until shortly before his testimony, and other doctors also lacked knowledge of Michael's treatment with Suboxone. A notice challenge would be plausible if medical records had been requested and deemed insufficient, but no records were obtained, and GNS doctors were unaware of Michael's substance abuse history despite existing reports. Moreover, Dr. Grossinger did not discuss the risks and benefits of the prescribed medications, and there was no documentation of such discussions. Although Regulation 18.4 does not mandate a specific frequency for urine drug screenings, it requires practitioners to adhere to their pain-management agreements, which GNS failed to enforce. A urine drug screening requested in June was not completed, nor was it rescheduled or followed up. Finally, Dr. Grossinger did not conduct any review of Michael's pain management, including periodic reviews.

Dr. Grossinger's argument regarding the vagueness of "periodic" in Regulations 18.5 and 18.7 is insufficient to negate the requirement that periodic reviews must occur; failing to conduct any reviews does not meet regulatory standards. The Board's regulations do not infringe on Dr. Grossinger’s due process right to confrontation, as the determination of the reasonable-physician standard of care is a legal issue rather than a factual one, thus denying the right to cross-examine the Board's methods. 

Both parties contest the sufficiency of evidence supporting the Board's decision on alleged violations, which must be backed by substantial evidence—sufficient evidence accepted by a reasonable mind. The court will not reassess evidence or make factual determinations. 

1. **Violation of Regulation 18.1.1**: The Board found Dr. Grossinger in violation for not obtaining, evaluating, and documenting a medical history and physical examination, particularly concerning the patient Michael’s substance abuse history. Testimonies revealed that neither Dr. Grossinger nor his colleagues obtained relevant medical records or communicated with Dr. Lifrak, Michael's treatment provider for heroin addiction, which constituted a failure to meet regulatory documentation requirements.

2. **Violation of Regulation 18.3**: The Board determined Dr. Grossinger did not adequately discuss the risks and benefits of controlled substances with Michael and failed to ensure that such discussions occurred through his partners’ documentation. In response, Dr. Grossinger cited testimony claiming he had discussed these aspects with Michael and referenced informed consent forms used by GNS, which indicated that alternatives were fully explained.

Dr. Grossinger contends that the hearing officer neglected to acknowledge key evidence in his findings, claiming that a legal conclusion cannot be based on the absence of evidence. However, the hearing officer did address Dr. Grossinger's testimony and the informed consent forms related to Board Regulation 18.3, ultimately rejecting the forms as proof that a GNS physician discussed the risks and benefits of prescribed medications with Michael. The officer emphasized that the forms lacked specific discussions about the oral medications and only referenced discussions about injection procedures. Furthermore, he found that the forms did not confirm that GNS explained the relevant risks and benefits regarding alternative treatments or the potential consequences of not receiving care. The timing of when the consent forms were signed—immediately before injections—also supported the officer's conclusion that no discussions about the oral medications took place.

The hearing officer questioned the credibility of Dr. Brajer’s and Dr. Grossinger's testimonies regarding the discussion of risks and benefits with Michael, determining that Dr. Grossinger's assertion was insufficient without written documentation. The absence of such documentation justified the hearing officer's finding that no discussion occurred.

Additionally, the Board concluded that Dr. Grossinger violated Board Regulation 18.4 by not utilizing Michael’s pain-management agreements. The officer found that Michael had agreed to undergo random drug testing and understood that any breach of the agreement would lead to his discharge from GNS. Evidence revealed that Michael missed a urine drug screen in June 2014, which was not conducted again until six months later.

GNS, including Dr. Grossinger, failed to discharge patient Michael and continued to refill his opiate prescriptions without conducting required urine drug screenings, violating Regulation 18.4. The Board determined that pain-management agreements must be actively used rather than merely signed. The hearing officer found substantial evidence supporting the conclusion that GNS did not use these agreements, as it continued treatment and prescriptions without the necessary screenings.

Furthermore, Dr. Grossinger violated Regulation 18.5 by not conducting any periodic reviews of Michael's pain treatment. Testimony indicated that he did not review significant medical records, relying instead on the prescriptive history of his partners. The hearing officer's findings regarding his lack of independent review were upheld as credible.

Dr. Grossinger also violated Regulation 18.7 by failing to maintain complete and accurate patient records. He did not obtain necessary medical charts, failed to discuss medication risks with Michael, and neglected to document any reviews of the treatment course. These violations were backed by substantial evidence.

Under 24 Del. C. § 1731(b)(3), the Board concluded that Dr. Grossinger's actions constituted unprofessional conduct, including failure to maintain proper patient records as defined by Board Regulation 8.1.13. The Board's findings were affirmed, and the Superior Court's decision reversing the Board was reversed, thus upholding the Board's disciplinary action against Dr. Grossinger.