A handful of cases pending in circuit court are challenging the Illinois Department of Public Health’s reluctance to expand legal access to marijuana for medical purposes.

Since a state law passed in 2014 listing 39 medical conditions a doctor can prescribe cannabis for, Illinois has approved only two new conditions — post-traumatic stress disorder and terminal illness. Both were added through legislative action in direct opposition to the executive branch appointee in charge of the state public health department.

The law that enacted the Medical Cannabis Pilot Program created an advisory board meant to review and recommend petitions to add new conditions to the approved list. Between 2014 and 2016, the board recommended letting doctors prescribe cannabis for an additional 30 conditions not listed in the statute.

Illinois Department of Public Health Director Nirav Dinesh Shah — who holds both a medical degree and a J.D., and who worked at Sidley Austin LLP before being appointed by Gov. Bruce Rauner — denied all of them.

The political deal that legislatively added PTSD and terminal illness to the approved list in 2016 also disbanded the advisory board, placing the power to evaluate any new petitions squarely with the IDPH director.

Since then, 14 petitions have come to the IDPH. No action has been taken on any of them, with the agency in several cases letting the 180-day deadline for action quietly expire.

Feeling stonewalled by the executive branch, some patients have turned to the judiciary, filing at least eight lawsuits in Cook County against the department and Shah.

IDPH has won outright in some of the lawsuits, gaining a favorable ruling from Cook County trial judges on particular conditions such as osteoarthritis and polycystic kidney disease.

But trial judges took issue with Shah’s decisions in the other court cases, finding he employed the wrong standard to evaluate petitions for new illnesses. Some remanded it for a new hearing, while others simply ordered him to approve the conditions.

On appeal when given direct judge’s orders, panels have agreed that Shah used the wrong standard, but stop short of letting a trial judge force the director to take a specific action.

As a result, even the plaintiffs who won their cases on administrative review have yet to see their conditions added to the approved list.

Three cases where the plaintiffs won and two where a judge held in favor of Shah are broken down in this report. They illustrate how different tactics have fared in this battle between the judicial and executive branches.

Robert M. Morgan was the former director of the medical cannabis pilot program from its 2014 launch until he stepped down in May 2016. He’s now special counsel to Much Shelist P.C. and a Democratic candidate for state representative in the North Shore suburbs.

“Ordinarily, courts throughout the state give state agencies and other governmental agencies a lot of discretion to make these kinds of decisions,” Morgan said. “But there are limits, and I think what we are seeing here is whether or not the director really exceeded that limit and just made a decision that wasn’t in any way based on reasonable response and a reasonable interpretation of what the evidence was in front of him.”

State Rep. Louis I. Lang, a Skokie Democrat who crafted the medical cannabis pilot program, said he believes the courts are fulfilling the role they are supposed to serve.

“When a court feels that a branch of government or government official is violating the law, they have a duty to step in,” he said. “We are not talking about a judgment call. We are not talking a political choice — we are talking about a state agency that willingly ignored the law.”

An IDPH spokeswoman declined to comment on the department’s procedures regarding petitions, citing the ongoing litigation.

‘A giant yo-yo’

Ann Mednick was among the first group of patients to ask the state to add new medical conditions to the medical cannabis law, or Compassionate Use of Medical Cannabis Pilot Program Act.

In July 2015, Mednick submitted a petition to the department requesting it add intractable pain as a debilitating medical condition. Three months later, all 10 members of the Medical Cannabis Advisory Board recommended the condition be added.

Shah issued his decision to deny Mednick’s petition on Jan. 29, 2016.

His decision found that “the safety and efficacy of cannabis to treat or alleviate symptoms of intractable pain have not been thoroughly evaluated.”

Shah cited a 2015 review of data in the Journal of the American Medical Association that contained “high-quality evidence supporting efficacy of cannabis to address pain is lacking.”

Shah found that the potential benefits from medical cannabis to treat or alleviate symptoms of intractable pain are outweighed by known risks “because of the lack of high-quality data from randomized, controlled clinical trials.”

Mednick, represented by Goldberg Law Group LLC, filed her complaint in February 2016 in Cook County Circuit Court. That case is Mednick v. Ill. Dept. of Public Health, 16 CH 2777.

Cook County Circuit Judge Rodolfo Garcia reversed Shah’s decision on Oct. 25, 2016, with instructions to reconsider the evidence in the record and issue a new decision.

Shah subsequently issued another denial of Mednick’s petition in March 2017.

After Shah’s second denial of Mednick’s intractable pain petition, Mednick filed suit again. On Jan. 12, Cook County Circuit Judge Raymond W. Mitchell reversed the director’s decision in using a “clearly erroneous” standard in Mednick v. Ill. Dept. of Public Health, 17 CH 6032.

Under the Administrative Review Law, judicial review of an agency decision extends to all questions of law or fact presented by the entire records before the court, and the standard of review depends on whether the issue presented is one of law, fact or a mixed question of law and fact, which uses a “clearly erroneous” standard.

Mitchell found Shah’s conclusions of law falsely stated that intractable pain is not listed in the International Statistical Classification of Diseases and Related Health Problems, 9th and 10th revision (ICD-9 and ICD-10). Intractable pain is classified in both publications.

Further, Mitchell found Shah ignored the advisory board’s assertions that intractable pain is a form of chronic pain.

“The director’s decision to ignore that intractable pain is a form of chronic pain is significant, because he dismisses several supporting articles on the grounds that they fail to inform ‘whether an individual suffering from intractable pain, rather than chronic pain, would benefit,’” Mitchell wrote.

Mitchell’s order also clarified the standard Shah should use: Conditions should be added if individuals with that condition would benefit from medical cannabis use.

“Notably, the Pilot Program Act does not charge the department with a drug regulatory role akin to the Food and Drug Administration,” Mitchell wrote.

His order called out Shah for criticizing several of the scientific articles in Mednick’s petition “as not involving human clinical trials, even though those same articles analyze dozens of human clinical trials.”

“The record shows that individuals with intractable pain would benefit from the use of medical cannabis,” he wrote. “The director’s March 2017 final order misstates the Advisory Board’s analysis and contorts the records to minimize evidence supporting Mednick’s petition.”

Mitchell’s order not only reversed Shah’s decision but it also remanded the decision back to Shah with instructions to add intractable pain to the list of debilitating medical conditions.

IDPH filed a notice to appeal Mitchell’s decision to the 1st District Appellate Court. The Illinois Department of Public Health and Illinois Attorney General’s Office confirmed the appeal was filed.

The Goldberg Law Group represents Mednick as well as the other seven petitioners for other conditions.

Robert A. Bauerschmidt, a partner at Goldberg Law Group, describes the process as a “giant yo-yo.”

“I mean, we keep winning, but it’s not getting us anywhere because Shah is not adding the conditions,” he said. “At some point maybe the appellate court will say that he evidenced some sort of bad faith or some other reason where … the courts can order him to do something or fine him if he doesn’t, or jail him if he doesn’t. But at this stage, we are not there. So, it’s just a giant yo-yo.”

Evidence thin, a Shah win

Not all of Shah’s decisions on medical cannabis petitions have been overruled by trial judges.

His decisions to deny petitions for osteoarthritis and polycystic kidney disease were affirmed by the circuit court.

In December, Cook County Circuit Judge Michael T. Mullen found the director properly applied the standard to rule on Mednick’s petition for osteoarthritis in a separate case from her complaint involving intractable pain. Mullen, in a one-page written opinion, also determined Shah’s decision on the osteoarthritis petition was not arbitrary capricious, clearly erroneous or against the manifest weight of the evidence. That case is Mednick v. Ill. Dept. of Public Health, 17 CH 2669.

Mitchell affirmed Shah’s decision regarding polycystic kidney disease earlier this year, in Arquilla v. Ill. Dept. of Public Health, 17 CH 738.

That case stems from Kristen Arquilla’s petition to add polycystic kidney disease, which the advisory board recommended unanimously for approval in May 2015. Shah denied her petition in October 2015, and Arquilla then sought administrative review in Cook County Circuit Court.

In September 2016, Garcia remanded the case back to Shah with instructions to reconsider the record and issue a new decision that identifies the standard he relied upon.

Shah issued a new decision denying her petition in December 2016.

When Arquilla challenged his denial for the second time, Mitchell found Shah’s decision was not clearly erroneous and Shah used the proper standard.

Mitchell agreed with Shah that the record lacked persuasive evidence for adding polycystic kidney disease.

To support this conclusion, Shah’s decision states that the letter from Arquilla’s doctor claims she has not benefited from pain medication but her doctor does not take a position on the use of medical cannabis for polycystic kidney disease.

Additionally, Shah states in his decision that the single medical journal article attached to Arquilla’s petition does not advocate for the routine use of cannabinoids in treating chronic kidney disease.

Mitchell’s ruling also supports Shah’s finding that the unanimous recommendation of the advisory board was not persuasive because, he wrote, the board “did not discuss any particular evidence indicating that individuals with polycystic kidney disease would benefit from the use of medical cannabis.”

Mitchell’s ruling was issued Feb. 27.

On appeal: The Doe cases

Two medical cannabis cases have reached the 1st District Appellate Court. The petitioners in those cases are also represented by Goldberg Law Group.

John Doe Three v. The Department of Public Health, 2017 IL App (1st) 162548, addressed post-operative chronic pain.

The plaintiff, identified only as “John Doe Three,” asked IDPH to approve the condition. His petition was denied twice by Shah.

Cook County Associate Judge Neil H. Cohen reversed Shah’s decision and remanded it back after the first denial. Similarly to the Mednick cases, Cohen found Shah violated Doe’s due process by using a higher standard than the one set in department rules and introducing new evidence after the hearing.

After the second denial, Cohen again reversed Shah’s decision and instructed Shah to add the condition by rule within 30 days. Shah appealed, and on May 22, 2017, the 1st District Appellate Court affirmed Cohen’s reversal.

On behalf of a unanimous panel, Justice Maureen E. Connors wrote Shah “did not follow Department rules when rendering his decision in this case … There is nothing in the rules that mandates ‘substantial evidence from adequate, well-controlled clinical trials to support the use of cannabis.’ Rather, at the time of plaintiff’s petition, the rules indicated that petitions should be supported by information about chronic pain, why conventional medical therapies were insufficient, the proposed benefits from the medical use of cannabis, evidence from the medical community, and letters of support, all of which were included in plaintiff’s petition.”

While Connors wrote that there was no rule requiring Shah to follow the advisory board’s recommendation, there was also “nothing in the rules indicating that the Director should be using a heightened standard of which plaintiff was unaware or the [d]irector’s own research that was not presented at the hearing.”

Having found that the director’s findings were invalid, the Doe Three panel then addressed whether the case on remand should follow the old law’s guidelines or should follow the new law retroactively.

Finding the law’s amendments were substantive and not procedural, the panel held the amendments were not retroactive.

The Doe Three panel affirmed Cohen’s judgment “insomuch as it reversed the [d]irector’s decision denying plaintiff’s petition,” but reversed the portion of Cohen’s order directing Shah to add chronic post-operative pain by rule.

Later in 2017, the 1st District issued an unpublished order, John Doe One v. Illinois Department of Public Health, et al., 2017 IL App (1st) 162867-U. Justice John B. Simon, the author, wrote that the case addressing irritable bowel syndrome is “nearly identical” to Doe Three.

Just as in Doe Three, Shah twice denied John Doe One’s petition for IBS, and Cook County Circuit Judge Anna Helen Demacopoulos twice reversed his denial. Demacopoulos’ second reversal also included instructions that Shah approve IBS. Shah appealed, and the appellate court panel affirmed the court’s reversal.

“The Director applied a higher standard of proof and persuasion than contemplated by the Act and by Department rule. Accordingly, as in Doe Three, the Director’s decision cannot stand,” Simon wrote.

The Doe One panel affirmed the part of the trial judge’s order finding that Shah used the wrong standard, but reversed the part that ordered IBS be added to the list of approved conditions.

In explaining the partial reversal, Simon wrote in the Dec. 4 that “[t]here is no reason that Doe cannot receive adequate due process protections when the issue is considered by the [d]irector on remand. And Doe provides no authority or any reasoned basis to support the trial court’s decision to outright order that a condition be added to the list of debilitating medical conditions as the result of a due process violation.”

Shah has yet to issue his third and latest decisions on the petitions for post-operative chronic pain or IBS.

Goldberg Law partner Michael K. Goldberg said he expects them to come out soon.

“If the director doesn’t add the conditions, the trial court has jurisdiction to possibly hold someone in contempt for not following an order,” Goldberg said. “We are a few steps away from that.”

That is, unless there is a political solution or public pressure, it is going to take a judge to force Shah to add these conditions, he said.

“The way its supposed to work is that the judicial system is supposed to interpret a dispute, and the losing party is supposed to abide by it,” Goldberg said. “And when it’s a private party, they usually do. But when it’s another branch of government, they put up a fight and that’s sort of what’s happening right now.”