DEA Delays FDA Sanctioned Marijuana Clinical Trials- Researcher's Suit Moves To DC Appellate Court

, November 15, 2022 (Newswire.com) - "Justice delayed is justice denied," Duane Boise, the president of MMJ, told Law360 on Thursday.

A Rhode Island federal judge has referred a suit by cannabis researcher MMJ International Holdings Corp. alleging the Drug Enforcement Administration has delayed processing its application to import and study cannabis, saying the circuit courts are a better venue for the dispute.

In an order filed Thursday, U.S. District Judge Mary S. McElroy said while the law isn't clear on whether the appellate courts have exclusive jurisdiction over challenges to the DEA and attorney general's actions, they are available courts and on the balance MMJ will see little harm from dismissal because it can refile the case in the D.C. or First Circuit courts.

MMJ sued the DEA in April, alleging that the agency had been stonewalling its applications to import and study cannabis for potential uses in treating chronic illnesses for the past three years, even though the planned clinical trials had already been approved by the U.S. Food and Drug Administration.

According to court documents, the DEA allegedly completed its inspection of MMJ's facilities in October 2021 but has not moved on the applications. MMJ said that, in months before filing the lawsuit, it had reached out to the agency director, asked its congressman to intervene and called the DEA's general customer line to no avail.

In May, MMJ asked the court for an injunction ordering the DEA to make a final determination on an application to import and study cannabis, saying the DEA has 90 days to make a final determination after the public comment portion of the application process is done. Those portions finished in December 2019 and November 2020, and yet the DEA still hasn't given its final say.

And in June, the DEA moved to dismiss the suit, arguing the plaintiffs should refile their action in the D.C. Circuit, as federal courts of appeal had exclusive authority to hear cases challenging the attorney general's actions under the Administrative Procedure Act, and any injunction granted by the district court would have unintended ramifications.

MMJ, in response, had argued that the law only grants exclusive jurisdiction on final decisions, and the complaint alleges that there has been no final decision and was filed for the purpose of compelling one from the government.

Judge McElroy said it's "not entirely clear" that the First Circuit has adopted a ruling from the D.C. Circuit that held that the court of appeals' exclusive jurisdiction over final decisions extends to cases concerning delayed determinations, noting that when the First Circuit dismissed a complaint on such grounds in Sea Air Shuttle Corp. v. United States , it made clear that it relied "primarily on an alternative reason" to dismiss the suit.

But the judge noted that case law indicates that a remedy exists in the courts of appeals for MMJ's case, which is reason enough to dismiss without prejudice as the Administrative Procedure Act and Mandamus Act, which MMJ cited as supporting its argument to keep the suit in Rhode Island federal court, limit relief to when there is no adequate alternative remedy.

"Justice delayed is justice denied," Duane Boise, the president of MMJ, told Law360 on Thursday.

He added the company is close to resolving the outstanding issues with the DEA and anticipate the agency will issue a registration to the company soon but are prepared to file in the circuit courts if they need to.

Representatives for the government could not immediately be reached for comment Thursday.

MMJ is represented by Megan E. Sheehan of Sheehan & Associates.

The government defendants are represented by Brian M. Boynton, Brigham J. Bowen and Hannah M. Solomon-Strauss of the U.S. Department of Justice's Civil Division.

The case is MMJ International Holdings Corp. et al. v. Merrick Garland et al., case number 1:22-cv-00152, in the U.S. District Court for the District of Rhode Island.

CONTACT:
Sara Parker
media@mmjih.com
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SOURCE: MMJ International Holdings

Source: MMJ International Holdings