Supplement manufacturer requests dismissal of indictment on eve of criminal trial

Editor's note: On Oct. 8, the same day this article was published, the U.S. District Court continued the case to the two-week trial calendar beginning Nov. 22, 2021.

Government lawyers on Thursday described as “meritless” a request by Blackstone Labs and former executives of the dietary supplement company to dismiss an indictment.

Recently, lawyers for Blackstone Labs, Aaron Singerman, Phillip Braun and James Boccuzzi, requested dismissal of the indictment with prejudice.

The defendants are charged with introducing into interstate commerce unapproved new drugs, conspiracy to distribute controlled substances, money laundering and other offenses.

A trial is scheduled to begin Oct. 12 against the defendants in Fort Lauderdale in the U.S. District Court for the Southern District of Florida.

Defense lawyers argued in an Oct. 1 motion that the indictment should be dismissed with prejudice due to violations of the Speedy Trial Act, which establishes limits for completing various stages of a federal criminal prosecution.

The U.S. government in February 2017 seized more than $1 million in nutritional supplement products from Blackstone Labs, and the indictment was filed in March 2019—about four years after the government began its investigation with undercover purchases from Blackstone’s website, according to the defendants’ motion.

At the time the indictment was filed, the government had neither completed its investigation nor was it prepared to try its case, the motion added.

“The premature indictment,” defense lawyers wrote, “triggered a cascade of errors that cost the defendants millions of dollars while denying them their statutory and constitutional right to a speedy trial and constitutional right to prepare an adequate defense.”

The defendants’ request is the third motion in which they made “unsubstantiated claims about government misconduct,” and “the current motion falls particularly flat given the defendants’ many attempts to continue trial,” according to an Oct. 7 court filing by lawyers with the U.S. Department of Justice (DOJ).

The prosecution’s filing cited several instances in which the court continued the trial at the request of the defendants. In other cases referenced in the filing, the trial was continued due to the COVID-19 pandemic.

More recently, the defendants requested continuance of the trial until January or March of 2022, DOJ lawyers observed. U.S. District Judge William Dimitrouleas denied the request.

“The government has diligently prosecuted this case,” DOJ lawyers asserted in their court filing. They also described as “fanciful” the alleged discovery violations committed by the prosecution.

As of press time, Dimitrouleas had not ruled on the motion, or a separate request by the defense to suppress evidence based on allegedly unlawful searches and seizures.

Testimony of Blackstone Labs' customers 

Last month, the judge granted, in part, the defense’s motion to forbid the testimony of certain Blackstone Labs customers. However, he ruled certain customers could testify at the trial who allegedly suffered “serious adverse events”—as that term is defined under federal law—associated with the company’s products.

Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, manufacturers of supplements must report to FDA "serious adverse events" associated with their products.

Among the witnesses the government plans to introduce at trial is an individual named “C.H.” in the indictment, who allegedly suffered serious bodily injury due to the use of a Schedule III controlled substance, or anabolic steroid, sold by Blackstone Labs. DOJ lawyers indicated they plan to introduce his testimony about the bodily harm he suffered, as well as the testimony of medical experts who treated him while he was hospitalized for liver and kidney failure.

According to the government's response to the defense's motion, "The FDA was unable to locate any record that Blackstone ever reported an adverse event to FDA."  

It appears two other witnesses described in court documents as "R.R." and "S.L." reported to Blackstone Labs that they were hospitalized, noted the judge, who ruled in a Sept. 15 order that those individuals could testify.

"That testimony may be relevant to allegations that the defendants disregarded complaints from customers who reported getting ill or injured," Dimitrouleas wrote in his order. 

But an account from another Blackstone Labs customer who reported experiencing a medical condition called gynecomastia—what John Hopkins Medicine describes as "a condition of overdevelopment or enlargement of the breast tissue in men or boys"—is not relevant to such allegations, the judge found. 

Defense lawyers in their motion cited several instances of customers who complained about adverse events, including feeling "light-headed" and having "swollen gums," none of which obligated the company under the law to notify FDA.

DOJ and defense lawyers have not commented on the case in response to previous requests by Natural Products Insider.