In its defense to a felony prosecution that has alleged fraud and the risk of harm to consumers, USPlabs LLC is seeking to introduce experts to testify its dietary supplement OxyElite Pro was safe.
“Defendants can present multiple experts to show that the USPlabs product in question was safe for consumers under the conditions of use recommended or suggested in the labeling," lawyers for the defendants declared in a July 1 court filing.
An 11-count indictment unsealed in November alleged USPlabs reaped hundreds of millions of dollars through a criminal conspiracy that included the circulation of fake documents to conceal the source of synthetic chemicals in its dietary supplements. The indictment also cited the use of a controversial ingredient DMAA (dimethylamylamine) and an outbreak of liver injuries that was linked to USPlabs’ dietary supplement OxyElite Pro three years ago.
Charges have been brought against USPlabs, its contract manufacturer S.K. Laboratories, and executives of both companies. A Nebraska-based consultant who worked with USPlabs also was named in the indictment.
Lawyers for the defense want the judge overseeing the case to hold a hearing to decide whether experts can testify regarding the safety of OxyElite Pro, or lack thereof. Such expert testimony should be addressed with a hearing before the case goes to trial, the filing said.
“The Government’s most inflammatory and unfairly prejudicial allegation in this case is that Defendant sold a product—OxyElite Pro ‘New Formula’—that placed consumers at risk of physical injury or harm," the defense’s legal team noted in the filing. “This allegation—found only in the misdemeanor in Count 10—will pervade the entire case unless checked. If a jury believes that Defendants sold a dangerous product, it will shape their view about the rest of the allegations and evidence. Thus, this Court must take care that there is a firm scientific basis for such an allegation before it reaches the jury."
The defendants intend to call several experts to support their position that OxyElite Pro was safe, including medical clinicians who can review the medical records, treatment and history of patients who were allegedly harmed by OxyElite Pro or other products relevant to the government’s case. Federal prosecutors also intend to call seven specialists, including an expert who can discuss the safety of dietary supplements generally, as well as the results of research into the safety of OxyElite Pro and its association with a hepatitis outbreak, according to a June 30 court filing.
In a wrongful death lawsuit filed against USPlabs that was dismissed earlier this year with prejudice, a magistrate judge struck the testimony of three of plaintiffs’ experts, who wanted to show the dangers of the ingredient DMAA in USPlabs’ supplement Jack3d and that it was likely a contributing factor in a soldier’s death.
Federal regulators have described DMAA as an amphetamine derivative that doesn’t belong in dietary supplements, though products containing DMAA are still being sold in the U.S. marketplace.
Last month in the USPlabs criminal case, U.S. Magistrate Judge Paul Stickney granted the defendants permission under certain conditions to communicate with each other in order to prepare their defense. The case is pending in the U.S. District Court for the Northern District of Texas, Dallas Division.