IronMag Labs Dismissal Reversed by Ninth Circuit, Allowing Ostarine Case to Proceed

A federal appeals court ruled a judge improperly dismissed a lawsuit against seller of Ostarine sports supplements

 

A 9th U.S. Circuit Court of Appeals panel handed client Nutrition Distribution LLC a victory today in its ongoing battle to prevent IronMag Labs LLC from its false advertising of its sports supplements containing Ostarine, a substance developed by pharma giant GTx to treat degenerative muscle diseases and cancers, announced Robert Tauler of Tauler Smith LLP in Los Angeles. The lawsuit alleges that IronMag Labs sells Ostarine without a prescription and markets Ostarine as a bodybuilding supplement, even though Ostarine is still in clinical trials. IronMag does not disclose to its customers that Ostarine has well known side effects, according to the lawsuit.

In 2016, U.S. District Judge Manuel Real dismissed the lawsuit under a legal theory called primary jurisdiction, holding that because the FDA had not yet determined if Ostarine was a new drug requiring further study and testing before it could be distributed, the court could not interfere by making its own determination.

The 9th Circuit reversed and remanded, ruling that the lower court had abused its discretion and misapplied the law. “We are pleased that the Ninth Circuit recognized the Plaintiff’s right to move forward with its claims.” explained Tauler.

Nutrition Distribution‘s position was bolstered by an amicus curiae brief filed by GTx Inc., which said that Ostarine is being investigated as a new drug, is the subject of clinical trials, and, as such, cannot be sold in supplements.

“We are pleased that the Ninth Circuit acknowledged GTx’s position that since Ostarine is the subject of publicly disclosed clinical trials, it cannot subsequently be marketed as a dietary supplement. It is important that the creators of drugs like Ostarine are able to protect their inventions and the integrity of the clinical trial process to ensure the safety of products,” Tauler said.

False advertising lawsuit wrongly dismissed; 9th U.S. Circuit panel rules in favor of Tauler Smith client

A 9th U.S. Circuit Court of Appeals panel handed client Nutrition Distribution LLC a major victory in its ongoing battle to prevent IronMag Labs LLC from its false advertising of its sports supplements containing Ostarine, a substance developed by pharma giant GTx to treat degenerative muscle diseases and cancers, announced Robert Tauler of Tauler Smith LLP in Los Angeles. The lawsuit alleges that IronMag Labs sells Ostarine without a prescription and markets Ostarine as a bodybuilding supplement, even though Ostarine is still in clinical trials. IronMag does not disclose to its customers that Ostarine has well known side effects.

Nutrition Distribution’s position was bolstered by an amicus curiae brief filed by GTx Inc., which said that Ostarine is being investigated as a new drug, is the subject of clinical trials, and, as such, cannot be sold in supplements.

Tauler Smith’s Lisa Zepeda made the successful appeal, arguing in part that “the FDA has made a clear statement that Defendants are selling their products illegally. Thus, even according to the district court’s own reasoning, Nutrition Distribution’s claims are not precluded.”

“We are pleased that the Ninth Circuit acknowledged GTx’s position that since Ostarine is the subject of publicly disclosed clinical trials, it cannot subsequently be marketed as a dietary supplement. It is important that the creators of drugs like Ostarine are able to protect their inventions and the integrity of the clinical trial process to ensure the safety of products,” Tauler said.

The decision was covered by the industry’s leading news source, Natural Products Insider.

  • This story spells out the issues involved in the lawsuit: https://tinyurl.com/FDAs-role
  • Coverage of the 9th Circuit judges’ decision to dismiss, with prejudice, a lower court’s ruling as “an abuse of discretion … due to a misapplication of the law.” https://tinyurl.com/primary-jurisdiction.
  • Watch the arguments made before the court here (Dec. 6, 2017).
  • Read the Jan. 24, 2018 ruling here.

Civil laws clean up the illicit sports supplement marketplace as FDA is overwhelmed, underfunded

Robert Tauler, in this guest column for Law360, spelled out how the illegal and illicit sports supplement business works, where the gaps are in criminally investigating and prosecuting companies that ignore federal rules to push poisons to an unsuspecting public.

“Until these dangerous substances are eliminated from the marketplace, laws that govern competition in the marketplace will remain the strongest weapon to protect consumers and hapless teenagers alike,” Tauler wrote. “The teenagers might be disappointed they are not seeing the “explosive gains” they want right away, but parents will happily exchange dangerous shortcuts to bigger muscles for the comfort that comes from knowing their child is staying drug­free.”

Read the column here (subscription may be required): https://tinyurl.com/Law360-Loopholes