Natural products insider writes about Tauler Smith’s recent court victory against Enhanced Athlete and their managing agent Charles Anthony Hughes, a California lawyer who refers to himself as “Dr. Tony Huge” to market patented drugs called SARMs to bodybuilders.
Read the full article on Natural Products Insider.
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.
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
When Allergan PLC alleged false advertising in a lawsuit against large compounding pharmacies, Law360’s reporter turned to Robert Tauler for his insight and expertise on the Lanham Act. “I think this (litigation) may be groundbreaking,” he said. “If you are a large pharmaceutical company, it’ll have ripple effects if you start pursuing compounders.”
Read the story here (subscription may be required): http://bit.ly/2I7WX4g
The Guardian’s top health reporter published an exclusive, three-part package on a raid by British Food Standard’s Agency on the European operation of a Sacramento-based supplement company facing a lawsuit from Tauler Smith for selling the chemical DNP (2,4-dinitrophenol) for human consumption.
Excerpt: “The substance heats up the body’s metabolism, burning fat, but it can cause drastic overheating. Its victims’ organs literally cook inside the body. Once taken, there is no antidote…”
“DNP is basically pesticide coming out of a smoke stack and these folks are ingesting it and losing weight because their body is trying to get rid of it. It is ingested poison,” Robert Tauler told The Guardian.
The stories appeared in both the U.S. and U.K. versions of theguardian.com, as well as in print.
A series of raids in northern England has uncovered an operation suspected of selling a deadly fat-burning chemical used by bodybuilders that has killed eight young people in Britain in the last two years.
Around 11 kilos of the chemical 2,4-dinitrophenol, known as DNP, was found last month at premises in Wigton, Cumbria, alongside other legal supplements and equipment that could be used for making tablets.
Continue reading the story on The Guardian.
A false advertising lawsuit filed against an international sports supplement company based in Sacramento eventually caught international media attention, and the Sacramento Business Journal is covering all the major developments.
“This case is emblematic of the profound dysfunction in the nutritional supplement marketplace,” Robert Tauler told the Business Journal. “Low barriers to entry, high rewards and intermittent regulatory enforcement create perverse incentives for manufacturers and retailers.”
The Sacramento Business Journal has written several stories about the litigation and other interesting developments in this case.
Read the stories here (subscription may be required):
- Sacramento supplement company’s false advertising claims pose danger to consumer health and safety
- Supplements company facing lawsuit suggests patrons could harass opposing counsel
- CEO of Enhanced Athlete arrested for alleged probation violations
- Bodybuilding supplement company says its facility was raided by FDA
- ‘Dr. Huge’ allegedly connected to supplement facilities raided in Europe