Deseret News – Proposed SARMs Control Act could be tougher

Rob Tauler‘s undisputedly one of the nation’s experts in the legal fight to protect consumers and the natural supplement industry against unproven chemicals promoted by unscrupulous manufacturers and retailers. Here’s his guest op-ed from the Deseret News saying the proposed SARMs Control Act of 2018, introduced by Sen. Orrin Hatch and Sen. Sheldon Whitehouse is a great first step — but it needs more teeth.

Natural Products Insider Updates on Enhanced Athlete Case

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.

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

Tauler Smith Obtains Five Figure Sanctions Award Against Opposing Counsel for Attorney Misconduct

Los Angeles, Nov. 15, 2017 — A Los Angeles Superior Court judge last month dispensed with one of the complaints against Pablo David Cienfuegos, attorney Mona Deldar, and their businesses, granting the defendants’ motion to completely dismiss that lawsuit, defense attorney Robert Tauler announced. In addition, the court imposed $11,460 in sanctions against a large regional law firm.

“The court agreed with our argument that filing a second complaint after the court had already dismissed one lawsuit on the same facts was an impermissible attempt to circumvent a court order,” explained Tauler, of Tauler Smith LLP in Los Angeles.

Plaintiffs Joubin Sedgh and Adinja LLC allege that the defendants and their businesses, Serfin Capital Secured High Yield Income Fund, Serfin Capital LLC, and Deldar Legal, defrauded them in the sale and transfer of property.

“The court’s ruling sends a message that litigants can’t be bullied,” stated Tauler. “Just because a party engages a big firm, does not mean that they will get favorable treatment in court.”

Tauler Smith LLP specializes in high-stakes commercial litigation representing both plaintiffs and defendants in a variety of areas, including: false advertising, business disputes, and unfair competition.

Allergan PLC sues compounding pharmacies over false advertising

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

‘Seminal’ Allergan Cases Test Copycat Drug Limits

Law360, New York (November 27, 2017, 11:08 PM EST) — Two recently filed lawsuits from Allergan PLC are teeing up a pivotal test of the extent to which drug compounders can mass-produce virtual copies of brand-name prescription drugs, attorneys say.
Continue reading the story on Law360.

The Guardian: U.K. sellers of deadly pesticide for weight loss unmasked in California lawsuit

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.

UK raids uncover suspected suppliers of deadly diet drug

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.