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DOJ to Investigate USPlabs Over OxyElite Pro Hepatitis Outbreak

Dallas-based supplement manufacturer USPlabs is under criminal investigation by federal authorities after a 2013 hepatitis outbreak was linked to the company’s OxyElite Pro fat burner. The outbreak was associated with hundreds of injuries and at least 1 death in more than a dozen states around the U.S.

Free Confidential Lawsuit Evaluation: If you or a loved one has been injured by OxyElite Pro, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.

Will DOJ Prosecute Dallas Supplement Manufacturer?

The U.S. Attorney’s Office in Texas said in Nov. 2013 that no charges had been filed against USPlabs; however, this doesn’t mean the supplement maker is out of the woods. The federal government often takes years to file charges in cases of foodborne illness.

The Dallas Morning News first reported on the USPlabs investigation on Dec. 15, 2014. The U.S. Food & Drug Administration (FDA) reportedly suspected that the company and its owners — Jacob Geissler, Jon Doyle and Matt Hebert — violated the Federal Food, Drug & Cosmetic Act (FDCA) by introducing an adulterated food into interstate commerce. Federal authorities raided USPlabs’ facilities, confiscating business records including OxyElite Pro sales records and product complaints, and seized more than $1 million from a JPMorgan Chase Bank account, according to court documents.

Geissler, Doyle and Hebert may face prison time if they are found guilty of violating FDCA. The commission of a “prohibited act” under FDCA is classified as a misdemeanor, punishable by up to 1 year in jail for each violation even if the men didn’t intend to do anything wrong. If a judge or jury determines they acted with intent to defraud, they would be convicted as felons and face up to 3 years in prison for each count.

USPlabs’ Legal Problems Go Back Years

USPlabs has been on the FDA’s radar since at least 2010, when consumers started filing complaints about adverse reactions to the company’s products. That summer, following an inspection of USPlabs’ Dallas facility, FDA cited the company for failing to comply with regulations, according to court records. USPlabs promised to make the necessary charges, but ultimately failed to bring the plant up to compliance, according to a Nov. 6, 2013 affidavit signed by John Hover, special agent with FDA’s Office of Criminal Investigations (OCI).

In 2012, the FDA conducted another inspection after reports surfaced of a 22-year-old soldier who allegedly suffered a cardiac arrest and died after using Jack3d, a DMAA-containing supplement made by USPlabs. Records indicate the soldier collapsed on June 1, 2011, while training with his unit at a military base in Fort Bliss, TX. His parents sued USPlabs, alleging that Jack3d caused his death.

On April 24, 2012, FDA sent USPlabs a warning letter ordering the company to remove all of its supplements that contained DMAA from the market.

“Failure to immediately cease distribution of your products Oxy Elite Pro and Jack3D and any other products you market that contain dimethylamylamine could result in enforcement action by FDA without further notice,” the letter said.

It took USPlabs a full year to comply, citing business reasons rather than health concerns for its decision to reformulate its supplements without DMAA. During the summer of 2013, USPlabs destroyed over $8 million worth of DMAA-containing supplements, a move that would finally bring the troubled company into full compliance… for a few short months.

Hepatitis Outbreak

On Sept. 25, 2013, the Hawaii Department of Health (DOH) and Centers for Disease Control and Prevention (CDC) contacted the FDA about an outbreak of hepatitis that had been linked to the reformulated version of OxyElite Pro. FDA obtained a search warrant to again search the company’s Dallas facility on Nov. 1, 2013, at which time the outbreak had caused 18 hospitalizations, 1 liver transplant and at least 1 death. By March 2014, CDC had identified 97 hepatitis cases in 16 states linked to the outbreak. Following an investigation, FDA identified a “causal connection” between the illnesses and aegeline, a substance contained in the new version of OxyElite Pro that the agency had determined to be adultered.

Civil Litigation

As a result of the hepatitis outbreak, USPlabs faces dozens of civil lawsuits pending in state and federal courthouses around the country. In Dec. 2014, a panel of federal judges denied a request by the company to centralize 16 personal injury lawsuits filed against it and other co-defendants, including GNC. The judges noted that only 5 lawsuits against the companies are pending outside of Hawaii, and most of those pertain to DMAA products rather than aegeline, which the majority of the complaints relate to.

Do I Have an OxyElite Pro Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in OxyElite Pro lawsuits. We are handling individual litigation nationwide and currently accepting new OxyElite Pro injury and death cases in all 50 states.

Free Confidential Case Evaluation: If you or a loved one has been injured by OxyElite Pro side effects, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.

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