The dangers of OxyElite Pro, a now-banned weight loss supplement, include liver damage, liver failure, and acute hepatitis. In November 2013, Dallas-based USPlabs recalled OxyElite Pro after it was identified as the likely source of a nationwide outbreak that caused dozens of injuries and at least one death. In addition to being linked to liver damage and hepatitis, OxyElite Pro dangers have been reported to include heart attacks, heat strokes, seizures, loss of consciousness, and death.
OxyElite Pro Lawsuit Update 4/16/14: Earlier this month, a panel of federal judges denied a motion by the makers of OxyElite Pro and Jack3d to transfer and consolidate a number of products liability lawsuits to federal court in Philadelphia. The litigation contends that the supplements contained altered ingredients that were unsafe and unapproved by the FDA, leading to a nationwide hepatitis outbreak. Click here to learn more.
Free Confidential Lawsuit Evaluation: If you or someone you love was injured by OxyElite Pro side effects, 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.
What’s the Problem with OxyElite Pro?
In response to a request submitted by the U.S. Food & Drug Administration (FDA), a nationwide OxyElite Pro recall was announced on November 10, 2013, impacting all lots and sizes of the product. The FDA sent USPlabs a letter indicating that due to the reports of liver injuries associated with OxyElite Pro, there is a reasonable probability that the supplement was adulterated.
“We took this step to ensure that adulterated and harmful products do not reach the American public,” said Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor. “We will continue to work with our state, industry and regulatory partners to prevent such products from reaching the public.”
FDA Rules For Dietary Supplements
Manufacturers of dietary supplements such as OxyElite Pro are not required to seek approval from the FDA before selling their products on the U.S. market. They are, however, required to notify the administration of plans to include a ‘new dietary ingredient’ (defined as an ingredient not marketed in the U.S. before October 1994) at least 75 days before bringing the product to market. These companies are required to provide scientific evidence that a new dietary ingredient would be expected to be reasonably safe for use per the supplement’s labeling.
USPlabs did not provide the federally required notice before it began including a new ingredient called dimethylamylamine (DMAA) in OxyElite Pro. DMAA was found to significantly elevate users’ blood pressure, leading to heart attacks, seizures, psychiatric problems, and death. After being held under FDA order, the remaining stockpile of DMAA-containing OxyElite Pro was destroyed.
When USPlabs replaced DMAA with another new dietary ingredient known as aegeline in OxyElite Pro, the company once again failed to take the correct steps and notify the FDA. According to the administration, aegeline is an alkaloid extract derived from leaves of the bael tree, which is native to Asia.
“Twice in a short period, this company has added new dietary ingredients to supplements without notifying the FDA and providing a reasonable of safety, as required by law,” said an FDA representative. “Losses to the company should also serve as a reminder that FDA’s laws and regulations serve a purpose and must be followed.”
Additional Dangers of OxyElite Pro
In addition to being linked to liver failure and hepatitis, OxyElite Pro has been associated with the following dangers:
- Irregular heartbeat
- Heart attack
- Kidney damage or kidney failure
- Psychiatric side effects
- Elevated blood pressure
- Sudden cardiac dangers
What OxyElite Pro Lawsuits Need to Prove
Victims of OxyElite Pro may be entitled to damages through the filing of a lawsuit. If you or someone you love has been injured by OxyElite Pro, you may be entitled to recoverable damages for your losses, including:
- Lost wages
- Wrongful death
- Pain and suffering
- Legal fees
- Reimbursement for medical expenses
With this type of lawsuit, an injured plaintiff may qualify for compensation if the following conditions are met:
- OxyElite Pro has been proven to be unreasonably dangerous. There must be a defect in the product that caused the plaintiff’s injury.
- The product was used in an “ordinary” way, as it was intended to be used per the instructions on the product’s labeling.
- OxyElite Pro was not significantly altered from the condition it was in at the time it was purchased. For example, if a third party had tampered with the packaging of OxyElite Pro after the products had been purchased, it would likely affect the plaintiffs’ claims.
Do I Have an OxyElite Pro Dangers 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 injury and death cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or someone you love was injured by OxyElite Pro, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.