OxyElite Pro Lawyer | OxyElite Pro Lawsuit
OxyElite Pro Recalled By FDA, oxyelite pro recall lawsuit, oxyelite pro lawsuit, oxyelite pro attorney
Manufacturers of OxyElite Pro, a popular dietary supplement, have agreed to recall the drug after the U.S. Food and Drug Administration (FDA) prompted such action. OxyElite Pro products have been linked to dozens of cases of non-viral hepatitis and acute liver failure. So far, at least one person allegedly has died as a result of taking OxyElite Pro, and several patients have required a liver transplant. Of the 41 cases being investigated by the Department of Health in Hawaii, one patient has died and two have received liver transplants. They range in age from 16 to 67 years old. Health officials say most had been taking OxyELITE Pro.
If you or a family member has suffered serious injury including acute liver failure or hepatitis as a result of taking the dietary supplement OxyElite Pro, you may be entitled to a claim under law. You should consult a OxyElite Pro lawyer as soon as possible, to find out if you should file an OxyElite Pro Lawsuit if you’ve been injured. It is important to consult an OxyElite Pro lawyer early, as this will serve to ensure that your rights to a claim remain fully protected. The OxyElite Pro attorneys at Wright & Schulte LLC are dedicated to ensuring that the victims of the OxyElite Pro recall receive the justice they deserve. To learn more, contact Wright & Schulte LLC as soon possible for a free, no-obligation OxyElite Pro lawsuit consultation to guarantee you are treated fairly and receive all the compensation the law allows.
OxyElite Pro Lawsuit Background
OxyElite Pro is a dietary supplement marketed and manufactured by a company called USPLabs. The supplement was advertised as a weight loss aid that assists in the building of muscles.
September 2013:, the FDA was alerted about seven cases of patients suffering from acute liver failure and/or non-viral hepatitis in Hawaii. During the joint investigation by the Hawaii Department of Health and the U.S. Centers for Disease Control (CDC) that followed, it was discovered that in all cases, the patients had consumed OxyElite Pro dietary supplement products.
October 2013:, the FDA warned the company that certain OxyElite Pro products are considered adulterated because they contain a new dietary supplement called aegeline, for which there had been no safety evidence provided. The FDA warned USPLabs that failure to immediately stop all distribution of OxyElite Pro could result in enforcement actions.
As of the end of October 2013, there were more than 50 cases of acute hepatitis or acute liver failure linked to OxyElite Pro. The FDA’s investigation is ongoing.
November 2013:, two OxyElite Pro lawsuits have been filed by Hawaii residents. One by a The 33-year old woman from Hilo, Hawaii who’s doctor thought it was gallstones causing excruciating pain so she underwent numerous tests. But all of those tests came up negative. The woman had been taking the diet pill OxyElite Pro and was actually suffering from liver damage. A 22-year old man from Kona, Hawaii was only taking the new formula of OxyElite for a month, but weeks later, he was in a coma. He received a liver transplant and is now recovering at home. Both have filed OxyElite Pro Lawsuits after suffering side effects. More OxyElite Pro lawsuits are expected to be filed.
USPLabs has agreed to a recall of OxyElite Pro. In addition, the company has assured the FDA that it will destroy its warehouse stocks of the drug, with a total retail value of approximately $22 million. The FDA will oversee the destruction of the product.
OxyElite Pro Recall And FDA Rules For Dietary Supplements
Manufacturers of dietary supplements such as OxyElite Pro are not legally required to provide proof of a supplement’s safety nor effectiveness prior to marketing. They are required, however, to notify the FDA of plans to include a “new dietary ingredient” (defined as a dietary ingredient not marketed in this country prior to October 15, 1994) at least 75 days before the product goes to market. These companies are required to submit evidence that a new dietary ingredient would reasonably expected to be safe under the conditions of recommended use per the supplement’s labeling.
The makers of OxyElite Pro did not provide the federally required notice before it began including a new ingredient called dimethylamylamine (DMAA). The new dietary ingredient was found to cause high blood pressure leading to heart attacks, seizures, psychiatric disorders, and death. After being held via an FDA administrative detention order, the stockpile of OxyElite Pro containing DMAA was destroyed.
When they replaced DMAA with another new dietary ingredient called aegeline, the makers of OxyElite Pro once again failed to notify the FDA. According to the federal agency, non-synthetic aegeline is an alkaloid extract from leaves of the bael tree, which is native to Asia.
According to an FDA representative, “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. Losses to the company should also serve as a reminder that FDA’s laws and regulations serve a purpose and must be followed.”
OxyElite Pro Linked To Liver Failure And Hepatitis
The FDA is advising consumers in and throughout the United States to exercise extreme caution if they have taken the dietary supplement OxyElite Pro. OxyElite Pro products have been recently tied to many cases of liver failure and hepatitis, resulting in required liver transplants and even death. Victims of these severe side effects may be entitled to damages from a lawsuit.
If you have suffered serious injury as a result of the side effects of 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
About Wright & Schulte LLC And Filing An OxyElite Pro lawsuit
The OxyElite Pro attorneys at Wright & Schulte LLC are dedicated to ensuring that the victims of the OxyElite Pro recall receive the justice they deserve. To learn more, contact Wright & Schulte LLC as soon possible for a free, no-obligation OxyElite Pro lawsuit consultation to guarantee you are treated fairly and receive all the compensation the law allows.