Two OxyElite Pro lawsuits have been filed after a nationwide recall.
Hawaii residents Everine Van Houten, 33, and Kenneth Waikiki, 22, allege that OxyElite Pro caused severe health problems, as reported by Honolulu’s KGMB-TV.
Van Houten visited the Emergency Room every week for two months before it was confirmed that she had liver damage. Waikiki fell into a coma and eventually required a liver transplant.
On September 13, 2013, the U.S. Food and Drug Administration (FDA) learned about seven Hawaii residents suffering from acute liver failure/non-viral hepatitis.
According to the FDA, OxyElite Pro is a dietary supplement sold as a “super thermogenic fat burner” that purportedly enhances the fat burning and muscle building benefits of working out. However, the supplements contain Aegeline, a synthetic version of a natural extract from the Bael tree. In October, the FDA sent out a warning letter to USP Labs LLC, the manufacturer of the supplements, pointing out that Aegeline was a new dietary ingredient, lacking adequate information needed to provide reasonable safety assurance, according to the Hawaii Reporter. This could be used to prove the product was dangerous.
On October 11, 2013, FDA warned the company that certain OxyElite Pro and VERSA-1 products were deemed adulterated and that failure to immediately cease distribution of both products could lead to enforcement actions. The FDA also outlined its findings of harm linked to OxyElite Pro.
The FDA urged the public to avoid using products labeled as OxyElite pro or VERSA-1 while they continue their investigation.
A joint investigation by the Hawaii Department of Health and CDC revealed that all of these patients had consumed OxyElite Pro products. Meanwhile, the FDA identified patients outside of Hawaii with similar liver dysfunction following use of OxyElite Pro.
By the end of October 2013, there were 56 reported cases of acute liver failure or acute hepatitis linked to OxyElite Pro, 43 of the cases were in Hawaii. There were 22 hospitalizations, two patients who required liver transplants and one fatality.
While reports do not indicate exactly what Waikiki’s lawsuit is alleging, Van Houten’s suit alleges negligence, breach of warranties and strict liability, according to Natural Products Insider.
According to the FDA, earlier this month, USP Labs issued an OxyElite Pro recall and agreed to destroy warehouse stocks of the supplement. The agency has advised anyone who used OxyElite Pro to seek medical attention if they experience any symptoms of liver injury, including fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay-colored bowel movements, joint pain, yellow eyes and/or jaundice.
If you or a loved one took this product and suffer liver injury, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).