HONOLULU, HI and IRVINE, CA (November 14, 2013) – Kenneth Waikiki, a 22-year-old from Kailua-Kona, Hawai‘i, enjoyed working out and going to the beach. He purchased OxyELITE Pro, a dietary supplement manufactured by Dallas-based USPlabs, from a Hawai‘i GNC retailer with the goal of improving his athletic performance. However, instead he suffered from nausea, vomiting, and jaundice and was rushed to the Kona Community Hospital Emergency Department. He underwent a liver transplant in October at The Queen’s Medical Center in Honolulu. Kenneth’s prognosis remains precarious, and he will have to take anti-rejection medication for the rest of his life.
Kenneth is not alone. OxyELITE Pro has been linked to dozens of other cases of liver failure and acute hepatitis throughout the country.
On November 10th, the United States Food and Drug Administration (FDA) announced that USPlabs is recalling the entire OxyELITE Pro product line after receiving multiple warning letters from the FDA regarding its violation of federal drug safety law. In its press release, USPlabs stated, “Epidemiological evidence shows that use of these products has been associated with serious adverse health consequences, namely serious liver damage or acute liver failure, concentrated in Hawai’i.”
The recall is too late for Kenneth and hundreds of other Americans who have already suffered liver damage as a result of taking OxyELITE Pro. But many of these patients will be able to seek justice and accountability in the courtroom. Two law firms anticipate jointly filing a lawsuit this week in Hawai‘i.
Attorney Anne Andrews, who has a national practice in major products liability litigation cases, knows that the liver failure outbreak is national in scope. Her law firm, Andrews Thornton Higgins Razmara, based in Irvine, California, has teamed up with the Wayne Parsons Law Offices to represent people in Hawai‘i like Kenneth who have been diagnosed with acute liver failure, drug-induced hepatitis, or other serious injuries such as stroke or brain hemorrhage, after taking OxyELITE Pro.
“This is also not the first time USPlabs has put Americans’ lives at risk. A prior formulation of OxyELITE Pro contained DMAA, an FDA-banned ingredient responsible for cardiovascular injuries, stroke and death,” Andrews stated. “This industry must be responsible for the safety of the products they put on the market and must be held accountable if their products harm Americans.”
Initial cases emerged out of Hawai‘i, where the most serious liver injury patients were treated at The Queen’s Medical Center. The medical team quickly identified OxyELITE Pro as the common link between the sudden surge of liver failure cases, Honolulu attorney Wayne Parsons,
explained. “But the damage caused by OxyELITE Pro is not limited to Hawai‘i. In fact, we are seeing patients throughout the country who have been severely harmed by this product and deserve justice.”
- In a warning letter issued on October 11, 2013, the FDA informed USPlabs that OxyELITE Pro and VERSA-1, another dietary supplement, were deemed to be adulterated because they contain aegeline. The FDA letter explained that USPlabs failed to provide sufficient evidence of safety regarding aegeline.
- On November 4th, USPlabs replied to the FDA, claiming that aegeline has been used safely for centuries. The FDA took clear action in response and reiterated the fact that distributing and selling adulterated drugs like OxyELITE Pro violates the Federal Food, Drug, and Cosmetic Act.