Following nationwide reports of liver problems associated with OxyElite Pro, a Hawaiian woman has filed a product liability lawsuit against USPLabs and GNC in federal court, alleging that the recalled dietary supplement caused her to develop hepatitis.
The complaint (PDF) was filed by Everine Van Houten in the U.S. District Court for the District of Hawaii on November 19, alleging that she was diagnosed with non-viral hepatitis after she began using of OxyElite Pro earlier this year.
According to the OxyElite Pro hepatitis lawsuit, Van Houten purchased tablets from a GNC store in Hawaii in February 2013. By March she began suffering abdominal pain, nausea, fatigue, and muscle aches, which caused her to seek emergency room treatment the following month. After continuing to experience problems throughout the summer, she was hospitalized in August 2013 and diagnosed with acute hepatitis that doctors attributed to an unknown cause at the time.
It was not until September 2013, when health officials began to report multiple cases of hepatitis and liver failure among users of OxyElite Pro that Van Houten made a connection between her illness and use of the dietary supplement.
After nearly 60 cases of OxyElite Pro liver damage were identified by state and federal agencies, the FDA forced an OxyElite Pro recall on November 10. USPLabs has subsequently expanded the recall to include OxyElite Pro flavored thermo powder as well.
Following an investigation by the FDA and other health agencies, it was determined that the weight supplement contains aegeline, an extract from the Bael tree, which is native to India and southeast Asia. The agency determined that the product was adulterated because aegeline is relatively untested and its side effects are unknown.
Most of the cases to date have been in Hawaii, including several individuals who required liver transplants and at least one death linked to the supplement. However, since the recall, a growing number of reports involving OxyElite Pro have surfaced throughout the contiguous United States.
The FDA says that aegeline is considered a new dietary ingredient since it has no safety history in the U.S. before 1994. USPLabs has disagreed with that assessment, however the company agreed to recall OxyElite Pro and has promised to destroy their current inventory, which will reportedly cost the company nearly $22 million, not including legal fees and possible awards from product liability lawsuits that may be brought by consumers diagnosed with hepatitis or other liver injury.
The company also faces an OxyElite Pro Class Action lawsuit filed earlier this month in Florida. However, that lawsuit targets the use of DMAA in OxyElite Pro and Jack3d. The substance, which some say is linked to heart problems, was removed from the products in April 2012 and has been banned in some countries and by Major League Baseball.
Van Houten’s lawsuit charges the defendants with strict liability, negligence, and breach of warranties. She is seeking compensatory damages for lost wages, medical expenses, travel expenses, emotional distress, pain, injury and other costs.