A lawsuit was filed Tuesday in U.S. District Court in Hawaii against USPlabs LLC and GNC Holdings, Inc., the manufacturer and retailer who sold OxyELITE Pro, a synthetic dietary supplement that public health officials have determined is the source of an outbreak of acute liver failure and hepatitis among residents of Hawaii.
The lawsuit was filed by Seattle-based Marler Clark and Michael F. O'Connor of Honolulu-based Ogawa, Lau, Nakamura & Jew.
According to the complaint, OxyELITE Pro is marketed and sold by USPlabs LLC as a beneficial dietary supplement for muscle increase and weight loss. The U.S. Food and Drug Administration previously found the supplement to contain Ageline, a synthetic version of a natural extract from the Bael tree.
Aegeline has not been proven to be safe and has not been approved by the FDA for inclusion in dietary supplements. The OxyElite Pro product was sold at GNC retail locations in Hawaii.
According to the complaint, the Hawai'i Department of Health was notified on Sept. 9 that doctors were treating seven patients with severe acute hepatitis and liver failure who shared a history of consuming OxyELITE Pro.
In an Oct. 8 press release, the health department, following its investigation into those cases of liver failure and acute hepatitis, requested that retailers remove OxyELITE Pro from store shelves.
By Nov. 9, USPlabs recalled numerous lots and sizes of various formulations of OxyELITE Pro dietary supplements due to epidemiologic evidence showing that the use of the products was associated with adverse health consequences.
Following the announcement, on Nov. 19, the media reported that health officials were planning to destroy more than $250,000 worth of OxyELITE Pro products. The plan has since been delayed.
Plaintiff Everine Van Houten, a Hawai'i County resident, alleges that she purchased two containers of OxyELITE Pro from the GNC store located in the Prince Kuhio Plaza in Hilo in March of 2013. She states that she also received two sample-sized containers of a "new" formulation of OxyELITE Pro as part of her purchase.
Her attorneys state that Ms. Van Houten consumed both the regular OxyELITE Pro tablets and the "new" formulation of OxyELITE Pro over the next several months and that she was treated for symptoms of abdominal pain, nausea, fatigue and muscle aches on numerous occasions at Hilo Medical Center during that time frame.
Ms. Van Houten alleges that she underwent multiple tests and medical procedures to determine the nature and extent of her liver illness before she saw a September public health notice advising of a possible link between cases of acute hepatitis and OxyELITE Pro products.
According to the complaint, Ms.Van Houten's liver illness was caused by her consumption of the OxyELITE Pro product.
Attorney Bruce Clark stated, "The liver injuries associated with this product are very severe. One would expect that companies selling a 'wellness' product would be scrupulous in ensuring the product is safe for consumers. That certainly does not appear to be the case with OxyELITE Pro."
According to the complaint, Ms. Van Houten was unable to work through much of 2013 due to her acute hepatitis and related symptoms and medical care. Her attorneys claim that she continues to undergo testing and medical monitoring of her liver and continues to experience symptoms related to her liver injury.
A national voluntary recall of OxyELITE Pro has been expanded to include the Raspberry Lemonade Super Thermo Powder.