A lawsuit was filed Tuesday in U.S. District Court for the District of Hawaii (Case No. CV 13-00635LEK-KSC) 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 Hawai’i.[1] The lawsuit was filed by Seattle-based Marler Clark, the nation’s leading law firm representing victims of foodborne illness, 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.[1] 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 September 9, 2013 that doctors were treating 7 patients with severe acute hepatitis and liver failure who shared a history of consuming OxyElite Pro. In an October 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.[2] By November 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.[1] Following the announcement, on November 19, the Hololulu Star-Advertiser reported that health officials were planning to destroy over $250,000 worth of OxyELITE Pro products.[3]

According to the complaint, 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, Hawai’i in March of 2013. Court documents state that she also received two sample-sized containers of a “new” formulation of OxyElite Pro as part of her purchase. The lawsuit alleges 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 timeframe. The lawsuit alleges that Ms. Van Houten underwent multiple tests and medical procedures to determine the nature and extent of her liver illness before she saw a September, 2013 public health notice advising of a possible link between cases of acute hepatitis and OxyElite Pro products. Court documents further state that Ms.Van Houten’s liver illness was caused by her consumption of the OxyElite Pro product.

Attorney Bruce Clark stated: “We are alleging in this lawsuit that OxyElite Pro was unsafe for human consumption and are asking the Court for just compensation for my client’s injuries.”

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. Court documents state that she continues to undergo testing and medical monitoring of her liver and continues to experience symptoms related to her liver injury.

BACKGROUND: Marler Clark has represented thousands of victims of E. coli and other foodborne illness outbreaks since the 1993 Jack in the Box E. coli outbreak (Pierce County Superior Court Case No. 93-2-00930-1). The law firm has recovered over $600 million for victims of food-related outbreaks.

1. OxyElite Pro Supplements Recalled. U.S. Food and Drug Administration. Last Updated Nov. 18, 2013.

2. See “Department of Health Requests Voluntary Removal of Oxyelite Pro Supplement from Sale.” Hawai’i Department of Health. October 8, 2013.

3. See “Dodgy dietary supplement is headed to the incinerator” Sarah Zoellick, Honolulu Star Advertiser. November 19, 2013.