HONOLULU (CN) - Two dozen people got nonviral hepatitis from the "OxyElite Pro" diet supplement, an alleged victim claims in a lawsuit against USPlabs and GNC Holdings.
Everine Van Houten sued the two companies in Federal Court.
USPlabs admits that "several formulations of the product" have been recalled, due to "serious liver damage and/or acute liver failure," Van Houten says in the lawsuit.
"On September 9, 2013, the Hawaii Department of Health ('DOH') was notified of seven patients with severe acute hepatitis and sudden liver failure of unknown cause," the complaint states. "These patients were previously healthy. Doctors reported that all seven patients had consumed defendant USP's product OxyElite Pro marketed for weight loss and muscle gain prior to onset of their illnesses.
"To date, clinicians have reported at least 45 patients to Hawaii DOH in response to a public health alert. Of those, 24 patients, including the original seven, have been confirmed to have acute hepatitis after using OxyElite Pro during the 60 days before illness onset."
Van Houten claims the U.S. FDA notified USP on Oct. 11 "that its OxyElite Pro products which contained aegeline may be deemed adulterated because they contain a new dietary ingredient for which there was inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury."
The FDA announced on Nov. 9 that USP had issued a national recall of the product, due to serious risk of liver damage.
Aegeline is "a synthesized version of a natural extract from the Bael tree," and has not been approved by the FDA as a diet supplement, Van Houten says.
Recalled products included OxyElite Pro Super Thermo capsules, OxyElite Pro UltraIntense Thermo capsules and OxyElite Pro Super Thermo Powder.
Van Houten says she was hospitalized with common symptoms of hepatitis, including malaise, nausea and anorexia.
She seeks damages for product liability, negligence and breach of warranty, lost wages and pain and suffering.
She is represented by Michael O'Connor, with Ogawa, Lau, Nakamura & Jew.
A supine Congress allows diet supplements to be loosely regulated.
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