Approximately 180 million Americans use diet supplements every day, but it is extremely difficult for the FDA to oversee their use. Manufacturers do not need FDA approval before selling dietary supplements, although they are required to prove that any new ingredients are safe for consumption. The burden is on the FDA to prove that a supplement is unsafe before any actions can be taken to restrict its use or take it off the market.
Aegeline Though to be the Culprit
OxyElite Pro contains aegeline, an extract from the Bael tree native to India and Southeast Asia. According to the FDA, aegeline is relatively untested and its side affects are largely unknown, but doctors say they are relatively certain that aegeline was the harmful ingredient in OxyElite Pro that caused serious side effects, including hepatitis and liver damage.
According to WebMD, one person has died, numerous people have been hospitalized, and others have received or are awaiting liver transplants due to the dangerous side effects of OxyElite Pro. After nearly 60 cases of liver damage were linked to the supplement, the FDA required the supplement’s maker, USPLabs, to remove the product from the market in November 2013.
OxyElite Pro Lawsuits
OxyElite Pro was recalled, but not in time to stop a growing number of product liability lawsuits brought by victims alleging that the supplement caused them to suffer hepatitis or liver damage severe enough to require liver transplants.
Concerns about OxyElite Pro began in September 2013 when health officials in Hawaii noticed a growing number of hepatitis and liver injury claims from those who had taken the supplement, which is designed to help lose weight and increase muscle mass. Although most of the OxyElite Pro liver injury cases have occurred in Hawaii, since the recall the adverse side effects of the supplement have begun to spread across the continental U.S., and numerous federal lawsuits have been filed.
The lawsuits raise allegations that USPLabs placed unsafe ingredients in OxyElite and then failed to adequately warn consumers about the risk of liver damage. The U.S. Judicial Panel on Multidistrict Litigation (JPML) will consider a motion later this month on whether to consolidate and centralize all the OxyElite Pro lawsuits filed nationwide in federal court.