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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Proposed Class-Action Lawsuit Filed Against Manufacturer & Distributor of OxyElite Pro

Posted in FDA Regulation, Lawsuits, Safety Alerts

A man by the name of Sandeep Barot has filed a proposed consumer protection class-action lawsuit against the manufacturer and distributor of dietary supplements that allegedly cause liver damage. See Barot v. USPLabs LLC et al., No. 1:14-cv-00562, complaint filed (D.N.J. Feb. 3, 2014).

The defendant companies are USPLabs, LLC (“USPLabs”) and General Nutrition Center Holdings Inc. (“GNC”). USPLabs sells a variety of energy and weight loss dietary supplements under the brand name of OxyElite Pro through GNC.

The complaint was filed in the U.S. District Court for the District of New Jersey. In it, Plaintiff Barot says he bought and used OxyElite Pro supplements while living in New Jersey between March 2010 and October 2011. He says he bought the product at a GNC store. Barot says OxyElite Pro was sold in New Jersey between January 2008 and November 2013.

In April 2012, the Food and Drug Administration warned USPLabs about the use of a dangerous stimulant called dimethylamylamine (“DMMA”) in its products. A class-action complaint followed and was resolved by a settlement agreement. Hogan v. USPLabs LLC, No. BC486925 (Cal. Super. Ct., L.A. County).

However, during and subsequent to Hogan v. USPLabs, LLC, Defendant USPLabs contained and or included another dangerous ingredient in OxyElite Pro called, Aegeline. Public health officials are currently investigating severe illnesses allegedly connected to Aegeline, including liver disease and hepatitis.

Plaintiff Barot points to medical records submitted to the FDA by the Hawaii Department of Health in which patients who used OxyElite Pro became severely ill. The complaint states that the use of the product was the only common factor among the patients and many became well again after stopping its use. Therefore, the complaint argues, the likelihood that OxyElite Pro caused the illnesses is strong.

While some consumers were lucky enough to get well after they ceased ingesting the dietary supplement, for others, the damage had already been done. Several patients sustained liver injuries that required transplantation. Tragically, one patient died before a transplant could be performed. As of February, OxyElite Pro has been linked to 97 cases of hepatitis.

On Oct. 11, 2013, the FDA issued a warning to USPLabs to stop distribution of all products containing aegeline. The company conducted a voluntary recall about one month later, but Barot says it failed to provide any notice to consumers.

The complaint alleges violations of the New Jersey Consumer Fraud Act, N.J. Stat. Ann. § 56:8-1; breach of implied warranty; unjust enrichment; and violation of the Magnuson-Moss Warranty Act, 15 U.S.C. § 2301.

Specifically, Barot says he and other potential class members suffered economic damage in buying USPLabs’ products, which they would not have taken had they known of aegeline’s potential adverse effects. He also alleges that inadequate labeling on the product constituted an unfair trade practice because the ingredients were unfit for safe use and that the defendant companies were unjustly enriched at the expense of consumers’ health.