CHARLESTON – The makers of a popular weight loss supplement removed a putative class action lawsuit to federal court after plaintiffs say the supplement was responsible for numerous incidents of kidney damage, including jaundice, and even a death.

In her complaint filed Aug. 7 in Kanawha Circuit Court, lead class plaintiff Rhonda M. Hawkins blames the weight loss drug Hyrdroxycut for numerous reports of serious liver damage that ranged from jaundice to elevated liver enzymes to liver damage requiring a liver transplant. A man even died after taking the supplement, according to the complaint.

The first signs of the drug's toxicity became apparent in 2002 when the Center for Food Safety and Applied Nutrition's adverse event reporting system began receiving information of liver-related illnesses in people who consumed Hydroxycut for as little as a week to as long as two months, the suit states.

Believing these adverse events were caused by an ingredient in Hydroxycut named ephedra, makers of the weight loss supplement removed the ingredient from their drug. However, reports of liver injuries continued to roll in, the complaint says.

In fact, since 2009, at least 23 cases of liver toxicity have been reported in association with use of the weight loss supplement, Hawkins claims.

"The severity of illness ranged from asymptomatic elevations in serum bilirubin to acute liver failure (one patient was reportedly waiting for a liver transplant in 2004) to one death," the suit states.

According to the complaint, a 20-year-old male died after experiencing liver failure and hepatic encephalopathy on Jan. 20, 2007. He was taken to a liver transplant center where he was found to have necrosis of both the large and small intestines. Because of these findings, a liver transplant was abandoned and the male was returned to the intensive care unit where he died on Feb. 12, 2007, the complaint says.

Not only was Hydroxycut responsible for deaths and for liver damage, but a CAERS database revealed the weight loss supplement caused seizures, rhabdomyolysis and at least 46 cases of cardiovascular disease, Hawkins claims.

In one example, a 26-year-old Hydroxycut user increased her Hydroxycut intake from two to four capsules per day on Dec. 6, according to the complaint.

"At 2 p.m. that day, following ingestion of the second serving of 2 caplets, the consumer felt tired and lay down," the suit states. "She was found by another person to be having a 'seizure' (shaking and drooling). The consumer was taken to an emergency room where a physician told her to discontinue using Hydroxycut."

On April 30, the FDA finally wrote to Hydroxycut marketer Iovate to express its concerns that the weight loss supplement may pose a life-threatening situation to some consumers, the complaint says.

Given the seriousness of the allegations, Iovate voluntarily agreed to cease distribution of all existing formulations of Hydroxycut and to recall all existing formulations of Hydroxycut, Hawkins claims.

On May 1, the FDA issued an advisory warning customers to immediately discontinue use of Hydroxycut and saying, "Although the liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risk."

Named as defendants in the suit are Iovate Health Sciences and its subsidiaries, which marketed Hydroxycut, and Muscletech, which manufactured the more than 9 million Hydroxycut products that were sold in 2008.

In the class action suit, Hawkins is seeking a return of the money plaintiffs paid for Hydroxycut products and a court order certifying the putative class. In addition, she is seeking equitable, injunctive and declaratory relief; treble, exemplary, punitive and statutory damages; pre- and post-judgment interest at the maximum rate allowed by law; costs; a disgorgement of profits from the defendants' sale of Hydroxycut; and other relief the court deems just.

Because both Iovate and Muscletech are Canadian organizations and because Hawkins is West Virginia resident, diversity of citizenship exists. Therefore, the defendants removed the case to federal court. In addition, the amount in controversy could exceed more than $5 million.

Harry F. Bell Jr. of The Bell Law Firm in Charleston will be representing Hawkins and the putative class.

John W. Tinney, John H. Tinney Jr. and James K. Tinney of The Tinney Law Firm in Charleston, Lauri A. Mazzuchetti of Kelley, Drye and Warren in Parsippany, N.J., and John W. McGuinness of Kelley, Drye and Warren in Washington, D.C. will be representing Iovate and Muscletech.

U.S. District Court case number: 2:09-cv-995




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