The class action lawsuit (CV 09-04337) was filed in the United States District Court for the Central District of California, against the manufacturers of Hydroxycut: Iovate Health Sciences USA Inc. (Blasdell, N.Y.); Iovate Health Sciences Inc., (Ontario, Canada); and MuscleTech Research and Development, Inc. (Ontario, Canada).
According to the complaint, the Hydroxycut products that were the subject of the May 1, 2009 and May 7, 2009 Food and Drug Administration (FDA) recalls, were a series of dietary, weight loss and muscle building supplements and drugs which posed serious health risks, including serious liver injuries, or hepatotoxicity (chemical-driven liver damage).
Because Hydroxycut is a dietary supplement and not a prescription drug, it was not regulated by the FDA and did not require approval by the FDA, according to one of Mr. Thomas’ attorneys, Ilyas Akbari, also a bio-engineer. “In this case they cannot hide behind the dubious FDA preemption defense.
“We believe defendants have known for a long time that their products were unsafe yet they continued to mass market them for profit,” according to Mr. Akbari. He went on to say that questions concerning the safety of Hydroxycut can be traced back to 2003 when the state of Missouri filed a complaint alleging that Hydroxycut’s claims of being “clinically proven” and “safe” were false and misleading. That case settled but nothing changed. The first scientific publications that Baum Hedlund was aware of which associated Hydroxycut with liver injury were reported in March 2005. Since then, numerous publications have reported injuries associated with these products and, recently, at least 23 adverse event reports were submitted to the FDA. The FDA informed Iovate of its belief that Hydroxycut was not safe. The manufacturers finally agreed with that assessment, which led to the May, 2009 recalls.
Baum Hedlund warns that the number of adverse events has almost certainly been under-reported. Approximately 15% of the U.S. population uses dietary/weight loss supplements and Hydroxycut, which was promoted as “America’s #1 Selling Weight-Loss Supplement,” was by far the leading product in this market, selling about 9 million units in 2008 alone. With such wide usage, the actual number of reported cases likely underestimates the true incidence of injuries by several degrees of magnitude, especially here in Southern California, which may have been hit the hardest by this fraud. Californians have always been among the most health conscious in the country and probably consume dietary supplements on a larger scale than any other part of the nation.
Baum, Hedlund, Aristei & Goldman is recognized as a preeminent plaintiff national mass disaster law firm which handles personal injury, wrongful death and consumer class actions across the U.S. They routinely handle complicated evidence and choice of law issues in both state and federal courts throughout the country.