Consumers of Metabolife Products v Metabolife International, Inc.

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Can Using Metabolife Products Be a Fatal Mistake?

The Dugan Law Firm is investigating possible legal actions on behalf of persons who have been harmed by Metabolife International products, such as Metabolife 356, that contain ephedra. While these products are sold as diet aids because they increase the consumer's metabolic rate, they also increase blood pressure and heart rate, potentially leading to serious side effects such as heart attack, stroke, seizure or psychosis. Less-serious adverse effects of ephedra-based products include nervousness, dizziness, tremor, headache, stomach upset, and chest pain. Reportedly, the U.S. Food and Drug Administration (FDA) has received reports of 100 deaths among ephedra users. The most important of the several chemicals in ephedra is ephedrine.

The U.S. Justice Department has recently launched an investigation into the safety of Metabolife products. At issue is a 1998 statement from Metabolife President Michael Ellis to the FDA that his company had "never received one notice from a consumer that any serious adverse health event has occurred because of the ingestion of Metabolife 356." Metabolife has now announced that it will be giving the FDA 13,000 reports from consumers about health-related issues linked to its products. While some 80 of the reports mention serious disease or death, a total of 100 to 200 deal with people who were hospitalized, Metabolife insists they don't prove that ephedra is dangerous when used as directed. The company says that its reports merely were complaints called in to a consumer hot line for weight-loss advice and thus are suspect.

The History of Metabolife

Metabolife founder Michael Ellis developed the herbal supplement in the early 1990s as a means to help his father counter the fatigue of cancer treatment. Ellis, a former California police officer, has had no medical experience. In 1992 Ellis launched his first product, Fosslip, as a bodybuilding formula containing 18 vitamins, minerals, and herbal extracts including an ephedrine derivative. Fosslip did not sell, so in 1995 Ellis renamed the supplement and began to market it as a weight-loss aid. Reportedly, Metabolife's annual revenues now top $1 billion.

Ellis was arrested in 1989 on a charge of helping a friend manufacture methamphetamine. He later pled guilty to a lesser charge. While ephedra is an herbal cousin to methamphetamine, he claims this is merely a coincidence.

Studies Suggest That Ephedra Can Be Deadly

In 2002, the Mayo Clinic revealed the results of a study of 976 adverse reaction reports, relating to products containing ephedra, received by the FDA between 1995 and 1997. The study found 16 cases of stroke, 10 heart attacks and 11 sudden deaths related, at least time-wise, to the use of a product containing ephedra. The physicians conducting the study concluded that (1) underlying heart or vascular disease is not a prerequisite to an ephedra-related adverse event, and (2) the cardio-toxic effects of ephedra are not limited to massive doses.

Previously, two physicians at the University of California, San Francisco reviewed 140 reports of deaths or injuries the FDA received related to ephedra. The senior researcher, Dr. Neal Benowitz, chief of clinical pharmacology at the university, declared that "the substance is unreasonably hazardous as marketed." The results of the study were published in the December 21, 2000, issue of the highly respected New England Journal of Medicine.

The study concluded: Thirty-one percent of cases were considered to be definitely or probably related to the use of supplements containing ephedra, and 31 percent were deemed to be possibly related. Among the adverse events that were deemed definitely, probably, or possibly related to the use of the supplements, 47 percent involved cardiovascular symptoms and 18 percent involved the central nervous system. Hypertension was the single most frequent adverse effect (17 reports), followed by palpitations, tachycardia, or both (13); stroke (10); and seizures (7). Ten events resulted in death, and 13 events produced permanent disability, representing 26 percent of the definite, probable, and possible cases.

Federal Regulators' Hands are Tied

Because dietary supplements are considered foods, not drugs, under a federal law, the 1994 Dietary Supplement Health & Education Act, they do not require FDA approval for safety or efficacy before they are marketed. Instead, the law shifts the burden of proving dietary supplements unsafe to the FDA and state health departments. The FDA still has the authority to regulate herbal products, but it now must prove in court that an herbal product poses a significant or unreasonable risk--or is an imminent hazard--before it can be pulled from shelves.

In June 2002, the U.S. Department of Health and Human Services hired the RAND Corporation to review all scientific evidence on ephedra's safety. Results are due in April 2003.

Canada warned consumers in 2001 not to use ephedra, and it has been banned by the International Olympic Committee, the National Football League and the National Collegiate Athletic Association.

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