Metabolife Lawsuit

METABOLIFE CRIMINAL INVESTIGATION . . .

The Justice Department has opened a criminal investigation to determine if Metabolife International lied when telling the FDA they had not received any reports of adverse health effects caused by Metabolife weight loss pill. Metabolife is the nation’s number one maker of ephedra supplements. Since Metabolife is derived from ephedra, a plant, any product containing it can be marketed as an all-natural food supplement and is not regulated except in cases where the FDA can prove the products are dangerous.

Michael Ellis, former president of Metabolife told the FDA in 1998 that, “Metabolife has never received one notice from a consumer that any serious adverse health event has occurred because of the ingestion of Metabolife 356”. When the FDA’s news for their request for the Justice Department’s criminal investigation got out, Metabolife lawyer’s released their records of more than 13,000 health complaints they had received since 1997 from Metabolife consumers. This move by Metabolife was considered “disingenuous” by the FDA after the agency’s attempts since 1997 to obtain this information unsuccessfully due to Metabolife’s repeated refusal and resistance.

Why Is Metabolife Not Federally Regulated?

Metabolife is an ephedra-based product that stimulates the nervous system and speeds up metabolism. Contained in hundreds of other herbal products, despite being linked to more deaths and injuries than every other type of herbal product combined, the 1994 federal law allows ephedra to be exempted from federal regulation because it is classified as a food. Supplements like Metabolife are not subjected to the same strict clinical testing standards as prescription and most over-the-counter drugs. The FDA has been criticized for trying to obtain information on the adverse effects associated to Metabolife and other ephedra products. The FDA has not been able to get Metabolife to provide any information until the Metabolife criminal investigation was launched.

In 1997, Metabolife had started a toll-free number that was included on their product label informing customers to call with questions regarding weight loss. In a five year time period, the Metabolife number received over 400,000 calls, but for the first year the company did not have a system of tracking the questions or complaints. Metabolife responded that “of those calls, between 1997- September 2001, approximately 13,000 reported certain health-related issues and of those, based upon the expert reports explained below, only approximately 80 reports even mention the primary categories of potential concern that FDA has identified,” including seizure, stroke, heart attack, or death. Metabolife did not explain what the other 387,000 calls involved.

There had been 120 more calls that were referred to hospitalization. Metabolife never reported any information to the FDA, nor did the company follow up with the customers, although the company was not required by any law to do so. The FDA had been receiving reports of heart attacks, seizures, strokes, and other health problems from Metabolife users, in addition to other ephedra products users. The FDA has now collected over 100 reports of ephedra related deaths since 1994.

The Public Citizen, who had petitioned the FDA September 5, 2001 for the ban of ephedra containing products like Metabolife, noted in a letter to HHS Secretary Tom Thompson of Michael Ellis’ criminal record. Ellis was convicted in 1990 on a drug-related charge for the illegal manufacture and sale of methamphetamine and pleaded guilty to a felony charge. Methamphetamine can be produced from ephedra.

In addition, Metabolife has had a considerable involvement with political influence. Metabolife was ranked seventh among all pharmaceutical companies nationwide for donating $638,000 to federal campaigns by October 1, 2000. The Texas state health department had been trying to more tightly regulate dietary supplements and had been battling with ephedra makers, and Metabolife had spent over $4 million between 1998 and 2000 to lobby against the state regulations. The San Diego based company also ranked fourth in California for “soft money” contributions with $493,000 in 2000 and a $100,000 donation to Governor Gray Davis’ campaign. Governor Davis announced, in an unusual veto message, that he agreed with virtually all the major arguments for Metabolife regulation. The governor’s office announced on August 16, 2002, that California would regulate ephedra-based dietary supplements, such as Metabolife, unless the federal government takes swift action.

The future of Metabolife is still uncertain because under law the FDA cannot check the safety or effectiveness of herbal products and may not require herbal makers to disclose health hazards they find. Public Citizen concluded their August 15, 2002 letter to Secretary Thompson saying, “Any failure by your department to: a) agree to aggressively pursue a criminal investigation against Metabolife President Michael Ellis for apparently lying to the government; b) to pursue the acquisition of now-sealed court documents concerning serious adverse effects of Metabolife, many likely not to have been reported to the FDA because there is no requirement to do so; and c) to order a ban on the production and distribution of ephedra products will ultimately bring disgrace to you and your department.”

If you have taken, or are still taking Metabolife or any other ephedra-based products, please contact us to confer with a Metabolife lawyer.