EPHEDRA LAWSUIT

The safety of ephedra products, like Metabolife, has continued to be debated over the years in addition to whether federal and state lawmakers and regulators are adequately policing the diet industry as a whole. In 1999, the FDA tried to enforce dosage requirements for ephedra supplements like Metabolife, but congressional investigators criticized its use of adverse event reports and the FDA stopped pushing for it. In a 1997 FDA proposal for safety measures to be put into place for ephedrine dietary supplements, the Deputy Commissioner of Food and Drugs, Dr. Michael Friedman, stated that “consumers should be aware that just because a product is labeled ‘natural’ or from an herbal source it is not guaranteed to be safe.”

The 1997 FDA proposal noted that since 1994 the agency had received and investigated more than 800 reports of adverse events associated to ephedra products, including death, seizures, heart attacks, strokes, high blood pressure, irregularities in heart rate, insomnia, nervousness, and tremors and headaches that mainly occurred in young to middle aged adults that were otherwise healthy. Bill Gurley, a University of Arkansas pharmacologist, said in 1999 that he was worried about people taking ephedra products and that “if a conventional pharmaceutical company had this kind of quality control, the FDA would shut them down in a heartbeat.” When Gurley analyzed about 20 ephedra products he found that there was great variability in the amount of active ingredient between products, in addition to within the same brands. Now, after years of trying to obtain Metabolife reports on consumer complaints the agency asked the Justice Department to pursue a criminal investigation on Metabolife. Lester Crawford, deputy commissioner of the FDA, stated, “we are greatly disturbed that Metabolife has repeatedly refused to cooperate with the FDA.”

Michael Ellis, former Metabolife president, told the FDA in 1998 in a statement that the company had “never received one notice form a consumer that any serious adverse health event has occurred because of the ingestion of Metabolife 356.” Information obtained from Metabolife lawsuits show that Metabolife has received reports of Metabolife adverse reactions according to a lawyer from the Justice Department. The Justice Department is trying to obtain the records for the criminal investigation that had been protected by judicial gag orders.

A few hours after news that a federal investigation on Metabolife was made public, Metabolife announced they were finally going to give the FDA the 13,000 complaints it has received since 1997, with 80 of them involving deaths, seizures, heart attacks, or other serious events. The number that Metabolife provided caused even more concern than initially thought, according to Dr. Lester Crawford, the acting commissioner of the FDA. Crawford finds that “there is even more concern than when we started the investigation three weeks ago, now they have come forward with at least 80 serious adverse event reports. We still have Americans who are consuming this product, and allegedly vital information is being withheld from us, and we are reaching the end of our tethers.”

Although Metabolife claims to be involved in no wrongdoings and has described themselves as “being totally transparent”, Crawford thinks that Metabolife’s last minute attempt to be forthright is insincere, saying “given their (Metabolife’s) long history of being uncooperative, we view their offer to make these reports available now to be disingenuous.” The Public Citizen Health Research Group had petitioned the FDA to pull ephedra products such as Metabolife off the market on September 5, 2001. Public Citizen wanted “a rapid response to this urgent petition. From the perspective of defending the public health, you must be willing to take on this drug (ephedra)-pushing part of the dietary supplement industry.”

The future of Metabolife continues to be investigated, but already a growing list of organizations has banned ephedra-based products. The list of organizations to not allow Metabolife and other ephedra products includes, the National Football League, the International Olympic Committee, and the National Collegiate Athletic Association. Last year the Canadian government warned people to not use Metabolife or any other ephedra products. If you have taken, or are still taking Metabolife or any other ephedra-based products, please contact us to confer with a Metabolife lawyer.