Diet aids blamed in lawsuits Many companies change product labels

Sunday, July 23rd 2000, 12:00 am
By: News On 6

Dozens of lawsuits have been filed around the country against makers of the controversial dietary supplement ephedra, blaming the stimulant for causing serious illness or death.

The Washington Post found 33 cases that companies have settled since 1994 with claimants reporting adverse reactions ranging from nervousness and insomnia to cardiac arrhythmia, high blood pressure, seizure and stroke. The Post found 42 more cases pending, including two seeking certification as class action suits, representing potentially hundreds of people.

With the Food and Drug Administration's efforts to restrict ephedra stymied by the industry, the courts have become the main battleground in the fight over the supplement, enabling consumers to recoup damages from companies that aggressively promote their products as a safe way to lose weight or boost energy.

"You're dealing with such a large industry, and you're so angry there's nothing you can do," said New Jersey's John Lesemann, whose son John, 21, collapsed and died during a workout last year after taking an ephedra product.

One knowledgeable insurance broker said lawsuits already have prompted insurers to raise ephedra companies' liability rates and appear to have begun affecting how the companies do business. Company attorneys routinely review and suggest changes in ephedra product labels.

Despite these changes, companies maintain that their products are safe if taken as directed, and, with help from congressional supporters, have been able to discredit the FDA's efforts to amass data to the contrary.

On Aug. 8, the FDA will hold a public meeting to discuss 148 new reports of serious illness and death related to ephedra, cases the industry's research and lobbying group, the Ephedra Education Council, already has dismissed as being based on "insufficient data." A council study issued in May identified "25 serious adverse events" from 3 billion doses of ephedra products consumed in 1999.

"These figures are very much in line with virtually all other food products that companies manufacture and market on a regular basis," said Wes Siegner, counsel to the Ephedra Council. "Why does the FDA keep reporting [their] numbers out and using the phrase 'associated with ephedra,' promoting some sort of causal relationship that doesn't exist?"

Ephedra is derived from the Chinese herb ma huang, and has long been used as a treatment for asthma. But as a powerful stimulant, supplement companies today promote it either as an energy-booster or a weight-loss aid under brand names such as Metabolife 356, Ripped Fuel, Ultimate Orange and Hydroxycut. And because of its potentially powerful "rush," it is occasionally sold as "legal speed."

There is no agreement on what constitutes a "safe dose" of ephedra. Most companies have agreed to a labeling standard of 25 milligrams per serving and no more than 100 mg per day. The FDA failed to impose a standard of 8 mg per serving and 25 mg per day after the industry questioned FDA research.

Under the 1994 Dietary Supplement Health and Education Act, ephedra products may be marketed without FDA screening and are sold with almost no restrictions.

In the absence of stronger federal regulation, at least 12 state or local governments have imposed some restrictions on ephedra sales.

But lawsuits may provoke the greatest changes in the industry. For example, ephedra first gained legal notoriety in 1994, when an Austin woman died and more than 100 Texans fell ill after taking Nature's Nutrition Formula One, an ephedra product made by Chemins Co., of Colorado Springs, and distributed by a Texas company.

Over the years, Chemins and the now-bankrupt Texas distributor settled at least 21 lawsuits. Terms of the agreements were sealed, as were most of the accompanying court papers.

The industry's confidence in combating the government has given it an intimidating public presence, but the lawsuits tell a different story – of image-conscious companies willing to settle in exchange for having case records sealed from public scrutiny.

The suits are changing the way ephedra companies do business. Industry groups have agreed to stop marketing ephedra as causing an herbal high and have added label language to discourage teenagers from using it.