Ephedrine Comes Under Fire
Many lawsuits crop up for companies that make supplements used by athletes and others to enhance workoutsApr 11, 2003 | KNIGHT RIDDER NEWSPAPERS
A Morris Plains, N.J., woman was watching TV with her son when she suddenly lost consciousness. When she awoke minutes later, she said, she had no feeling in the left side of her body.
Five years later, the feeling hasn't returned, she said.
Sayonara Bhattacharya blames ephedrine, a chemical in a diet supplement she said she took to enhance her workouts. She said it caused a debilitating stroke, which has forced the former model to move back to her family's home in Brazil.
"I lost my freedom, I lost everything," said Bhattacharya, 40, who is suing the Long Island-based company that produced the supplement. "If I knew ephedrine could cause the destruction of my life, I never would have taken it."
Bhattacharya's lawsuit is one of dozens across the country against companies that make weight-loss and body-building supplements containing ephedrine. In her case, the product was Ripped Fuel by Twinlab Corp., one of the nation's largest producers of nutritional supplements, with $147 million in reported revenue in 2002.
When she filed suit in Superior Court in Morris County in 2000, Bhattacharya faced an uphill battle to prove that the popular over-the-counter product caused her stroke. But her lawyer says recent studies, combined with the high-profile deaths of professional athletes who used ephedrine, have bolstered her case.
"Before, (the company's) defense would have been, 'If it's not safe, they wouldn't let us market it,'" said David Mazie, a Livingston, N.J., attorney representing Bhattacharya. "But now we know it's not safe. There's a lot of new evidence that we can utilize."
Ephedrine is a chemical derived from the herb ephedra, also known as ma huang. It increases the blood pressure and heart rate and stimulates the central nervous system. About $3 billion worth of ephedra products are sold in the United States each year.
Last week, the U.S. Food and Drug Administration announced that every bottle of ephedra will soon bear warnings that the herb can cause heart attacks, strokes, or even death.
The FDA stopped short of an immediate ban of the herb, which some consumer groups had requested. The agency said it has not compiled enough proof of danger to stand up in court under a 1994 law that severely limits federal safety regulation of dietary supplements.
Twinlab's lawyer says there's not enough proof because the herb isn't dangerous.
The recent backlash against ephedra is a product of misleading studies and media hype, said Joseph Thomas, the company's national counsel. So many people take ephedra that some are bound to die from heart attacks and strokes, but that doesn't mean the herb is to blame, he said.
"All the true science where there has been a controlled clinical study has demonstrated in every occasion that it is safe and efficacious," Thomas said.
Twinlab announced in November that it planned to stop selling Ripped Fuel with ephedrine. But the company blamed slowing sales, not concern that the product was dangerous.
Ephedra entered the national consciousness 18 months ago when Korey Stringer, a professional football player for the Minnesota Vikings, died of heat stroke after a practice. A bottle of Ripped Fuel was found in his locker, although no reports have concluded that it killed him.
Congress held hearings on the use of ephedra in diet supplements last fall.
Then, in February, baseball player Steve Bechler of the Baltimore Orioles died of heat stroke in Florida while taking the weight-loss supplement Xenadrine. The coroner's report found ephedrine in his blood and concluded that it was partially to blame.
Around the same time, a medical journal concluded that ephedrine is unsafe even when taken in recommended doses. The authors of the report in the Annals of Internal Medicine found that U.S. poison control centers reported 1,178 adverse reactions to the supplement in 2001.
Calls to ban the supplement intensified.
Last week, a study conducted at the request of the U.S. Department of Health and Human Services associated the use of ephedrine with health risks such as heart palpitations and nervous system problems. It also found no sufficient evidence that ephedrine enhanced athletic performance or promoted long-term weight loss.
Bhattacharya said she began taking Ripped Fuel in 1996 to energize her workouts at a Gold's Gym. She took about three pills a day, less than the recommended dosage on the bottle, she said.
On Dec. 18, 1998, she suffered her stroke while sitting in her living room with her 9-year-old son, who called a family friend for assistance.
"She went from being a beautiful, vivacious, healthy individual to somebody with severe handicaps who can't live on her own," Mazie said.
Her lawsuit, which says Twinlab "knew or should have known about the health risks posed by ephedrine," is scheduled for trial in September. It seeks an unspecified amount of damages. Judging from other ephedrine cases, however, she probably is seeking at least a six-figure payout.
A federal court in Alabama in January awarded $4.6 million in damages to four former users of the ephedra-based appetite suppressant Metabolife 356. The San Diego company that makes the supplement also faces dozens of other lawsuits.
In February, a Texas jury awarded $500,000 in a lawsuit that blamed Ripped Fuel for causing the death of a man who was taking a National Guard fitness test.
Each ephedrine lawsuit has unique circumstances and will not affect Twinlab's defense in the Bhattacharya case, Thomas said.
Her claims "make very little sense," the company lawyer said. "It's a safe and effective product."
If it is safe, Bhattacharya countered, she would still be able to care for her son on her own.
"People who are taking ephedrine need to be aware of the consequences," she said.