Ephedra Products Users v Ephedra Products Manufacturers

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Ephedra Called "Unreasonably Hazardous"

The Dugan Law Firm is investigating possible legal actions against various manufacturers of dietary supplements containing ephedra (also called ma huang) by people who were harmed by ephedrine, which is one of the compounds found in ephedra. Ephedrine is used in a few FDA-regulated over-the-counter asthma medications, but it is also sold in some 200 unregulated dietary supplements, for weight loss, building muscle or boosting energy, and occasionally in large doses as an "herbal high." Americans consume an estimated three billion doses per year. At least 54 deaths and about 1,000 reports of complications have been linked to ephedra since the mid-1990s. Use of products containing ephedra has been linked to dizziness, nervousness, rapid heartbeat, insomnia, heart arrhythmia, heart attack and stroke.

Like its chemical cousins the amphetamines--speed--ephedrine is a stimulant. It curbs appetite, constricts blood vessels and raises blood pressure. Herbal Fen-Phen, a popular herbal formulation used for dieting, is a combination of ephedra and St. Johns Wort. The ECA Stack (ephedra, caffeine, aspirin) has been used by bodybuilders to burn fat, and increase energy.

There have been several reports of ephedra-induced psychosis, including agitation, paranoia, depression and hallucinations. A recent case reported in the British Medical Journal involved a 34-year-old man who jumped out a second-story window to escape imagined attackers. In the emergency room, doctors determined that the patient, who had no history of mental illness, had been taking ephedra for 10 days. His symptoms disappeared once he went off the pills.

A federal law known as the Dietary Supplements Health and Education Act, which was passed in 1994, makes it difficult for the U.S. Food and Drug Administration (FDA) to regulate ephedra and other products that are considered nutritional supplements rather than drugs.

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.

Halt Ephedrine Abuse Today (HEAT) was formed in February, 1998. In March, 1997, 24-year-old Kristopher Michal died from using a product containing synthetic ephedrine. His mother, Barbara Michal of Novi, Michigan, started researching this drug and met Henry and Katy Porras of Fillmore, California. Their 15-year-old daughter, Rosanna, died in April, 1998 after using an ephedra product. The three parents joined forces to create HEAT.

HEAT is conducting a survey of ephedra users. As of August 11, 2000, of the people who responded to this survey, 60% of the people using only herbal ephedrine products reported side effects of some kind, and 26% reported that they were addicted. The vast majority of these people were taking the recommended dosage or less. The figures are even higher among people using synthetic ephedrine products.

The stories of several people who may have been harmed by ephedra have come to light. While these people are not necessarily part of an ephedra class action, their experiences illustrate the damage that ephedra may do.

In August, 2000, Hannah Zechzer testified at an FDA public meeting that, after taking diet pills made with ephedra for only a week, "I had respiratory failure and heart failure. When I was taken to the hospital, I was termed a 'train wreck' because there were so many things going on with me."

On April 8, 1998, 15-year-old Rosanna Porras collapsed during soccer practice and died without regaining consciousness. She had taken Ripped Fuel just before practice to boost her energy. It turned out she had a rare congenital heart condition, Bland-Garland-White syndrome.

On June 6, 1996, according to the Food and Drug Administration, a healthy 38-year-old man took his usual dose of Ripped Fuel along with a cup of coffee and went jogging for 20 minutes. He had been taking two capsules of the supplement each morning for one year as directed on the product label. After returning home, he was talking with his family when he suddenly collapsed. He was in full cardiac arrest when paramedics arrived and could not be resuscitated.

Earlier in 1996, George Korizis, a master's candidate in mechanical engineering at Tufts University, was found dead in his room after taking Ripped Fuel, an ephedra product marketed to body builders to lose fat and build muscle. A health-food enthusiast who did not smoke cigarettes and rarely drank alcohol, Korizis had been taking the product before his workouts for six months. At autopsy, the young man's heart was riddled with bits of dead tissue, a potential side effect of stimulants.

In the spring of 1996, Peter Schlendorf, 20, a student at the State University of New York in Albany, died in a Florida hotel room during spring break, after taking "Ultimate Xphoria." The manufacturer settled the resulting lawsuit for $2.5 million.

On February 12, 1996, a 30-year old woman started taking an ephedrine dietary supplement which also contained caffeine. She immediately experienced manic symptoms and insomnia. Within a week, she started to hear voices and she exhibited bizarre behavior. She was admitted to the psychiatric ward of the medical center and was diagnosed as having ephedrine-induced psychosis. She had no history of any psychiatric condition prior to her admission to the hospital.

In 1994, an Austin woman died and 100 other Texans became ill after taking "Nature's Nutrition Formula One."

In December 1993, a 44-year-old man died from a heart attack approximately 3 weeks after beginning daily use of a dietary supplement containing ephedrine. He was an active swimmer and tennis player with no known cardiovascular risk factors. He received the dietary supplement from his family physician during a routine physical examination when he requested a substitute for his daily coffee and cocoa.

Claims for injuries resulting from ephedra are in many ways similar to claims to recover for PPA side effects.

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