Local woman sues drug company

By Thomas Wilson
STAR STAFF
twilson@starhq.com

   A Carter County woman has filed a lawsuit against the maker of a popular dietary supplement that contains the herb ephedra as well as the convenience market where she bought the product.
   Filed in Carter County Circuit Court by Kingsport attorney Richard A. Spivey, the suit alleges plaintiff Jessica L. Whaley had a seizure after taking "Stacker 2". The product's ephedra herb is a dietary supplement containing the active ingredient ephedrine -- a controversial Chinese herb that drew regulatory action from the Department of Health and Human Services (HHS) earlier this year.
   The suit names the product's manufacturer, NVE Pharmaceuticals, Fred Zeidan, doing business as Fred's Amoco Automotive Center, and Amoco Oil Company as defendants in the lawsuit.
   The lawsuit reads that Whaley purchased the Stacker 2 product at Fred's Amoco Automotive Center on West Elk Avenue in April 2002. Whaley used the substance in accordance with its instructions to take no more than three capsules per day, the complaint reads.
   "On April 20, 2002, Whaley experienced serious side effects, specifically a seizure that required her to seek emergency medical treatment as a direct result of having taken Stacker 2 on the previous day," the lawsuit alleges.
   The lawsuit alleges negligence on behalf of the defendants for " ... (Whaley's) injuries and damages arising from the misrepresentations of the safety and efficacy of Stacker 2 when used as recommended by them."
   Whaley's lawsuit seeks $200,000 in compensatory damages and $600,000 in punitive damages as well as a jury trial to hear the case.
   According to the NVE Web site, the company touts itself as being the only manufacturer of Stacker 2, which the company calls "The World's Strongest Fat Burner".
   The Department of Health and Human Services announced in February a series of actions designed to protect Americans from potentially serious risks of dietary supplement products containing ephedra.
   Ephedra is a naturally occurring substance derived from the Chinese herbal "Ma Huang". Its principal active ingredient is ephedrine, which when chemically synthesized is regulated as a drug, according to the U.S. Food and Drug Administration.
   According to the Department of Health and Human Services release in Feb. 27, 2003, evidence is accumulating about potentially serious safety problems following the use of ephedra-containing products.
   An HHS-commissioned study has reported that ephedra is associated with higher risks of mild to moderate side effects such as heart palpitations, psychiatric and upper gastrointestinal effects, and symptoms of autonomic hyperactivity such as tremor and insomnia, especially when it is taken with other stimulants.
   The Stacker 2 product's labeling instructs users to consult a physician or licensed qualified health care professional before using this product if they have, or have a family history of various physical ailments such as heart disease, thyroid disease, diabetes, high blood pressure, recurrent headaches, depression or other psychiatric condition, or glaucoma.
   The product labeling also warns users to consult their doctor if he or she is using a monoamine oxidase inhibitor (MAOI) or any other dietary supplement, prescription drug or over-the-counter drug containing ephedrine, pseudoephedrine, or phenylpropanolamine -- ingredients found in certain allergy, asthma, cough/cold, and weight control products.