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JENNIFER LIBERTOA California man claims the diet pills, containing ephedra and manufactured by a Brooksville company, are unsafe.
BROOKSVILLE - A Los Angeles County, Calif., man who suffered a stroke after taking a month's worth of a dietary supplement that contained ephedra has sued the product's Brooksville manufacturer.
Mark Hagen and his wife, Gina, are seeking unspecified damages from Sho Me Natural Products Inc., according to a lawsuit filed Thursday in Hernando County Circuit Court.
The supplement Hagen consumed for about a month was called Dymetadrine Xtreme, which contains "ephedra extract," caffeine and willow bark extract, among other ingredients, the lawsuit stated.
The Food and Drug Administration is in the process of reviewing the ephedra supplement, which is not strictly regulated since it's not considered a drug under a 1994 law. The federal agency has received numerous complaints about ephedra and is considering whether to require warning labels for the supplement or to ban it altogether.
The civil lawsuit was originally filed in California, but a California court agreed to dismiss the case, when Sho Me Natural Products contested California's jurisdiction.
Sho Me Natural Products owner Christopher Reckner said he had not seen the civil lawsuit filed in Hernando County. But he understood from the California case that Hagen was genetically inclined to have an aneurysm, and that his product did not cause the problem.
"Realistically, the lawsuit's a farce," said Reckner, whose vitamin manufacturing company has been located in the Hernando County Airport Industrial Park for six years.
Sho Me Natural Products does manufacture nutritional supplements, including Dymetadrine Xtreme, which, according to Reckner, is safe for consumers.
In January 2002, Hagen had gone to an undisclosed store in Los Angeles County and bought a bottle of Dymetadrine Xtreme. He consumed one or two tablets of the supplement in the mornings before he worked out, according to the lawsuit.
Hagen understood that Dymetadrine Xtreme was intended to be used to lose weight and to increase strength and stamina, the lawsuit stated.
On Feb. 11, 2002, Hagen had a massive stroke, and he has yet to recover, said his Florida attorney, Stanley Buky of West Palm Beach.
Hagen was 39, at the time of his stroke, Buky said.
"He's disabled now and his prospects for working in the future are slim to nil," Buky said.
The lawsuit charges that the Dymetadrine Xtreme product is unsafe, because Sho Me Natural Products failed to label potential adverse reactions with other drugs or dietary supplements. It also charges that the company failed to warn consumers of "inherent dangers of the botanical stimulants and other constituent harmful chemicals" contained by Dymetadrine Xtreme.
- Staff writer Jennifer Liberto can be reached at 848-1434 or liberto@sptimes.com Times researcher Cathy Wos contributed to this reported.