PORTLAND, Ore. — The parents of a 10-year-old boy who suffered a stroke and eventually died after taking Dimetapp filed a $41 million lawsuit against the makers of the popular over-the-counter cold medicine on Monday.
Brad and Donna Walker of Portland accuse American Home Products Corp., based in Madison, N.J., of being negligent and failing to provide warnings that a key ingredient in the medication could be dangerous for children.
A similar lawsuit was filed in federal court in Philadelphia Monday by a Pennsylvania woman who suffered a debilitating stroke a day after taking Dimetapp. Vicki D. Vogt of Honeybrook, Pa., is seeking $40 million.
The lawsuits do not appear to be linked.
Officials with American Home Products, the nation's fifth-largest drug maker, did not immediately return phone calls seeking comment Monday.
Last November, the U.S. Food and Drug Administration warned that dozens of over-the-counter cold medicines and diet pills contain phenylpropanolamine, or PPA, that could cause hemorrhagic strokes, especially in young women.
The unusually strong warning led a number of major drugstore chains to strip the products from shelves, while drugmakers reformulated the medicines to remove PPA.
Dimetapp, like many other drugs that used PPA, has since been reformulated.
Mathew Walker suffered a seizure on June 17, 1996, after his pediatrician told his mother to give him Dimetapp to avoid an ear infection from swimming. The boy died at a Portland hospital in October 1999, after suffering a hemorrhagic stroke, which is rare in children. He lapsed into a coma and never regained consciousness.
"Had somebody warned me, or had it been on the label, I would have chosen another method of treatment," Donna Walker said at a news conference with her husband Monday. "I would never have risked my child's life."
The Walkers' lawsuit, filed in Multnomah County Circuit Court, also names Mathew's pediatrician, Dr. Steven Burns. A spokeswoman for Burns said he could not comment until he talked with an attorney.
In the Philadelphia lawsuit, Vogt said she took Dimetapp on Nov. 27, 1998, then suffered a hemorrhagic stroke the next day leading to permanent disabilities related to balance, memory and strength. Her husband also is a plaintiff, saying the stroke caused him to lose her companionship.
Both lawsuits charge that American Home Products — and its Whitehall-Robins Healthcare division — knew about the risks of Dimetapp and failed to appropriately warn consumers.
PPA has been used in dozens of cold remedies and diet pills, including such widely known brand names such as Alka-Seltzer and Dexatrim. Most products have been reformulated to remove PPA.
Concerns were raised about PPA beginning in 1969 in a British medical journal, but the first public hearing was called in 1991, after Dr. David Kessler was appointed U.S. Food and Drug Administration commissioner, according to the lawsuits.
A six-year Yale University study concluded last year that "PPA should not be generally recognized as safe," prompting the FDA to issue a strong warning to immediately stop using any drugs containing PPA.
More than 9,000 lawsuits have been filed against American Home Products relating to its manufacturing of fenfluramine, the "fen" in the fen-phen diet drug combination. The drugs were withdrawn in September 1997 after a Mayo Clinic study linked fen-phen to potentially fatal heart valve damage.