A stimulant once doled out by the billions in weight-loss and cold medications, then later linked to deaths, is the subject of a slew of federal lawsuits across the country, the first of which will be tried here April 4.
Loretta Rorie, a Will County, Ill., woman whose lawsuit will go to trial in federal court in East St. Louis, claims she suffered a crippling stroke after ingesting some Alka Seltzer Plus cold medicine in September 2000.
The medicine contained phenylpropanolamine, once a staple of such household brands such as Dexatrim, Robitussin and Alka-Seltzer Plus. It has been indisputably linked to an increased risk for hemorrhagic stroke, bleeding on the brain. In scores of lawsuits filed nationwide, it is being blamed for severely injuring and killing thousands of healthy young Americans.
In November 2000, the federal government recommended that all products containing phenylpropanolamine be pulled from store shelves. Major drugmakers like the Bayer Corp., the maker of Alka Seltzer Plus cold medicine, have replaced it with a far safer ingredient, and drugstore chains such as Walgreens have pulled PPA-tainted products from their shelves.
Still, a tsunami of PPA-related lawsuits continues to roll through America’s courts.
The lawsuits assert that Bayer, Walgreens and other major pharmaceutical firms and drugstore chains knew the risks posed to consumers by PPA but did too little, too late to protect them.
“They should’ve pulled this off the market in the late 1980s, the early 1990s,” said Ron Brown, managing partner of the law firm of Brown & Crouppen PC, which has filed eight PPA-related lawsuits since late December in U.S. District Court in East St. Louis.
Drug makers continued to sell products containing PPA long after it became clear it was dangerous, Brown said.
“These drug companies are extremely powerful; they got extremely good lobbies,” he said. “It’s all about the money.”
Chris Placitella, a lawyer for a New Jersey law firm representing dozens of PPA stroke victims, faulted the drug companies and the federal government for not properly warning consumers of the dangers posed by products containing PPA.
“You get these small-town pharmacies; it’s pretty clear this stuff is still on the shelves because it’s never been pulled,” Placitella said. “Just as I’m sure there’s tons of this stuff in people’s cabinets because they’re not tuned in to it.”
Walgreens voluntarily removed all PPA-tainted products as soon as the federal government recommended doing so, said Carol Hively, a spokesman for the Chicago-based drugstore giant.
Anne Coiley, a spokesman for the Bayer, a German-owned firm whose American subsidiary is based in Pittsburgh, declined to comment on pending litigation.
“The products currently on the shelves do not contain that ingredient,” Coiley said.
In the mid-1980s, medical journals started reporting dozens of cases of young, healthy people suffering strokes soon after ingesting products containing PPA, such as appetite suppressants and decongestants.
PPA’s popularity stemmed from that it simultaneously constricts users’ blood vessels – helping dry out their stuffed-up noses – while stimulating blood flow and heart rate, which countered drowsiness, said Aaron Dickey, a lawyer in Brown & Croupen’s mass torts department.
But the side effects could prove fatal.
“It’d be like jacking up the water pressure in your house, but pumping it through smaller and more delicate pipes,” Dickey said.
The result in hundreds of documented cases: a brain aneurysm, or rupture of a weakened blood vessel, that victims experienced as an intensely painful headache, followed by sudden paralysis.
In 1991, the Food and Drug Administration held a hearing on PPA-triggered strokes. When it seemed likely the federal government would ban the drug, the drug companies agreed to spend $5 million on a study into the safety of PPA.
It took five years to work out details of the study, which was conducted by researchers at the Yale University School of Medicine, and another five years to carry it out.
“From our perception, it was a means to delay the inevitable,” Brown said. “They already had notice of the side effects of this thing but kept it on the market.”
In 1999, the last year before it was banned from the market, Americans swallowed at least 6 billion doses of medications containing PPA.
Meanwhile, as more and more evidence of PPA’s dangers emerged, the drug companies continued to reap huge profits off products containing this ingredient, Placitella said.
“The real issue is, why did it take so long?” he said.