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Judge Allows Study Linking Products To Strokes
Jul 24, 2003 | The Star Ledger
A controversial scientific study can be used as evidence in lawsuits charging several drug makers knew their products contained an ingredient linked to strokes, a judge ruled yesterday.The ruling by Judge Marina Corodemus of Superior Court in New Brunswick is a setback for several major drug companies, including Wyeth, Novartis, Bayer and Schering-Plough.
The ingredient, known as PPA, was used in numerous cold remedies and diet pills, including versions of Dimetapp and Tavist-D, that were taken by millions of consumers for decades. Those products were yanked from the market three years ago at the urging of regulators.
The companies argued that a 2000 study in The New England Journal of Medicine, which prompted regulators to warn consumers of the risks, used faulty science to link PPA to an increased risk of strokes. They maintained the study should not be used as evidence in the lawsuits.
In her ruling, Corodemus wrote the study "dramatically strengthens the plaintiffs' argument that their expert testimony be admitted because it supports and complements other scientific knowledge."
Lawyers for the 300 New Jersey residents who filed lawsuits cheered the decision.
A spokeswoman for Novartis said the drug maker is "disappointed the court has decided to admit the study into evidence" and vowed to contest the issues at trial. A trial is scheduled for October.
A Schering-Plough spokesman declined to comment and a Bayer spokeswoman couldn't be reached. A spokesman for Wyeth said the ruling only permitted some evidence to be submitted but not everything the plaintiffs sought.
More than 1,000 lawsuits have been filed around the country, including several hundred that are consolidated in a class-action lawsuit in federal court in Seattle.
The controversy over PPA, which is known in the pharmaceutical industry as phenylpropanolamine, has raged for years.
The ingredient, which was created in the early 1900s, was marketed for decades in various over- the-counter medicines as a way to suppress appetites or relieve runny noses. Those products included such popular items as Alka-Seltzer Plus, Contac and Dexatrim.
Until the recall in 2000, about 6 billion doses of PPA were reportedly sold each year in the United States. But reports of strokes prompted congressional hearings in 1991.
Regulators proposed additional warning labels on products in 1996 and a comprehensive safety study, which was conducted by Yale University researchers and appeared in The New England Journal of Medicine.
Phenylpropanolamine PPA
