Lawsuit Over OTC-Drug Ingredient BeginsNov 16, 2003 | The Star Ledger Five years ago, Rosemary Krenfeld took a popular nasal decongestant called Tavist-D, which was regularly sold without a prescription. She later suffered a stroke and, since then, the 48-year-old mother of three has been confined to a wheelchair.
Tomorrow, her lawyers will argue in Superior Court in New Brunswick that her problems can be traced to Tavist-D and the manufacturer, Novartis Pharmaceuticals, knew a key ingredient was linked to hemorrhagic strokes, especially in young women.
The ingredient at the center of this dispute is PPA, which was used in numerous cold remedies and diet pills that were taken by millions of consumers for decades. Among the widely used products were Alka-Seltzer Plus, Contac and Dexatrim.
These items were yanked from the market during 2000 at the urging of regulators. The move followed publication of a study in the New England Journal of Medicine that indicated PPA may increase the risk of strokes.
Until then, about 6 billion doses of PPA were reportedly sold each year in the United States. After the recalls, hundreds of lawsuits were filed against the companies that used PPA in their over-the-counter products, including Wyeth, Bayer and Schering-Plough.
The trial that begins tomorrow is only the second PPA trial in the nation and gathers together lawsuits brought by about 300 people, some of who are New Jersey residents. Kronfeld, a former medical office secretary, is from Illinois.
These trials are part of a wave of litigation against the pharmaceutical industry during recent years concerning serious side effects allegedly caused by its products. Most of the lawsuits, however, have involved prescription medicines, such as the fen-phen diet pills.
The run-up to the PPA trial has been marked by hurdles for the drug makers. Earlier this year, internal memos indicated Novartis and Wyeth knew of the link between PPA and strokes, according to court documents. The companies denied any scientific link.
Last summer, a Superior Court judge ruled the New England Journal study can be used as evidence. Although the drug makers funded the study, they argued for months that Yale University researchers used faulty science to link PPA to strokes.
Court documents also point to an apparent contradiction by Novartis. In a different lawsuit, which was filed by a woman who suffered a stroke after taking one of the company's prescription drugs, the East Hanover-based drug maker blamed PPA.
The other medication is called Parlodel and was designed to suppress the production of milk after childbirth. A Novartis predecessor company, Sandoz, withdrew Parlodel in 1994 under pressure from regulators, who received numerous reports of strokes and seizures.
The woman who sued Novartis in connection with her use of Parlodel also had taken Contac, which contained PPA and was made by another company. In a deposition, a Novartis expert cited PPA as a possible cause of the woman's stroke, according to court documents.
"There is strong evidence that PPA may be an important factor in cerebral hemorrhage," said Sheila Buchbinder, the Novartis expert.
A Novartis spokeswoman declined to comment, citing pending litigation.
In a court filing, lawyers for Kronfeld, the Illinois resident, claim "Novartis had been aware for years that PPA can cause hemorrhagic stroke."
Two more trials are tentatively scheduled in New Jersey next month against other drug makers whose products contained PPA.