Noduft v. Heritage Consumer Products LLC

JUDGMENT – $20,503,288
Product Liability / Pharmaceutical Negligence
PPA Case Involving Hemorrhagic Stroke Caused By Over-The-Counter Drug Allerest

On June 18, 2002, King County Superior Court Judge Catherine Shaffer entered a judgment against Heritage Consumer Products LLC (Heritage) of Brookfield, Connecticut. Heritage is a pharmaceutical company that sells over-the-counter drugs to consumers, one of which is Allerest, an allergy medication. Allerest contained phenylpropanolamine (PPA), a chemical that has been linked to the occurrence of hemorrhagic strokes. On May 10, 2000, Yale University School of Medicine released the findings of six years of research on the incidence of hemorrhagic stroke and the use of products containing PPA. The findings are contained in a report entitled “Phenylpropanolamine & Risk of Hemorrhagic Stroke: Final Report of the Hemorrhagic Stroke Study” (“Yale Study”). The Yale Study was published in the December 21, 2000 issue of the New England Journal of Medicine, Volume 343, number 25, pages 1826-1832. The Yale Study, an epidemiological study funded by the pharmaceutical industry, confirms earlier case reports and studies, and concludes that there is a causal link between the use of medicinal products containing PPA and the incidence of hemorrhagic stroke. That is, the risk of hemorrhagic stroke is substantially increased by the consumption of PPA. The Yale Study cites numerous published medical case reports and medical studies from as early as 1979 about the increased risk of hemorrhagic stroke and the use of products containing PPA.

On November 3, 2000, following the release of the Yale Study, the U.S. Food and Drug Administration (FDA) issued a letter to all manufacturers of products containing PPA in which the FDA recommended the discontinuation of any and all products containing PPA. On November 6, 2000, the FDA issued a Public Health Advisory regarding the causal connection between the use of products containing PPA and an increased risk of hemorrhagic stroke, and recommended that consumers not use any products containing PPA. No pharmaceutical company has issued a general recall of PPA containing products, nor was a warning issued. Most products, including Allerest, were withdrawn from the market. Many, including Allerest, have been returned to the market with the PPA replaced by another antihistamine component.