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Warnings That Work: Pharmaceutical Manufacturer Secures Defendant’s Verdict


Warnings That Work: Pharmaceutical Manufacturer Secures Defendant’s Verdict

June 1, 2012

On Wednesday, May 30, 2011, a Connecticut federal jury held Pfizer not liable for damages resulting from a wrongful death, allegedly stemming from the decedent’s use of the product, Prempro. Prempro was approved by the FDA in 1994 and used to treat symptoms of menopause as well as prevent osteoporosis. In 2002 several studies raised concerns over the use of Prempro which was linked to unusually high instances of breast cancer.

In this action, plaintiff alleged that the decedent’s six year use of the drug was a substantial factor in causing her to develop breast cancer, which ultimately resulted in her death. In issuing its verdict for the defendant, the jury stated that the product was “unavoidably unsafe.”  Fortunately for Pfizer, however, the drug contained sufficient warnings regarding the risks associated with the use of the drug.  This included a warning directly on the label advising potential consumer of a possible link to breast cancer.

For the majority of pharmaceuticals, side effects are unavoidable. A consumer’s decision to use a given prescription is almost always a balanced decision of risk and benefit. What is avoidable, however, is the unnecessary risk and legal expense manufacturers face when failing to provide consumers with the information needed to make that balanced decision.  Adequate and complete warnings of a drug’s side effects must be clearly and readily available to all potential consumers, despite the severity of those side effects in question. This case highlights the importance of pharmaceutical manufacturers, as well as other product manufacturers generally, insuring that all labeling and warnings are adequate, accessible and compliant with FDA and other federal regulations, no matter how restrictive those warnings may seem.

For more information, please contact any member of Goldberg Segalla’s Global Insurance Services Practice Group.