Propecia Lawsuit Alleges Merck Failed to Warn of Sexual Problems in U.S.

A lawsuit has been filed against Merck, alleging that the drug manufacturer warned European men that the hair loss and prostate drug Propecia may cause sexual problems in men, but decided against providing American men the same warning. 

Steven Rossello, of Harlingen, Texas, and Justin Herrman, of Las Vegas, Nevada, filed a Propecia lawsuit in February against Merck in the U.S. District Court for the District of New Jersey. According to the complaint, both men were prescribed Propecia to combat male pattern hair loss, and both suffered serious sexual dysfunction, which may be permanent.

The lawsuit points out that the warnings about the risk of sexual problems from Propecia differed significantly in Europe from the label warnings to users of Propecia in the U.S.

In Europe, Propecia labels stating that erectile dysfunction problems may persist after the patient discontinues use treatment with Propecia were added in 2008, after the Swedish Medical Products Agency began investigating reports of persistent erectile dysfunction problems linked to Propecia in 2006.

By August 2009, the Swedish Medical Products Agency concluded that Propecia side effects can cause permanent erectile dysfunction, and Merck changed Propecia labels again to warn of the risk of permanent erectile dysfunction. However, in the United States, the label for Propecia contradicts the labels on European Propecia, stating that “these side effects went away in men who stopped taking PROPECIA because of them.”

Propecia (finasteride) was approved in 1992 for the treatment of benign prostatic hyperplasia, and also is approved to treat male pattern baldness. It was originally marketed by Merck as Proscar.

Last month researchers from the U.S. published a study in the Journal of Sexual Medicine that found side effects of Propecia were linked to sexual problems in men. Researchers indicated that the class of drugs known as 5-alpha-reductase inhibitors can cause loss of libido, depression erectile dysfunction, reduced semen production and growth of male breast tissue. They also agreed that in some cases these side effects appeared to be permanent.

The lawsuit over Propecia charges Merck with negligence, failure to warn, strict product liability, and breach of warranty. The lawsuit is seeking compensatory damages in excess of $100,000, plus punitive damages and court costs for injuries as well as emotional distress and anxiety.