December 7, 2012 — Hundreds of plaintiffs have filed lawsuits against Merck & Co., the manufacturer of Propecia (finasteride). The anti-baldness drug has been linked to long-term side effects, including sexual dysfunction, cognitive impairment, and physical disfigurement. In Merck’s third quarter earnings report, they reported that about 265 Propecia lawsuits have been filed by 415 plaintiffs — a 30% increase in lawsuits since the the company’s second quarter earning report.
The majority of Propecia lawsuits are currently centralized in the U.S. District Court for the Eastern District of New York (Brooklyn). A federal judicial panel found that the lawsuits could be centralized into a Multi-District Litigation (MDL) because they all involve similar injuries and allegations. Defective drug litigation is often centralized into an MDL to conserve resources, reduce the risk of conflicting rulings, and expedite a resolution for plaintiffs.
Merck is accused of failing to warn about the risk of “persistent” side effects. When Propecia was introduced to the U.S. market in 1997, Merck warned that about 2% of men might experience sexual dysfunction. About a decade later, hundreds of men began coming forward with reports of long-term side effects that did not resolve when they stopped taking Propecia.
In 2008, the Swedish Medical Products Agency required label updates to warn about the “persistence of erectile dysfunction after discontinuation” of Propecia. In 2010, Italian health authorities required similar updates. However, it was not until 2011 that Merck made similar warnings on American Propecia. The labels did not include warnings about persistent ejaculation disorders, orgasm disorders, or decreased libido until 2012.
Most Propecia lawsuits allege that Merck knew about the long-term risks associated with Propecia, but they did not warn men about these risks for many years.
Recently, researchers have investigated the “persistent” sexual dysfunction associated with Propecia, and they have found high rates of erectile dysfunction, cognitive impairment, and physical disorders such as gynecomastia (growth of male breast tissue).
Dr. Michael Irwig has conducted most of the studies of Propecia’s “persistent” sexual dysfunction, and he said the research suggests that some cases may actually be permanent. In one study of men who reported at least 3 months of sexual dysfunction, 20% of the study participants had symptoms for at least 6 years. The average duration of “persistent” side effects was 40 months after discontinuing Propecia.