December 7, 2012 — Merck & Co., the manufacturer of Propecia (finasteride), has reported that they are facing approximately 265 Propecia lawsuits filed by 415 plaintiffs, according to the company’s third quarter earnings statement. The number of lawsuits has increased more than 30% since the second quarter, but profits have declined. Researchers and the U.S. Food and Drug Administration (FDA) have linked Propecia to many long-term side effects.
Most Propecia lawsuits have been centralized in a Multi-District Litigation (MDL) located in the U.S. District Court for the Eastern District of New York (Brooklyn). Most large drug litigations are centralized into an MDL to prevent conflicting rulings in lower courts, conserve resources, and expedite a resolution.
The lawsuits could be centralized because they all involve similar injuries and allegations against Merck — namely, that the company knew or should have known about “persistent” side effects, but they failed to adequately warn about the risk.
Propecia has been on the market since 1997. At the time, Merck warned that a small percentage of men who used the drug could suffer erectile dysfunction and decreased libido. For millions of men with male-pattern baldness, this was worth the risk.
About a decade later, researchers began investigating hundreds of reports of long-term sexual dysfunction and other side effects that lasted for months, years, or indefinitely after stopping Propecia. Sweden’s Medical Products Agency required Merck to warn about “persistence of erectile dysfunction after discontinuation,” and Italy required similar warnings in 2010. However, no warnings about long-term sexual side effects appeared on American Propecia until 2011. Since then, the FDA has also required Merck to add warnings about long-term libido disorders, ejaculation disorders, and orgasm disorders.
Researchers have also found high rates of sexual dysfunction, cognitive impairment, and disfiguring physical disorders such as gynecomastia (growth of male breast tissue). One study found that men who reported at least 3 months of sexual dysfunction still had symptoms after an average of 40 months, and 20% reported at least 6 years of symptoms. The researcher who conducted the study, Dr. Michael Irwin, said the data suggested that “persistent” sexual dysfunction may actually be permanent for some men.
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