Lawsuits alleging Merck & Co.’s Propecia (finasteride 1 mg) medication caused men to experience permanent sexual side effects, including erectile dysfunction, loss of libido, infertility and impotence, have been consolidated in a multidistrict litigation before U.S. District Judge John Gleeson in the U.S. District Court for the Eastern District of New York. So far, nine Propecia lawsuits are pending in the litigation, though plaintiffs attorneys expect that more will be filed in the future.
Propecia belongs to a class of drugs known as 5-alpha reductase inhibitors, or 5-ARIs, and is approved to treat male pattern baldness. A 5-mg dosage of finasteride, sold under the brand name Proscar, is also marketed by Merck to treat enlarged prostate. Both drugs work by preventing the conversion of androgen testosterone to DHT, a hormone critical to male sexual performance.
Last week, it was learned that the U.S. Food & Drug Administration (FDA) had ordered new warnings for Propecia and Proscar detailing possible long-lasting male sexual side effects associated with the drug. The Propecia label was updated to include information about libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug. Information regarding decreased libido that continued after discontinuation of the drug was added to the Proscar label. A revision to both the Propecia and Proscar labels will include a description of reports of male infertility and/or poor semen quality that normalized or improved after drug discontinuation, the FDA said.
Propecia lawsuits filed around the country allege Merck failed to warn users about the drug’s serious, and potentially permanent, side effects, including:
- erectile dysfunction
- low libido
- problems with orgasm
As we reported previously, Merck changed the Propecia label in Europe several years ago to warn that the drug could lead to permanent erectile dysfunction. But until last week, warnings provided to U.S. users of the drug suggested that these problems typically resolve.
The U.S. Judicial Panel on Multidistrict Litigation ordered the consolidation of federal Propecia lawsuits in the Eastern District of New York via an order dated April 16. In addition to the nine lawsuits pending so far in the New York Propecia multidistrict litigation, a number of claims have also been filed in New Jersey state court. In March, the Supreme Court of New Jersey centralized all complaints filed in the state before Superior Court Judge Jessica R. Mayer in Middlesex County, but declined to designate the Propecia litigation as a mass tort.