Case Filed on Behalf of Pennsylvania Man Joins Propecia MDL
A Propecia lawsuit filed on behalf of a 23-year-old Pennsylvania man has recently joined the Propecia MDL (multidistrict litigation) in the Eastern District of New York. Submitted on June 24, 2013, the case claims that manufacturer Merck & Co. was aware that the drug (finasteride) could cause sexual dysfunction, but failed to provide adequate warnings to physicians and patients. The plaintiff in this case seeks in excess of $1 million in damages.
The U.S. Judicial Panel on Multidistrict Litigation formed the Propecia lawsuit MDL in April 2012, to increase efficiency of pre-trial proceedings, reduce the risk of inconsistent rulings, and provide for the convenience of all parties involved.
Facts of Propecia lawsuit
According to this Propecia lawsuit, the plaintiff started using the prescription drug to treat his male pattern hair loss in November 2008. He continued to use it for about three years, and didn’t stop until November 2011. Prior to taking the medication, he suffered no sexual dysfunction, nor did he suffer from any mental or emotional issues like depression or anxiety.
After using the drug, however, the plaintiff reports that he suffered significant and permanent Propecia sexual side effects, including erectile dysfunction, decreased libido, ejaculation and orgasm disorders. He also claims to suffer from mental and emotional issues, including depression, anxiety, and cognitive impairment.
As a result of these alleged injuries, the plaintiff has had to incur medical, hospital, rehabilitative, and/or pharmaceutical expenses, and will continue to do so for the rest of his life. He also states that he lives in fear and anxiety that his condition will get worse, and that his injuries will never be resolved.
Merck fails to warn of Propecia side effects
The FDA first granted approval for Propecia as a treatment for male pattern hair loss in 1997. The drug is a smaller dose (one milligram) of the same medication as that used in “Proscar” (5 milligrams), which was previously approved for the treatment of benign prostatic hyperplasia (BPH).
Until April 2012, however, Merck failed to warn that the use of Propecia could increase the risk of persistent side effects like sexual dysfunction. Between 1997 and 2012, they warranted that less than 2 percent of men taking the drug exhibited sexual side effects, and these went away when the patients stopped taking Propecia. They also stated that the Propecia sexual side effects decreased to 0.3 percent of men or less by the fifth year of treatment.
The plaintiff in this Propecia lawsuit claims that these warnings were purposely offered to “encourage men to try Propecia for male pattern hair loss with no risk or concern of developing persistent and chronic side effects.”
Propecia lawsuit notes changes made to warnings in other countries
In 2008, Merck changed the product warnings and instructions on their products sold in Sweden to include the following:
“In addition, the following have been reported in post-marketing use: persistence of erectile dysfunction after discontinuation of treatment with Propecia.”
In 2009, the Swedish Medical Products Agency concluded that the drug could lead to permanent erectile dysfunction. Merck then changed the product warnings in the United Kingdom to contain similar verbiage as the warnings in Sweden, but no such changes were made to U.S. products until years later.
Later studies would confirm what Sweden had found. In 2011, research by Traish, et al., showed that sexual side effects did not necessarily resolve in all patients who stopped using finasteride. Another study the same year by Irwig, et al., found that the mean duration of persistent Propecia sexual side effects was 40 months.
Resources
- FDA, Questions and Answers: Finasteride Label Changes, http://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm299754.htm