Propecia Lawsuit Argues Merck Failed to Warn about Lasting Sexual Dysfunction
Since 1997, Merck has promoted Propecia as an efficacious treatment for androgenic alopecia, better known as male pattern hair loss. Over one million men have used the medication since its launch, under the assumption that Propecia (generic name: finasteride) carried minimal risks of adverse side effects.
However, according to a recent Propecia lawsuit filed by a California man, Merck has continually failed to warn American consumers and their health care providers about the risks of sexual dysfunction and cognitive impairment – two debilitating effects the plaintiff says he continues to suffer to this day, despite cessation of the drug. He is suing Merck for all of his alleged injuries and damages, both past and present, including medical expenses, costs for rehabilitation and/or home health care, lost wages, permanent disability and pain and suffering.
The case is proceeding in the U.S. District Court, District of New York (Brooklyn) – site of the Propecia products liability multidistrict litigation (MDL 2331).
Allegations raised in Propecia lawsuit
Court documents state that the plaintiff was just 31 years old when he began experiencing signs of male pattern baldness. The year was 2005, and at the advice of his doctor, the claimant began taking Propecia on a regular basis. He discontinued use of the drug for some time between 2006 and 2008, but resumed the regimen again in 2010, at the age of 36. In total, he took the hair loss medication on and off from 2005 through 2011, during which time the plaintiff says he began to suffer severe sexual dysfunction and cognitive impairment.
Like the hundreds of others who’ve filed claims against Merck, the California man says he never had issues with erectile dysfunction or sexual side effects before taking Propecia. Even more disturbing, the plaintiff alleges these side effects have lingered, despite stopping the drug. The claimant argues that such intimate and disabling side effects have severely diminished the quality of life and have caused him great pain and emotional trauma.
Propecia warning labels still inadequate, argues plaintiff
While Merck has updated Propecia warning labels in several European countries, including the United Kingdom and Italy, to include a warning of persistent and/or permanent erectile dysfunction after discontinuation of treatment, the manufacturer has yet to strengthen warnings in the States. The FDA indicates that nine Propecia label revisions have been made in the U.S. since 1997, though none of these contained cautionary language regarding lasting or permanent sexual side effects in patients who discontinued the drug.
The lawsuit claims that it wasn’t until April of 2011 that the defendants updated the patient information insert to indicate that patients have reported “difficulty in achieving an erection that continued after stopping the medication.”
Clinical research dating back to 2003 supports several of the plaintiff’s allegations, as the rates of sexual dysfunction resulting from finasteride are reported to be as high as 39 percent. In the same study, only 50 percent of Propecia users experienced resolution of their sexual problems after discontinuing the medication.
Merck held liable for negligence and fraud
The plaintiff claims that Merck designed, manufactured and distributed a dangerous, defective and unreasonably dangerous drug, while failing to alert patients about the risks of permanent sexual dysfunction.
Several causes of action are listed in the Propecia lawsuit, including:
- Strict liability
- Breech of implied warranties
- Breach of express warranty
- Violation of Unfair and Deceptive Trade Practices Acts
- Negligent infliction of emotional distress
To further punish Merck for its purported wanton conduct and reckless indifference for the safety of the public, the plaintiff is also demanding punitive damages.
- Time, Propecia Problems: Baldness Drug Linked with Long-Lasting Sexual Side Effects http://healthland.time.com/2012/07/12/propecia-problems-baldness-drug-linked-with-long-lasting-sexual-side-effects/
- Judicial Panel on Multidistrict Litigation- Pending MDL Dockets http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_by_MDL_Number-October-17-2013.pdf
- FDA, Questions and Answsers: Finasteride Label Changes http://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm299754.htm