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Propecia Lawsuits

PropeciaPropecia (finasteride) is a medication commonly prescribed to men diagnosed with male pattern baldness. However, the results of numerous clinical studies and post-market reports indicate that Propecia is associated with persistent sexual dysfunction.

Hundreds of men have filed lawsuits against Merck, the drug maker, accusing the defendant of failure to warn, negligence, and fraudulent concealment, among other causes of action.

Propecia for male baldness

Finasteride was first approved for use by the U.S. Food and Drug Administration (FDA) in 1992. At that time, it was sold under the name Proscar in 5 mg pills for the treatment of benign prostatic hyperplasia (BPH). The drug works by blocking the effects of 5-alpha-reductase, an enzyme that converts testosterone into dihydrotestosterone. Blocking the production of this hormone can increase hair growth on the scalp and prevent the prostate from becoming enlarged.

Noting the effect the drug had on male pattern baldness, Merck sought approval to market the medication toward men who suffered from alopecia. The dosage of finasteride was reduced to 1 mg and the FDA approved Propecia in 1997. Since finasteride was first approved, well over one million men have been prescribed Propecia, making the drug a lucrative one for Merck. By 2010, sales of Propecia had made Merck more than $447 million richer.

Although the generic version of the drug became available in 2013 and sales have plummeted since a slew of lawsuits were filed, the drug still churns out about $140 million in revenue annually.

Common allegations in Propecia lawsuits

Currently, there are at least 1,132 Propecia lawsuits pending against Merck in courts around the country. These claims contain similar allegations, arguing that Merck initially warned that less than 2 percent of users may experience sexual side effects from taking the drug. The labeling information also claimed that these side effects would resolve once the drug was discontinued.

However, plaintiffs claim that the risk of sexual dysfunction is much more serious and that the side effects linger long past discontinuation. In one study, about 20 percent of men report lingering erectile problems as long as five years after discontinuing use, which suggests that there is a possibility of permanent dysfunction.

Lawsuits allege the following side effects from Propecia:

  • Erectile dysfunction
  • Loss of libido
  • Testicular pain
  • Genital shrinkage
  • Decreased sperm count
  • Peyronie’s disease
  • Anxiety
  • Depression
  • An increased risk of male breast cancer
  • An increased risk of prostate cancer

Propecia plaintiffs commonly claim that Merck failed to fully advise them of the risks. They are also suing on counts of fraudulent concealment, defective design, strict liability, and negligence.

To support these claims, many lawsuits point to the growing body of evidence regarding the link between the hair loss drug and persistent sexual side effects. One such study published in the March 2011 issue of the Journal of Sexual Medicine determined that 96 percent of the 71 patients they monitored who used Propecia developed sexual dysfunction that persisted at least three months.

FDA actions regarding Propecia

Based on its review of clinical evidence and the increasing number of adverse event reports, the FDA has taken steps to warn consumers of Propecia risks. In June 2011, the FDA released a safety announcement warning men that Proscar and Propecia could increase the risk of aggressive prostate cancer.

On April 11, 2012, the FDA announced that finasteride would carry new labels. The new labeling information warned Propecia users that the drug could cause libido disorders, ejaculation disorders, and orgasm disorders that could persist after discontinuation of the medication. It also warned of poor semen quality and male infertility that persisted after discontinuation.

Pending Propecia litigation

Despite these safety warnings, many men have already suffered severe complications. To date, there are 390 Propecia lawsuits pending in the New Jersey Superior Court in Middlesex County before Judge Jessica Mayer. These lawsuits have been centralized for streamlined case management.

Another centralized litigation is proceeding in the U.S. District Court for the Eastern District of New York under Judge John Gleeson. The multidistrict litigation (MDL) No. 2331 was created in April 2012 by the U.S. Judicial Panel on Multidistrict Litigation (JPML). The case list, which was last updated in November 2014, reflects a total of 742 active Propecia cases pending.

All plaintiffs who transfer their cases to the MDL retain their rights to an individual trial or settlement negotiation. The cases are consolidated for the purpose of streamlining pre-trial discovery to avoid the possibility of contradictory rulings across different courts. Following discovery, a series of bellwether trials will be heard by the court and it is expected that Merck and the plaintiffs may engage in settlement discussions. Any cases that have not been settled will then be remanded back to their home districts for trial.

Filing a Propecia lawsuit

When drug injury lawyers review a case, they look for certain elements that determine whether filing a lawsuit is appropriate.

Some of these elements may include:

  • Whether the claimant used Propecia as prescribed
  • Whether the claimant suffered complications directly linked to Propecia
  • Whether these medical problems may have been caused by other drugs
  • Whether the side effects persisted after the claimant discontinued use of Propecia

Claimants who take legal action may demand compensation for:

  • Past, present, and future medical expenses
  • Pain and suffering
  • Emotional trauma
  • Loss of wages
  • Loss of earning capacity
  • Loss of spousal consortium
  • Punitive damages

  1. Seeking Alpha, Product Pipeline That Rivals Rogaine And Propecia To Propel DS Healthcare's Valuation,

  2. FDA, Questions and Answers: Finasteride Label Changes,

  3. Time, Propecia Problems: Baldness Drug Linked with Long-Lasting Sexual Side Effects,

  4. JPML, MDL Statistics Report,