Propecia MDL Litigation Moves Forward
Lawsuits have been filed over Propecia (known generically as finasteride), a drug used to treat male pattern baldness. Merck is being sued over the hair loss drug, with plaintiffs alleging that it caused sexual side effects, including sexual dysfunction, loss of libido and erectile dysfunction. Plaintiffs allege that Merck failed to warn them or their physicians about the risk of sexual side effects with Propecia. These claims have been consolidated into a federal multidistrict litigation (MDL).
Parker Waichman LLP is a national law firm with decades of experience in personal injury and product liability litigation. The firm continues to offer free legal consultations to individuals with questions about filing a Propecia sexual side effects lawsuit.
The U.S. Judicial Panel on Multidistrict Litigation (JPML) creates MDLs, which transfer similar lawsuits to one court. Cases are consolidated to make litigation move along quicker, as it eliminates duplicate discovery and streamlines legal proceedings. In Propecia MDL, plaintiffs similarly allege that the hair loss drug caused sexual dysfunction and that Merck failed to adequately disclose the risks. The plaintiffs allege they would not have taken Propecia if they were fully informed about the risk of sexual side effects.
In an MDL, lawsuits remain separate. This is distinct from a class action lawsuit, which is one lawsuit representing numerous plaintiffs.
The Propecia MDL is underway in the Eastern District of New York, containing over 1,000 lawsuits. Court records indicate that bellwether trials have been selected. Bellwether trials are the first lawsuits selected for trial; since they are the first to be heard in court, they are considered test cases, where both parties see how the case proceeds.
Lawsuits allege adverse events such as erectile dysfunction, decreased libido, genital shrinkage, infertility and problems with cognition. Plaintiffs state that in Europe, the Propecia label was updated to reflect the risk of permanent sexual side effects in 2008. In the United States, however, no such warning was added until 2012, suits state. Studies have linked Propecia to an increased risk of sexual side effects, plaintiffs state.
Propecia Users with Sexual Dysfunction are Depressed, Study Suggests
Recent findings published in The Journal of Clinical Endocrinology suggest that Propecia users suffering persistent sexual side effects were more likely to have a depressed mood. The study was conducted by researchers at Harvard Medical School, who noted that “Some men who use finasteride for hair loss report persistent sexual and other symptoms after discontinuing finasteride therapy.”
The authors wanted to determine whether symptoms of persistent sexual side effects in Propecia users were associated with certain physiological characteristics, including androgen deficiency, decreased peripheral androgen action, or persistent inhibition of steroid 5α-reductase (SRD5A) enzymes. The study involved Propecia users reporting persistent sexual side effects, Propecia users who did not report sexual dysfunction and healthy men who never used Propecia.
The authors did not find differences in androgen deficiency, decreased peripheral androgen action, or persistent peripheral inhibition of SRD5A. However, they did find that men with persistent symptoms had depressed mood. “Symptomatic finasteride users revealed depressed mood and fMRI findings consistent with those observed in depression.” authors wrote. “Men with persistent sexual symptoms after finasteride use had depressed mood and affect but no evidence of androgen deficiency or insensitivity, or persistent inhibition of 5α± reductase.”
Propecia and Sexual Side Effects Overview
The U.S. Food and Drug Administration (FDA) approved finasteride, the main active ingredient in Propecia, in 1992. Finasteride was sold under the brand name Proscar to treat men with an enlarged prostate. Later on, finasteride was marketed under the brand name Propecia for male pattern baldness. Propecia and Proscar contain the same ingredient, but the dosage is lower in Propecia.
In 2012, the FDA warned that Propecia may be associated with sexual side effects that persist even after stopping the drug. The warning label was updated to reflect this risk. The year prior, regulators said that erectile dysfunction may persist after stopping Propecia. The 2012 update included information about other sexual side effects, including libido disorders, ejaculation disorders and orgasm disorders that persisted after stopping Propecia. The label was also updated to include reports of male infertility and poor semen quality, which improved once the drug was stopped.
“Despite the fact that clear causal links between finasteride (Propecia and Proscar) and sexual adverse events have NOT been established, the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs.” FDA stated.
The FDA reviewed its Adverse Events Reporting System (AERS) and identified 421 reports of sexual dysfunction associated with finasteride between 1998 and 2011. Sexual dysfunction lasting at least three months after discontinuing the drug was reported among 59 users. The adverse events included erectile dysfunction, decreased libido, problems with ejaculation and orgasm disorders. The FDA also noted 251 cases involving semen quality with Propecia, but only 13 reports contained enough information for the agency to analyze.
The consumer safety group Institute for Safe Medication Practices (ISMP) has addressed Propecia sexual side effects. In 2013, the group said in its QuarterWatch report, “Nearly 20 years after approval, evidence is now emerging that the sexual side effects of finasteride may sometimes be irreversible and were most notable in the younger men taking finasteride for male pattern baldness,”
Out of 61 serious adverse event reports submitted over finasteride, 46 (75 percent) involved a sexual side effect. Twenty cases said the adverse event caused significant or persistent disability.
The report stated, “The proposition that these side effects might be persistent was supported by an FDA analysis of adverse event data and a published scientific paper that described a full range of sexual side effects in otherwise healthy men 21-46 years old that persisted for a mean of 40 months after ceasing treatment.”
The Journal of Sexual Medicine published studies in 2010 and 2012 linking Propecia to persistent sexual side effects. The 2012 study found that, among men who continued experiencing sexual side effects after taking Propecia, 96 percent continued to experience symptoms one year after stopping the drug.
Filing a Propecia Lawsuit
If you or someone you know suffered sexual side effects after taking Propecia, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).