April 12, 2012 - Two of pharmaceutical giant Merck’s best-selling drugs, Propecia and Proscar, will be required to carry warnings linking them to severe persistent sexual side effects, the U.S. Food & Drug Administration (FDA) announced yesterday.
The FDA’s announcement came as no surprise to plaintiff lawyers and their clients around the country. To date, a number of Propecia and Proscar lawsuits have been filed throughout the United States claiming serious sexual side effects related to these drugs.
According to the FDA, Propecia’s new warning labels will include information about libido, orgasm and ejaculation disorders that persist after patients discontinue treatment with the drug. Proscar’s warning will be limited to decreased libido, and both medications will include verbiage regarding reports of infertility and poor semen quality that returned to normal after patients quit taking the drugs.
“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,” the FDA said in its announcement.
The FDA based the decision to update the warnings on its review of 421 reports of sexual dysfunction linked to Propecia between 1998 and 2011. Of these, 59 patients reported their conditions lasted at least three months after discontinuing treatment with the drug. Additionally, the administration reviewed 131 cases of erectile dysfunction and 68 cases of decreased libido associated with Proscar between 1992 and 2010.
“Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure,” Pamela Eisele, a spokeswoman for Merck, said in a statement. “Merck believes that Propecia and Proscar are generally well tolerated and effective for their respective indicated use when used in accordance with their approved labeling.”
As the number of Propecia lawsuits around the country continues to grow, consolidation proceedings have also been initiated in a number of jurisdictions. Men in New Jersey who have filed lawsuits involving Propecia will now have their cases overseen by Judge Jessica R. Mayer in the Superior Court of Middlesex County. The lawsuit coordination was conducted in response to an order issued by the Supreme Court of New Jersey.
While the Propecia litigation is not currently designated as mass tort, the coordination of these cases is intended to allow a larger number of similar claims to move through the process quickly by consolidating discovery and other pretrial proceedings. On March 16, Judge Mayer scheduled an initial conference with all parties involved for April 19 at the Middlesex County Courthouse. An attorney will be appointed to act as a liaison for procedural issues involving Propecia sexual side effects claims.
In addition to the New Jersey consolidation, the federal panel on multidistrict litigation is currently in the process of considering coordination of all federal lawsuits involving Propecia sexual dysfunction to a single location.
Late last year, a motion was filed to consolidate all federal Propecia lawsuits into one of two jurisdictions: the Eastern District of New York or the Western District of Washington. While Merck agreed with the need to consolidate the claims into an MDL, the company argued that it should be assigned to the U.S. District Court for the District of New Jersey, since it is where the vast majority of the Propecia lawsuits originated. New Jersey is also where Merck is headquartered.
Men who filed Propecia lawsuits after experiencing sexual side effects claim that Merck did not adequately warn users of the risks associated with the drug. Propecia sexual dysfunction can be particularly devastating to men who took the drug as a hair loss remedy, since most men who fall into this category are in their 20s to 40s. In addition to sexual side effects, both Propecia and Proscar have been increasingly linked to a number of other serious health complications including male breast cancer, prostate cancer, gynecomastia, body disfigurement, endocrine system failure, and severe psychological trauma.
Michael E. Schmidt is recognized as one of America’s most passionate, accomplished and skilled trial lawyers. His law firm, Schmidt & Clark, LLP is currently accepting Propecia lawsuits in all 50 states. To learn more about this topic, please visit his website: http://www.schmidtandclark.com/propecia