Lawsuit Alleges Viagra and Cialis Side Effects Caused Melanoma Diagnosis

According to allegations raised in a recent complaint filed against Pfizer and Eli Lilly, side effects of Viagra and Cialis used for treatment of erectile dysfunction caused an Alabama man to be diagnosed with melanoma, an aggressive and potentially life-threatening form of skin cancer.

The complaint (PDF) was filed by William Kelly in the U.S. District Court for the Northern District of California earlier this month, indicating that the drug makers failed to adequately warn users and the medical community about the melanoma diagnosis risks associated with the blockbuster drugs.

Kelly indicates that he was prescribed Viagra for treatment of erectile dysfunction in 2000, and later switched to Cialis, which he continued to use until 2012. In November 2011, a biopsy of a skin lesion on his left leg led to a malignant melanoma diagnosis, requiring excisions in December 2011 and April 2012. As a result of the diagnosis, Kelly indicates that he must remain vigilant for a return of the skin cancer for the rest of his life.

“While designing and formulating Viagra and Cialis, Defendants discovered or should have discovered that the drugs’ mechanism of action, the inhibition of PDE5, also presented a significant risk of exacerbating melanoma,” the lawsuit states. “Despite these significant findings, Defendants have made no efforts in their ubiquitous Viagra and Cialis advertisements to warn users about the potential risk of developing melanoma that has been scientifically linked to these drugs.”

The case joins a growing number of Viagra lawsuits currently pending against Pfizer, as well as potential Cialis lawsuits being investigated against Eli Lilly, which allege that if users had been provided warnings about the risk of melanoma, they may have avoided a diagnosis of the skin cancer by carefully monitoring for changes in the skin, or by electing not to use the prescription drugs for treatment of erectile dysfunction.

Viagra and Cialis Melanoma Risks

Viagra (sildenafil citrate) was introduced by Pfizer in 1998, and it has become one of the most widely recognized brand-name medications on the market in the United States, used by millions of men to treat impotence and sexual dysfunction, including the inability to develop or maintain an erection. Cialis (tadalafil) was approved by the FDA in 2003 for the treatment of erectile dysfunction, joining the lucrative erectile dysfunction market, and quickly reaching blockbuster status.

The erectile dysfunction drugs have been prescribed to millions men, and are widely marketed direct-to-consumers in television and print advertisements that encourage men to ask their doctors for a prescription if they have trouble obtaining or maintaining an erection.

While the Viagra and Cialis are generally believed to be safe by most users and doctors, independent studies released in recent years have found a melanoma risk with Viagra, suggesting that the erectile dysfunction drug may reduce the body’s ability to resist the spread of the skin cancer.

Most of the cases filed to date involve use of Viagra, which has been the market leader in this class of treatments for nearly two decades. Given similar questions of fact and law raised a growing number of lawsuits over Viagra filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) recently established consolidated pretrial proceedings, centralizing all cases before U.S. District Judge Richard Seeborg in the Northern District of California. The move is designed to reduce the risk of duplicative discovery into common issues in the cases, avoid conflicting pretrial rulings from different courts and to serve the convenience of the parties, witnesses and the judicial system.

As part of the coordinated Viagra MDL proceedings, it is expected that a small group of “bellwether” cases will be scheduled for early trial dates to help gauge how juries may respond to certain evidence and testimony that may be offered throughout the claims. However, if Viagra settlements are not reached for men diagnosed with melanoma following pretrial proceedings, each case may ultimately be remanded back to the U.S. District Court where it was originally filed for a separate trial date in the future.