Cialis Melanoma Risk Withheld from Users and Medical Community, Lawsuit Alleges

Eli Lilly faces a product liability lawsuit that alleges side effects of Cialis caused a Florida man to develop of melanoma, a deadly form of skin cancer. 

The complaint (PDF) was filed by Ralph Motes, Jr. in U.S. District court for the Northern District of Florida last month, indicating that the drug maker failed to adequately warn men or the medical community about the potential Cialis melanoma risks.

Cialis (tadalafil) was approved by the FDA in 2003 for the treatment of erectile dysfunction, joining the lucrative erectile dysfunction drug market that was dominated by Viagra. Amid aggressive marketing, it quickly reached blockbuster status, with an estimated 45 million men having taken Cialis by May 2014.

Motes indicates that he was prescribed Cialis for the treatment of erectile dysfunction in October 2009, and took it regularly until December 2012. In August 2012, he was diagnosed with melanoma after he had a suspicious lump in his right axillary area examined.

As a result of the diagnosis of melanoma following Cialis use, Motes has required multiple surgeries, CT scans, chemotherapy and radiation treatments to battle the potentially lethal form of cancer, and must remain vigilant for its return for the rest of his life to monitor for return of the skin cancer.

The case raises allegations similar to those being pursued in dozens of Viagra lawsuits being pursued by men nationwide, which allege that the the class of erectile dysfunction drugs increase the risk of melanoma. Motes and other plaintiffs indicate that the skin cancer diagnosis could have been avoided if proper warnings about the melanoma risk had been provided, as they could have more closely monitored for signs of skin changes, or chosen not to use a drug treatment for erectile dysfunction, which is not a life-threatening illness.

The Viagra and Cialis skin cancer litigation began to emerge after a study was published in the medical journal JAMA Internal Medicine in April 2014, in which researchers from Harvard Medical School found that men who took erectile dysfunction drugs may be 84% more likely to be diagnosed with melanoma than men who do not use the medications.

Motes alleges that Eli Lilly knew or should have known about the Cialis cancer risk for years, indicating that studies published as early as 2011 suggested that the erectile dysfunction drug may promote melanoma cell invasion. Another study published in the Journal of Cell Biochemistry in 2012 also found that PDE5 inhibitors like Cialis and Viagra could exacerbate melanoma development.

“The risk presented by the use of Cialis through PDE5 inhibition — a characteristic inherent to the drug’s potential efficacy — was unquestionably far more significant than the benefit to its users,” the lawsuit filed by Motes states. “Because the risk of using Cialis so greatly outweighs the benefits of such use, the drug presents an unreasonably dangerous risk when used in its intended condition.”

Of the two erectile drugs, 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.

It is unclear at this time whether Motes case, or other Cialis melanoma lawsuits filed in the coming months and years may be added to the Viagra MDL.