Cialis Melanoma Lawsuit Filed Against Eli Lilly Over Failure to Warn

Eli Lilly and Company faces a product liability lawsuit recently filed by a Michigan man, alleging that side effects of Cialis caused him to develop melanoma, a serious and potentially life-threatening form of skin cancer. 

The complaint (PDF) was filed by Dennis Bjorge in the U.S. District Court for the Northern District of California on January 13, alleging that the drug maker failed to adequately warn that the popular erectile dysfunction treatment may increase the risk of melanoma or allow the skin cancer to spread more rapidly.

Cialis (tadalafil) was approved by the FDA in 2003, 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.

Bjorge raises claims similar to those presented in hundreds of Viagra melanoma lawsuits being pursued against Pfizer, indicating that plaintiffs could have avoided serious cases of melanoma if the erectile dysfunction drug had carried warnings about the risk of skin cancer and importance of monitoring for signs of skin changes.

According to the Cialis lawsuit filed by Bjorge, he bean taking the medication in December 2007 and continued to use the drug for six years. In January 2013, a lesion on the left side of his neck was biopsied and he was diagnosed with malignant melanoma.

“Had Defendant properly disclosed the melanoma-related risks associated with Cialis, Plaintiff would have avoided the risk of developing melanoma by not using Cialis at all; severely limiting the dosage and length of its use; and/or more closely monitoring the degree to which the Cialis was adversely affecting his health,” the lawsuit states. “Furthermore, had Defendant properly disclosed the melanoma-related risks associated with Cialis, Plaintiff’s physician would have avoided such risk to his patient by not prescribing Cialist to him; severely limited the dosage he prescribed to Plaintiff; and/or closely monitored the length to which the Cialis was adversely affecting Plaintiff’s health.”

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.

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) 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 Bjorge’s case, or other Cialis melanoma lawsuits filed in the coming months and years may be added to the Viagra MDL or centralized as part of a separate proceeding.