Malignant Melanoma Diagnosis Blamed On Viagra Side Effects

Pfizer continues to face a growing number of lawsuits over failure to warn about the potential risk of skin cancer from Viagra, with one of the latest complaints claiming that the widely used erectile dysfunction drug caused a Florida man to develop malignant melanoma on his chest. 

The complaint (PDF) was filed by Harvey Ellenthal in U.S. District Court for the Northern District of California on August 11, alleging that the drug maker knew about the potential Viagra side effects, yet failed to warn consumers and the medical community about the risk.

Ellenthal indicates that he was prescribed Viagra to treat erectile dysfunction in 1999, and continued to use the drug until September 2001. However, in August 2012 a biopsy conducted on a skin lesion on his left chest revealed that he had malignant melanoma. As a result of the skin cancer diagnosis, Ellenthal underwent a re-excision in September 2012, and now has to be vigilant for the rest of his life for the cancer’s return.

The case joins dozens of other Viagra melanoma lawsuits pending throughout the federal court system, which have been consolidated in the Northern District of California for pretrial proceedings, as part of an MDL, or multidistrict litigation.

Ellenthal’s lawsuit alleges that Pfizer withheld information about the Viagra malignant melanoma risks, despite years of data indicating that it could be a problem.

“At the time Viagra was formulated and manufactured, Pfizer knew or should have known that the drug posed a significantly heightened risk to users, specifically through the increased likelihood that those users would develop melanoma because of the chemical reactions inherent to the drug’s functioning,” the lawsuit states. “Through the testing and formulating of Viagra, and before the initiation of the drug’s mass manufacture, Pfizer knew or should have known in the exercise of ordinary care that the chemical reactions inherent to Viagra’s mechanism of action would present a cancer related health hazard to potential future users.”

Since its approval, Viagra has been prescribed to an estimated 35 million men, and is widely marketed direct-to-consumers, encouraging men to ask their doctors for a prescription if they have trouble obtaining or maintaining an erection.

While the medication is 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.

In the mounting Viagra litigation emerging in courts nationwide, plaintiffs allege that if Viagra skin cancer warnings had been provided, they may have avoided serious and sometimes fatal cases of melanoma by catching the condition earlier if warnings had been provided, or by electing not to use the prescription treatment for erectile dysfunction.

Given the similar questions of fact and law raised in 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.

Ellenthal presents claims of unfair and deceptive trade practices, defective design, failure to warn, failure to test, negligence, gross negligence, negligence per se, breach of warranty, fraudulent misrepresentation and concealment, negligent misrepresentation and concealment, fraud and deceit, willful, wanton, and malicious conduct, and unjust enrichment.