Viagra Skin Cancer Lawsuit Filed Over Malignant Melanoma Diagnosis

A North Carolina man has filed a product liability lawsuit against Pfizer, alleging that the side effects of Viagra caused malignant melanoma, requiring him to undergo surgical procedures and future testing for the rest of his life to ensure the skin cancer does not return.

The complaint (PDF) was filed by Roy Roger Faircloth in the U.S. District Court for the Middle District of North Carolina on June 16, claiming that the drug maker knew or should have known about the link between Viagra and skin cancer, yet failed to adequately warn consumers or the medical community.

Faircloth was diagnosed with malignant melanoma following use of Viagra for about seven years. He was first prescribed the drug in April 2005 to treat erectile dysfunction. After noticing a spot on his left forearm, a melanoma diagnosis was confirmed in July 2012, resulting in surgery to have the malignancy removed.

According to the complaint, Faircloth will have to undergo regular dermatological testing to ensure that the cancer does not return. The lawsuit notes that a previous melanoma diagnosis increases the risk of a future melanoma diagnosis by a factor of nine.

The case joins a growing number of Viagra skin cancer lawsuits being pursued in courts throughout the U.S. by men diagnosed with melanoma, alleging that the drug maker failed to adequately warn about the risk due to concerns that it would negatively impact revenues from the blockbuster drug, which generated about $2 billion in sales in 2012.

“Despite the billions of dollars Pfizer spent in advertising and on prescribers, Pfizer has not spent any resources notifying or otherwise educating consumers or the medical community that Viagra use may be associated with the development or exacerbation of melanoma,” the lawsuit filed by Faircloth states. “Pfizer does not note on the current label for Viagra that the drug may be associated with the development or exacerbation of melanoma. Nor has Pfizer noted on any prior version of the label for Viagra that the drug may be associated with the development or exacerbation of melanoma.”

Faircloth accuses the company of negligence, failure to warn, designing and manufacturing a defective drug, and breach of warranty, seeking compensatory and punitive damages.

Viagra Skin Cancer 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.

Since its approval in 1998, Viagra has been prescribed to an estimated 35 million men, and is generally considered safe by most consumers. However, recent studies suggest that the medication may reduced the body’s ability to resist the spread of melanoma, a serious and potentially fatal form of skin cancer, which plaintiffs allege is not adequately disclosed on the warning label.

As early as 2011 a study was published in the medical journal Cancer Cell which warned that Viagra could promote melanoma cell invasion. Another study published in the Journal of Cell Biochemistry in 2012 also found that PDE5 inhibitors like Viagra could exacerbate melanoma development.

Public attention was not brought to the skin cancer risks from Viagra until a study published last year in the medical journal JAMA Internal Medicine. Researchers from Harvard Medical School found that men who took Viagra were 84% more likely to be diagnosed with melanoma than men who do not use the drug.

The American Cancer Society indicates that melanoma is diagnosed in about 69,000 Americans each year and causes about 8,650 deaths annually. The skin cancer usually manifests as unusual moles or patches of skin. While it is often curable if caught early, once melanoma has spread beyond the skin and local lymph nodes, treatment is difficult and it may ultimately result in death.