Lawsuit Over Viagra Melanoma Diagnosis Filed by a Texas Man

Pfizer faces another product liability lawsuit brought by a former Viagra user diagnosed with melanoma, alleging that the drug maker failed to adequately warn about the risk of skin cancer associated with side effects of Viagra. 

The complaint (PDF) was filed in the U.S. District Court for the Southern District of New York on April 30, by Texas resident Michael Gardiner, who received a melanoma diagnosis after using Viagra for treatment of erectile dysfunction for more than two years.

After starting to take Viagra in April 2011, Gardiner indicates that he developed suspicious lesions n his left scalp and neck, which a biopsy conducted on May 6, 2013 revealed were signs of melanoma. Gardiner underwent invasive surgery to remove the lesions, leaving him with permanent scars. He must also regularly monitor his skin for future lesions due to the risk that the fatal form of skin cancer may return.

The case joins a growing number of Viagra lawsuits filed against Pfizer in recent weeks by men diagnosed with melanoma, which indicate that the drug maker knew or should have known about the skin cancer risk for years, yet failed to adequately warn consumers or the medical community.

Viagra 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.

Pfizer reported that Viagra generated $1.8 billion in revenue worldwide in 2013, and the drug has been prescribed to an estimated 35 million men since its 1998 approval. 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.

The Gardiner complaint notes that as early as 2011 a study was published in the medical journal Cancer Cell which warned that Viagra could promote melanoma cell invasion.

“Specifically, by inhibiting PDE5, Viagra mimics an effect of gene activation and therefore may potentially function as a trigger for the creation of melanoma cells,” the lawsuit states.

It also notes that another study published in the Journal of Cell Biochemistry in 2012 found that PDE5 inhibitors like Viagra could exacerbate melanoma development.

Despite these studies published before Gardiner was ever prescribed the medication, public attention was not brought to the risks 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.

Gardiner’s lawsuit accuses Pfizer of negligence, breach of warranty, fraud, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, strict liability, and violation of unfair trade practices and consumer laws. The complaint seeks both punitive and compensatory damages.