Viagra Melanoma Warnings Knowingly Withheld by Pfizer, Lawsuit Alleges

Pfizer faces yet another lawsuit alleging that the drug maker knowingly withheld warnings and information from consumers and the medical community about the risk of melanoma from Viagra, which has been linked to reports of the serious and potentially life-threatening form of skin cancer.

In a complaint (PDF) filed in the U.S. District Court for the Southern District of New York on August 12, James A. Tune indicates that he had to have lesions caused by melanoma removed from his temple after using Viagra for years to treat erectile dysfunction.

Tune indicates that he developed suspicious lesions on his right temple, which a biopsy revealed to be lentigo maligna melanoma. He underwent invasive surgery on October 4, 2011 to remove the lesions and must now undergo regular medical monitoring to ensure that the cancer does not return.

The lawsuit claims that Pfizer has known, or should have known, about the link between Viagra and melanoma skin cancer, yet failed to add melanoma warnings to the Viagra label.

“Had Defendant properly disclosed the melanoma-related risks associated with Viagra, Plaintiff would have avoided the risk of developing melanoma by not using Viagra at all; severely limiting the dosage and length of its use; and/or more closely monitoring the degree to which the Viagra was adversely affecting his health,” the lawsuit indicates.

The case joins a growing number of men throughout the U.S. who are pursuing Viagra lawsuits over the lack of melanoma warnings. Many of the complaints allege that Pfizer withheld information about the potential risk of skin cancer from Viagra due to concerns that it may negatively impact sales for the blockbuster drug, which generates about $2 billion in sales each year.

Tune presents claims against Pfizer for negligence, breach of warranty, fraud, fraudulent misrepresentation. fraudulent concealment, negligent misrepresentation, strict liability, and violation of deceptive trade practices laws, seeking both compensatory and punitive damages.

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.

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.