A woman from Minnesota is suing Pfizer, Inc. on the theory that Pfizer’s drug Viagra caused the melanoma that took her husband’s life.

Plaintiff Juliene W.’s husband John was prescribed Viagra for erectile dysfunction in 1998, and he took it regularly for several years afterward. In January 2009, he was diagnosed with late-stage malignant melanoma. He died of that melanoma in April 2012. Juliene is now bringing a wrongful death claim against Pfizer based on a study showing a link between Viagra and an increased risk of melanoma.

Viagra Melanoma

Juliene’s Viagra lawsuit cites a study published online by JAMA in April 2014 that examined the relationship between sildenafil citrate – the active ingredient in Viagra – and development of melanoma.

Out of over 25,000 participants, the researchers found that those who had recently used sildenafil were 84 percent more likely to develop invasive melanoma. They also found that participants who had used sildenafil at all were almost twice as likely to develop melanoma as those who had never used it.

Despite these findings, Juliene says, Pfizer has not changed its Viagra advertising to alert consumers to the risk of melanoma.

On the contrary, Pfizer has redoubled its advertising efforts. In the same year the JAMA study was published, Pfizer’s advertising budget was the highest in the pharmaceutical industry at $1.4 billion, much of it spent on direct-to-consumer ads.

Juliene alleges that Pfizer’s direct-to-consumer Viagra advertising was overly aggressive and led her and her husband to believe Viagra was safer than it actually was. Had her husband known of the increased risk of melanoma, Juliene says, he never would have taken Viagra.

The FDA first approved Viagra as a treatment for erectile dysfunction in March 1998. The active ingredient, sildenafil citrate, works by relaxing smooth muscle and increasing blood flow. It is also sold under the brand name Revatio to treat pulmonary arterial hypertension in both men and women.

Since entering the prescription drug market, Viagra has been a huge moneymaker for Pfizer. In 2013 alone, Viagra sales exceeded $1.8 billion. Worldwide, more than 35 million men have been prescribed Viagra.

Some scientists caution that the findings in the 2014 JAMA study are relatively new, and that more research into the subject is needed. In fact, as recently as 2011 other studies had suggested Viagra could be effective as a treatment for melanoma.

The FDA has not yet issued any warning or labeling requirement about melanoma as a Viagra side effect; its most recent drug safety communication about sildenafil addressed the use of Revatio for pulmonary hypertension in children.

Juliene’s wrongful death lawsuit raises claims for negligence, strict liability for a defective product, breach of warranty, misrepresentation, fraudulent concealment of important product information, and loss of consortium (a claim for compensation for the effect of Viagra side effects on Juliene and John’s marital relationship).

She seeks compensatory damages, statutory damages, restitution of Pfizer’s Viagra profits, and costs of litigation including attorneys’ fees.

Juliene’s Viagra lawsuit, Case No. 0:15-cv-02048, is pending in the U.S. District Court for the District of Minnesota.