In the Absence of Causal Effect, Viagra and Cialis Melanoma Lawsuits Keep Coming

Los Angeles, CANo one disagrees that more research is needed to further quantify, prove or disprove the association, and potential causal relationship between erectile dysfunction drugs such as Viagra and Cialis, and the onset of melanoma, one of the more aggressive cancers out there. However, that hasn’t stopped Cialis risk for melanoma lawsuits, and similar litigation alleging Viagra melanoma.

While it remains a slippery slope, plaintiffs are not waiting for more definitive studies that might one day speak to a cause. For now, an apparent association appears to be sufficient.

To that end, plaintiffs whose PDE5 inhibitor side effects lawsuits against Pfizer Inc. – the makers of Viagra – are housed in multidistrict litigation in California, continue to hold Pfizer at fault for continuing to aggressively promote and market Viagra (Sildenafil) without referencing research that suggests an increased risk of melanoma in association with use of the medication.

Cialis has also been absorbed into the fray, with Cialis side effects lawsuits alleging that plaintiffs developed melanoma cancers in association with their use of Cialis. Both Cialis and Viagra are drugs designed to combat erectile dysfunction in middle-aged and older men who require help achieving, and maintaining an erection in order to maintain a sexual relationship with a partner.

Critics have been quick to pounce on a study published in 2014 in JAMA Internal Medicine that suggested men who use Viagra were 84 percent more likely to develop melanoma over a period of 10 years. Researchers correctly admitted they were not in a position to prove, or arrive at any finding suggesting a causal link without much more study. There are also other risk factors and behaviors at play, including prior and present sun exposure,age and other risk factors.

Thus, while a cause has not been established, a connection certainly has.

Viagra, Cialis and other drugs of their ilk work by inhibiting the secretion of a specific enzyme known as phosphodiesterase 5, or PDE5. The enzyme is known to prevent erection. However, the scientific hypothesis related to an association with melanoma is borne from studies over the past few years that have come up with a finding that suppression of the PDE5 enzyme can also trigger the creation of melanoma cells.

The master complaint in the California-based Viagra MDL makes this assertion. Thus, PDE5 inhibitor side effects may be associated with a diagnosis of melanoma.

Again, not a cause, but a connection. Plaintiffs assert if they were aware of this connection, they would have either lessened their dependence on Viagra or Cialis, or lessened their sun exposure – or both – in an effort to minimize risk.

Viagra melanoma plaintiffs accuse Pfizer of engaging in a “continuous, expensive and aggressive” marketing campaign to promote the drug worldwide – and have done so since Sildenafil was initially approved by the US Food and Drug Administration (FDA) in 1998.

“As a direct, proximate and legal result of Pfizer’s negligence and wrongful conduct, and the unreasonably dangerous and defective characteristics of the drug Viagra, individual plaintiffs suffered severe and permanent physical and emotional injuries,” the master complaint says. “These physical injuries have included melanoma as well as the resulting treatment and surgeries necessitated by the skin cancer diagnosis.”

Pfizer said in a statement last year that “Viagra’s safety and efficacy have been studied in 136 clinical trials, and there is no reliable scientific evidence that the medicine causes melanoma,” the company said.

That statement is true: there is no conclusive evidence to suggest Viagra causes melanoma. However, there is evidence to suggest an association or connection – together with other risk factors and behaviors – that may link Sildenafil (Viagra) and Tadalafil (Cialis) to melanoma.

Meanwhile, Viagra and Cialis melanoma attorneys are continuing to evaluate cases.

The Pfizer Viagra MDL is In re: Viagra (Sildenafil Citrate) Products Liability Litigation, No. 3:16-md-02691, in the US District Court for the California Northern District.