SAN FRANCISCO -- The number of lawsuits filed against pharmaceutical giant Pfizer Inc. over the alleged melanoma risks associated with its popular erectile dysfunction drug Viagra are likely to grow.
Brenda S. Fulmer, a shareholder with personal injury law firm Searcy Denney Scarola Barnhart & Shipley, said “hundreds, if not thousands,” of additional lawsuits could be filed in the U.S. District Court for the Northern District of California in the coming months, even years.
Fulmer, in a recent blog post on the law firm’s website, pointed to the “widespread use” of the drug.
Last month, the U.S. Judicial Panel on Multidistrict Litigation issued a three-page transfer order establishing a MDL for lawsuits brought against Pfizer over allegations that Viagra, or sildenafil citrate, causes or increases the risk of developing melanoma and that the company failed to warn consumers and health care providers of the alleged risk.
The panel decided to centralize in the Northern District of California, assigning the MDL to Judge Richard Seeborg. The panel noted Seeborg already was overseeing three of the lawsuits that had been filed ahead of the MDL and the federal court in San Francisco is experienced in handling such complex pharmaceutical MDLs.
The panel’s initial order transferred 14 pending lawsuits to the California federal court. A second, conditional transfer order was issued by the panel on April 20. It transferred another 12 individual lawsuits to the MDL court.
The first hearing in the MDL is set for June 15 in San Francisco.
The lawsuits have been filed by men who have been diagnosed with melanoma, a form of skin cancer, after taking the popular ED medication.
Some studies have suggested there is a link between ingestion of Viagra and melanoma.
One study, in particular, published in medical journal JAMA Internal Medicine in 2014, indicated that men taking the medication were 84 percent more likely to be diagnosed with the serious form of skin cancer compared to men not using the drug.
Researchers reviewed data involving more than 25,000 men who were followed for 10 years. At least 142 men were diagnosed with melanoma, resulting in the conclusion that recent use of Viagra was “significantly associated with increased risk of melanoma.”
The lawsuits allege that Pfizer knew about the melanoma risk from Viagra, or should have discovered the link and then warned patients and prescribing physicians.
Pfizer refutes the allegations.
“Viagra’s safety and efficacy have been studied in 136 clinical trials, and there is no reliable scientific evidence that the medicine causes melanoma. Moreover, Viagra has been prescribed to millions of men worldwide since it was first approved by regulators 18 years ago, and this real world experience confirms its favorable benefit-risk profile,” Pfizer said in a statement regarding the filing of both parties’ position statements in the MDL.
The position statements are not motions and were requested by the federal court in connection with the initial conference in the litigation.
“Pfizer stands behind this important medicine and will vigorously defend these lawsuits,” the company said.
Pfizer noted that, contrary to the plaintiffs’ assertions, the JAMA article on which their claims are based expressly stated that the study “cannot prove cause and effect” and that the reported statistical results “are insufficient to alter current clinical recommendations” regarding the use of Viagra.
“The European Medicines Agency, which considered the same study in 2014, concluded that a causal relationship between the use of Viagra and the risks claimed by plaintiffs ‘is not supported by the data currently available,’” the company said.
First approved by the U.S. Food and Drug Administration in 1998, Viagra has been prescribed to more than 28 million patients in the U.S. and more than 68 million patients worldwide.
Reach Jessica Karmasek by email at jessica@legalnewsline.com.