Coming on the heels of a 2014 study published in JAMA Internal Medicine that linked the active ingredient of viagra, sildenafil, and an 84% increase in the risk of developing melanoma, a number of lawsuits have been filed against pharmaceutical giant Pfizer.
Now, the MDL is expected to swell with an estimated 500-1,000 individual suits.
As we covered on this blog back in April, the JAMA study revealed that sildenafil use “increases the invasiveness of melanoma cells, which raises the possible adverse effect of …melanoma risk”. This is through its action on cell-to-cell signaling pathways.
More than 30 lawsuits were filed on behalf of men who suffer from invasive melanoma after taking the drug. Thus a motion to consolidate the cases in an MDL located U.S. District Court for the Northern District of California was granted on April 7th, 2016.
According to the transfer order, the litigation was assigned to The Honorable Richard Seeborg. He has entered a number of orders and held hearings to shaped the course of the litigation going forward.
According to attorney Brenda Fulmer of Searcy Denney Scarola Barnhart & Shipley writing in JDSupra, the initial discovery process, in which documents and fact witness testimony related to the development of Viagra will be produced and reviewed, could last anywhere from 12-24 months.
After this initial discovery, parties will then introduce expert evidence. This will include both extensive expert reports and depositions. These will help both the plaintiffs and the defendant to substantiate their positions.
As we mentioned in April, the presence of similar erectile dysfunction drugs on the market will add an additional layer of complexity to the litigation. Newer erectile dysfunction therapies including Cialis (Tadalafil) and Leveitra (Vardenafil) were approved for use after the 2014 JAMA study had begun. Any relationship between these therapies and melanoma remains speculative.
This complexity was acknowledged in an August 2016 hearing held by Judge Seeborg, where “mixed use” cases. In which plaintiffs ingested Viagra as well as another erectile dysfunction treatment, were discussed.
As an MDL rather than a class action, each claim remains an individual lawsuit. This means that every plaintiff will need to establish the merits of his case on an individual basis. Thus making record review and independent medical examinations by experts a key aspect of the litigation going forward.
Since its approval in 1998, Viagra has become one of the most recognizable pharmaceutical brands in America. It has been prescribed to more than 35 million men.