Revised Discovery Scheduled Issued for Melanoma Lawsuits Over Viagra and Cialis

The U.S. District Judge presiding over all federal melanoma lawsuits filed on behalf of former users of Viagra and Cialis has issued a revised discovery schedule, extending various deadlines over the next year and a half.

In April 2016, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established consolidated pretrial proceedings for all lawsuits filed against Pfizer in U.S. District Courts nationwide over the failure to warn about the risk of melanoma from side effects of Viagra.

The Viagra litigation was centralized before U.S. District Judge Richard Seeborg in the Northern District of California to reduce duplicative discovery into common issues raised in the cases, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

As a growing number of Cialis lawsuits began to be filed against Eli Lilly, raising similar allegations over the competing drug, those cases were also included in the multidistrict litigation (MDL) pending before Judge Seeborg.

In a pretrial order (PDF) issued on April 3, Judge Seeborg approved a revised discovery schedule proposed by the parties to incorporate Eli Lilly into the exchange of information about general causation involving link between the erectile dysfunction drugs and melanoma skin cancer.

The court has given the parties until May 1, 2018 to propose separate orders with a proposed case-specific discovery plan and a proposed schedule for selection of individual cases that will be included in a bellwether pool for early trial dates, which are designed to help gauge how juries may respond to certain evidence and testimony that may be repeated throughout the litigation.

The revised schedule also calls for all deposition of general causation experts to be completed by August 15, 2018, and provides a deadline for filing Daubert and other motions regarding general causation issues by September 17, 2018.

Melanoma Side Effects of Viagra and Cialis

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, Viagra has been prescribed to an estimated 35 million men. However, recent studies suggest that the medication may reduce the body’s ability to resist the spread of melanoma.

The Viagra melanoma cases began to emerge after a study was published in the medical journal JAMA Internal Medicine in April 2014, in which 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.

Cialis (tadalafil) is a similar erectile dysfunction drug introduced in 2003, which also become a blockbuster treatment amid aggressive direct-to-consumer advertisements.

Plaintiffs allege that Pfizer and Eli Lilly knew or should have known about the melanoma skin cancer risk for years, indicating that studies published as early as 2011 suggested that the erectile dysfunction drug may 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.

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.

Following any bellwether trials scheduled in late 2018 or 2019, if the makers of Viagra and Cialis fail to reach melanoma settlements to resolve large numbers of cases, hundreds of individuals lawsuits may be remanded to U.S. District Courts nationwide for individual trial dates.