The federal multidistrict litigation involving the erectile dysfunction (ED) medication Viagra (sildenafil citrate) continues to proceed.
Viagra is manufactured by Pfizer Inc. and is a phosphodiesterase (PDE) 5A inhibitor (PDE5A) that is typically used in the treatment of ED. Viagra received U.S. Food and Drug Administration (FDA) approval in 1998.
Lawsuit allegations include that using Viagra is tied to increased risks of developing melanoma. Melanoma is the deadliest of the skin cancers and, according to a prior The Associated Press (AP) report, over three-quarters of all skin cancer fatalities involve melanoma; approximately one person dies from melanoma every hour in the United States.
Judge Seeborg, the federal judge appointed to oversee the Viagra cases filed in the federal multidistrict litigation (MDL), held his first hearing in San Francisco, California in June. A second hearing was held in August and the next Viagra MDL hearing is scheduled for October 14, 2016.
The judge has been updated on the individual cases filed in the MDL, to date. The August hearing covered various administrative and management issues and provided Judge Seeborg with information on how to handle cases that involved what is known as “mixed use” medications, how to use master pleadings to expedite the MDL, and how preserve party and court resources. Mixed use occurs when patients take both Viagra and other ED drugs such as Cialis (tadalafil) or Levitra (vardenafil). The makers of Cialis and Levitra are not included in this MDL.
To date, approximately 50 individual Viagra lawsuits have been filed; however, that number is expected to increase to at least 500 to 1,000 additional individual claims against Pfizer on behalf of men who allegedly developed Viagra melanoma. Another 70 individual claims have been filed in state court in St. Louis, Missouri.
Judge Seeborg entered a number of orders regarding MDL management, including for a briefing on initial discovery-related issues. This includes a pending dispute over methods to be used for electronically stored information (ESI) and concerns the way in which to electronically search and produce Pfizer’s digital documents and electronic data concerning critical key scientific and liability issues in the MDL, as well as important evidence plaintiffs must gather to meet the burden of proof over their Viagra melanoma claims.
The judge also ordered the parties to file legal briefs concerning Pfizer’s refusal to produce documents to the plaintiffs concerning its research on other PDE5 inhibitor drugs. Pfizer asserts that the research concerning phosphodiesterase (PDE) 5A inhibitor drugs—the same class that includes Viagra—is not related to the issues involved in the MDL.
Plaintiffs maintain that what Pfizer was aware of concerning this class of drugs and the effects of inhibition of PDE5 in the body—prior to Viagra’s approval in 1998—does concern what Pfizer knew, or should have known, about increased risks of Viagra melanoma.
