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Viagra MDL Proceeding Lawsuits Expected to Increase

Oct 11, 2016

Some developments have been made in the federal multidistrict litigation (MDL) concerning the erectile dysfunction (ED) medication Viagra (sildenafil citrate), including updating the judge on the individual cases filed, to date. Viagra was approved by the U.S. Food and Drug Administration (FDA) for ED in 1998.

Allegations include that Viagra's use is associated with increased risks of patients developing melanoma. Melanoma is the deadliest form of skin cancer. According to a prior The Associated Press report, more than three-quarters of all deaths related to skin cancer involve melanoma and approximately one person dies from melanoma every hour in the U.S.

Judge Seeborg, the federal judge appointed to oversee all of the Viagra cases filed in federal court nationwide, held his first hearing in San Francisco, California this June. A second hearing was held in August and Judge Seeborg scheduled the next Viagra MDL hearing for October 14, 2016.

The August hearing covered an array of administrative and management issues concerning the MDL and provided Judge Seeborg information on the way in which to handle cases involving so-called "mixed use" medications as well as using master pleadings to expedite the MDL and preserve party and court resources. Mixed use occurs when patients take both Viagra and other ED drugs; for example, Cialis (tadalafil) or Levitra (vardenafil). The manufacturers of Cialis and Levitra are not included in this MDL.

Judge Seeborg has entered various orders concerning management of the MDL. To date, some 50 individual Viagra lawsuits have been filed and it is expected that the MDL will grow to more than 500-1,000 individual claims against Pfizer on behalf of patients who allegedly developed Viagra melanoma skin cancer. Some 70 individual claims have also been filed in state court in St. Louis, Missouri.

The judge also ordered a briefing on the first of the discovery-related issues, which includes a pending dispute over the methods to be used for electronically stored information (ESI). This concerns the methods to be used to electronically search and produce Pfizer's digital documents and electronic data relating to key scientific and liability issues in the MDL and key evidence plaintiffs must collect to meet the burden of proof over their Viagra melanoma claims.

The MDL 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 maintains that this research is not related to the issues in this litigation.

Of note, Viagra is a phosphodiesterase (PDE) 5A inhibitor (PDE5A) and works by inhibiting PDE5, which typically destroys cGMP in the body. When PDE5 activity is blocked, cGMP levels increase. Research suggests that high cGMP levels may lead to cell mutation and may promote cancer cell growth.


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