Lawsuits over Viagra Melanoma Risk Mounting

The Judicial Panel on Multidistrict Litigation heard arguments at a hearing on March 31, 2016, about the need for national coordination of Viagra claims.  Pfizer, the manufacturer of Viagra, did not oppose this request by the Plaintiffs.  Pfizer’s attorneys also agreed with the Plaintiffs’ suggestion that all of the pending Viagra lawsuits be transferred to a federal court judge in the Northern District of California.  Judge Seeborg in San Francisco was recommended to the Panel by the parties, as he was already overseeing three of the lawsuits that had been filed prior to the request for establishment of an MDL and the federal court in San Francisco has experience handling complex pharmaceutical MDLs.

On April 7, 2016, the JPML issued its transfer order establishing MDL No. 2691.  The Panel agreed that Judge Seeborg would be a good fit as the judge assigned to oversee the national coordination of products liability claims against the manufacturers of Viagra.  This initial MDL order transferred 14 pending lawsuits to the federal court in San Francisco; a second conditional transfer order was issued by the JPML on April 20, 2016, and transferred another 12 individual Viagra lawsuits to the MDL Court.

On April 12, 2016, Judge Seeborg issued his first Pretrial Order in the MDL which outlines a number of procedural rules to be followed by lawyers filing new Viagra lawsuits. The order also includes a reminder that both plaintiffs as well as the drug manufacturer are to preserve any relevant documents or electronic evidence, and it is expected that the MDL judge will issue further orders with regard to the preservation and production of evidence in this case in the near future.  Judge Seeborg scheduled the first hearing in the MDL to take place on June 15, 2016, in the federal courthouse in San Francisco.  It is anticipated that hundreds, if not thousands, of additional lawsuits could be filed in the coming months and years given the widespread use of Viagra.

The lawsuits filed thus far contend that Pfizer, as the designer and marketer of Viagra, should have known of the significantly increased risk of developing melanoma due to the mechanism of action for Viagra since the drug was approved in 1998 or certainly before the first studies were published in 2011.  Also, the lawsuits contend that Pfizer should have studied this potential cancer risk further as well as warning patients and their prescribing physicians. The lawsuits allege claims relating to strict liability, negligence, fraud, and breach of warranty under various state court law due to the defective condition of Viagra and the inadequate warnings provided to doctors and patients about the potential link to skin cancer.  There were 8 million prescriptions written for Viagra in 2012.  The drug has had worldwide sales in excess of $1.8 billion, and Pfizer holds approximately 45% of the market for drugs promoted for the treatment of erectile dysfunction.

In 2011, a study was published in the Cancer Cell journal noting that Viagra (sildenafil citrate) might promote cell invasion.  A 2012 study published in the Journal of Cell Biochemistry noted that PDE5 inhibition could lead to melanin synthesis, which, in turn, may exacerbate the development of melanoma.  The most significant study to date regarding the potential link between ingestion of Viagra and the development of melanoma was published in the Journal of the American Medical Association in June of 2014.  This study focused on whether there was an increased risk of melanoma associated with ingestion of Viagra, rather than focusing merely on the mechanism of potential injury like earlier studies.  In the JAMA study, which included 25,848 participants, the authors noted an 84% increased risk of patients developing invasive melanoma who had ingested the ED drug, Viagra.  The JAMA study focused on Viagra, so that is the current focus of the MDL litigation, although it is possible that the same mechanism (and associated risk) could apply to other erectile dysfunction drugs, such as Cialis and Levitra.  We believe that there are additional studies currently underway which may help to further document the link between ingestion of Viagra and other erectile dysfunction drugs (all of which are part of the class of drugs known as PDE5 inhibitors) and melanoma.

Special Note on the Judicial Panel on Multidistrict Litigation

The Judicial Panel on Multidistrict Litigation (often referred to as the “JPML”) is a group of federal judges who meet six times each year to decide whether national coordination is necessary for cases that involve multiple plaintiffs with pending individual lawsuits in federal courts around the country.  Multidistrict litigation (often referred to as an “MDL”) has been used for several decades for legal claims involving common defendants and liability evidence.  In this process, a single judge is assigned to oversee the early stages of the mass tort litigation (including the gathering of generic evidence regarding liability and scientific issues) and prepare the individual cases for ultimate transfer and trials in their home jurisdictions.  This type of judicial coordination is often confused with class actions claims, but is distinct in that each plaintiff has their own lawsuit alleging individualized damages but is able to share resources with other plaintiffs in gathering the generic evidence required for each and every case.  Some of the largest MDLs in the past have included claims relating to defective drugs (Vioxx, Xarelto, Pradaxa, Actos, etc.); medical devices (metal-on-metal hip implants, breast implants, defibrillators, etc.); consumer products (air bags, vehicles, and asbestos); airline crashes; hotel fires; environmental spills; financial fraud claims; or other events involving multiple injuries and deaths (such as the 9/11 attacks).