The Judicial Panel on Multidistrict Litigation will hold a hearing to consider a request to establish coordinated national litigation against the manufacturers of Viagra. The Judicial Panel is a group of federal judges who meet every other month to consider requests for the establishment of multidistrict litigation (also known as an “MDL”) for cases involving multiple plaintiffs, which usually include drug and medical device product liability claims, class actions, securities lawsuits, and claims involving mass accidents or natural disasters. Both plaintiffs and defendants will often request the establishment of an MDL for the coordination of complex lawsuits where the plaintiffs have been harmed in the same manner by the defendants. An MDL is often confused with a class action, but it is distinct because each plaintiff has a separate lawsuit but all of the plaintiffs can work cooperatively and share expenses in developing common liability evidence.
On December 22, 2015, Pfizer filed its response to the request for the establishment of MDL No. 2691, and agreed that MDL coordination was appropriate for this new Viagra litigation and agreeing with the plaintiffs’ recommendation on the proper venue for future consolidated proceedings.
The manufacturers of Viagra were previously involved in MDL proceedings in federal court in Minnesota nearly 10 years ago. In MDL No. 1724, several patients filed individual lawsuits against Pfizer after developing non-arteritic anterior ischemic optic neuropathy (“NAION”), blindness, and other eye injuries which they claimed were caused by a drug-induced lack of blood flow to the frontal portion of the optic nerve.
Viagra, like other erectile dysfunction drugs in this same class (which includes Cialis and Levitra), inhibits the secretion of phosphodiesterase type 5 (“PDE5”), an enzyme responsible for the degradation of cyclic guanosine monophosphate (“cGMP”). When cGMP is not degraded by PDE5, the smooth muscles in the corpus cavernosum relax, which allows for blood flow into the penis and the ability to maintain an erection. Recent medical studies have linked this same process, however, to cell mutation, which can lead to melanomagenesis and developing cancer. Several medical studies since 2011 have noted the possibility of Viagra triggering this process, which can lead to malignant melanoma in patients. In June of 2014, these safety concerns over Viagra were also discussed in a study published in the Journal of the American Medical Association. This article in JAMA noted in a study (which involved 25,848 participants over a ten-year time period) there was an 84% increased risk of developing invasive melanoma for patients who had ingested Viagra.
A petition requesting the establishment of a new MDL for Viagra claims was filed there were originally15 individual lawsuits filed by plaintiffs who developed melanoma after ingesting Viagra (which is also known as sildenafil citrate). These Viagra lawsuits were pending in federal courts in Alabama, California, Minnesota, New York, and North Carolina. It is anticipated that hundreds of additional lawsuits could be filed on behalf of plaintiffs who have developed cancer due to the erectile dysfunction drugs.
The individual lawsuits filed against Pfizer include allegations that Viagra and its accompanying warning label are defective, that the manufacturer failed to properly test the drug prior to promoting it to doctors and patients, that the marketing materials for Viagra were false and misleading, and several other causes of action relating to the alleged safety issues associated with Viagra.
There are also some Viagra cases pending in state court in St. Louis, Missouri. In that venue, 16 plaintiffs who live in 11 states sued Pfizer alleging that their ingestion of Viagra between 1998 and 2012 caused them to develop melanoma. Pfizer attempted to remove the state court case to federal court, but a Missouri federal court judge remanded the case and rejected Pfizer’s claims that federal court diversity jurisdiction applied to the claims since one plaintiff was a resident and citizen of New York (which is also the home state for Pfizer).
Viagra was first approved for sale in the United States by the Food & Drug Administration in 1998 to treat impotence. Since then, it is believed that Viagra may have been taken by over 35 million male patients worldwide, with over 8 million prescriptions being written for Viagra in just 2012. In its 2013 Annual Report, the manufacturers of Viagra noted more than $1.8 billion in Viagra sales around the globe. Viagra is reported to hold approximately 45% of the market share in the United States for ED drugs.