In April of 2016, the Judicial Panel on Multidistrict Litigation determined that coordination of federal court lawsuits involving men who developed melanoma after taking Viagra was appropriate. MDL No. 2691, styled In Re:  Viagra (Sildenafil Citrate) Products Liability Litigation Viagra, was then established before Judge Seeborg, a federal court judge, in the Northern District of California, San Francisco Division.  Nearly a year later, more than 100 individual personal injury and wrongful death lawsuits have been filed by patients alleging that Viagra, manufactured by Pfizer, was defectively designed, inadequately tested, and improperly marketed as patients and prescribing physicians were not properly informed that Viagra use can cause or promote the growth of melanoma cancer cells.   Recently, the MDL judge expanded the Viagra melanoma litigation efforts to also include claims against Eli Lilly & Company for patients who ingested Cialis (or both drugs) and developed melanoma.

Viagra Melanoma Is One Of Deadliest Cancers

According to the American Cancer Society, melanoma accounts for only about 1% of skin cancers, but, sadly, is one of the most deadly cancers.  It is estimated that 87,110 new cases of melanoma skin cancer will be diagnosed in the United States in 2017, with men being diagnosed more frequently than women.  Nearly 10,000 patients are projected to die from melanoma in 2017.  The rates for melanoma have been rising for the last 30 years, with melanoma cancer rates being much higher in Caucasians and in patients who are over age 60.bluepill

Viagra Has Been On The Market Since 1998

Viagra was first approved for sale in the United States in March of 1998 by the Food & Drug Administration. The drug entered the market with quite a lot of fanfare in 1998, and has been aggressively promoted by Pfizer ever since for the treatment of erectile dysfunction.  It was one of the first drugs introduced to treat erectile dysfunction, a condition that affects an estimated 30 million men in the United States.  Erectile dysfunction (which is often referred to as “ED”) can be caused by a number of common medical conditions:  diabetes, high blood pressure, heart disease, smoking, alcoholism, obesity, prostate problems, low testosterone, and as a side effect of other medications.  In just 2013, Pfizer enjoyed approximately $1.8 billion in sales of Viagra worldwide.

Cialis (also known as tadalafil) is another erectile dysfunction drug that is very similar to Viagra.  It is currently sold by Eli Lilly and Company, an international pharmaceutical company based in Indianapolis, and was initially developed through a partnership between Glaxo Wellcome (now GlaxoSmithKline) and ICOS.  Cialis was first approved by the FDA in 2003, and was the third drug approved for sale in the PDE5 inhibitor drug class (with Viagra being the first and Levitra (also known as vardenafil) being the second).  Cialis has a longer half-life than Viagra, which means that the drug is able to continue working in the body for a longer period of time.  This longer half-life may also be part of the liability case against the drug manufacturer in the pending lawsuits, as it is theorized that this longer half-life may also make Cialis more likely than Viagra to promote the growth of cancer cells.   Hopefully, ongoing scientific studies and internal documents (once they are produced in the consolidated litigation efforts) will shed some light on this critical issue.

Both Viagra and Cialis treat erectile dysfunction by inhibiting the secretion of phosphodiesterase type 5 (“PDE5”), an enzyme responsible for the degradation of cyclic guanosine monophosphate (“cGMP”). When the cGMP is not degraded by the PDE5, smooth muscles in the corpus cavernosum relax; this, in turn, permits an inflow of blood to the corpus cavernosum, creating an erection.   Some recent studies published by independent scientists have shown that this same mechanism of blocking the production of PDE5 can lead to the creation of melanoma cells and promote melanoma cell invasion.  This potential link to cancer was not included in the warning labels or advertising materials for the drugs, and is a key focus of the pending lawsuits.

Progress in Viagra Melanoma Lawsuits

Over the past 12 months, Judge Seeborg has held regular hearings to obtain reports on the progress of the litigation.   The attorneys who represent the injured patients are seeking the production of millions of pages of documents from the drug companies involved in the development and marketing of Viagra and Cialis to help prove the plaintiffs’ claims that the manufacturers should have known of the link to cancer many years ago and provided proper warnings to the patients and their doctors (if the drugs should have ever been approved at all by the FDA).   It is estimated that it will likely take another 6 to 12 months to complete the production of documents from the drug companies, which are anticipated to be tens of millions of pages of documents that were produced by employees in the United States as well as overseas.  Once the document production is complete, dozens of depositions will need to be taken of drug company employees who played critical roles in the development of the drug, interaction with the FDA and other drug safety regulatory agencies, marketing of the medication to doctors and directly to consumers, conducting and monitoring scientific studies, and surveillance of adverse event reports to determine whether there were potential signals of safety issues associated with the ED medications.

Cialis Claims Added

Since the Cialis claims were added to the litigation effort just recently, it is likely that the first cases that will be ready for jury trials in the coordinated proceedings will involve ingestion of Viagra.   Judge Seeborg has not yet scheduled for first trials for the litigation, but will likely do so in the coming months.  Once the judge selects individual cases to be included in the MDL bellwether trial process, those plaintiffs, their family members, and their treating doctors will provide sworn testimony in depositions.  Experts hired by both the plaintiffs and the defendants will be required to file detailed reports with regard to scientific and medical issues and provide sworn deposition testimony as well.  The plaintiffs are hopeful that the first Viagra and perhaps Cialis cases will be tried in 2018 or 2019.  Prior to any jury trials, Judge Seeborg will also be required to rule upon a number of legal issues, including admissibility of scientific testimony and evidence.

The drug and medical device lawyers at Searcy Denney have represented patients who developed melanoma after ingesting Viagra and/or Cialis and are still accepting new cases in the pharmaceutical litigation.  Sadly, since both drugs have not been recalled and many patients remain unaware of the potential link to cancer, it is likely that the litigation could persist for years as new patients are diagnosed with melanoma.

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