For more than two decades, drugs like Viagra (sildenafil) and Cialis (tadalafil) have been prescribed to millions of men to treat erectile dysfunction. But while Viagra’s manufacturers have been sued many times since this drug hit the market in 1998, the consolidated lawsuit currently pending involves some unusual allegations.
The following facts hold serious implications for law firms involved in similar litigation:
1. Viagra has been sued for many reasons over the years, and not always successfully.
The use of Viagra has been linked to health conditions ranging from heart attacks and strokes to vision and hearing loss. The resulting product liability lawsuits have been dismissed before trial.
However, litigation over Viagra’s link to melanoma tells a very different story.
Heart Attack and Stroke
The earliest Viagra lawsuits involved allegations that the use of this drug led to various heart and circulatory conditions, most often heart attacks or strokes. The vast majority of these lawsuits were dismissed when none of the plaintiffs could show that these conditions were a direct result of their Viagra use.
Researchers found these problems were likely to occur when someone who was already taking nitrate medications for heart disease or high blood pressure began taking Viagra as well. The combination of these drugs increased the risk of a drop in blood pressure during sexual activity.
Sudden Blindness
In 2005, the FDA added reports of vision loss to Viagra’s warning label. Some men who had taken Viagra claimed they experienced sudden (and irreversible) vision loss, which was attributed to a loss of blood flow to the front of the optic nerve.
In January 2006, the “Viagra blindness” cases were consolidated into a multidistrict litigation (MDL) proceeding. Three years later, after certain plaintiffs missed key filing deadlines, several of these cases were dismissed.
In October 2011, the remaining cases were all settled through dismissal.
Melanoma and Skin Cancers
The current Viagra litigation doesn’t directly involve allegations of misplaced blood flow. Instead, these lawsuits were filed after a 2014 JAMA (Journal of American Medicine) study revealed a clear link between the use of Viagra and an increased risk of developing melanoma, the most serious form of skin cancer.
Because Viagra is generally considered a “lifestyle” drug, not one that is necessary to maintain one’s health, plaintiffs argue that if they had been properly warned of these serious side effects, they would have never sought out the drug in the first place.
In April 2016, these melanoma lawsuits, consisting of nearly 1,000 individual cases, were consolidated into multidistrict litigation. The MDL, case number 2691, is titled “In re: Viagra (Sildenafil Citrate) Products Liability Litigation.”
2. Cialis joined the Viagra MDL.
In 2018, a lawsuit against Cialis, alleging a similar melanoma connection, led to “In re: Viagra and Cialis Products Liability Litigation.” Like the Viagra plaintiffs, those who are suing Cialis allege that the manufacturer should have, but did not, include product labels to warn of the increased risk of developing melanoma.
The integration of Cialis into the Viagra MDL (No. 2691) suggests other drugs may be folded into the MDL in the future. For instance, Revatio and Adcirca use the same biological mechanisms as Viagra and Cialis.
3. Evidence linking Viagra to melanoma is mixed.
The 2014 JAMA article sent shock waves through the medical community by pointing out a link between Viagra use and the development of melanoma.
However, just one year later, JAMA published a follow-up study that analyzed more than 20,000 medical records and concluded that Viagra use may be related to melanoma but is not a cause of it.
Researchers determined there is no relationship between the amount of the drug consumed and the likelihood of developing melanoma. Instead, they point to the fact that the majority of Viagra users are middle-to upper-middle-class men, most of whom can also possibly afford more relaxation time in the sun.
Despite these findings, in 2016, the FDA began to study the links between Viagra, Cialis and malignant melanoma.
4. The MDL is proceeding on schedule.
As of October 2018, the Honorable Richard Seeborg, who oversees the Viagra/Cialis MDL, was reviewing the bellwether trial schedule. One year later, medical researchers testified about causation in a four-day hearing, pointing to a “plausible” link between the drugs and melanoma.
Dr. Rizwan Haq of the Dana Farber Cancer Institute testified that his conclusion on a plausible link came from an analysis of 50 studies. Pfizer attorney Joseph Petrosinelli countered that the American Academy for Dermatology found no such causal link. Judge Seeborg noted that this was not the same as a doctor claiming Viagra and Cialis do not cause cancer.
5. Viagra, Cialis and other erectile-dysfunction drugs use the same biological mechanism.
Viagra and Cialis may be the only two drugs named in the MDL, but they’re not the only two erectile-dysfunction drugs on the market susceptible to this kind of lawsuit.
The origin of these drugs is an interesting story of unintended consequences: after doctors noticed that a certain blood pressure medication tended to cause patients to experience long-lasting erections, researchers isolated this compound and began producing it under the Viagra label.
Like Viagra and Cialis, Levitra and Stendra also rely on PDE5 inhibitors to increase blood flow to the penis and prevent erectile dysfunction. Although these two drugs are not yet named in the MDL, should their users begin to file melanoma-related lawsuits, these drugs could be candidates for inclusion.
6. The MDL currently has 955 pending lawsuits.
As of July 2019, the Viagra and Cialis MDL has 955 individual lawsuits now pending. Several cases were dismissed earlier in the MDL for the plaintiffs’ failure to abide by certain deadlines. Other cases were dismissed at the plaintiffs’ direction.
As of January 2017, only 263 cases had been filed. When In re: Viagra Products Liability Litigation MDL was filed in 2015, there were only 15 claims pending.
7. Major plaintiffs are represented by two to five different law firms.
Like other MDL proceedings, the Viagra/Cialis MDL involves multiple attorneys and law firms, each hoping to recover a share of the pie for the plaintiffs they represent.
While the jury is still out on the causal connection between Viagra, Cialis and conditions such as fading vision, heart problems and melanoma, the sheer number of plaintiffs involved in this litigation has made it one of the biggest MDL cases to watch.
Sifting through dozens of leads per day to find potential plaintiffs, firms need a scalable solution to qualifying those leads and not waste billable hours on intake qualification and conversion.
Law firms that don’t have a dedicated intake specialist (or multiple) should consider outsourcing their intake process with bilingual services. Doing so casts a wider net over potential new clients, including plaintiffs who might provide your firm with a foothold in the Viagra/Cialis MDL.
