As of May 15, 2017, 428 men are plaintiffs in a Viagra (sildenafil) multidistrict product liability litigation in U.S. District Court for the Northern District of California.
The suit alleges that the “little blue pill,” manufactured by Pfizer, is connected to a significant increase in the risk of melanoma, the most dangerous form of skin cancer. Viagra has been prescribed to millions of men to solve problems with erectile dysfunction.
The lawsuit alleges that Pfizer has known since the late 1990s of the increased risk of skin cancer for Viagra users but chose not to warn the public or the medical community.
Melanoma
The American Cancer Society says melanoma the most serious form of skin cancer. If not caught early, melanoma can spread to other parts of the body. For early-stage melanoma, removal of the melanoma along with a border of normal skin and a layer of tissue beneath the skin may be the only treatment needed. But if the melanoma has spread beyond the skin, the individual may need chemotherapy, radiation, or biological therapy to boost the immune system, according to the Mayo Clinic.
The melanoma survival rate depends on the stage of the cancer at diagnosis. Survival rates are higher for people with earlier stage cancers, but survival also depends on the person’s overall health, and how the cancer responds to treatment.
Viagra
Viagra helps a man achieve an erection by inhibiting the secretion of a specific enzyme that can prevent erection. But blocking this enzyme can also trigger the growth of melanoma cells, according to the master complaint filed in the federal multidistrict litigation. Blocking the secretion of PDE5 leads to an increase in cGMP, which can cause cell mutation and the creation and proliferation of melanoma cells.
Research studies published in 2011, 2012 and 2014 found that blocking the enzyme can trigger the creation of melanoma cells. The most recent study cited in lawsuits (published in JAMA in 2014) looked at nearly 26,000 men in the United States who take Viagra and found that the melanoma risk for recent users increased by 84 percent, compared with the risk for nonusers. Pfizer does not list the melanoma risk among possible side effects for the drug.
Viagra Melanoma Lawsuits
National law firm Parker Waichman notes that the proliferation of lawsuits began after the 2014 study in the Journal of American Medical Association. The study did not establish that using Viagra (sildenafil) caused melanoma, but the researchers found a “statistically significant” increase in the incidence of melanoma in men who used Viagra.
The JAMA article reported on a long-term cohort study “examining the associations between Viagra use and risk of melanoma.” In 2000, participants in the Health Professionals’ Follow-up Study were questioned about sildenafil use for erectile dysfunction. Participants rated their ability to have and maintain an erection without treatment before 1986, from 1986 to 1989, 1990 to 1994, and 1995 to 2000, and during the past three months. Men with poor or very poor ability to have and maintain an erection at or before 2000 were considered to have erectile dysfunction at baseline.
The study found that of every 1,000 men in the study who used Viagra, 8.6 men developed melanoma, compared to 4.3 of every 1,000 men who did not use Viagra.
The researchers noted that although there was a statistically significant relationship between Viagra and melanoma the study could not definitely connect the two. The study has also been criticized because the data was self-reported, meaning the data on Viagra use and information about the melanoma was not gathered directly from the participants by scientists.
The legal complaint in a lawsuit filed in late 2015, says Pfizer “purposefully downplayed, understated and outright ignored the melanoma-related health hazards and risks associated with using Viagra.” Pfizer also “deceived potential Viagra users” by relaying positive information through the press, including testimonials from retired U.S. politicians, while downplaying known adverse health effects.
Pfizer denies any connection between Viagra use melanoma and claims that there are at least 130 studies that prove Viagra is a safe drug that has improved the lives of millions of men around the world.
The MDL is now in the discovery process. The attorneys are reviewing millions of pages of documents, taking depositions from witnesses, and identifying experts. At a hearing expected to be scheduled for early 2018, the court will rule on the admissibility of expert evidence each side plans to offer.
Legal Help for Viagra Users Who Have Developed Melanoma
If you or someone you know has developed melanoma after using Viagra or another drug in the PDE5 inhibitor class, you may be entitled to compensation for your injuries. The attorneys at Parker Waichman LLP can provide for a free, confidential, no-obligation case evaluation. To reach the firm, fill out the online contact form or call 1-800-YOURLAWYER (1-800-968-7529).
