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Viagra Litigation

Pfizer has frequently defended itself in courtrooms because the company's popular erectile dysfunction drug, Viagra, has a history of alleged side effects, including heart issues and vision and hearing problems. Now Pfizer is fighting claims from patients who allege they developed melanoma as a result of taking “the little blue pill.”

*Please seek the advice of a medical professional before discontinuing the use of this drug.

Men who took Viagra have filed numerous lawsuits against the drug's manufacturer throughout the years. They suffered the following complications and sought legal compensation:

  • Melanoma
  • Heart Attack
  • Vision Loss
  • Stroke

Number of Lawsuits MDL No. 2691 (Melanoma) – 428; Unknown number of prior lawsuits

Plaintiff Injuries Melanoma (skin cancer); Plaintiffs have previously filed suits claiming heart attacks or strokes, vision impairment or loss of vision (known as NAION), and hearing impairment or loss of hearing

Defendants Pfizer

MDL Location MDL No. 2691 – Northern District of California (Melanoma); MDL No. 1724 – District of Minnesota (Vision loss)

Class-Action None

Litigation Status MDL No. 2691 – Pending; MDL No. 1724 – Dismissed with prejudice

Viagra has earned notoriety as “the little blue pill” capable of helping men suffering from erectile dysfunction (ED) get and maintain erections, thereby enabling and enhancing their sexual performance. Pfizer estimates Viagra has been prescribed to more than 35 million men worldwide, with physicians writing about 8 million prescriptions for Viagra in 2012 alone.

But shortly after Viagra entered the market in 1998, Pfizer has faced many lawsuits alleging varied claims and injuries.

Pfizer World Headquarters
The entrance to Pfizer World Headquarters in Manhattan, New York

The multibillion-dollar company first dealt with injured patients claiming that their adverse heart and blood vessel conditions, including heart attacks or strokes, resulted from their use of the ED drug.

These lawsuits were mostly dismissed as new studies found that Viagra may not be directly responsible for the adverse heart outcomes experienced by plaintiffs, but rather that many of the injured patients already suffering from cardiovascular conditions and were being treated concurrently with nitro compounds, such as nitrate medicines for angina. The combination of these nitrates taken with Viagra was essentially “doubling up” on the medications’ effects, which both resulted in dilation (opening) of a patient’s blood vessels, raising the risk of a sudden drop in blood pressure during sex.

Viagra, approved by the U.S. Food and Drug Administration in 1998, was originally designed to treat high blood pressure and cardiovascular disease.

In 2005, Pfizer faced lawsuits stemming from an FDA-initiated drug label change for Viagra regarding post-marketing reports of vision loss related to a condition known as NAION (or non-arteritic anterior ischemic optic neuropathy). Again, in 2007, the FDA recommended another label change to include warnings about the potential for sudden hearing loss associated with the use of Viagra.

And most recently, in 2014, a study published in JAMA Internal Medicine revealed a link between Viagra use and a potentially significant risk of subsequent development and worsening of a serious and potentially life-threatening skin cancer — melanoma. This prompted new patients to come forward with injury claims that have risen to over 400 consolidated legal actions now pending in a federal court in California.

Why Are Viagra Patients Filing Lawsuits Now?

In 2016, the FDA said it was “evaluating the need for regulatory action” as to the link between phosphodiesterase (PDE)-5 inhibitors, including Viagra, and skin melanomas. But some patients are now coming forward as plaintiffs seeking legal retribution, claiming the pharmaceutical company and defendant, Pfizer, should have warned them from the start.

Recent lawsuits filed against Pfizer over Viagra claimed injuries (mainly the development of melanoma – skin cancer) as a “direct and proximate result of [the defendant’s] negligent and wrongful conduct in connection with the design, development, manufacturing, testing, packaging, promoting, marketing, distribution, labeling and/or sale of sildenafil citrate [Viagra] tablets.”

Plaintiffs claim that Pfizer intentionally “concealed material information related to melanoma development from potential Viagra users,” specifically in its commercials, online and print advertisements. They claim that as a result, “men in the United States pervasively seek out prescriptions for Viagra.” But had the plaintiffs known the actual risks, many claim they “would have elected not to take Viagra” and, consequently, would have also avoided its serious side effects.


"The melanoma related risks associated with Viagra rendered Viagra unreasonably dangerous or far more dangerous than a reasonably prudent consumer or health care provider would expect."

- Recent lawsuits filed against Pfizer


The lawsuits assert that “Viagra is inherently dangerous and defective, unfit and unsafe,” and that “the melanoma related risks associated with Viagra rendered Viagra unreasonably dangerous or far more dangerous than a reasonably prudent consumer or health care provider would expect.” Plaintiffs further assert that Pfizer was “reckless” in its promotion of the drug as a “safe medication for skin cancer patients” and that Pfizer “knew or should have known, that Viagra increased the risk of developing melanoma cells and was significantly associated with an increased risk of subsequent melanoma.”

The plaintiffs are suing Pfizer for negligence, strict liability, failure to warn, misrepresentation, fraudulent concealment, and pain and suffering. They are seeking restitution for their injuries and losses, including loss of spousal companionship, emotional distress, mental anguish and economic losses, as well as compensatory damages for medical aid, treatment, monitoring, medications and other expenditures “as a proximate result of [the defendant’s] misconduct.”

Robert Eubanks

Doctor examining mole
Eubanks was diagnosed with melanoma on his back

Plaintiff and patient Robert Eubanks began treatment for erectile dysfunction (ED) with Viagra in 2000. Eubanks continued using the drug regularly until 2013, when he made the switch to Cialis (an ED medicine manufactured by Eli Lilly). On November 12, 2012, Eubanks was diagnosed with melanoma on his back. The cancer later spread to his thyroid and lymph node under his left arm. Eubanks underwent surgery to remove the cancerous area.

In June 2015, Eubanks and his wife, Teresa, sued Pfizer stating, “had [the defendant] properly disclosed the melanoma-related risks associated with Viagra, [Eubanks] would have avoided the risk of developing melanoma by not using Viagra at all.” In the alternative, Eubanks pointed out that had he been aware of the serious risks, he could have also severely limited the dosage and length of use of Viagra, and more closely monitored its adverse effects on his health.

Edward Corboy Jr.

In 2014, Edward Corboy Jr. filed a lawsuit against Pfizer claiming the pharmaceutical company “failed to adequately warn that the use of Viagra significantly increases a person’s risk of developing skin cancer.”

Corboy began taking Viagra to treat erectile dysfunction (ED) in 2008. In his complaint, Corboy stated that he had a biopsy performed on a mole on his neck in December 2012, and that the results revealed melanoma. Corboy subsequently underwent a surgical procedure to remove the cancer.

Viagra Adverse Effects

Corboy alleged that his use of Viagra over the course of several years put him at an increased risk of developing melanoma.

Corboy asserted that “despite [Pfizer’s] knowledge regarding the risks of Viagra, it did not sufficiently warn doctors who prescribed or patients who were prescribed Viagra of the risk of developing melanoma.” Corboy’s complaint further alleged that his use of Viagra over the course of several years put him at an increased risk of developing melanoma and for the melanoma, once developed, to become more invasive.

Finally, Corboy stated that he been properly warned about the risks, he would have chosen not to take Viagra.

Viagra Multidistrict Litigation (MDL)

In April 2016, Viagra litigations were centralized into a single proceeding in the Northern District of California.

Fact

multidistrict litigations (MDL), are designed to speed along the process of handling complex cases.

Such consolidations, called multidistrict litigations (MDL), are designed to conserve resources and streamline pre-trial proceedings.

A judicial panel determined the legal actions all included common factual questions “arising out of the allegation that Viagra (sildenafil citrate) causes or increases the risk of developing melanoma and that [the] defendant [Pfizer] failed to warn consumers and health care providers of the alleged risk.” The Panel also found that the actions all relied upon the same studies to support their claims. The plaintiffs and Pfizer did not oppose the MDL, which now consists of over 400 pending actions.

What is multidistrict litigation (MDL)?

Multidistrict litigation (MDL) proceedings are designed to speed along the process of handling complex cases, such as product liability suits that could involve hundreds, or even thousands, of plaintiffs in several different federal court districts. Typically, the court will schedule bellwether trials, which become indicators of expected future trends in the litigation.

During this process, a group of plaintiffs is selected to represent all plaintiffs with similar pending actions. Sometimes, depending on the verdict (outcome), bellwether trials can help to encourage settlements as well as provide a valuation for what is to be considered a fair number for settlement. Once a settlement is proposed and approved by the court, plaintiffs can choose to accept it or move forward with their own individual trial.

Cialis Claims Added to MDL

Cialis Pills
Plaintiffs claim that Cialis also causes or contributes to melanoma

In December 2016, plaintiffs suing Cialis manufacturer Eli Lilly for similar injuries allegedly resulting from the use of Cialis (another erectile dysfunction drug, also a PDE5 inhibitor) sought to “expand the scope of MDL No. 2691 [involving Viagra claims] to encompass actions alleging that Cialis causes or contributes to melanoma” as well.

While Eli Lilly was on board with “mixed-use” transfers (meaning patients injured by the use of both Cialis and Viagra), the pharmaceutical company opposed the transfer of Cialis-only actions.

The Panel ultimately found in favor of the transfer, stating that “Cialis has the same mechanism of action as Viagra and causes or contributes to the development of the same injury.” Therefore, it was concluded that the inclusion of the additional product to the existing Viagra MDL was warranted.

History of Viagra Litigation

Minneapolis Courthouse
District of Minnesota Courthouse in Minneapolis

In January 2006, legal actions filed against Pfizer over its erectile dysfunction (ED) drug Viagra were consolidated into a multidistrict litigation (MDL) proceeding in the District of Minnesota. Injured plaintiffs claimed that taking Viagra caused a vision loss disorder called non-arteritic anterior ischemic optic neuropathy (or NAION), resulting from diminished blood flow to the front of the optic nerve.

Beginning in November 2009, the court dismissed several of the plaintiffs’ cases with prejudice (meaning they could not be refiled) due to their failure to comply with a prior scheduling order of the court, which provided strict due dates for all relevant discovery to be exchanged prior to trial. The parties ultimately entered into a settlement agreement to dismiss all cases with prejudice and without costs afforded to any of the parties involved.

The case was closed in October 2011.


Kristin Compton is a medical writer with a background in legal studies. She has experience working in law firms as a paralegal and legal writer. She also has worked in journalism and marketing. She’s published numerous articles in a northwest Florida-based newspaper and lifestyle/entertainment magazine, as well as worked as a ghost writer on blog posts published online by a Central Florida law firm in the health law niche. As a patient herself, and an advocate, Kristin is passionate about “being a voice” for others.

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