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The Timeline of the Viagra® Lawsuit


The timeline of the Viagra® lawsuit begins with the drug’s FDA approval in 1998 and continues through the current stage of litigation. Originally developed as a treatment for angina, early trials showed that while the drug was not a viable treatment option for the condition, it did increase blood flow to the penis. Pfizer, the manufacturer of Viagra®, submitted the medication to the U.S. Food and Drug Administration (FDA) for approval as a treatment for erectile dysfunction (ED). Shortly after the drug's approval, serious complications were reported, resulting in countless lawsuits against the manufacturer. The first claims against Pfizer involved heart attacks and strokes as early as 1998. Recent studies have also shown a potential link between the drug and melanoma, prompting additional lawsuits against the company. If you or a loved one has suffered from a serious complication after taking Viagra®, please contact an attorney today for a complimentary case evaluation. An experienced dangerous drug attorney can conduct a thorough evaluation of your claim and review your options for legal recourse.

A man holding a viagra pill
Viagra® has been the subject of many lawsuits after patients experienced troubling complications.

Developed to Treat Angina

Angina is a pain in the chest that is caused by reduced blood flow to the heart muscle. Angina can also be a symptom of coronary artery disease. Pfizer initially developed Viagra®, with the active ingredient sildenafil, as a treatment for angina and pulmonary arterial hypertension. Sildenafil works by inhibiting a protein that constricts your blood vessels. This allows the vessels to dilate and increase blood flow.

Clinical Trials

Early clinical trials of the drug confirmed that Viagra® was not a viable treatment option for angina. During these trials, however, researchers discovered an unintended side effect of the medication. Sildenafil was effective in dilating blood vessels in the penis, and when combined with sexual stimulation, could improve a man’s ability to achieve and maintain an erection. After this discovery, Viagra® was resubmitted to the FDA for approval as a treatment for ED.

Approved for Treatment of Erectile Dysfunction

By the age of 40, nearly 50 percent of men experience ED to some extent, and by age 70, nearly 70 percent of men suffer from ED. With successful studies on Viagra® and its results, the FDA approved the medication as the first oral treatment for ED in 1998. Viagra® quickly became Pfizer’s most popular drug, making the manufacturer billions of dollars.  

Heart Attacks and Strokes

Pfizer started having troubles with Viagra® almost immediately. Less than a year after the drug’s approval by the FDA, reports of sudden drops in blood pressure leading to heart attacks or strokes began to surface. The risk of this serious side effect could be increased if the patient was also taking nitrate medications for a heart condition. Later that year, in response to these serious claims, the FDA recommended including additional warnings for Viagra® to warn patients and health care providers of these risks for patients with heart or blood pressure conditions.

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NAION and Vision Problems

Soon after, men taking Viagra® began to experience vision problems, specifically non-arteritic ischemic optic neuropathy (NAION). NAION can occur when blood flow to the optic nerve is inhibited. This results in visual changes, typically within the first 36 hours of taking the medication. Patients report a haziness or dark shadow in the upper or lower halves of their vision, usually in just one eye. While NAION typically does not cause complete blindness, the damage is irreversible. More recent studies, however, have found possible links between Viagra® and permanent blindness.

FDA Warning Update

In addition to the previous warning update in 1998 that cautioned those with heart or blood pressure conditions, the FDA required the addition of a “black box” warning in 2005 to warn patients of the increased risk of blindness, other vision problems, and NAION.

Hearing Problems

Patients who experienced sudden hearing impairment or loss also prompted numerous lawsuits against Viagra® and Pfizer. After numerous studies, the FDA found multiple instances of hearing loss in patients who took Viagra®. Auditory experts have hypothesized that the increase in blood flow can damage sensitive hearing mechanisms, resulting in partial or complete hearing loss.

FDA Label Revisions

In response to the numerous claims about hearing loss, the FDA again requested that Pfizer make changes to Viagra® packaging. In 2007, the risk of sudden hearing loss was added to Viagra®’s growing list of potentially serious side effects and complications.

Studies Concerning the Link Between Viagra® and Melanoma

A 2014 study published in JAMA Internal Medicine found a strong correlation between Viagra® and melanoma, a rare but deadly form of skin cancer. The study included more than 25,000 men and took other risk factors for melanoma into consideration, including genetics, medical history, skin tone, hair color, pre-existing moles, and history of sun exposure. The researchers concluded that Viagra® patients were developing melanoma at a higher rate than those who were not taking the drug. It is important to understand that this study only proves a correlation between Viagra® and melanoma. It does not prove a causal relationship between Viagra® and melanoma. The study, however, will encourage further research on the topic to find a stronger connection between Viagra® and melanoma.

Lawsuits Filed

Countless lawsuits have been filed against Pfizer over complications involving Viagra®. Most of the current litigation against Pfizer involves patients who were diagnosed with melanoma after taking Viagra®. In April 2016, the majority of these  cases were consolidated into multidistrict litigation (MDL), for more efficient pretrial processing. Although similar to a class action, MDL is typically more beneficial to the individual plaintiffs, as they receive a settlement or verdict that is unique to their case. Our skilled legal team is continually researching and investigating these cases and will provide updates on the Viagra® lawsuits as they become available.

Schedule a Consultation

If you or a loved one has suffered a serious complication after taking Viagra®, contact a pharmaceutical attorney today to schedule a complimentary case evaluation. An attorney with extensive knowledge and experience with pharmaceutical litigation will carefully review your claim and discuss your legal options.

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