The Viagra litigation is ramping up. Last April the U.S. Judicial Panel on Multidistrict Litigation (JPML) created a multidistrict litigation site in the Northern District of California for lawsuits alleging injury against Pfizer from the use of Viagra. Since then, the Viagra lawsuits have piled up in California federal court.

The U.S. Food and Drug Administration approved Viagra (sildenafil citrate) for sale in 1998. It set out to fix an intimate and unhappy problem: erectile dysfunction. One study indicated that thirty million men may suffer from erectile dysfunction. And it worked (I’ve heard). Millions of men standing on the sidelines were back in the game.

The reason I know it worked is because Viagra’s manufacturer, Pfizer, Inc., sold $1.8 billion dollars worth of the drug in 2013. Pfizer has self-reported that it has prescribed Viagra to 35 million men. All over the country and all over the world, those 30th wedding anniversary weekends were suddenly a lot more fun. And that’s a wonderful thing.

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Unfortunately, some of these men developed skin cancer. Melanoma is the most aggressive and most dangerous form of skin cancer. Melanoma develops when damage to skin cells triggers mutations that lead the skin cells to multiply rapidly and form malignant tumors. Many people think of melanoma as dark, asymmetrical moles, and in fact melanoma can develop from existing moles, but melanoma can also form directly on the skin. Melanoma has been estimated to cause over 10,000 deaths in the United States each year.

The problem is, men taking Viagra seemed to be developing melanoma at a greater rate than the general population developed melanoma.

The Master Long Form Complaint in the Viagra Litigation

The Master Long Form Complaint in the Viagra MDL sets out the narrative of the claims of men who developed melanoma after taking Viagra. I will bullet-point some of the important allegations:

• The Plaintiffs allege that Pfizer knew or should have known about the connection between Viagra use and melanoma, even going back to the late 1990s.
• Several studies linked Viagra use and the increased risk for melanoma.
• A 2014 study indicated an 84% increase in the risk of developing melanoma after taking Viagra, or worsening the effects of existing skin cancer.
• A 2016 study from Northwestern University reported “’a significant association with melanoma’ for users of sildenafil and tadalafil. Significantly, the study found a doubling of the risk for sildenafil.” (I write more about the science behind the connection between Viagra use and melanoma here.)
• Despite these studies, Pfizer continued to market Viagra aggressively (and you would think this medication would sell itself, given what it cures).
• Pfizer has marketed Viagra to younger men.
• Through the years, and through increasingly aggressive marketing campaigns, Pfizer did not warn users about the increased risk of developing melanoma.
• The general public and doctors who prescribe Viagra would not have known of the risks of taking Viagra.
• Pfizer knew or should have known that the drug posed a significant health risk to the men taking Viagra.
• The health risks of taking Viagra outweighs the benefits of using the drug, but Pfizer kept selling it anyway. After all, erectile dysfunction, while unpleasant, does not pose any health risks to men.
• Pfizer aggressively marketed and sold Viagra, for decades, and made a lot of money selling it.
• As a result of all these sales, consumers of the drug were placed at increased health risks.
• Many men developed melanoma.
• These men were seriously injured by taking Viagra. Melanoma is a serious health issue.
• Pfizer downplayed the risks through the manufacture and sale of Viagra.
• Pfizer did not mention any potential risks for developing melanoma in the medication label or package inserts.
• Pfizer did not mention any potential risk for developing melanoma in its advertising materials.
• As a result of Pfizer’s actions, the plaintiffs were injured.
• If doctors would have known of the risks, they would not have prescribed the drug.
• If patients would have known of the risks, they would not have taken the drug.

The Plaintiffs’ Claims

From these allegations, plaintiffs bring many claims or “causes of action,” including:

1. Negligence 2. Unfair and Deceptive Trade Practices (Unfairness, Fraud, Unlawfulness) 3. Defective Design 4. Failure to Warn 5. Failure to Test 6. Breach of Express and Implied Warranties 7. Negligent Misrepresentation 8. Fraudulent Misrepresentation and Concealment 9. Fraud and Deceit; Willful, Wanton, and Malicious Conduct 10. Unjust Enrichment 11. Loss of Consortium 12. Survival 13. Wrongful Death 14. Punitive Damages

Pitched Court Battle Inevitable

Please remember: at this stage of the litigation, the allegations listed above are not yet proven. Pfizer has denied many of the allegations and will have the opportunity to defend itself, and intends to . . . vigorously. Pfizer is represented by Williams & Connolly, DLA Piper, and Kay Scholer, three of the most expensive defense law firms in the country. Look for a pitched court battle. Still, the scientific studies are mounting which point to a clear connection between Viagra use and the increased risk for melanoma. Please talk to your doctor if you are taking Viagra (or Cialis or Levitra); it may not be worth the risks.

I’ve written about Viagra and the Viagra litigation on this site. Check it out for more information.

This is the safe and correct call. If you are diagnosed with melanoma, you need to focus on getting back to health. I suggest you stop taking the drug and schedule an immediate appointment with your dermatologist. In fact, I would say that even without a diagnosis of any skin cancer, you should ask your doctor (or a second doctor) if you should stop taking Viagra (or Cialis or Levitra). If a doctor you trust reviews your patient history and encourages you to remain on Viagra, fine.

2. Get Healthy

See your dermatologist or personal physician immediately. This is the most important thing to do if you are diagnosed with melanoma. Melanoma is the most serious of the skin cancers, and can certainly cause death is untreated or if treatment is delayed. Your health comes first. So move briskly to have the cancer removed. And of course stay out of the sun until you speak at length with your doctor.

3. Read the Studies

The starting point should be the post I wrote recently about the latest study identifying a possible connection between the use of Viagra (and Cialis and Levitra) and the onset of melanoma. This study is peer-reviewed and appears scientifically reliable. From my site you can click through to the study itself, or here. Read it carefully. Discuss the study’s findings with your dermatologist. In fact, discuss the findings with as many medical professionals as you have access to.

After reviewing the recent Sildenafil Study, do some additional research on the Internet. Many websites are well-researched, well-meaning, and helpful. But not all of them. I can’t stress this enough: The Internet is a freaky place. I once saw a funny cartoon depicting a doctor handing a prescription to a patient with the caption, “take two of these before you Google your symptoms.” Indeed, within a matter of minutes on the Internet you can be reading about the worst possible outcomes from taking a medication. Also, most people understand this but there is no requirement for truth on the Internet. People can write anything. (Of course, this rule applies to this website and to me too.) If something sounds unbelievable on a website, it is likely false. So again, be cautious and skeptical when conducting research on the Internet. The goal is to find reliable, helpful information, not the most sensational or terrifying.

4. Keep a Melanoma Journal

If you’ve read my posts in the past, you know I’m a big advocate of keeping detailed notes on your physical condition after any injury, whether that involves pain from a faulty artificial hip or strange symptoms after taking testosterone. In this case, write down when you first discovered the melanoma on your skin, what pain you may be experiencing (if any), what your doctor tells you about your treatment, what medical care you’ve received, etc. If the information is related in any way to your skin cancer, write it down. This journal will assist you in getting back to health, and it may also assist your attorney with a possible court case down the road. A melanoma journal (for lack of a better name) can provide extremely valuable information to an attorney putting together the best case for you in the event you have a viable claim against a pharmaceutical company for a harmful drug like Viagra.

5. Maintain Records of Medical Bills, Expenses

Keep accurate records of all bills incurred and any out-of-pocket expenses you are paying for your medical care related to the melanoma, including surgeries, chemotherapy and radiation treatments, recovery, rehabilitation, medications, etc. In some cases, pharmaceutical companies will pay the out-of-pocket expenses of a victim of a failed drug like Viagra. In addition, keep detailed records of all time missed from your employment, including sick days which you were forced to use, and days out of work for which you lost compensation.

6. Call an Attorney You Trust

Let me say this: the scientific study linking melanoma to the use of erectile dysfunction drugs like Viagra, Cialis, and Levitra is in the early stages. Studies so far show an increased risk of developing melanoma among men who use these drugs, but we still need to look more closely at the connection. That said, a multi-district litigation site has already been established for the dozens of lawsuits filed against Pfizer, the manufacturer of Viagra, and I suspect we will shortly see MDLs against the makers of Cialis and Levitra, as those drugs work in the body in similar ways to Viagra. For more information on choosing the right product liability lawyer, you can check out my posts here and here and here. You can also simply call me for more information: (919) 830-5602.

Note: I am no doctor. As a product liability attorney, of course I can’t diagnose your health issues and cannot connect any injury you may have suffered to Viagra or to any other drug. Please see your doctor immediately if you suffer any negative health issue (related to the use of Viagra or not). That said, the general recommendations in this post are common-sense and reasonable, and consistent with the research I have done on this class of drugs.

As if erectile dysfunction were not harrowing enough. In March 2016 a published study concluded that the use of the drug sildenafil (Viagra), vardenafil (Levitra), and tadalafil (Cialis) “could promote melanoma in humans.”

As you probably know, melanoma is the most aggressive and most dangerous form of skin cancer. Melanoma develops when damage to skin cells (usually caused by ultraviolet radiation from sunshine or tanning beds) triggers mutations that lead the skin cells to multiply rapidly and form malignant tumors. Most people think of melanoma as dark, asymmetrical moles, and in fact melanoma can develop from existing moles, but melanoma can also form directly on the skin. Melanoma is often caused by intense, sustained exposure to ultraviolet light, the kind which causes suntans and sunburns. Melanoma has been estimated to cause over 10,000 deaths in the United States each year.

The Latest Study

A team of researchers recently published findings from a study of the potential connection between the increased risk of melanoma in humans who take erectile dysfunction drugs like Viagra. The study is titled Sildenafil Potentiates a cGMP-Dependent Pathway to Promote Melanoma Growth, which you can access here. This study identified a pathway in the cells of the human body which can permit the growth of melanoma. The science behind the study is complex and technical, but let’s give it try:

Sildenafil (Viagra) is a phosphodiesterase 5 inhibitor (PDE5). When PDE5 is inhibited, a man has the enhanced ability to gain an erection. And that’s a good thing. Unfortunately, according to the study, the inhibition of PDE5 in the human body also increases the level of “cyclic guanosine-3′, 5′-monophosphate” (cGMP), which is described as “a signaling molecule,” and increased levels of cGMP in the body promotes “mitogen-activated protein kinase” (MAPK), which is a pathway in the molecules associated with the increased growth of melanoma cells. When PDE5 is not inhibited, there are low cGMP levels and less active melanoma growth. But when sildenafil or other drugs inhibit PDE5, it causes a molecular reaction which promotes the malignant growth of melanoma cells. So the inhibition of PDE5 increases cGMP levels, which promotes MAPK, which encourages melanoma cell growth. Got it?

Vardenafil (Levitra) and tadalafil (Cialis) are also PDE5 inhibitors. The study states that Levitra and Cialis would also operate like Viagra to promote melanoma cell growth through similar molecular reactions.

Other studies have linked the use of Viagra to an increased risk of melanoma, including one from the Journal of American Medical Association (JAMA) in 2014.

Viagra Maker Denies Increased Melanoma Risk

Pfizer is the manufacturer of Viagra, the first and most popular of the drugs used to treat erectile dysfunction. Pfizer has denied any increased melanoma risk, stating that Viagra has been studied in 136 clinical trials and that “there is no reliable scientific evidence that the medicine causes melanoma.” It is important to listen to the denial, as Pfizer states there is no reliable scientific evidence, which recognizes that there is scientific evidence; Pfizer thus discounts the existing scientific evidence as “unreliable.” Pfizer has stated that it stands behind “this important medicine” and intends to “vigorously defend these lawsuits.”

I also read one article which suggested that the Viagra lifestyle was the cause of the increased incidence of melanoma (and not the Viagra itself). The “Viagra lifestyle” was suggested to be a world where men would take their romantic partners to places like the Caribbean or on a boat, places where exposure to the sun’s damaging rays was higher. I would advise skepticism for this theory. I have not seen any evidence that men who use Viagra had better sun tans than those men who did not take Viagra, except on all the commercials.

The Lawsuits Are Mounting

In April, the U.S. Judicial Panel on Multidistrict Litigation created a MDL site in the Northern District of California for lawsuits from those alleging injury against Pfizer from the use of Viagra. Judge Richard Seeborg of San Francisco has been assigned to preside over the Viagra MDL. The central allegations are that (1) sildenafil increases the risk of developing melanoma and that (2) Pfizer failed to warn consumers and medical care providers of the risk. Originally fourteen cases were transferred to the Viagra MDL, but more are being filed each week.

Pfizer first sold Viagra in 1998. And to no one’s surprise, it became hugely popular and very profitable. In 2013 alone Pfizer made $1.8 billion dollars from the sale of Viagra worldwide. All this to say that many millions of men have taken Viagra over the past eighteen years. If the studies are accurate, this is an army of men more vulnerable to the onset of life-threatening skin cancers.

The Takeaway

Let’s face it, compromised conditions of aging, like bad knees or erectile dysfunction, can dramatically reduce a person’s quality of life. For years medications like Viagra seemed like a great way to extend an aging man’s ability to engage in sexual intercourse (which is a great thing to engage in). However, the most recent study of Viagra, coming as it does after other studies concluding that Viagra may increase the risk of melanoma, suggests that the use of erectile dysfunction drugs may not be worth it. Talk at length to your doctor about the risks of taking Viagra or Levitra or Cialis. Of course avoid excessive sun exposure and always wear sunscreen. Above all, keep a careful watch about any news reports of new studies linking Viagra and similar drugs to the onset of melanoma.