Viagra Skin Cancer MDL Expanded to Include Cialis

melanomaThe US Judicial Panel on Multidistrict Litigation expanded MDL 2691 Viagra (Sildenafil Citrate) Products Liability Litigation to include claims against Eli Lilly and Company, the manufacturer of Cialis, alleging that the erectile dysfunction drug causes melanoma, or skin cancer.

Both drugs work the same way by inhibiting an enzyme known as phosphodiesterase type 5, 1 or PDE5. Three studies link this action to increasing melanoma cells. Pfizer is the manufacturer of Viagra.

The MDL was created on April 7, 2016 and grew from 35 cases in May to 246 cases in December, 2016. US District Judge Richard Seeborg is supervising the MDL in the Northern District of California in San Francisco.

Pfizer knew of the risks

Among the plaintiff cases is Sue Matthews, Individually and as Personal Representative of the Estate of Robin Matthews v. Pfizer Inc., Case No.: 3:16-md-02691-RS. It charges that Pfizer knew of the significant risks of developing melanoma caused by Viagra, but the company did not adequately and sufficiently warn consumer or the medical community.

Robin Matthews of Virgin, Utah, took Viagra from 2005 to 2012. On Sept. 23, 2013 he went to urgent care for abdominal pain and doctors discovered melanoma lesions on his liver, kidneys, spleen, adrenal glands and lymph nodes. A MRI on Oct. 11, 2013 showed the cancer had spread to his bones and lungs. On Oct. 22 he died due to metastatic malignant melanoma.

The FDA approved Viagra on March 27, 1998. By 2012 doctors had written prescriptions for Viagra to more than 35 million men worldwide, producing worldwide revenue of $1.8 billion.

  • A study published in 2011 found that treatment with Viagra can promote melanoma cell invasion. Specifically, by inhibiting PDE5, Viagra mimics an effect of gene activation and may potentially function as a trigger for the creation of melanoma cells.
  • A 2012 study published in the Journal of Cell Biochemistry also found that PDE5 inhibitors were shown to promote melanin synthesis, which may exacerbate melanoma development.
  • On April 7, 2014, an original study (“the JAMA study”) was published on the website for the Journal of the American Medical Association Internal Medicine which, in light of the earlier studies, sought to examine the direct relationship between sildenafil use and melanoma development in men in the United States. The JAMA study was published in the journal’s June 2014 edition. The study found that 25,848 participants who had recently used sildenafil exhibited an 84% increase in risk of developing or encouraging invasive melanoma.

“Despite these significant findings, Defendant has made no efforts in its ubiquitous Viagra advertisements to warn users about the potential risk of developing melanoma that has been scientifically linked to its drug,” the complaint alleges.

 

Read More

Considerations for Plaintiff Attorneys when Starting a Successful Mass Tort Practice

John Ray
John Ray

Mass Tort Litigation has emerged as the only effective check on pharmaceutical and medical device companies that make dangerous products injuring thousands of Americans. Mass tort attorneys have filed 140,000 lawsuits in 250 federal multidistrict litigation dockets as of September 2016.

Many attorneys are expanding their personal injury practices to include mass torts because the US Judicial Panel on Multidistrict Litigation has organized the litigation so effectively against the multi-billion-dollar drug and medical device industry.

“The FDA is not a check or a balance on the pharmaceutical industry,” said Mass Tort Nexus Consultant John Ray, recently teaching a four-day course about mass torts in Fort Lauderdale, FL. “Plaintiff attorneys are the only check on the pharmaceutical industry.”

In recent years mass tort lawyers have recovered $10 billion in settlements for injured Americans: $4.8 billion for Vioxx, $1.8 billion for Yaz, $1.3 billion for the Stryker hip and $2.5 billion for the DePuy hip.

“The drug companies bake these cases into their business model,” Ray said. “Defendants call it a win when they don’t put a warning on their labels, don’t get sued and don’t have to pay a judgment at all. This means they got away with it. That happens a lot.”

When a federal MDL is created, the supervising judge will approve a standard short-form or long-form complaint, plus a plaintiffs’ fact sheet which replaces interrogatories. The consolidation of cases means that a mass tort lawyer can file a notice of appearance and file cases regardless of the jurisdiction of the plaintiff, defendant company or the location of the plaintiff’s attorney.

Criteria for a viable case

Cases that are attracting many mass tort attorneys now involve Xarelto, IVC filters and Pradaxa. Among the many factors determining the viability of a mass tort are:

  • Preemption. Congress has expressly preempted certain claims. Further, courts have ruled that generic manufacturers cannot be sued.
  • Statute of limitations: State laws govern when the statute of limitations starts to run, but in most federal litigation, the date that the FDA issues a “black box warning” for a drug marks the date when the time limit begins to run.
  • Legal viability. In many cases, research will show a connection between a drug and injuries among patients, but specific causation must be proved in a trial. Experts must be found who will survive a Daubert motion to disqualify.
  • Financial viability of the defendant. While Johnson & Johnson had $46.8 billion in annual income in 2015, some small makers of IVC filters went out of business before they could sell one.
  • Average case value. The average Pradaxa case settled for $160,000 in 2014, with some settlements valued up to $500,000, according to a grid created by US District Judge David R. Herndon.
  • Plaintiff numerosity. Cases in the Syngenta Corn Market Crash Litigation involve every corn producer in America, and IVC Filters have been implanted in millions of patients over the last 40 years.
  • Cost per client acquired. Costs can add up with Facebook advertising, website marketing, and lead generation companies. For example, The Sentinal Group will advertise for clients for a fee of $100,000 to obtain 250 calls for Xarelto plaintiffs, with 1 out of 5 calls leading to a signed client.
  • Case duration. Mass torts are litigation for the long haul, with the average case lasting 5 years and 4 months before settlement, according to Ray, with 7 years being a good benchmark for the duration of a case.
  • Case value. An example of a good outcome is with Pradaxa. The average settlement is $162,000. Calculating 40% in gross contingent fees would equal $64,800. Another 7% is deducted ($4,536) for the common benefit to pay the steering committee. Of the remaining fee of $60,204, a 40% referral fee of $24,015 is deducted for the co-counsel that handled the litigation. This leaves a net fee of $36,189 for the attorney who originated the case.
  • Financial resources. Costs to fund a case can be in the tens of thousands of dollars, with costs reaching hundreds of thousands for members of the plaintiffs steering committee.
  • Personnel resources. A law firm will have to train a small army of intake specialists to answer incoming calls when advertising is running. Additional personnel will be needed to obtain and review medical records.

Perfect timing

There are three phases of mass tort litigation, and perfect timing will be needed to enter a particular case.

Emerging Phase Cases. In this early phase, the cost to acquire a client is the least expensive, but there many issues of case viability. For example, the courts are still considering motions to consolidate cases involving Abilify and Roundup. With Abilify the FDA has issued a safety warning but not a black box warning. With Roundup the EPA has not classified the herbicide as a carcinogen, but foreign governments have.

Litigation Phase Cases. It is considered an ideal time to enter into a mass tort when the JPML has created a multi-litigation docket (MDL). Some 250 MDLs include mature litigation involving Benicar, Lipitor, Viagra, Xarelto and Zofran, and many legal issues have been settled. The supervising judge will schedule bellwether or test cases for trial.

Settlement Phase Cases. This is the very safest time to enter litigation because all an attorney must do is find qualified plaintiffs. Example cases involve transvaginal mesh, Levaquin and Pradaxa. However at this late phase the cost to acquire a client is at its highest.

“Whatever you do, maintain your single-event plaintiff’s practice,” Ray advised. “You will have to keep paying the costs of a mass tort case until it settles, and you will need a huge cash supply or credit line.”

Read More

Court Establishes MDL in in California for Viagra Products Liability Litigation

viagra-pillsThe US Judicial Panel on Multidistrict Litigation has issued a transfer order centralizing federal lawsuits in the Viagra melanoma litigation in the Northern District of California. According to the order, responding plaintiffs and the defendant, Pfizer, Inc. support or do not oppose the action. The panel also ordered that the MDL 2691 be renamed In re: Viagra ( Sildenafil Citrate) Products Liability Litigation.

Attorney Ernest Cory of Cory Watson Attorneys argued a motion on behalf of plaintiffs before the Judicial Panel of Multidistrict Litigation on March 31, 2016, asking the panel to consider a request that all Viagra melanoma cases filed in federal courts be consolidated. The federal judges on the MDL panel issued today’s Transfer Order based on hearing arguments from attorneys for Pfizer and from attorneys representing plaintiffs. Attorneys nationwide are involved in the litigation. The court proceedings have been assigned to the Honorable Richard Seeborg of the Northern District of California.

Failed to warn consumers about melanoma risk

The Transfer Order states that “These actions share actual questions arising out of the allegation that Viagra (sildenafil citrate) causes or increases the risk of developing melanoma and that defendant failed to warn consumers and health care providers of the alleged risk. Additionally, all actions rely principally on the same studies to support their claims. Issues concerning general causation, the background science, regulatory history, and marketing will be common to all actions. Centralization will eliminate duplicative discovery, prevent inconsistent pretrial rulings on Daubert and other issues, and conserve the resources of the parties, their counsel, and the judiciary.”

Plaintiffs’ lawsuits, including Dennis Andrews v. Pfizer, Inc., United States District Court for the Northern District of California, Case No. 3:15-cv-4884, allege Pfizer knew Viagra posed a cancer risk, and purposely hid facts about the drug’s safety. The plaintiff also alleges that Pfizer failed to sufficiently test the link between the use of the drug and the risk of deadly melanoma before the drug was approved by the FDA. Additionally, Plaintiffs allege in the suit that that even when studies linked Viagra to an increased risk of melanoma, Pfizer failed to warn users about the important risks associated with Viagra use and instead, continued to spend millions of dollars to promote Viagra.

In June of 2014, the Journal of the American Medical Association reported the results of a long-term study linking melanoma and Viagra use.

Researchers examined data from The Health Professionals Follow-up Study, a long-term study by the Harvard School of Public Health, which tracked the data of nearly 26,000 men from 1986 through 2000.  The researchers looked at both the instances of melanoma in these men as well as their reported Viagra use.

Even after controlling for factors like a history of skin cancer and UV light exposure, men who had taken Viagra were significantly more likely to develop melanomas than those who did not. Of the men who never used Viagra, 4.3 out of every 1,000 developed melanoma skin cancer. Of the men who reported using the erectile dysfunction drug, 8.6 men out of every 1,000 developed melanoma–an 84% increase.

Read More

Despite Attacks, Strokes, Vision problems, Men’s Sex Dysfunction Drugs are Best Sellers

Side-Effects-of-ViagraThe global erectile dysfunction drugs market size was valued at over $4.39 billion in 2014. Key drivers of the market include an increase in patient awareness and education levels and growing base of geriatric population, according to Grand View Research, Inc.

However, reported side effects from the existing drugs are negatively affecting the industry growth. Availability of cost-effective counterfeit drugs is further expected to decrease the valuation of the branded erectile dysfunction drugs, according to Grandview, a U.S. based market research and consulting company, registered in the State of California and headquartered in San Francisco.

Litigation against Viagra has been consolidated in US District Court in Minnesota in multidistrict litigation docket MDL 2691.  Sr. Judge Paul A. Magnuson Judicial Panel on Multidistrict Litigation (JPMDL) on Dec. 29 denied a joint request by Pfizer Inc. and Viagra plaintiffs to place a motion for a skin cancer multidistrict litigation on the panel’s Jan. 28 agenda (In Re: Viagra Products Liability Litigation, MDL Docket No. 2691, JPMDL). The panel’s next hearing in March.

Heart attacks, strokes, vision problems

Does your law firm have a mass tort case in active litigation? Kindly send your press releases directly to attorney Larry Bodine, Editor, Mass Tort Nexus.

Since its release in 1998, the erectile dysfunction (ED) drug, Viagra brought in billions of dollars for drug giant Pfizer.  Men who suffered heart attacks, strokes, vision problems and hearing troubles filed lawsuits against the drug maker. In 2005, the U.S. Food and Drug Administration ordered that warnings about vision loss be added to the drug’s label.

Government reforms and public awareness initiatives in developing regions of Asia Pacific and Latin America are expected to drive market growth during the forecast period. Economic development, healthcare infrastructure establishment, and increasing target population are estimated to provide potential growth platforms for this industry in these regions.

Novel molecule combinations and drug delivery techniques such as the use of creams and pellets that show better efficacy and performance are expected to become an opportunity for the erectile dysfunction drugs industry.

North America erectile dysfunction drugs market, by product, 2012-2022, (USD Million)

Viagra is top-selling drug worldwide.North America erectile dysfunction drugs market

The main line of drugs for erectile dysfunction treatment includes:

  • Vitaros
  • Zydena
  • Stendra
  • Levitra
  • Cialis
  • Viagra.

Viagra (sildenafil citrate) is one of the most widely distributed products worldwide. Viagra’s primary competitors are estimated to be Cialis (tadalafil) by Eli Lilly & Co. and Levitra (vardenafil) by Bayer AG.

Key players of this market include Apricus Biosciences Inc., Bayer AG, Cristalia Dong-A Pharmaceutical Co. Ltd., Produtos Quimicos Farmaceuticos Ltd., Eli Lilly and Company, Pfizer, Inc., S.K. Chemicals Co. Ltd., Meda Pharmaceuticals, Inc., and Vivus, Inc. The industry for branded erectile dysfunction drugs is consolidated with key players involved in intense competition and rivalry.

Pfizer, Inc. accounted for the largest share at over 40.0% in 2012. However, the company’s market share is likely to decline over the forecast period owing to the patent expiry of Viagra in 2019. Generics are expected to boost industrial growth. In addition, post-patent expiration, mergers, acquisitions and collaborations activities, and geographic expansion are expected to keep industry rivalry at higher levels over the forecast period.

Read More