Viagra

  • Viagra Medical Record Review & Outsourcing Services

Viagra (Sildenafil citrate) is a phosphodiesterase inhibitor manufactured by Pfizer and approved by the Food and Drug Administration (FDA) in 1998. It is a drug widely used to treat erectile dysfunction in men and pulmonary hypertension. Pfizer has two patents for Sildenafil, one is indicated to treat cardiovascular disease and marketed as Revatio, the patent for which was published in 1993 and expires in 2012, and another is indicated to treat erectile dysfunction and marketed as Viagra. The Viagra patent is expected to expire in 2020 in the US.

A study conducted in 2014 stated that there is an 84% increased risk of melanoma (skin cancer) associated with Viagra while other studies also suggest that it may increase the risk of vision problems like blindness. It has been said that men who use Viagra tend to double the risk of developing melanoma, the most dangerous form of skin cancer. Viagra use has been previously linked to potential health risks, including hearing loss and vision loss, which can occur within 48 hours of first use.

Some studies have estimated that people dying from Melanoma cancer, includes a majority of the male population. FDA approved the first-ever generic version of Viagra in 2016 to be manufactured by Teva, a Pennsylvania-based pharmaceutical company. The drug entered the market in December 2017. Since 2012, ED medications have been estimated to bring in $4.3 billion in sales worldwide.

In April 2014, a study indicated that over 25,000 men taking Viagra were 84% more likely to develop melanoma cancer. Men who previously took Viagra continued to be at risk even when the drug was discontinued.

Serious Alleged Injuries may include:

  • Melanoma skin cancer
  • NAION (Non-arteritic Anterior Ischemic Optic Neuropathy)
  • Heart Attacks
  • Strokes
  • Hearing Loss
  • Priapism

FDA Safety Warnings:

October 2005: A petition required a black box warning for erectile dysfunction drugs Sildenafil (Viagra), Tadalafil (Cialis) and Vardenafil (Levitra). Though less severe warnings had already been added, a black box was not added.

2005: The FDA ordered to add a warning to the drug's label about vision loss.

October 2007: Changes were requested in the label to include warnings about sudden hearing loss associated with the drug when 29 reports of patients who experienced sudden hearing loss within hours to two days of taking Viagra were received.

2012: The FDA advised that Revatio (Sildenafil) should not be prescribed to children ages 1 through 17 for pulmonary arterial hypertension (PAH), or high blood pressure in the blood vessels leading to the lungs. 

2014: The FDA issued an update and clarification of its earlier recommendation suggesting that it was up to the health care professionals to consider whether the benefits of treatment are likely to outweigh the potential risks to their patients.

April 2019: The FDA is yet to recall Viagra from the medical market.

Legal Updates:

Defendants: Pfizer Inc., Eli Lilly.Co 

Defendants Liaison Counsel:
David P Graham & William P Studer - OPPENHEIMER WOLFF & DONNELLY LLP. 

Defendant Law firm: Pfizer is represented by Kaye Scholer LLP and Oppenheimer Wolff & Donnelly LLP.

Plaintiff Steering Committee:

  • Robert R. Hopper - Zimmerman Reed, P.L.L.P.

  • Daniel E. Becnel, Jr. - Law Offices of Daniel E. Becnel, Jr.

  • Camilo K. Salas III - Salas & Co., L.C.

  • Shelly A. Sanford - Goforth, Lewis, Sanford LLP

  • Ronnie Penton - Law Offices of Ronnie G. Penton

  • Zoe Littlepage -  Littlepage & Booth

  • Michael J. Miller - Miller & Associates

  • Neil Overholtz - Aylstock, Witkin & Sasser, PLC

Allegations: Plaintiffs allege that Pfizer knew or should have known about melanoma skin cancer risk for years, indicating that studies published as early as 2011 suggested that the erectile dysfunction drug may promote melanoma cell invasion.

Lawsuit status: 

April 7, 2016: Viagra skin cancer lawsuits were centralized before U.S. District Judge Richard Seeborg in the Northern District of California as part of multidistrict litigation (MDL No. 2691; In Re: Viagra Products Liability Litigation).

September 2016: Plaintiff Dianne Parish filed a lawsuit in the U.S. District Court for the Southern District of Indiana on September 9, alleging that the drugmaker failed to warn about the melanoma risk cancer caused from Viagra resulted in the death of Rex Parish. A wrongful death lawsuit was filed that stated Rex began taking pills for the treatment of erectile dysfunction in July 2007 and continued till 2013. He died on September 2014 of malignant melanoma complications. The lawsuit states that the death could have been avoided if the defendant Pfizer would have provided warnings for consumers and the medical community about the risk between melanoma and Viagra.

December 2016: Claims against Eli Lilly and Company, the manufacturer of Cialis, included in the Viagra MDL 2691 by the U.S. JPML.

2018: About 900 lawsuits were filed throughout the federal court system. Judge Richard Seeborg announced to meet attorneys for a case management conference to review the bellwether trial schedule and provide an update on the litigation status for claims filed by men diagnosed with melanoma skin cancer due to the alleged use of erectile dysfunction drugs. The parties were required to submit an agreed-upon pretrial order which would be used in the completion and execution of Plaintiff Fact Sheets (PFS), along with case specific-discovery and release of plaintiffs' records.

2019: There is no sign that Pfizer is planning to offer a global settlement to resolve the coordinated MDL proceedings for centralized Viagra lawsuits. Most of the lawsuits were dismissed by the judge claiming that the drug caused cardiovascular problems while Pfizer settled cases implicating Viagra in patients' loss of vision. As of April 2019, 900 plus melanoma lawsuits remained pending in the federal court in the Northern District of California.

Important Verdicts & Settlements:

1998: A 55-year-old man alleged that Viagra use caused him to have a heart attack seeking a settlement of $85 million. This was dismissed in 2000 by a New York Supreme Court
Judge stating there was no scientifically accepted evidence that Viagra side effects include the risk of a heart attack.

MDL Status: MDL No. 1724 – Dismissed with prejudice
                       MDL No. 2691 – Pending

Evidence:

  • Indication of usage in Medical Records
  • Indication of Usage in Pharmacy Records
  • Duration of Usage
  • Complications and their treatment after intake

Medical Record Review and claim validation of Viagra case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.

Accreditations

HIPAA

Neural IT has successfully implemented HIPAA for securing Health records....

ISO 27001 Certification

Neural IT has successfully passed the ISMS re-certification audit and is now ISO 27001:2013 certi...

NSIC - CRISIL

NSIC-CRISIL has assigned a "SE 2A" rating to Neural IT, indicating a company with High Performanc...

Associations

CAALA

CAALA - "Neural IT is proud to be associated with CAALA (Consumer Attorneys Association of Los An...

CAOC

CAOC - "Neural IT is proud to be associated with CAOC (Consumer Attorneys of California) as a Ven...

NYSTLA

NYSTLA - "Neural IT is proud to be associated with NYSTLA (New York State Trial Lawyers Associati...

News & Events

posh-awareness-session-conducted-at-neuralit-for-2019
An Act To Enact For Betterment Of Our Society
Rewards & Recognition Program - July 2019
Neural IT organized ‘Rewards & Recognition Program' on July 5, 2019, to motivate employees an
International Yoga Day - Image - Neural IT
International Yoga Day celebrated at Neural IT to bring physical and emotional health for our tea

Latest Tweets