Developments in Viagra Litigation | Searcy Denney

Our Fee Promise: No Recovery,

You Owe Us Nothing


Searcy Law Blog


Brenda Fulmer

Viagra — Developments in Litigation

» Written by // September 27, 2016 // ,


There have been some very recent developments in the national litigation regarding the erectile dysfunction (ED) drug Viagra and the allegation that its use increases a patient’s risk of developing melanoma. Judge Seeborg, the federal judge appointed to oversee all of the Viagra cases filed in federal court from across the country (which is MDL No. 2691), held his first hearing in San Francisco on June 15, 2016. A second, more substantive hearing was held before the MDL judge on August 10, 2016.

This August 2016 hearing also covered various administrative and management issues for the MDL 2691 litigation including providing the judge with an update on the individual Viagra cases filed so far, discussion of how to handle cases that involve “mixed use” (which means patients who ingested both Viagra and other ED drugs, such as Cialis or Levitra, the manufacturers of which are not included in this consolidated litigation effort), and using master pleadings to expedite the litigation and conserve the resources of the parties and the court.

These lawsuits over Viagra’s cancer link are not the first time that Pfizer has been sued over its popular ED drug. Nearly 10 years ago, some lawsuits were filed by patients who developed non-arteritic anterior ischemic optic neuropathy (NAION) that was attributed to their use of Viagra (also known as sildenafil citrate). NAION causes vision loss due to insufficient blood supply to the optic nerve. In 2008, there were approximately 134 individual lawsuits filed in a federal court MDL based in Minneapolis by patients who had suffered vision loss attributed to ingestion of Viagra.

Little blue pills, spilling from a bottle. Could they be those "Special Pills"? Only you can say. This image became my second flame on Saturday, January 7th, 2006. It also was my 5,000th download on August 10th, 2006.

There was also an unsuccessful lawsuit filed several years ago against Pfizer by a Louisiana patient who blamed his hemorrhagic stroke on his use of Viagra. The judge dismissed the patient’s claims due to insufficient scientific proof, including the lack of causation testimony from the patient’s treating surgeons identifying Viagra as the cause of that plaintiff’s debilitating stroke.

Since the initiation of this latest round of Viagra litigation a few months ago, Judge Seeborg has entered several orders relating to the overall management of the federal court litigation. There are approximately 50 individual Viagra lawsuits filed, but it is anticipated that the national litigation will ultimately grow to exceed 500 to 1,000 individual personal injury and wrongful death lawsuits filed against Pfizer on behalf of patients who developed melanoma skin cancer after ingesting Viagra. There are also approximately 70 individual claims filed in state court in St. Louis, Missouri on behalf of cancer patients.

Judge Seeborg has also ordered briefing on the first discovery-related issues, including a pending dispute over the methods to be used for “ESI” discovery. “ESI” stands for “electronically stored information” and relates to the methods to be utilized in electronically searching and producing Pfizer’s digital documents and electronic data, all of which relates to critical scientific and liability issues in the Viagra cases and essential evidence that the plaintiffs must gather to meet their burden in proving their product liability and negligence claims against the pharmaceutical company.

The MDL judge has also ordered the parties to file legal briefs in the coming weeks on Pfizer’s refusal to produce documents to the plaintiffs relating to its research on other PDE5 inhibitor drugs, as the drug company contends this research regarding the class of drugs of which Viagra is a part is unrelated to the issues in this litigation. Obviously, the plaintiffs contend that what Pfizer knew regarding this entire class of drugs and what was known about the effects of inhibition of PDE5 generally in the body (going back to before Viagra’s first approval by the FDA in 1998) relates to what Pfizer knew or should have known regarding the risks of developing melanoma due to ingesting Viagra.

As I have stated on this blog in the past, the link between Viagra and melanoma is complex. In the Viagra cases, the plaintiffs have argued that scientific studies have documented that Viagra blocks of the secretion of PDE5, which leads to an increase in levels of cGMP (cycle guanosine monophosphate) in the body. The presence of high levels of cGMP has been noted by scientists to cause cell mutation and the creation and proliferation of melanoma cells.

The generic fact and liability discovery phase of the case will include the production of millions of pages of documents from the drug manufacturer and third parties that will span over 20 years of drug research and development, FDA approval, marketing, and safety surveillance. During the discovery phase, which usually lasts 12 to 24 months, the parties will also complete depositions of fact witnesses involved in the development, marketing and safety monitoring of Viagra.

Once this initial discovery is completed, the parties will also complete expert witness discovery, including the production of extensive reports relating to the medical, scientific and liability issues as well as completing depositions of experts retained by the plaintiffs and the defendant to substantiate their claims and defenses, respectively. This generic discovery must be completed for the benefit of all plaintiffs with pending Viagra claims, as each plaintiff must prove that Viagra causes an increased risk of malignant melanoma (to the high standards of certainty required by our federal court rules) besides also proving that a particular patient’s melanoma was also caused by the drug (which requires an exclusion of other potential causes and risk factors for developing melanoma in a particular patient).

The MDL judge is also expected to approve forms for case-specific discovery, and will likely require plaintiffs to complete a lengthy questionnaire, known as a Plaintiff’s Fact Sheet, that includes information about a patient’s background, family and personal medical history, potential exposures and pre-existing conditions that might be possible causes of melanoma, and details regarding the economic losses (lost wages, loss of earning capacity, medical expenses paid by insurers, insurance co-pays and deductibles, out of pocket expenses, etc.) and non-economic damages (such as pain and suffering, emotional distress, loss of consortium, etc.) sustained by the plaintiff.

Judge Seeborg has scheduled the next Viagra MDL hearing for October 14, 2016. We hope that the initial generic discovery issues will be resolved by that time, such that the production of documents by Pfizer can begin. Also, the MDL judge will probably announce at that hearing or soon thereafter a timetable for completing discovery and preparation for the first trials in the MDL. Drug and medical device cases coordinated through the MDL process in federal court take about 3 years on average. It is too soon to know how much time this case might take (both regarding the preparation of the generic case and the individual cases that are pending) since most delays common in litigation are encountered during the document production and deposition stage.

 


West Palm Beach

Searcy Denney 2139 Palm Beach Lakes Blvd.
West Palm Beach, FL 33409-6601
Toll-free: (800) 780-8607
Phone: (561) 686-6300
En Espanol: (800) 220-7006

Tallahassee

Searcy Denney The Towle House, 517 N. Calhoun St.
Tallahassee, FL 32301-1231
Toll-free: (888) 549-7011
Phone: (850) 224-7600
En Espanol: (800) 220-7006


Free Initial Consultation

Personal injury attorneys ready to fight for you.

Searcly Law

Our Fee Promise: No Recovery
You Owe Us Nothing.

Yes, I want to Schedule
My Free Case Evaluation
No Thanks, I do Not
Need Assistance