Viagra and Cialis MDL Litigation Update

In April of 2016, the Judicial Panel on Multidistrict Litigation, a panel who determines whether to coordinate federal court lawsuits into multidistrict litigation (MDL), centralized lawsuits involving men who developed melanoma after ingesting Viagra. This MDL was established in San Francisco federal court before Judge Seeborg and styled as In Re: Viagra (Sildenafil Citrate) Products Liability Litigation. Recently, Judge Seeborg expanded the MDL proceedings to include claims against Eli Lilly & Company, after patients who ingested Cialis (a drug similar to Viagra) also developed melanoma. To date, hundreds of individual personal injury and wrongful death lawsuits have been filed by patients alleging that Viagra and/or Cialis were defectively designed, inadequately tested, and improperly marketed, as the manufacturers did not properly inform the patients or their prescribing physicians that the use of the drug could cause or promote the growth of melanoma cancer cells.

The discovery efforts concerning both drugs are now moving on nearly-parallel tracks and are progressing smoothly, especially with Judge Seeborg’s recent rulings.

Judge Seeborg entered a scheduling order, which governs the progress of the case by setting certain deadlines for each of the parties involved. This specific order imposed a timetable requiring the parties to complete key parts of the general and scientific liability discovery by certain dates.

What Does Judge Seeborg’s Scheduling Order Mean for the Parties?

Both defendants have been producing documents relating to the development of the drugs, clinical studies before and after FDA approval, interactions with the FDA and other drug regulators, how the drugs were marketed, monitoring of safety issues, etc. Per Judge Seeborg’s order, the Plaintiffs Steering Committee is only allowed to conduct 14 depositions of key fact witnesses from the two international drug manufacturers. Considering the complexity of the case and the length of time that both Cialis and Viagra have been on the market, the permitted amount of depositions seems exceptionally low, but the plaintiffs are hopeful that Judge Seeborg will allow additional depositions in the future. Nonetheless, the depositions of Pfizer’s fact witnesses relating to Viagra must be completed by October 30, 2017 and Eli Lilly’s fact witness depositions must be completed by January 15, 2018.

The plaintiffs have also been limited to a total of 12 general causation experts – 6 for Viagra and 6 for Cialis. These experts are scientists who will be hired by the plaintiffs to provide expert witness opinions to substantiate the plaintiffs’ case and to satisfy the high thresholds required for admissibility of expert witness testimony in federal court. These experts will cover subjects including how the drugs cause cancer, whether the risks of melanoma are higher n patient who have ingested ED drugs, how much of an exposure to the ED drugs is required in order to cause an increased risk of melanoma, why the cancer link should have been discovered sooner by the manufacturers, whether the rugs were properly tested before being sold to patients, the adequacy of the drug manufacturers’’ systems to detect potential safety issues, and whether the drugs were ethically and honestly marketed by the Defendants. The plaintiffs’ experts must prepare and file their extensive reports by February of 2018. Thereafter, the experts will testify in depositions regarding their opinions. The Defendants’ experts will likewise be required to file their extensive reports by April 2, 2018, and the depositions of those experts must be completed by August 15, 2018.

The Daubert Challenge

Following the completion of the expert witness depositions, both sides will file briefs requesting the MDL judge to strike, or remove, expert witness testimony that they believe does not meet the rigorous standards required for admissibility at trial in federal court. The judge may decide to strike all, some, or none of the expert testimony. In making that determination, the MDL judge will focus on the methods used by the experts in arriving at their opinions. If the judge determines that the experts for both the plaintiffs and defendants have relied upon accepted scientific procedures, even if they have reached differing opinions, the testimony will be admissible and the responsibility of determining which testimony is most credible and reliable will be left for a jury to decide in future trials. This process is known as a Daubert challenge and must be completed by November 19, 2018.

Bellwether Trial Plan for Viagra & Cialis MDL

Judge Seeborg has also ordered the parties to present him with a bellwether trial plan, a plan for selecting the first Viagra and/or Cialis cases to be tried in the MDL, by May 1, 2018.  Once Judge Seeborg selects the cases to be prepared for trial, case-specific depositions and expert witness discovery will be completed.  These trial preparation efforts will be coordinated with the general liability and expert witness discovery discussed above. The purpose of the bellwether trial process is to complete a trial or trials of individual cases that are representative of many of the cases that are pending in the MDL, such that the parties will receive feedback as to the value of the cases, the likelihood of prevailing, etc.  In preparing the bellwether cases for trial, the MDL judge will make several rulings relating to legal issues and will also decide on the admissibility of evidence and case-specific expert witness testimony (which must also endure the Daubert challenge, similar to the generic expert witness testimony).  In this part of a case, the judge will evaluate whether the plaintiff’s treating doctors and expert witnesses have properly followed scientific and medical methodology in determining that Cialis or Viagra were the legal cause of the plaintiff’s melanoma (as opposed to other causes).

Once the bellwether trial process is complete and Judge Seeborg is ready to dismantle the MDL, it is likely that he will remand each individual case back to its respective local federal court jurisdiction for trial settings.  Since the first MDL trials will not occur until 2019, it is doubtful that the remaining cases will be set for trials until late 2019 or, more likely, 2020 and later.

But, for now, the judge and the parties will remain heavily focused on completing the generic liability discovery and the generic expert witness discovery, which must be completed prior to preparing for the first bellwether trials and potential trials in the future.