Updates on Gardasil Lawsuit Bellwether Discovery To Be Provided To U.S. Judge Presiding Over HPV Vaccine Litigation

The U.S. District Judge presiding over all federal Gardasil lawsuits will hold a hearing tomorrow to review the latest updates in the litigation, including the status of discovery and ongoing efforts to prepare a small group of representative claims for early test trials over injuries caused by the HPV vaccine.

There are currently more than 130 product liability lawsuits being pursued against Merck & Co. in the federal court system, each involving similar allegations that the drug maker failed to adequately warn about the potential side effects of Gardasil, which has been widely administered to teens and young adults in recent years, to protect against the development of HPV infections and cervical cancer.

Although the drug maker has promoted the vaccine as safe and effect, lawsuits claim that Merck withheld information about severe and debilitating autoimmune complications, including postural orthostatic tachycardia syndrome (POTS), neurological problems, premature ovarian failure and other side effects.

However, the filed lawsuits likely represent only a small portion of the total liability Merck may face, as hundreds of additional claims have been presented in the U.S. Vaccine Court, where claimants must initially bring any claims over HPV vaccine side effects, and then wait at least eight months before transferring their claim to the U.S. District Court for a civil trial.

Given common questions of fact and law raised in the litigation, centralized pretrial proceedings have been established before U.S. District Judge Robert J. Conrad in the Western District of North Carolina, where the parties are engaged in coordinated discovery into common issues that apply to all lawsuits, and are preparing a small group of representative cases for early trial dates, to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.

Gardasil Lawsuit Discovery Update

On Tuesday, Judge Conrad will hold a Gardasil lawsuit status conference, to review the current state of the litigation and allow each side to update the court on any discovery issues.

In preparation for the meeting, the parties issued a joint proposed agenda (PDF) on January 2, indicating that they should discuss a proposed order regarding discovery, a discovery update from Merck, how the cases should be coordinated with lawsuits filed in California state court, and an update on the bellwether cases.

A status report (PDF) was issued the same day, indicating that the parties have completed depositions linked to Merck’s pharmacovigilance processes and Gardasil clinical trials. More Merck witnesses are scheduled to be deposed over the next three months.

In addition, the plaintiffs have requested 37 additional Merck document sources, and Merck has objected to production of three of those sources, so the parties continue to meet to resolve the dispute.

The parties have filed a joint request asking for an extension of discovery deadlines, which will be reviewed at tomorrow’s conference.

Gardasil Bellwether Trial Update

In June, plaintiffs and defendants selected 16 Gardasil bellwether cases eligible for early test trials, which will help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.

“Many depositions of bellwether Plaintiffs and their parents have occurred, and the parties are conferring on scheduling additional depositions for other bellwether Plaintiffs and their parents,” the status report indicates. “The parties are also conferring about certain bellwether Plaintiffs’ and their parents’ counsel’s objections to and instructions not to answer questions regarding family medical history, including plaintiffs’ family members’ diagnoses of mental health conditions, during their depositions. If the parties are unable to reach agreement, the parties will be prepared to present the dispute at the January MDL Conference.”

The report indicates that the parties are working on scheduling depositions of bellwether plaintiffs’ vaccinating healthcare providers in those cases where the plaintiffs’ depositions have been completed.

On January 3, Judge Conrad issued a second case management order (PDF), amending the discovery schedule. The new schedule calls for written discovery to be completed by February 15, with a deadline for general causation expert discovery to be completed by August 30. The order sets October 11 as the deadline for motions challenging the admissibility of general causation expert testimony, and a series of hearings on the admissibility of that testimony will be held in late January 2025, as the last step before jury trials are scheduled.

While the outcome of these early bellwether trials will not have any binding impact on other claims, they will be closely watched to gauge how juris may respond to certain evidence and testimony that will be repeated throughout the litigation, and the average Gardasil lawsuit payouts awarded may impact any settlement amounts offered by Merck to avoid the need for each individual case to go before a jury in future years.