MDL Judge Dismisses Gardasil Lawsuits Filed Outside Vaccine Act Requirements

The U.S. District Judge presiding over all Gardasil lawsuits filed in federal courts nationwide has dismissed several claims, indicating that his court does not have the power to override decisions by a special federal vaccine court, which determined the cases were not brought in a timely manner.

Merck’s Gardasil HPV vaccine has been widely used for years among both young girls and boys, to help protect against HPV infections that can be sexually transmitted and lead to the later development of cervical cancer.

Although the vaccine has been widely promoted as safe and effective, Merck currently faces hundreds of product liability lawsuits being filed in the federal court system, each raising similar allegations that the drug maker failed to disclose the risk of serious autoimmune disorders that may result from side effects of the Gardasil vaccine.

Lawsuits indicate that a number of teens and young adults have been left with severe and debilitating complications after receiving one or more injections, including postural orthostatic tachycardia syndrome (POTS), neurological problems, premature ovarian failure, idiopathic thrombocytopenic purpura (ITP), chronic pain, brain fog, fatigue, headaches, nerve damage and other injuries.

While there are some cases pending in state courts, the vast majority of the litigation has been brought in the federal court system, where all Gardasil lawsuits have been centralized as part of a federal multidistrict litigation (MDL) in the Western District of North Carolina. U.S. District Judge Kenneth D. Bell, Sr. is currently presiding over coordinated discovery and pretrial proceedings in about 200 claims pending in the MDL, and preparing a small group of cases for early trial dates.

Some Gardasil Lawsuits Dismissed for Untimeliness

Before a civil Gardasil lawsuit can be filed, federal law requires that families must initially bring a petition to the U.S. Vaccine Court, seeking compensation under the National Vaccine Injury Compensation Program. They can only file a civil claim if the case is not resolved after eight months, and many Gardasil injury claims are still undergoing that process.

Last month, attorneys for Merck argued that four Gardasil lawsuits filed in the federal MDL should be dismissed since they were not brought in the U.S. Vaccine Court in a timely manner. The manufacturer indicated that one of the claims was never been filed before the U.S. Vaccine Court, as the law required, and that the others were filed in the federal court system after the Vaccine Court determined the initial claims were not submitted within the proper time period.

The Vaccine Court dictates that claims of injury linked to a vaccine must be filed within three years of the first occurrence of symptoms. However, many plaintiffs in Gardasil lawsuits indicate that not only were they children when they received the vaccinations, but for many years they were unaware that their side effects were even caused by the vaccinations. The plaintiffs allege that Merck purposefully hid the full extent of Gardasil vaccine side effects from the medical community and federal regulators.

In a court order (PDF) issued on July 31, Judge Bell granted Merck’s motion to dismiss the four cases.

One of the claims was dismissed because it had never been filed with the Vaccine Court. However, the other three had been filed with the U.S. Vaccine Court previously, which had ruled against the claimants on the timeliness issue, and plaintiffs proceeded to file their civil claims while their appeals of the decisions were under review.

In his decision, Judge Bell indicated that his court did not have the authority to overrule a still-standing ruling by the U.S. Vaccine Court.

“The threshold issue before the Court is whether it has the authority and duty to reconsider (and potentially overrule) the Vaccine Court/Court of Federal Claims’ decision on the timeliness of these Plaintiffs’ Vaccine Court petitions,” Judge Bell noted. “There is no clear guidance on this issue from any federal circuit court, although the few courts that have ruled on the issue have all supported Defendants’ position.”

It is unclear how the ruling will affect other Gardasil lawsuits pending in the federal MDL, or whether the ruling will be appealed.

August 2024 Gardasil Vaccine Lawsuit Update

Last year, Judge Bell ordered the parties to select 16 Gardasil “bellwether” lawsuits for case-specific discovery in preparation for a series of early trial dates, which will help gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation. However, with the court expected to hold hearings over the admissibility of expert witness testimony in late January 2025, the first federal trials are not expected to begin until the end of 2025 or beginning of 2026.

It is expected that the court will later narrow the group of 16 selected claims down to a smaller group that will be eligible for the first trial dates in the federal court system.

Currently, California state courts anticipate starting the first Gardasil lawsuit trial, in any court, to go before a jury starting on October 7 of this year. It will be followed by several other California state court cases in January 2025 and February 2025. However, Merck is pushing to have the start of those trials delayed.

While the amount of any damages awarded in the California cases will not have any binding impact on other Gardasil claims pending in the federal MDL, the trials will be watched closely to see how juries rule, and whether they hit Merck with large financial penalties for failing to adequately warn about the potential Gardasil side effects.