Appeals Court Finds Hundreds of Gardasil Lawsuits Barred by Vaccine Court Deadline

Before filing a Gardasil lawsuit against Merck, claims must first be brought in the Vaccine Court, which has a harsh deadline requiring claims to be filed within three years, even though many are unaware of the cause of their injuries.

A federal appeals court has shut down an effort to revive Gardasil lawsuits, ruling that the plaintiffs missed a key filing deadline required by the U.S. Vaccine Court, a misstep that strips federal courts of jurisdiction to hear the failure to warn claims presented against Merck.

The decision marks a significant setback for individuals who say they developed serious autoimmune conditions after receiving Gardasil as children, including postural orthostatic tachycardia syndrome (POTS), premature ovarian insufficiency (POI) and other debilitating injuries, which may not be immediately linked to the widely used HPV vaccine.

At the height of the litigation, Merck faced about 200 Gardasil lawsuits, each claiming that the HPV vaccine can cause devastating neurological and autoimmune disorders. 

Three years ago, the claims filed throughout the federal court system were consolidated as part of a Gardasil MDL (multidistrict litigation) in the Western District of North Carolina, where U.S. District Judge Kenneth D. Bell was appointed to preside over coordinated discovery and pretrial proceedings.

In March, before the parties could hold a series of early bellwether trials slated to begin next year, Judge Bell issued a controversial ruling granting a motion for summary judgment, determining that plaintiffs had insufficient evidence linking Gardasil and POTS for the claims to move forward. He then issued a final judgment in June, dismissing all remaining Gardasil lawsuits involving POTS injury claims. However, prior to that date, several other lawsuits were dismissed based on Merck’s argument that they were not filed within a required three year vaccine court deadline.

In July, a group of Gardasil vaccine lawsuit plaintiffs filed a notice of appeal with the U.S. Court of Appeals for the Fourth Circuit. The appeal was filed by Tessa Needham, Angela M. Walker and Shanie D. Roman, whose complaints were deemed to be filed in an untimely manner in the Vaccine Court.

All vaccine injury claims must be submitted to the Vaccine Court before a plaintiff can file a civil lawsuit. The Vaccine Court maintains a fund to pay for injuries caused by vaccines, allowing drug manufacturers to continue to make vaccines that often have low profitability, in return for not having to face liability risks.

According to an opinion (PDF) by the Appeals Court issued on September 4, the court did not have to address the appropriateness of Judge Bell’s ruling, because the Gardasil lawsuits should not have been filed in federal court at all.

The appeals court noted that plaintiffs had first submitted their claims to the U.S. Vaccine Court, but a special master ruled they were filed too late. Although plaintiffs challenged that decision in federal court, the panel found it had no authority to review the Vaccine Court’s timeliness rulings.

“We therefore conclude that whether a Vaccine Act petition was timely is a question for the special master, with any review or reconsideration of that decision taking place in the Court of Federal Claims and Federal Circuit. Once those forums have settled the question, their answer can’t ordinarily be relitigated in a later tort suit.”

– Chief Judge Albert Diaz, U.S. Court of Appeals for the Fourth Circuit

The judges determined that there was no need to weigh the merits of Bell’s dismissal because the lawsuits should have never been filed in federal court, concluding that the plaintiffs do not have a right to an equitable tolling agreement that would allow the court to disregard the untimely filings.

The appeals court has not yet addressed challenges filed by individuals who did bring their claim within the three year vaccine court deadline.