Appeals Will Be Pursued Over Gardasil Lawsuit Dismissals Due to Vaccine Act Deadlines

Lawsuits allege that Merck hid the link between Gardasil and autoimmune disorders for years, making it difficult to file with the U.S. Vaccine Court in a timely manner.

In response to a decision by the federal judge presiding over all Gardasil lawsuits to dismiss four claims last month, after finding that they were not brought in a timely fashion under the U.S. Vaccine Act, plaintiffs have filed notice of appeal to the U.S. Court of Appeals for the Fourth Circuit.

The claims raise allegations similar to those being presented in more than 200 other product liability lawsuits currently being pursued against Merck, indicating that the drug maker withheld information about the potential side effects of the Gardasil HPV vaccine for years, failing to disclose that some users may be left with severe and debilitating complications.

Merck’s Gardasil vaccine has been widely promoted for use among both young boys and girls, to help protect against HPV infections that can be sexually transmitted and lead to the later development of cervical cancer. However, a number of teens and young adults now indicate that they have been left with postural orthostatic tachycardia syndrome (POTS), neurological problems, premature ovarian failure, idiopathic thrombocytopenic purpura (ITP), chronic pain, brain fog, fatigue, headaches, nerve damage and other debilitating 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 before U.S. District Judge Kenneth D. Bell, Sr. in the Western District of North Carolina, as part of a federal multidistrict litigation (MDL).

Judge Bell has determined that before a civil Gardasil lawsuit can be filed, federal law requires that families must first bring a petition to the U.S. Vaccine Court, seeking compensation under the National Vaccine Injury Compensation Act, which requires that any claim be presented within three years. However, many of the injuries associated with Gardasil were not recognized until much later.

Plaintiffs Appeal Gardasil Lawsuit Dismissals

In July, the vaccine manufacturer successfully convinced Judge Bell to dismiss four Gardasil lawsuits because they were not brought within the vaccine act deadline. Those plaintiffs have now filed a Notice of Appeal (PDF), indicating that they intend to challenge the ruling, which may have an impact on the ability of other claimants to file Gardasil lawsuits.

Many of the individuals injured by Gardasil are now young adults, and received the HPV vaccine as children, so they were unaware that their side effects may have been caused by the injection. In addition, plaintiffs argue that Merck purposefully hid the full extent of Gardasil vaccine side effects from the medical community and federal regulators, which prevented claims from being filed.

One of the plaintiffs now pursuing an appeal is Tessa Needham, who filed her lawsuit in March 2024, indicating that she developed POTS after receiving a Gardasil injection when she was just ten years old. Angela Walker also filed notice of appeal, following the dismissal of her lawsuit brought in April 2024. She received the injection when she was 22 years old, later developing chronic fatigue syndrome (CFS), autonomic dysfunction and POTS-like symptoms. However, she did not discover that the injuries were caused by Gardasil until much later.

“Plaintiff’s medical provider did not provide Plaintiff with the Vaccine Information Statement required by the National Vaccine Childhood Injury Act,” Walker stated in her lawsuit. “Therefore, Plaintiff was unaware of any available remedy for an adverse reaction to a vaccine or that the Vaccine Court program even existed. Plaintiff first learned of a link between her symptoms and Gardasil in early 2023.”

Each of the women now intend to challenge Judge Bell’s dismissal of their claims before a panel at the U.S. Court of Appeals for the Fourth Circuit.

September 2024 Gardasil Lawsuit Update

While those four plaintiffs pursue the appeal, pretrial proceedings are continuing before Judge Bell, where parties are engaged in discovery into common issues that impact all claims, and preparing case-specific discovery in a small group of representative bellwhether claims.

On August 15, Judge Bell issued an updated Gardasil scheduling order (PDF) for moving the litigation forward, pushing several deadlines back about a month on average.

Plaintiffs now have until September 9 to submit general causation and regulatory expert reports. Merck’s general causation expert reports are due by September 27. The new schedule sets the due date as January 1, 2025 for Daubert motions, which can challenge the use of certain expert witnesses.

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.

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. However, with Judge Bell not expected to hold hearings over the admissibility of expert witness testimony until late January 2025, the first federal trials are not expected to begin until the end of 2025 or beginning of 2026.

Currently, California state courts anticipate the first Gardasil lawsuit trial to go before a jury on October 7, 2024, which will be the first time evidence in the litigation will be presented in open court. That trial 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.