Gardasil Lawsuits Over Failure To Warn Doctors About HPV Vaccine Risks Cleared To Move Forward

Judge indicates hundreds of additional lawsuits over undisclosed health risks of the HPV vaccine are likely to be filed in the coming months and years.

The U.S. District Judge presiding over all federal Gardasil lawsuits is allowing the litigation to move forward, after narrowing down plaintiffs’ claims to whether Merck fraudulently concealed the HPV vaccine risks from doctors, or failed to adequately warn them about potential side effects users may experience.

There are currently about 200 product liability lawsuits filed against Merck & Co. in the federal court system, each involving similar allegations that the drug maker failed to disclose potentially serious health risks from the Gardasil vaccine, 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 Merck has promoted the vaccine as safe and effective, lawsuits claim the company withheld critical information from both users and the medical community about severe and debilitating autoimmune complications, including postural orthostatic tachycardia syndrome (POTS), neurological problems, premature ovarian failure and other side effects.

However, the currently filed cases likely represent only a small portion of the total number of Gardasil lawsuits that Merck will face in the coming months and years, as hundreds of additional claims have been presented in the U.S. Vaccine Court, where claimants must initially bring any claims over HPV vaccine risks, 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 presented in the Gardasil lawsuits, the cases have been centralized as part of a federal multidistrict litigation (MDL) in the Western District of North Carolina for coordinated discovery and pretrial proceedings, which is expected to involve a series of early bellwether trials that will help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation.

While the Gardasil MDL was originally assigned to U.S. District Judge Robert J. Conrad, last month the Judicial Panel on Multidistrict Litigation reassigned the pretrial proceedings to U.S. District Judge Kenneth D. Bell, Sr., who issued a critical ruling last week that allows the lawsuits to move forward.

Gardasil Lawsuits Narrowed, But Proceeding

In February, Merck filed a motion to dismiss all Gardasil lawsuits filed over failure to warn about the HPV vaccine risks, arguing that they should be insulated from liability under a host of protections granted under the National Childhood Vaccine Injury Act.

On March 20, U.S. District Judge Kenneth Bell issued an order (PDF) rejecting the request. While Judge Bell did find that plaintiffs’ claims for defective design, manufacturing defect, and failure to warn patients about the risks of HPV vaccine risks are preempted by federal law, he did not find that the litigation must be dismissed entirely.

Judge Bell determined that plaintiffs’ failure to warn claims that indicate Merck should have provided more information on Gardasil risks to healthcare providers are not blocked by the Vaccine Act, and neither are claims that Merck fraudulently concealed that information from the medical community.

April 2024 Gardasil Lawsuit Update

In his order, Judge Bell noted that there are currently nearly 200 Gardasil lawsuits filed in federal courts nationwide. He also revealed that Gardasil injury lawyers predict hundreds of additional claims will be eventually be added to the litigation, which involves an HPV vaccine that has been administered more than 120 million times since it was introduced in 2006.

While the parties continue to work to prepare a group of Gardasil cases for trial, injury lawyers are continuing to investigate and file new lawsuits for individuals who experienced a variety of complications from the HPV vaccine, including:

• Autoimmune Diseases
• POTS (Postural Orthostatic Tachycardia Syndrome)
• Premature Ovarian Failure
• Premature Menopause
• Polycystic Ovary Syndrome (PCOS)
• Idiopathic Thrombocytopenic Purpura (ITP)
• Irregular Heartbeat/Tachycardia
• Lupus
• Neurologic Disorder
• Brain Fog or Chronic Inability to Concentrate
• Chronic Fatigue
• Chronic Pain
• Severe Headaches
• Difficulty Sleeping
• Fibromyalgia
• Nerve Damage
• Menstrual Disorders/Problems
• Gastrointestinal Issues (food intolerances, nausea, vomiting)

Following coordinated discovery and any bellwether trials in the federal MDL, if the parties fail to reach Gardasil settlements or another resolution for the litigation, Judge Conrad may later establish a process to begin remanding each individual claim back to U.S. District Courts nationwide for individual trial dates in the future.