Merck Ordered To Produce Entire Gardasil Adverse Event Database in Lawsuits Over HPV Vaccine Side Effects

With a growing number of teens and young adults pursuing Gardasil lawsuits alleging they suffered serious side effects from the HPV vaccine, the U.S. District Judge presiding over the litigation has ordered Merck to turn over its entire adverse event database to plaintiffs.

Over the past two decades, the Gardasil vaccine has been aggressively marketed for use before sexual activity, to help protect against HPV infections that can lead to the development of cervical cancer later in life. However, Merck now faces lawsuits alleging the HPV vaccine side effects caused debilitating autoimmune complications, including postural orthostatic tachycardia syndrome (POTS), neurological problems, premature ovarian failure and other side effects.

There are currently about 80 complaints pending in the federal court system, which have been centralized before U.S. District Judge Robert J. Conrad in the Western District of North Carolina, since they each involve common questions of fact and law. However, over the coming months and years, it is widely expected the litigation will continue to expand, and hundreds of individual cases may ultimately be filed.

To help gauge how juries are likely to respond to certain evidence and testimony, Judge Conrad has begun the process of selecting a number of “bellwether” cases, which may be ready to go before a jury by late 2024 or early 2025. Therefore, the parties are currently engaged in general discovery into issues that apply to all claims, then they will begin case-specific depositions and trial preparations.

Judge Orders Gardasil Adverse Event Databases Turned Over

Early in the discovery process, plaintiffs filed a motion to compel in November 2022, indicating that Merck had failed to provide adequate productions and responses to questions posed, including information about other adverse event reports submitted by users involving any problems after receiving the HPV vaccine.

The Court heard oral arguments on the motion by both parties on February 28, and Judge Conrad issued an order (PDF) on March 30, granting most of the plaintiffs demands, indicating that Merck must turn over all of its Gardasil Adverse Events Databases, including the Merck Adverse Event Reporting and Review System (MARRS).

The order also compels Merck to turn over numerous other documents involving its communications regarding the HPV vaccine’s side effects, and the names of the company’s key opinion leaders on the vaccine.

The information produced during discovery will be presented during a series of bellwether trials, which may impact the amount of any Gardasil settlements Merck offers to avoid the need for each individual case to go before a jury in future years.

April 2023 Gardasil Lawsuit Criteria

As parties work to prepare the bellwether cases for trial, Gadasil 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)