POTS Lawsuit Alleges Gardasil HPV Vaccine Manufacturer Failed To Disclose Autoimmune Side Effects

The parents of a young girl who suffered severe side effects from Gardasil HPV vaccine injections have filed a lawsuit against Merck, indicating that the drug maker failed to warn about the risk of devastating autoimmune problems, including postural orthostatic tachycardia syndrome (POTS).

The complaint (PDF) was filed earlier this month on behalf of a minor child, identified only with the initials C.A.B., in the U.S. District Court for the Western District of North Carolina, indicating that Merck has continued to sell a vaccine that is known to create a dangerous and unreasonable risk of injury for users.

Gardasil was introduced by Merck in 2006, and has been widely used to protect against HPV infections, which can be sexually transmitted and lead to the later development of cervical cancer. The Gardasil injection has been promoted for use among both young girls and boys before sexual activity, and is now recommended by most medical providers, since they believed it carries few, if any, serious side effects.

However, this case now joins a growing number Gardasil lawsuits being pursued against the manufacturer, alleging that Merck has withheld information about permanent and life-changing autoimmune side effects linked to the HPV vaccination from users, families and the medical community for years.

Although the drug maker has promoted the vaccine as safe and effect, lawsuits claim that Merck has known about a number of severe autoimmune complications experienced by users, including postural orthostatic tachycardia syndrome (POTS), neurological problems  and other side effects.

According to the lawsuit, C.A.B. was only 11 years old when she received her first Gardasil HPV vaccine injection in January 2018, for the prevention of cervical cancer. The lawsuit indicates her parents were told that the injections were very safe.

The lawsuit notes that C.A.B. had no autoimmune diseases or autonomic issues before receiving the injections. However, that changed after she received the second Gardasil injection.

“Immediately after her second Gardasil injection, Plaintiff experienced severe injuries,” the lawsuit states. “She was seen by multiple physicians and specialists for her complaints, which included: chronic abdominal pain, headaches, body aches, trigger-point pain, increased heart rate, nausea, vomiting, constipation, dizziness, fatigue, dehydration, and extreme weight loss.”

C.A.B. received emergency medical treatment, which required her being both fed and hydrated through a nasal tube for months. She then had to undergo physical therapy, leading to her having to withdraw from school.

“As recent as October 2022, Plaintiffs injuries flared up, causing her to be admitted into the Yale New Haven Hospital for nasojejunal tube-feeding again,” the lawsuit indicates. “As a result and despite her diligence with online school, Plaintiff is at least one-half semester behind in her education.”

According to the complaint, the girl has been diagnosed with encephalitis, ataxia, dysautonomia, POTS, fibromyalgia, chronic headaches, and gastroparesis; also known as stomach paralysis. She requires continuing medical treatment and medications.

The lawsuit presents claims of negligence, strict liability, failure to warn, manufacturing defect, breach of express warranty and common law fraud.

February 2024 Gardasil Lawsuit Update

The young girl’s Gardasil lawsuit will be consolidated with similar complaints brought throughout the federal court system over side effects linked to the HPV vaccine, which have been centralized as part of a Gardasil MDL (multidistrict litigation) in the U.S. District Court for the Western District of North Carolina.

According to a docket report (PDF) issued on February 1, there are currently at least 140 complaints involving Gardasil POTS injuries and other autoimmune side effects pending in the federal court system. There are also a substantial number of additional claims pending in the U.S. Vaccine Court, where families must initially bring a petition seeking compensation under the National Vaccine Injury Compensation Program, before they are able to bring a civil lawsuit if the claim is not resolved within eight months.

Given common questions of fact and law presented in the Gardasil injection lawsuits, the cases were originally assigned to U.S. District Judge Robert J. Conrad for coordinated discovery and pretrial proceedings, which is expected to involve a series of early bellwether trials designed to help gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation.

However, on February 2, the Judicial Panel on Multidistrict Litigation issued an order reassigning the litigation (PDF) to U.S. District Judge Kenneth D. Bell, Sr., who is also assigned to the Western District of North Carolina. The order did not state the reason for the change in judges.

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.