Lawsuit Alleges Gardasil Injection Caused Postural Orthostatic Tachycardia Syndrome (POTS) and Other Injuries

Amid a growing number of Gardasil HPV vaccine lawsuits being filed by recipients who suffered serious side effects, allegations raised in a recently filed product liability lawsuit claim the side effects of Gardasil injections caused a Florida woman to develop neurological and heterogenous autoimmune injuries, including a condition known as postural orthostatic tachycardia syndrome (POTS), which has left her with permanent pain and health problems.

The complaint (PDF) was filed by Ashley Muller in the U.S. District Court for the Northern District of Florida in October, presenting claims against Merck & Co. as the defendant.

Gardasil was first approved in 2006, and has been widely marketed for young girls and boys before adolescence and potential sexual activity, to help prevent HPV, which can be sexually transmitted and lead to the development of cervical cancer.

According to the Gardasil lawsuit, Muller received three injections, beginning at age 19, with one in August 2015, another in October 2015, and a third in March 2016. However, within a month of receiving the first injection, Muller began to experience symptoms of fatigue, headaches, joint pain, dizziness and brain fog, the lawsuit indicates.

Over time, and following the other Gardasil injections, her condition worsened, causing severe joint pain which worked its way to her jaw and led to a temporomandibular joint disorder (TMJ) diagnosis. Her symptoms led her to quit her job in October 2015.

Later, she developed severe stomach pains, nausea, anxiety, depression and panic attacks, and began to suffer hair loss. In May 2016, her gall bladder failed and it had to be removed.

“Based upon her chronic and severe post-Gardasil symptoms and adverse events as outlined above, and the tests performed by her medical providers, Plaintiff has been diagnosed with various medical conditions, including but not limited to, postural orthostatic tachycardia syndrome (POTS), dysautonomia, alopecia areata, biliary dyskinesia, irritable bowel syndrome (“IBS”), small intestinal bacterial overgrowth (SIBO), bile acid malabsorption (BAM), and temporomandibular joint disorder (TMJ),” the lawsuit states. “(T)he medical literature has documented other patients who, like Plaintiff, have suffered serious autonomic dysfunctions, and who experienced the same side effects as those Plaintiff has suffered, and who were diagnosed with Gardasil-induced autonomic diseases.”

The lawsuit claims Merck engaged in false advertising both to deceive the public about the efficacy of the Gardasil injections, and to overemphasize the risks of HPV.

“Merck aggressively and fraudulently concealed the risks of the vaccine in broadcast materials and in propaganda that it disseminated in the United States,” Muller’s lawsuit alleges. “Merck sold and falsely promoted Gardasil knowing that, if consumers were fully informed about Gardasil’s risks and dubious benefits, almost no one would have chosen to vaccinate.”

Muller’s lawsuit presents claims of negligence, failure to warn, manufacturing defect, breach of warranty and common law fraud.

Studies Linking Gardasil and POTS

Gardasil contains a number of ingredients including Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and HPV LI-DNA fragments, which are known to sometimes cause harmful immunological responses. Studies have suggested a strong link between the active ingredients in Gardasil and POTS.

Multiple peer reviewed medical journals have published studies stating this aluminum adjuvant used in Gardasil may cause the immune system to lose its ability to differentiate from human proteins and foreign proteins, causing an unintended attack on the body’s own proteins and organs, resulting in a variety of autoimmune disorders including postural orthostatic tachycardia syndrome (POTS).

In a study published in Vaccines & Autoimmunity in 2015, researchers stated adjuvants such as AAHS used in Gardasil are responsible for post-vaccination autoimmune diseases such as POTS. Researchers state the aluminum used in Gardasil’s proprietary blend of AAHS adjuvants boosts this harmful immunological response to recipients.

In a review of Gardasil’s immune response booster published in The European Journal of Neurology in 2013, Dr. Svetlana Blitshteyn stated “Awareness that POTS may occur after (HPV) vaccination in young women is essential for prompt and effective management of this condition”.

2022 Gardasil POTS Lawsuit Update

Given the growing number of Gardasil POTS lawsuits being filed by young adults and teens nationwide left with debilitating injuries after receiving the HPV vaccine, the U.S. Judicial Panel on Multidistrict Litigation (JPML) issued a transfer order in August 2022, centralizing the cases for pretrial proceedings before U.S. District Judge Robert J. Conrad, Jr. in the Western District of North Carolina.

The Gardasil multidistrict litigation remains in the very early stages, with the first 49 cases just being transferred to Judge Conrad for coordinated management during the MDL proceedings.

However, over the coming weeks and months, it is expected that hundreds of lawsuits will be filed by individuals left with devastating long-term side effects from Gardasil, including:

• POTS (Postural Orthostatic Tachycardia Syndrome)
• Idiopathic Thrombocytopenic Purpura (ITP)
• Autoimmune Disorders
• Gastrointestinal Issues
• Fibromyalgia
• Other Long-Term Vaccine Injuries

As part of the coordinated management of the Gardasil lawsuits, it is expected that Judge Conrad will establish a bellwether process, where small groups of representative vaccine injury claims will go through case-specific discovery and be prepared for early trial dates, to help gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation. However, if Gardasil injury settlements are not reached during the MDL proceedings, each case may later be remanded back to the U.S. District Court where it was originally filed for separate trials.