Gardasil Injury Lawsuit Filed Over Lupus, Tourette’s Syndrome Diagnosis

After receiving two injections, a young woman says her crippling Gardasil injury symptoms matched those described in medical literature, but not in the HPV vaccine’s warning label.

A young West Virginia woman has brought a product liability lawsuit against Merck & Co., alleging that the drug maker failed to adequately warn about the risk of permanent and life-altering autoimmune injuries from Gardasil, which left her wracked with pain, involuntary movements and seizures after receiving the HPV vaccine as a teen girl.

The complaint (PDF) was filed earlier this month in the U.S. District Court for the Western District of North Carolina by Shyla Smith, presenting claims for negligence, strict liability, failure to warn, manufacturing defect, breach of express warranty, common law fraud, and violations of West Virginia consumer protection laws.

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

However, a growing number of Gardasil injury lawsuits now allege that Merck provided false and misleading information to doctors, and never disclosed that the HPV vaccine may result in permanent and life-changing autoimmune complications, including lupus, fibromyalgia, postural orthostatic tachycardia syndrome (POTS), premature ovarian failure, premature menopause, idiopathic thrombocyteopenic purpora (ITP), chronic pain, brain fog, fatigue, headaches and nerve damage.

According to the lawsuit filed by Smith on June 12, the Gardasil vaccine was first administered when she was 13 years old, and she received a second injection a year later, at age 14.

Smith’s mother and doctor decided to use the vaccine because of assurances by Merck, which indicated that it was a safe and effective way to prevent cervical cancer. However, the lawsuit indicates Merck placed a desire for profits before the health and safety of users, failing to disclose reports of permanent injuries from Gardasil to the medical community.

“After receiving the second Gardasil vaccine, Plaintiff began experiencing extreme fatigue and stomach pains. The fatigue was so severe that she required help from her mother to lift her from bed,” the lawsuit states. “These symptoms only continued to worsen as the months passed.”

Stomach pains became nausea, which became loss of appetite, and Smith rapidly lost weight and could not eat normally or gain the weight back. The lawsuit claims that by January 2020, Smith’s stomach pains were so severe that even drinking a glass of water caused “unbearable pain.”

Smith was first diagnosed with fibromyalgia in early 2020. Then, earlier this year, she was diagnosed with Lupus. Since she received the second injection the number of diagnoses has grown to include Tourette’s syndrome, migraines, non-epileptic spells, and undefined functional neurologic symptoms.

The lawsuit indicates Smith continues to suffer from anxiety, depression, fatigue, daily pain, migraines, weakness, stomach pain, weight loss, seizures, muscle spasms, involuntary twitching and insomnia, and will likely experience debilitating health problems, due to her Gardasil injuries, for the rest of her life.

“(T)he medical literature has documented other patients who, like Plaintiff, have suffered serious autoimmune, autonomic, and neurological dysfunctions, and who experienced similar side effects as those Plaintiff has suffered, and who were diagnosed with Gardasil-induced autoimmune, autonomic, and neurological diseases,” Smith’s lawsuit notes. “Plaintiff contends that her Gardasil injections caused her to develop serious and debilitating autoimmune, autonomic, and neurological, injuries.”

July 2024 Gardasil Injury Lawsuit Update

Given common questions of fact and law presented in Gardasil lawsuits filed by young adults throughout the U.S., a federal multidistrict litigation (MDL) has been established in the Western District of North Carolina, for coordinated discovery and pretrial proceedings.

While the Gardasil MDL was originally assigned to U.S. District Judge Robert J. Conrad, the Judicial Panel on Multidistrict Litigation reassigned the pretrial proceedings to U.S. District Judge Kenneth D. Bell, Sr, in April 2023, who is expected to schedule a series of early bellwether trials to help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation.

Last year, while still being overseen by Judge Conrad, plaintiffs and defendants selected 16 Gardasil injury cases eligible for early test trials, which will soon be narrowed down to a smaller group of claims that will be prepared for the first trial in the federal court system.

Following coordinated discovery and test trials held in the federal MDL, if the parties fail to reach Gardasil settlements or another resolution for the litigation, Judge Bell 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.