Dozens of lawsuits, including the one filed by Ljubitza Ghiardi, were filed, alleging that Merck intentionally concealed information about the efficacy and potential risks of its HPV vaccine, Gardasil. Given the common questions of fact and law raised in the lawsuits, U.S. District Court Judge Robert J. Conrad, Jr., in the Western District of North Carolina ordered all Gardasil vaccine lawsuits consolidated in an MDL.
What is Gardasil?
Gardasil is a vaccine developed by Merck to protect against the human papillomavirus (HPV). HPV is one of the most common sexually transmitted diseases and may be passed through skin-to-skin contact. Most HPV cases are benign. However, if left untreated, a small percentage of HPV cases among women can eventually develop into cervical cancer.
In June 2006, Merck obtained fast-track approval from the U.S. Food and Drug Administration (FDA) for its Gardasil vaccine. The FDA approved Gardasil for girls ages nine through 26 and boys ages nine through 15 as a vaccine to prevent cervical, vaginal, and anal cancers. During this fast-track approval process, Merck allegedly failed to perform comprehensive and successful clinical studies and research on the safety and efficacy of the vaccine. In December 2014, the FDA approved the current version of Gardasil, Gardasil-9.
Merck marketed Gardasil as a safe and effective vaccine to protect against HPV. However, prior to its introduction on the market, there was not an HPV public health emergency in the U.S. In fact, prior to the introduction of Gardasil, many women were unaware of HPV, let alone the necessity for a vaccine. To effectively market Gardasil, Merck launched an awareness campaign targeted at parents to emphasize the dangers of HPV in adolescents. Merck also utilized political lobbyists and financial incentives to persuade state legislatures to mandate Gardasil for school-aged children.
Gardasil’s Serious Side Effects
According to the lawsuits filed by the teens and young adults who were injected with Gardasil, many reported experiencing a variety of problems shortly after injection. Such problems included postural orthostatic tachycardia syndrome, premature ovarian failure, premature menopause, seizures, and other autoimmune disorders.
Other alleged side effects from Gardasil included paralysis, death, Guillain-Barre syndrome, spontaneous abortions, blood clots, coma, Bell’s palsy, and anaphylactic shock. As of February 14, 2011, the CDC reported 51 deaths among females who received the HPV vaccine.
The Gardasil Vaccine Lawsuits
Ljubitza Ghiardi’s Case
On November 16, 2022, Ljubitza Ghiardi filed a complaint in the U.S. District Court of Colorado. She alleged that she suffered serious and debilitating injuries shortly after receiving the Gardasil injection.
On October 24, 2019, at age 38, Ghiardi consented to receive her first dose of the Gardasil vaccine. She claimed that she was assured that Gardasil was safe and effective at preventing cervical cancer. By December 19, 2019, she reported that her hair began to fall out. Undeterred, she received her second dose of the Gardasil vaccine in January 2020. By April 2020, the plaintiff received a diagnosis of alopecia and telogen effluvium. According to the plaintiff, she had no history of autoimmune disorders before the injection.
The plaintiff also reported severe headaches for extended periods of time, dizziness, numbness around her mouth and arm, and blurred vision.
In her complaint, Ghiardi alleged that Merck’s claim that Gardasil prevents cancers was unproven. She further claimed that Gardasil may even increase one’s risk of cervical cancer by initiating genetic changes in the virus that can lead to cancer. According to the plaintiff, Merck conducted no successful clinical study to support its claim that Gardasil was safe and effective at preventing certain forms of cancer.
In addition, the plaintiff alleged that Merck unlawfully engaged in fear-mongering as a marketing technique by overstating the risks associated with HPV and the effectiveness of Gardasil to treat cancers caused by HPV. The plaintiff also alleged that Gardasil contains hazardous ingredients, which are known to cause autoimmune diseases and fertility issues. According to the plaintiff, Merck knew that Gardasil contained such ingredients. However, the company allegedly did not disclose the risks to consumers or the medical community.
Moreover, the plaintiff alleged that Merck also concealed the risks associated with Gardasil throughout the development stage in a variety of nefarious ways, including using a highly toxic “placebo” to mask the injuries caused by Gardasil.
The MDL Trial
In August 2022, Judge Conrad ordered that Ghiardi’s lawsuit, along with approximately 60 other lawsuits, be consolidated in an MDL. The defense counsel then submitted a joint bellwether program proposal. It proposed that a pool of 16 bellwether candidate cases prepare for litigation. Then, the parties would pick six of those cases for the initial bellwether trial. As of December 14, 2022, Judge Conrad has not approved this plan.
Potential expert specialties attorneys can use at trial include experts in the ethical marketing and researching of vaccines and other pharmaceuticals, as well as experts in HPV and its associated risks. Other potential experts include researchers with specialties in conducting clinical studies of vaccines seeking FDA approval.
If settlements are not reached during the MDL, then each case may be remanded to U.S. District Court for separate trials.