In a major development for Gardasil lawsuits nationwide, the Judicial Panel on Multidistrict Litigation (JPML) consolidated Gardasil HPV vaccine lawsuits into MDL-3606 on August 4, 2022. U.S. District Court Judge Robert J. Conrad, Jr. of the Western District of North Carolina will preside over the MDL entitled, In re: Gardasil Products Liability Litigation MDL No. 3036. Plaintiffs allege that they developed postural orthostatic tachycardia syndrome (POTS) and other injuries after receiving the Gardasil vaccine intended to prevent human papillomavirus.
Gardasil Designed to Combat HPV
In 2006, American pharmaceutical company Merck & Co. received FDA approval for its Gardasil vaccine to immunize the public against human papillomavirus (HPV). HPV is the most common sexually transmitted virus, with more than 42 million Americans currently infected. Many teens and young adults contract this easily transmissible STI each year through sexual activity or skin-to-skin contact. Symptoms generally include genital warts, but some HPV carriers may develop certain forms of cancer.
The Gardasil vaccine consists of tiny proteins that resemble HPV. Once administered, the body creates antibodies against the Gardasil proteins. These developed antibodies will prevent future HPV infections, thus providing the patient immunity.
Merck & Co. Accused of Falsifying Gardasil Clinical Trials
Medical professionals raised concerns over the FDA’s six-month fast-track approval of Gardasil. Researchers wondered if the expedited approval provided enough time to discern the safety and effectiveness of the Gardasil vaccine, but soon an even greater issue presented itself. Lawsuits allege Merck & Co. falsified the clinical trials and presented misleading or inaccurate evidence to secure Gardasil’s FDA approval.
The World Health Organization states that clinical trials must compare a vaccine against an inert placebo that will not produce any reaction. Yet, Gardasil lawsuits claim that no participants received a true salt water solution because the company tampered with the placebo. This supposedly skewed the results since it placed Gardasil in a much more favorable light and downplayed the vaccine’s side effects. Also, Merck may have failed to adequately follow up on Gardasil recipients in clinical trials to monitor the full extent of the side effects possibly linked to the vaccine.
Before these Gardasil accusations, Merck & Co. came under fire for concealing evidence in clinical trials for the arthritic drug, Vioxx. Internal documents reveal that scientists manipulated data in Vioxx trials to minimize the cardiovascular risks associated with the drug.
JPML Forms Gardasil MDL-3606
In April 2022, plaintiffs submitted a motion to transfer to the Judicial Panel on Multidistrict Litigation to consolidate federal Gardasil lawsuits. At that time, the motion cited 34 Gardasil lawsuits pending in 25 different courts nationwide, with attorneys expecting nearly a hundred more filings in the coming months. Recently, on August 04, 2022, the JPML granted the centralization of federal Gardasil lawsuits into MDL-3606. Lawsuits under MDL-3606 present factual issues related to “clinical trials, regulatory approval, manufacturing, pharmacovigilance, labeling and marketing of Gardasil and Merck’s knowledge of the vaccine’s adverse effects.” Plaintiffs in MDL-3606 allege that after receiving the Gardasil vaccine, they developed health conditions such as:
- Autonomic Dysfunction (Dysautonomia)
- Complex Regional Pain Syndrome (CRPS)
- Premature Ovarian Failure (POF)
- Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS)
- Orthostatic Intolerance (OI)
- Postural Orthostatic Tachycardia Syndrome (POTS)
Merck argued against the consolidation of Gardasil lawsuits by citing conflicts with the Vaccines Act and claiming that the decision would bring forth meritless claims. However, the JPML refuted these arguments, and attorneys anticipate the first Gardasil bellwether trial in 2023.