Pharmaceutical giant, Merck, was ordered by the federal judge overseeing the consolidated Gardasil lawsuits in multidistrict litigation (MDL) to produce its entire database of adverse events pertaining to the company’s human papillomavirus (HPV) vaccine.
Gardasil is administered to children, ideally before they are sexually active, in order to prevent HPV, which may cause genital warts and cervical cancer.
Attorneys representing plaintiffs who have sued Merck over Gardasil would have access to the company’s Gardasil adverse events database, U.S. District Judge Robert J. Conrad, Jr. ordered March 20.
According to a press release issued by a law firm representing Gardasil plaintiffs, the database, Merck’s Adverse Event Reporting and Review System (MARRS), is Merck’s internal version of the federal government’s Vaccine Adverse Event Reporting System (VAERS).
The VAERS database is completely open to the public, while Merck has fought to prevent its complete internal database from being accessible to Gardasil plaintiffs’ attorneys.
Plaintiffs allege that as a result of taking the Gardasil vaccine, they developed autoimmune disorders, including but not limited to Chronic fatigue syndrome (CFS), fibromyalgia, postural orthostatic tachycardia syndrome (POTS), and premature ovarian failure (POF).
Alleged adverse vaccine events in Merck’s internal database have been submitted by doctors, patients and publications, and have come from clinical trials.
To date, no Gardasil lawsuits have reached trial. However, 16 cases have been selected for test trials (also referred to as “bellwether trials”), which are expected to begin no sooner than late 2024.
The Gardasil MDL was approved in 2022. Currently, there are approximately 75 cases in the MDL, with a potential for an additional 400 cases to be filed later this year, after they have completed the mandatory Vaccine Injury Compensation, which has paid approximately $70 million for Gardasil injury claims.
With the exception of Covid-19 vaccines, Gardasil has had more adverse reaction reports than any other vaccine in history. The U.S. Centers for Disease Control and Prevention notes that “there have been no confirmed adverse events occurring at higher than expected rates following HPV vaccination” other than pain, redness, or swelling in the arm where the vaccine was given, dizziness, syncope, nausea, and headache with incidents occurring approximately 3 times per million vaccinations.
