US Court Orders Merck To Turn Over Gardasil Adverse Event Databases

A North Carolina district court has ordered Merck to turn over all of its Gardasil adverse events databases to plaintiffs suing the big pharma giant for injuries they claim were caused by the human papillomavirus (HPV) vaccine.

The databases, which include information from the Merck Adverse Event Reporting and Review System (MARRS), should contain all of the reports pertaining to Gardasil adverse events submitted by physicians, patients and publications, plaintiffs’ attorney Michael Baum told the Defender.

Dozens of lawsuits have been filed by individuals claiming they have suffered a range of injuries after taking Gardasil, including autoimmune disorders, premature ovarian failure, chronic fatigue, pain and even cancer.

The Defender reports: In his March 20 order, U.S. District Judge Robert J. Conrad, Jr., said, “Plaintiffs’ and their experts should have the same opportunity as Merck to review and analyze the entirety of the data.”

Merck until now has refused to make the entire MARRS databases available to the plaintiffs’ attorneys.

Gardasil is a widely used vaccine commonly administered to teens and young adults before they are sexually active to protect against HPV infections, which can be sexually transmitted later in life.

HPV infections may lead to the development of cervical cancer. However, most infections are benign and resolve on their own.

The firm Baum Hedlund Aristei & Goldman and Robert F. Kennedy, Jr., Children’s Health Defense chairman-on-leave, have filed more than two dozen lawsuits on behalf of young people injured by Gardasil, alleging Merck knowingly and fraudulently concealed the vaccine’s risks.

The lawsuits are some of the more than 80 pending in the federal court system, and that number is expected to grow. In August 2022, a judicial panel consolidated the lawsuits into a single federal courtroom.

Some of the signature impacts observed following HPV vaccination — which afflict a number of the plaintiffs — include permanently disabling autoimmune and neurological conditions such as postural orthostatic tachycardia syndrome (POTS), fibromyalgia and myalgic encephalomyelitis/chronic fatigue syndrome, The Defender Reported.

There have been thousands of reports of adverse events worldwide, peer-reviewed scientific literature from the U.S., Australia, Denmark, Sweden, France and Japan, and statistics published by public health agencies in each of these countries that demonstrate plausible associations between HPV vaccination and autoimmune conditions.

Merck maintains there is no safety signal in the data for autoimmune conditions. The plaintiffs allege Merck made this argument by discounting reports.

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Niamh Harris

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