Merck Faces Gardasil Lawsuits

At least two new Gardasil vaccine lawsuits were recently filed against Merck & Co. by plaintiffs who allege that they have suffered from autoimmune problems after receiving the injection that protects against cervical cancer caused by human papillomavirus (HPV), the most common sexually-transmitted infection. This comes as the Judicial Panel on Multidistrict Litigation (JPML) considers whether to grant Gardasil plaintiffs permission to band together into a multidistrict litigation (MDL).

In one lawsuit, plaintiff Madeline Counts alleges that in 2017, after she received the Gardasil vaccine at age 13, she temporarily lost the ability to walk and developed several autoimmune dysfunctions, including Postural Orthostatic Tachycardia Syndrome (‘POTS’), blurred vision, tremors, seizures, headaches, nausea and fatigue. Counts’ lawsuit claims that all of these symptoms were caused by the Gardasil vaccine.

Another Gardasil lawsuit was filed July 28 on behalf of a Los Angeles woman, Victoria Trevisan, who also claims to have developed POTS and other injuries caused by the Gardasil vaccine. Trevisan received three doses between 2015 and 2016 beginning when she was 13.

Trevisan’s attorneys stated in a press release that “Merck’s conduct, including its false promotion of Gardasil and its failure to issue appropriate warnings concerning the severe risks of Gardasil, created a substantial risk of significant harm to children and patients … and warrants punitive damages.”

Plaintiffs have pointed to a study published in the January 2020 edition of the Journal of the Royal Society of Medicine that raised doubts about HPV vaccines’ general effectiveness in preventing cervical cancer.

The attorneys representing Trevisan said, “Should Merck be trusted on Gardasil after causing one of the worst drug recalls in history with Vioxx, not to mention Fosamax and NuvaRing? Our evidence says no, they shouldn’t be trusted on Gardasil either.”

The JPML is expected to issue a ruling as to whether Gardasil lawsuits should be consolidated in an MDL soon. Merck has opposed Gardasil litigation being adjudicated as an MDL, arguing that the claims should be tried in The Office of Special Masters of the U.S. Court of Federal Claims. Popularly known as “vaccine court,” the Office of Special Masters of the U.S. Court of Federal Claims is a no-fault system for litigating vaccine injury claims where damages are paid out by the U.S. Department of Health and Human Services.

In a 2021 study by JAMA Network Open, researchers Dr. Kalyani Sonawane et al described an increased aversion to receiving the HPV vaccine. Primary concerns in the study cited doubts about the safety of the HPV vaccine. According to the study, from 2015–2018 there were 16,621 adverse events reported to the U.S. Food and Drug Administration’s (FDA’s) Vaccine Adverse Event Reporting System VAERS).

Of those adverse events reported, only 758 adverse events were classified as “serious.” The study defined serious adverse events as reports that claimed the HPV vaccine caused “hospitalization or prolonged hospitalization, disability, and death or a life-threatening event.”

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