Merck Concealed Problems with Gardasil HPV Vaccine, Lawsuit Alleges

The lawsuit claims Merck deceived regulators and the medical community during clinical trials designed to hide Gardasil HPV lawsuit injuries.

A Nevada man has filed a product liability lawsuit against Merck, indicating that the drug maker failed to honestly report potential Gardasil HPV vaccine side effects, which have caused neurological, autoimmune and autonomic injuries for many teens and young adults.

The complaint (PDF) was filed by Tarek H. Makki on October 27, in the U.S. District Court for the Western District of North Carolina, joining a growing number of individuals throughout the U.S. now seeking financial compensation for severe and debilitating injuries linked to the widely used vaccine.

Gardasil was introduced by Merck in 2006, for vaccination against HPV infections, which can be sexually transmitted and lead to the later development of cervical cancer. The injection has been promoted for use among both young girls and boys before sexual activity, and is now recommended by most medical providers, since they believed it carries few, if any, serious side effects.

However, Makki and other individuals now pursuing Gardasil HPV vaccine lawsuits allege that Merck actively concealed potential problems throughout the clinical trial stage of the drug’s development, and continues to hide information about the risks to this day.

The product liability lawsuits claim Merck did this in a variety of ways, including using a highly toxic placebo during small clinical trials to hide the true rate of Gardasil injuries and complications, manipulating study protocols, and claiming serious side effects that occurred during the clinical trials among many of the participants were coincidences.

According to Makki’s lawsuit, neither he nor his doctors knew the true risks of Gardasil when he received his first HPV vaccination in August 2019, when he was 35. He had agreed, on the advice of his doctor, to receive the vaccine for the prevention of the HPV virus. He received his second shot the next month, and a third injection in February 2020.

After the injections, Makki began to experience “extremely painful and incapacitating headaches” which prevented him from doing many daily activities, the lawsuit indicates. The migraines worsened over time, and he also began to experience anxiety attacks, short-term memory loss, insomnia, dizziness, vertigo, numbness and tingling in his extremities, photophobia and hair loss.

He has been diagnosed with autonomic dysfunction, migraines, alopecia, and telogen effluvium, according to the lawsuit.

Merck’s Deceptive Gardasil Vaccine Research

Makki indicates the medical community, and the U.S. Food and Drug Administration, were deceived by Merck during both the drug’s development and approval, and marketing.

“Merck engaged in wholesale fraud during its safety and efficacy clinical studies. In order to obtain its Gardasil license, Merck purposefully conducted its studies to conceal adverse events and exaggerate efficacy,” the lawsuit states. “The dishonesty in the clinical tests has led many physicians to recommend the vaccination, under false assumptions.”

The lawsuit claims Merck kept some of its clinical trial results secret, and injected “control” subjects with a placebo that contained a toxic adjuvant; an ingredient used to create a stronger immune response, which led to similar injuries in both groups. Merck presented those findings as indications Gardasil was as safe as a placebo without mentioning use of the adjuvant, according to Makki’s complaint.

Those results included increased death rates among recipients of the drug, an increase in fertility problems after Gardasil vaccination, as well as other injuries. These problems have resulted in several countries removing their recommendations, including Japan and Columbia. In addition, Denmark has opened specialized clinics dealing with Gardasil injuries, and India put a stop to Gardasil trials in its own country after several female subjects died, the lawsuit claims.

However, the lawsuit indicates Merck has still profited handsomely off the Gardasil vaccine, pulling in $6.9 billion in revenue from the injections in 2022. Two doses of the latest iteration, Gardasil 9, costs about $450.

November 2023 Gardasil Lawsuit Update

Makki’s complaint will be consolidated with about 100 other similar lawsuits over the Gardasil HPV vaccine currently pending in the federal court system, which have been centralized as part of a Gardasil MDL (multidistrict litigation) in the U.S. District Court for the Western District of North Carolina.

There are also a substantial number of additional claims pending in the U.S. Vaccine Court, where families must initially bring a petition seeking compensation under the National Vaccine Injury Compensation Program, before they are able to bring a civil lawsuit if the claim is not resolved within eight months.

Given common questions of fact and law presented in the HPV vaccine lawsuits, U.S. District Judge Robert J. Conrad is presiding over coordinated discovery and pretrial proceedings, which is expected to involve a series of early bellwether trials designed to help gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation.

While the parties work to prepare a group of Gardasil cases for trial, injury lawyers are continuing to investigate and file new lawsuits for individuals who experienced a variety of complications from the HPV vaccine, including:

• Autoimmune Diseases
• POTS (Postural Orthostatic Tachycardia Syndrome)
• Premature Ovarian Failure
• Premature Menopause
• Polycystic Ovary Syndrome (PCOS)
• Idiopathic Thrombocytopenic Purpura (ITP)
• Irregular Heartbeat/Tachycardia
• Lupus
• Neurologic Disorder
• Brain Fog or Chronic Inability to Concentrate
• Chronic Fatigue
• Chronic Pain
• Severe Headaches
• Difficulty Sleeping
• Fibromyalgia
• Nerve Damage
• Menstrual Disorders/Problems
• Gastrointestinal Issues (food intolerances, nausea, vomiting)

Following coordinated discovery and any bellwether trials in the federal MDL, if the parties fail to reach Gardasil settlements or another resolution for the litigation, Judge Conrad may later establish a process to begin remanding each individual claim back to U.S. District Courts nationwide for individual trial dates in the future.