Gardasil Vaccine Linked to Growing Number of Product Liability Claims

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In 2006, the Food and Drug Administration (“FDA”) approved the use of Gardasil for females 9-26 years old to protect against certain cancers caused by human papillomavirus (“HPV”). However, in the almost two decades since the FDA approved Gardasil, patients have reported that they are experiencing serious and life-threatening side effects and fatalities from using Gardasil. Despite these very concerning claims, the New Jersey-based pharmaceutical company Merck & Co. began direct-to-consumer advertising for their vaccine.

In the wake of Merck’s concerning position regarding the safety and continued sale of Gardasil, the company is facing various claims, including from patients who claim that the company engaged in deceptive research trials which misrepresented Gardasil’s safety and efficacy. Parents who feel pressured into vaccinating their young children, as well as adults who experienced serious side effects after taking Gardasil, are seeking compensation from Merck. As we’ve discussed in other posts, product liability laws allow consumers who suffered serious injury due to a potentially dangerous or defective drug to pursue a claim for compensation against the manufacturer. Currently, product liability attorneys are investigating consumers’ claims to determine whether Merck may be liable for damages related to Gardasil.

What is the HPV Vaccine?

HPV is a group of 200 related viruses; some spread through direct sexual contact. HPV can cause genital warts and related cancers, including cervical cancer, anal cancer, penile cancer, vulvar cancer, and vaginal cancer. HPV vaccines work by triggering an immune response through antibodies. Unlike inactivated or live attenuated viruses, the HPV vaccines work by inserting the DNA coding from HPV into the patient’s cells.

There have been three primary HPV vaccines in the United States:

Gardasil

Cervarix

Gardasil-9

Currently, only Gardasil-9 is approved for use or distribution in the United States.

While HPV vaccines are typically considered safe and effective, there are critical uncertainties about the benefits and harms of these vaccines.

Is Gardasil Safe to Use?

The FDA and Centers for Disease Control (“CDC”) monitor vaccine safety through their Vaccine Adverse Event Reporting System (“VAERS”). According to data, Gardasil is linked to the following adverse events:

Syncope,

Dizziness,

Nausea, and

Hypersensitivity reactions.

In addition, there have been reports of serious adverse events, including the following:

Guillain-Barré syndrome (GBS),

Transverse myelitis,

Motor neuron disease,

Venous thromboembolic events (VTEs),

Pancreatitis,

Autoimmune disorders, and

Death.

Despite these life-altering events, the FDA, CDC, and Merck continue to stand by these vaccines and have not modified how the vaccine should be prescribed or used.

Can Consumers File a Gardasil Lawsuit Against Merck?

Yes, consumers who believe they were injured or developed a serious medical condition after taking Gardasil may be able to bring a lawsuit against Merck, the manufacturer of the drug. In fact, the growing number of adverse events after using Gardasil has led to a series of product liability and negligence lawsuits against Merck. It is important to note that Gardasil lawsuits are not a broad condemnation of all vaccines. Instead, these claims specifically target what victims believe to be the pharmaceutical company’s negligence in promoting a potentially unsafe product.

The Gardasil class action lawsuits allege various claims based on the following:

Negligence,

Strict liability (failure to warn),

Strict liability (manufacturing defect),

Breach of warranty, and

Fraud (deceptive marketing and misrepresentation.

At its core, the lawsuits seek to compensate victims who experienced severe and debilitating adverse events after using Gardasil.

What Are Consumer’s Claims Against Merck?

Many victims argue that Merck failed to disclose material facts and information related to the safety and efficacy of Gardasil. Victims claim the company engaged in fear-mongering and false advertising to increase Gardasil sales. Similarly, victims contend that Merck used these disease-mongering tactics and provided incentives to legislatures in an attempt to make Gardasil mandatory for school children. Complaints allege that Merck systematically misrepresented the efficacy of Gardasil in preventing cervical cancer.

Additionally, Merck is facing allegations that the Gardasil vaccine contains various hazards. Gardasil is claimed to contain an aluminum adjuvant, borax, Polysorbate 80, and genetically modified yeast. Some argue that the clinical trials focused on preventing cervical lesions instead of cancer. Moreover, contrary to the company’s representations, Gardasil may increase the risk of cervical and other cancers.

Does the Vaccine Act Impact Gardasil Lawsuits?

The National Childhood Vaccine Injury Act of 1986 (the “Vaccine Act”) is a compensation program for individuals who suffer injuries from a vaccine. The Act is an alternative to product liability and medical malpractice claims. Typically, individuals who have suffered injuries because of a vaccine can file a claim with the U.S. Court of Federal Claims to secure compensation from the Vaccine Trust Fund. Fundamentally, the Vaccine Act protects pharmaceutical companies from product liability claims. However, while the Vaccine Act prevents many product liability lawsuits, it does permit certain negligence lawsuits against vaccine manufacturers.

The Vaccine Act has presented challenges to those pursuing claims for Gardasil injuries. Merck is contesting these claims by arguing that claimants are disguising design defect claims as negligence claims. In light of these outcomes, it is imperative that Gardasil injury victims consult with an experienced vaccine injury attorney to determine their rights and remedies.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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