Lawsuit Over Gardasil HPV Vaccine Risks Cleared To Move Forward

Merck was legally obligated to warn plaintiff’s medical providers of potential side effects of Gardasil HPV vaccines, the judge ruled.

A federal judge has cleared the way for a lawsuit over Gardasil HPV vaccine side effects to move forward, after determining that the plaintiff can pursue failure to warn charges against Merck.

Michael Colbath filed the lawsuit over problems experienced after receiving the vaccine in 2014, when he was 14 years old. However, after the Gardasil injections, he began experiencing burning sensations in his arm, extreme fatigue, severe foot pain that forced him to use crutches, headaches and memory problems. His doctor decided against giving him a third injection due to the potential risks.

According to the lawsuit, Colbath is pursuing claims for negligence, failure to warn, manufacturing defect, breach of express warranty, common law fraud and violation of California’s unfair competition laws.

Gardasil is a widely used vaccine for the prevention of certain types of sexually transmitted strains of HPV, which can cause cervical cancer. It was approved by the FDA in 2006, and widely given to young girls before adolescence and potential sexual activity. However, it is also administered to some boys.

In an order (PDF) issued on March 29, U.S. District Judge Thomas Whelan, of the Southern District of California, cleared the case to move forward on Colbath’s failure to warn and violation of California unfair competition law charges. However, he dismissed the other complaints and instructed Colbath to file an amended complaint.

Judge Whelan noted that while the Vaccine Act preempts claims of manufacturing defect and some other claims, his failure to warn action can still go before a jury.

“While Defendants do not have a duty to warn Plaintiff, his mother, or the public in general, they do have a duty to warn Plaintiff’s medical providers,” Judge Whelan ruled. “Because Plaintiff alleges that Defendants failed to warn his medical providers, the Vaccine Act and the Learned Intermediary Doctrine do not bar his failure to warn claims.”

Given that tens of thousands of vaccine recipients have experienced serious side effects, the ruling could result in many Gardasil injury lawsuits being filed in the coming months and years.

Gardasil Side Effects

Since it’s introduction, concerns about the potential Gardasil HPV vaccine risks emerged after one of the lead researchers responsible for developing the injection, Dr. Diane Harper, indicated that the drug’s protection may only last a few years, suggesting that the risks may outweigh the benefits.

Dr. Harper reportedly said at a conference in 2009, that while Gardasil was tested on 15 year old girls, it is commonly being given to girls as young as nine years old. She has called for more detailed warnings to parents about the Gardasil risks and to provide additional information about the unknown long-term benefits for girls who are not likely to be sexually active for several years.

Many health experts strongly support the use of Gardasil, indicating any risks are negligible and claims made by those concerned about vaccinations are often not scientifically supported.

The National Cancer Institute has heralded the HPV vaccine, saying that widespread use could reduce cervical cancer deaths worldwide by as much as two-thirds. Many also suggest men get the vaccine as well in order to promote “herd immunity,” which occurs when a large enough portion of the population is vaccinated against a particular disease that they act as a firewall, preventing that disease’s spread even to those who are not vaccinated.