Merck Sued for Negligence Relating to HPV Vaccine Gardasil

Plaintiff Megan Marie Roeder filed suit on Wednesday in the Central District of California against defendants Merck & Co., Inc. and Merck Sharp & Dohme Corp. (collectively, Merck). The complaint alleges that the defendants negligently manufactured and promoted their Gardasil vaccine, which caused the plaintiff to sustain “autonomic, neurological and heterogenous autoimmune injuries.”

The complaint claims that Merck made false marketing claims about the Gardasil vaccine, specifically claiming that the vaccine “provided lifetime immunity to cervical, anal and other HPV-associated cancers.” Roeder notes that in actuality, it is unproven that the vaccine has these effects, and it may even be more likely to cause cancer in those previously exposed to HPV than prevent it.

In addition to making false marketing claims about Gadasil providing “lifetime immunity” to certain types of cancer, the plaintiff contends that Merck “knows and actively conceals the fact that Gardasil can cause a constellation of serious adverse reactions and gruesome diseases, including autoimmune diseases, and death in some recipients.”

The complaint explained that the original Gardasil vaccine was intended to prevent infections from six types of HPV, with only two of those types being associated with cervical and anal cancer. Before a vaccine can hit the market, it must be approved by the FDA based on studies of the drug’s effectiveness and safety. After a company gains FDA approval, the complaint explains that they are responsible for conducting further scientific and medical investigation as is reasonable.

Gardasil was approved by the FDA in June of 2006, after the FDA allegedly fast-tracked the approval process. During the time of the approval process and immediately following, the defendants failed to disclose “material facts and information relating to the effectiveness and safety of Gardasil, as well as to whom the vaccine should or should not be administered.”

One year later, the FDA approved Gardasil 9, which contained the same ingredients but in greater amounts. The drug was approved for multiple types of cancer despite what the complaint describes as “little evidence of efficacy.”

The defendants marketed the Gardasil vaccine as an alternative to Pap smears “with no evidence that Gardasil was potentially superior” in combating cervical cancer. The plaintiff alleges that in an effort to obtain FDA approval on the vaccine, they allegedly designed and conducted fraudulent studies and influenced FDA votes.

Following FDA approval, the complaint contends that the defendants “engaged in unscrupulous marketing tactics designed to overemphasize both the risks associated with HPV and the purported efficacy of Gardasil to scare the public into agreeing to mass vaccinations of the Gardasil vaccine.” The suit also notes that in some cases, Merck even provided financial inventive to legislatures that would agree to mandating the Gardasil vaccine for all school children.

The complaint cites counts of negligence, strict liability (failure to warn), strict liability (manufacturing defect), breach of express warranty, common law fraud, and a violation of California’s Unfair Competition Law. The plaintiff is seeking compensatory damages, economic and non-economic damages, medical, incidental, hospital, and psychological expenses, loss of earnings and earnings capacity, pre-judgment and post-judgment interest, exemplary and punitive damages, preliminary and permanent injunctive relief, litigation fees, a trial by jury and any other relief deemed just by the Court.

The plaintiff is represented in the litigation by the Law Office of Paul Green.