Multiple lawsuits against Merck for serious side effects stemming from its Gardasil vaccine are pending. There are now approximately 60 active Gardasil lawsuits pending in the Gardasil class action MDL in the Western District of North Carolina. An influx of new cases are expected to be filed at some point in the near future as previously filed Gardasil claims clear the Vaccine Injury Compensation Program process.

On December 16, 2013, the CDC was informed by Merck that the company planned to implement a voluntary recall of one lot (lot J007354) of Gardasil Vaccine due to the potential for a small number of vials to contain glass particles as a result of breakage during the manufacturing process. Then again, in October 2020, Merck issued an urgent voluntary vaccine recall of Gardasil 9 belonging to Lot R030456. Merck recalled Gardasil, a temperature-sensitive vaccine because units were stored at inappropriate temperatures.

Many have complained of negative side effects after receiving Merck’s Gardasil vaccine. Complaints range from dizziness and fainting to developing autoimmune disorders and even death. According to the Vaccine Adverse Event Reporting System (VAERS), there have been 64,000 adverse events reported against Gardasil in the United States alone. Of these, nearly 10,000 have been serious negative events, including 547 deaths.

After the FDA fast-track approval of the Gardasil 9 vaccine in 2006, the original Gardasil vaccine was phased out of the U.S. Market; and is no longer available for sale in the United States. The last doses of Gardasil-4 expired on May 1, 2017. Since late 2016, Gardasil 9 is the only HPV vaccine distributed in the U.S.