A Rhode Island woman has filed a lawsuit over Gardasil, alleging Merck & Co. falsely promoted the efficacy and safety of the human papillomavirus vaccine, indicating the medication caused her to suffer “serious and debilitating autoimmune injuries.”
The complaint (PDF) was filed by Jula Balasco in Rhode Island federal court on August 19, presenting claims for negligence, failure to warn, manufacturing defect, breach of warranty, common law fraud and violation of the Rhode Island Deceptive Trade Practices Act.
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 is given to young girls before adolescence and potential sexual activity.
According to the lawsuit, Balasco received her first Gardasil injection in August 2014, when she was 13 years old. She then received a second shot in October 2014. However, she indicates the side effects of Gardasil caused her to immediately begin experiencing flu-like symptoms, resulting in aches, headaches, nausea, fever, and then ear pressure, tinnitus, headaches, dizziness, fatigue, migraines and vertigo.
Over time, her symptoms worsened, resulting in loss of balance, gastrointestinal problems, hives and numerous other ailments. In November 2016 she was diagnosed with a number of autoimmune conditions, including fibromyalgia, orthostatic intolerance (OI), and postural orthostatic tachycardia syndrome (POTS).
The Gardasil lawsuit notes that similar ailments have been linked to side effects of the HPV vaccine in medical literature, but warnings were withheld from consumers and the medical community.
Since it’s introduction, concerns about the safety of Gardasil have emerged after one of the lead researchers responsible for developing the HPV vaccine, Dr. Diane Harper, indicated that the drug’s protection may only last a few years, suggesting that the risks may outweigh the benefits for young girls.
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.
“The FDA approved Gardasil on June 08, 2006, after granting Merck fast-track status and speeding the approval process to a six-month period, leaving unanswered material questions relating to its effectiveness and safety as well as when and to whom the Gardasil vaccine ought to be administered,” the lawsuit notes. “Merck failed, during the preapproval processing period and thereafter, to disclose to the FDA and/or the public, 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.”
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.