WARREN, R.I. (WPRI) ─ A Rhode Island teenager alleges fraud and deception were part of the formula to legalize a widely used vaccine that is mandatory in Rhode Island and a handful of other states.
Julia Balasco was 13 years old in 2014 when she received a first dose of Gardasil, a vaccine created to stop Human Papilloma Virus (HPV) which is linked to cervical cancer.
The following year, the general assembly passed a law that made HPV vaccinations mandatory for school-aged children.
Balasco claims she was hit with inexplicable side effects almost immediately after the first inoculation.
“Headaches, ear issues, tinnitus,” Michaela Balasco said. “After the second dose, the symptoms got much worse.”
Before the third dose was administered, the Balascos and their doctor suspected the vaccine caused the problems that continue six years later.
“It definitely still impacts me,” Balasco said. “I don’t drive yet. It impacts my work life. My social life. It’s been horrible.”
The Balascos six-count federal lawsuit filed in R.I. District Court last week alleges Gardasil manufacturer Merck and Company created “a market for the vaccine out of thin air,” and “presented misleading data to the FDA,” to gain approval in 2006.
Nicole Maldonado, the Balasco’s attorney, said Merck was deceptive and negligent, and failed to warn anyone about the side effects.
“Merck was well aware of these adverse events associated with the vaccine but did nothing to disclose that,” Maldonado said. “They didn’t tell doctors. Patients. No one.”
The lawsuit alleges Merck used scare tactics and financial incentives to convince state legislatures to make HPV vaccination mandatory.
Balasco’s mother said the Gardasil ads impacted her family’s decision.
“They have some really awful campaigns out there that will make a parent feel awful about not giving the vaccine to their children,” Balasco said.
Her daughter said she wants her case to bring attention to the side effects she claims drastically changed her life.
“I’m trying to make sure everyone knows that they do have a choice and they shouldn’t have the life I’m living,” Balasco said.
Gardasil does have FDA approval and the company has insisted the vaccine is safe.
Merck has not responded to requests for comment about the lawsuit and so far, has not filed an answer to the complaint with the court.
According to the lawsuit, Gardasil is “crucial to Merck’s overall financial health,” pulling in $3.7 billion in revenue last year.
“Gardasil is Merck’s most lucrative vaccine and its third-highest selling product,” the filing said.
Balasco, who did not specify a dollar amount in her complaint, is asking for a jury trial.