ALBUQUERQUE, N.M. (AP) – An Albuquerque woman has filed a lawsuit over a vaccine intended to protect women from cervical cancer, alleging it caused physical and behavioral problems in her teenage daughter.
The lawsuit filed by Tracy Wolf said her now-16-year-old daughter was diagnosed with a seizure disorder, encephalitis and other health problems after receiving Gardasil’s three-shot series in 2007 and 2008, the Albuquerque Journal reported in a copyright story Monday.
Wolf observed physical problems such as heart palpitations and “significant, negative changes” in her daughter’s behavior about a month after the first injection, according to the lawsuit, which said the teen had been diagnosed with type-1 diabetes and mild cerebral palsy before receiving Gardasil.
The lawsuit was filed April 14 in the U.S. Court of Federal Claims in Washington, D.C., against the secretary of Health and Human Services. Wolf’s attorney, William Ronan of Overland Park, Kan., said lawsuits alleging harm by vaccines must initially be filed there. He filed a similar lawsuit in January on behalf of a Kansas girl.
A spokeswoman at HHS could not immediately say Monday whether the agency had received Wolf’s lawsuit.
The Centers for Disease Control and Prevention says Gardasil, made by Merck and Co., prevents four types of human papillomavirus, or HPV, the most common sexually transmitted infection in the United States. Two of the targeted types cause about 70 percent of all cervical cancers, the CDC said.
Gardasil is safe and effective “and its benefits continue to outweigh its risks,” according to the Food and Drug Administration’s website.
The National Institutes of Health estimate 11,200 new cervical cancer cases were diagnosed in the United States in 2009. About 4,000 women in the U.S. die of the disease each year.
Ronan said he wants to show Gardasil poses risks that don’t justify its potential benefits.
Wolf contends her daughter’s symptoms arising in the months after vaccination point to Gardasil as the cause.
Cossette Wheeler, a University of New Mexico microbiology professor who helped develop and test Gardasil, said there’s no evidence suggesting deaths or injuries among girls who have received it are attributable to the vaccine.
“People develop seizure disorders out of thin air – young kids, old kids, everybody,” she said.
CDC and FDA researchers who analyzed a federal database that tracks adverse effects of vaccines published results about Gardasil in the Journal of the American Medical Association’s August issue.
They found 12,400 adverse effects reported after Gardasil injections through December 2008, with 772 described as serious, including 32 deaths. The researchers found no common pattern suggesting the vaccine caused the deaths. In cases where an autopsy or death certificate existed, the death was attributed to factors other than the vaccine, such as diabetes, viral illness and heart failure.
Date: May 3, 2010
Source: Associated Press
Filed Under: Drug Discovery