Pharmaceutical Drug Litigation Updates

Albuquerque woman alleges human papillomavirus vaccine Gardasil injured teenage daughter

Quoted from http://www.startribune.com/business/92679104.html

Albuquerque woman alleges human papillomavirus vaccine Gardasil injured teenage daughter

Associated Press

Last update: May 3, 2010 - 4:16 PM

ALBUQUERQUE, N.M. - 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....

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Merck's Gardasil Has Higher Rates of Fainting, Clots

Quoted from http://online.wsj.com/article/SB125062519949640947.html

Merck's Gardasil Has Higher Rates of Fainting, Clots

AUGUST 18, 2009, 4:15 P.M. ET

By PETER LOFTUS

Recipients of Merck & Co.'s Gardasil cervical-cancer vaccine had higher rates of fainting and blood clots than those receiving other vaccines, but it doesn't appear to raise the risk of certain severe adverse events, according to a new safety analysis.

A separate article accompanying the safety study, published Tuesday in the Journal of the American Medical Association, criticized Merck's marketing of Gardasil, including the company's funding of education campaigns by professional medical associations, which the authors said didn't provide a balanced view of the vaccine.

The two articles add to questions about the safety, effectiveness and marketing of Gardasil, which have dogged the vaccine since its 2006 introduction.

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