Gardasil Lawsuit

Gardasil Lawsuit:

What is Gardasil?

Produced by Merck & Co, Gardasil is a vaccine used for the prevention of certain forms of HPV. More specifically, Gardasil is used to treat HPV types 6, 11, 16 and 18—forms 16 and 18 cause roughly 70% of cervical cancers and are responsible for the vast majority of HPV-induced vaginal, penile and anal cancers. Gardasil is an injection and only administered to individuals with the aforementioned conditions.

Gardasil Side Effects:

Gardasil side effects have been carefully observed in numerous clinical trials. In these studies, Gardasil side effects are recorded and compared to adverse reactions that occur in groups of people not using the medication. Based on these evaluations, the most prevalent Gardasil side effects include:

• Pain in the area of the injection—this is the most common Gardasil side effect, occurring in up to 85% of patients

• Swelling or redness in the area of the injection are also common Gardasil side effects, occurring in roughly 25% of patients

• Fever—occurs in roughly 13 percent of patients

• Headache—occurs in 12.3 percent of patients

• Dizziness—occurs in roughly 4 percent of patients

• Diarrhea—occurs in roughly 4 percent of patients

Other, less prevalent, Gardasil side effects include: vomiting; coughing; toothache; joint pain; trouble sleeping stuffy or runny nose; muscle pain and upper respiratory tract infections.

Gardasil and the FDA:

Approved by the United States Food and Drug Administration in 2006, the Gardasil vaccination inoculates women against several forms of the sexually transmitted human papillomavirus (HPV). Following its introduction to the market, public concerns over potential Gardasil side effects increased. In response, the FDA reviewed available information in 2008 before concluding that the Gardasil vaccine was safe and should remain on the market.

The information posted on the product’s label does not currently contain a FDA mandated "black box warning" regarding potentially fatal Gardasil side effects. Therefore, people who are seriously injured or killed after taking the drug may have grounds to file a Gardasil lawsuit. That being said, history regarding Gardasil lawsuits is sparse—no public settlements have been rendered concerning Gardasil lawsuits over the drug’s side effects.

Although Gardasil lawsuits regarding side effects are extremely rare, Merck faced potential liability in 2011, when the FDA received reports concerning the presence of HPV DNA fragments in the drug. This concern, which ultimately alleged that large quantities of Gardasil were contaminated, was quickly debunked as the FDA institutes strict regulations concerning the manufacturing process.

The USFDA continues to monitor the safety of Gardasil. For instance, the FDA recently assessed the results of a study, which included over 189,000 female patients ages 9 to 26 years old. The study was conducted to evaluate the risks associated with the development of autoimmune diseases following vaccination. The results of the study revealed no elevated risk for the formation of lupus, multiple sclerosis or rheumatoid arthritis. As a result of this study, patients would have difficulty filing successful Gardasil lawsuits concerning the development of the aforementioned diseases. For more information concerning Gardasil lawsuits, please read below:

In 2009, the Journal of the American Medical Association published the results of a study examining the impact of the Gardasil vaccine over a period stretching from June 2006 to December 2008. Examining reports of Gardasil side effects relating to 23 million doses of the drug, the study found that only 32 deaths had been reported. The study concluded that the impact of the Gardasil vaccine could not be directly related to fatalities.

The FDA has concluded that Gardasil side effects cannot be directly linked to serious adverse conditions. While more than one Gardasil lawsuit has been filed globally, in the United States Gardasil lawsuits have not achieved notable success.

Clinical information regarding adverse responses to the Gardasil vaccine such as blood clots, seizure and paralysis has been similarly inconclusive. To pursue Gardasil lawsuits regarding these conditions, an attorney would need to definitively establish the connection between the drug and resulting medical complications. Current studies do not exist to provide definitive proof of the incidence of fatal Gardasil side effects.

Those who experience severe medical complications while taking the Gardasil vaccine should report their case to the FDA. While private Gardasil lawsuits may be difficult to win, the presence of severe side effects must be taken into consideration to ensure proper regulation.

Sources:

1. "FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers" (Press release).

U.S. Food and Drug Administration (FDA). 2008-09-12

2. Gardasil Vaccine Safety". Vaccine Safety & Availability.

U.S. Food and Drug Administration (FDA). August 20, 2009.

3. FDA: Gardasil approved to prevent anal cancer" (Press release).

U.S. Food and Drug Administration (FDA).

4. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/

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5. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/

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