Gardasil was formulated byMerck & Co. on the heels of the discovery of the HPV virus, also known as the human papillomavirus. HPV is responsible for the development of cervical cancer in women.
Gardasil is prescribed in an attempt to curb the growing trend of cervical cancer. It’s estimated that approximately 11,000 women in the United States are diagnosed with this disease every year, and approximately 4,000 patients will die as a result of this disease. Gardasil works by formulating antibodies that are programmed to fight the HPV virus, and for a time it was seen as sort of a “miracle” drug.
The drug caught on quickly as well, as the SEC estimated that Merck & Co. generated $1.5 billion in revenue from Gardasil. The drug is administered in a series of injections, and an estimated 8 million women in the United States have used Gardasil since it was originally approved for use.
The FDA approved Gardasil for marketing, sale and distribution in the United States in 2006, and it was approved for that specific purpose – to fight the development and persistence of the HPV virus. While the drug was never purported to eliminate the disease, it was discovered that as many as 70% of the cervical cancer cases in the United States were the result of the presence of HPV.
After a little more than a year on the market, reports of upwards of 20 deaths by women who had used Gardasil surfaced. In addition to these reports, other instances of the development of side effects also surfaced, and some of the more common examples included:
- Optic lesions
- Spontaneous abortion
- Anaphylatic shock
- Guillain-Barre Syndrome
Further study revealed that there was no group of women that could be classified by age or race that were more or less susceptible to the side effects associated with Gardasil.
When reports of 20 deaths are associated with a particular drug, it’s unusual that the FDA does nothing in response. However, the FDA to date has not taken action, and even went so far as to issue the following statement: “Based on the review of available information by FDA and CDC, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks.”
The CDC has not changed its recommendations or its position in regards to Gardasil, and the FDA has not required the manufacturers of the drug to affix any sort of warning to the labels of the product. However, that does not mean that warnings, alerts and actions were not initiated by other groups, both individual and collective in nature.
Consumer advocacy groups such as Judicial Watch have been publishing the statistics associated with the side effects associated with Gardasil, and individual patients who have been harmed as a result of using this drug have taken action as well by way of filing lawsuits in civil courts across the United States.
The published contraindications that relate to Gardasil are few in number, and are restricted to those patients who have experienced a prior severe allergic reaction to yeast, which is a component of the vaccine, and/or previous allergic reactions to injections of Gardasil.
If the FDA has not taken action, will that affect my case if I’ve been injured by Gardasil?
While nothing is guaranteed, the likely answer is no, the lack of action by the FDA will not harm your case. While public health alerts, Black Box Warnings and recalls will generally help with an individual civil claim, the absence of them will not necessarily harm such a case. A skilled defective drugs attorney will present statistical evidence that should strengthen the position of anyone who has been harmed by Gardasil.
Should I stop using Gardasil?
If you are considering taking yourself off of this drug, you should consult your doctor and communicate the nature of your concerns. The worst aspect of the side effects associated with Gardasil are that they can arise with little or no warning and can be misdiagnosed as other problems given the common nature of some of the symptoms.
Can I file a lawsuit if I have suffered damages from taking Gardasil?
Possibly. While all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians adequately regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as “product liability.” Depending upon the particular circumstances of your case, damages may include recovery for any of the following:
- Past and future medical expenses
- Past and future pain and suffering
- Lost wages
- Loss of future earning capacity
- Emotional distress
If you or a loved one has experienced any health problems while taking Gardasil, you should contact your doctor immediately. You may also wish to contact an experienced Gardasil lawyer to discuss your legal options. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay.