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WHAT IS GARDASIL?

For more information or to arrange a meeting with one of our Medical Negligence Solicitors please contact Kathrin Coleman or call us on 01-5313800


Gardasil is a vaccine used to prevent genital warts and cervical/vaginal/anal cancers caused by human papillomavirus (HPV) types 6, 11, 16, and 18 in girls and young women ages 9 through 26.

It was approved in the US on June 8, 2006 by the U.S. Food and Drug Administration (FDA). In 2008, Gardasil was approved in 41 of U.S. states. The Gardasil vaccine has also been approved in 120 other countries.  The FDA recommends vaccination before adolescence and potential sexual activity.

In December 2014, the FDA approved a nine-valent Gardasil-based vaccine, Gardasil 9, to protect against infection with the strains covered by the first generation of Gardasil as well as five other HPV strains responsible for 20% of cervical cancers (HPV-31, HPV-33, HPV-45, HPV-52, and HPV-58).

Gardasil is also used to prevent genital warts caused by HPV types 6 and 11 in boys and young men ages 9 through 26. Human papillomavirus (HPV) can cause genital warts, cancer of the cervix, and various cancers of the vulva or vagina.

The quadrivalent form of HPV vaccine (Gardasil) is used in both females and males. Another form of HPV vaccine (Cervarix) is used only in females.

The Centers for Disease Control and Prevention (CDC) recommends HPV vaccine for all girls ages 11 or 12 years old. The vaccine is also recommended in girls and women ages 13 through 26 years old who have not already received the vaccine or have not completed all booster shots.  You may receive Gardasil even if you have already had genital warts, or had a positive HPV test or abnormal pap smear in the past. However, Gardasil will not treat active genital warts or HPV-related cancers, and it will not cure HPV infection.

SIDE EFFECTS OF GARDASIL

Gardasil and Cervarix, both HPV vaccines, have come under scrutiny from many sources and throughout many countries over the past few years.

The most common side effects of GARDASIL:

  • pain, swelling, itching, bruising, and redness at the injection site
  • headache
  • fever
  • nausea
  • dizziness
  • vomiting
  • fainting

Fainting can happen after getting GARDASIL. Sometimes people who faint can fall and hurt themselves. For this reason, your child’s doctor or health care professional may ask your child to sit or lie down for 15 minutes after getting GARDASIL. Some people who faint might shake or become stiff. This may require evaluation or treatment by your child’s doctor or health care professional.

Support groups in Ireland for those affected by side effects of the Gardasil vaccine

In May 2015 in Swords, Ireland, the R.E.G.R.E.T. Support Group was launched by parents of chronically ill teenage girls.  They blame an injection the girls received at school as the cause of their daughters’ illness. The drug in question is called Gardasil and is being marketed as an anti-cancer vaccine. R.E.G.R.E.T. is an acronym for “Reactions and Effects of Gardasil Resulting in Extreme Trauma”.

Members of ten families from all over the country came together to share experiences and express their exasperation at the inability of health authorities to recognise the pattern of serious adverse reactions being suffered by children who, up until receiving the Gardasil injection, enjoyed an active healthy lifestyle. One of the main complaints raised at the meeting was that the information provided by the HSE (as part of the ‘informed consent’ process) is extremely misleading, particularly with regard to how safe the vaccine is. A high incidence of serious reactions from Gardasil have been reported in the U.S since it was released there in 2006. Even the drug manufacturer’s own clinical trials reveal a 1 in 40 (2.5%) incidence of a serious adverse reaction*, yet Irish parents are still told by the HSE that Gardasil is ‘very safe’.

Although its cancer-preventing properties have never been proven, the HSE insists that the benefits of Gardasil outweigh the risks and even claim that it has been ‘fully tested’, This is despite the limited safety testing that took place as a result of this “life-saving vaccine” being fast-tracked through the regulatory approval process. The HSE did not inform parents that Gardasil contains genetically engineered non-human recombinant DNA, the effects of which are unknown and unpredictable when injected into a human host.

The types of long term debilitating health conditions reported by Irish parents have in many cases meant that the girls are unable to continue their education in school. Because of the nature of the chronic illnesses, Irish doctors and consultants are unable to offer any effective treatment. With 1 or 2 rare exceptions, these medical professionals dismiss these serious reactions as unrelated to Gardasil and merely coincidental. When tests come back negative, parents are often told that their girls simply have psychological/psychosomatic problems.

The group also launched the website www.regret.ie, where parents can read first-hand accounts from Irish victims and their families. The site is also a focal point for raising awareness among other parents whose daughters have yet to receive the injection with the schools vaccination program set to resume in September 2015.

With cases against the pharmaceutical companies that produce Gardasil mounting and thousands of articles available to view online and in the media, it is important to be aware of the risks and side-effects associated with a drug that advertises to prevent the onset of sexually transmitted diseases and cervical cancers.

GARDASIL Class Actions and Lawsuits

In June 2013, the Japanese government issued a notice that “cervical cancer vaccinations should no longer be recommended for girls aged 12 to 16″ while an investigation is conducted into certain adverse events including pain and numbness in 38 girls. The vaccines sold in Japan are Cervarix, made by GlaxoSmithKlein PLC of Britain, and Gardasil, made by Merck Sharp & Dohme.

In America, a class action has been taken and the National Vaccine Injury Compensation Program (VICP) has Paid Out Nearly $6 million in Claims to Victims of Controversial HPV (human papillomavirus) Vaccine, including Families of Two Dead, and further lawsuits have been taken in Canada against Merck.

An estimated 3.28 million people have received the vaccination; 1,968 cases of possible side effects have been reported. 

An Australian Class Action has been taken against Merck, the manufacturers of Gardasil, after suffering autoimmune and neurological complications following injections with the HPV vaccine, Gardasil.

The vaccine Gardasil has dominated the press in the recent past, not for its beneficial effects but for its damaging and sometimes fatal side-effects, not just in its country of origin (the USA) but on a worldwide scale.

New information regarding the use of the HPV vaccine Gardasil according to the Judicial Watch of Washington DC have verified that the National Vaccine Injury Compensation Program (VICP) has Paid Out Nearly $6 million in Claims to Victims of Controversial HPV (human papillomavirus) Vaccine, including Families of Two Dead. At the time this document went to press, over 200 claims had been logged with less than 25% of cases having reached court to date.

More than 60 adverse reactions to the cervical cancer vaccine, Gardasil, which is used in the State’s National Immunisation Programme have been reported to the Irish Medicines Board.

However to date, the HSE website, still recommends the immunisation of young teenage girls with the Gardasil vaccine as part of a school immunisation programme.

Criminal Lawsuits in Spain

On 19th June 2014 in  Logroño, Spain, Attorney Don Manuel Sáez Ochoa filed a criminal complaint against Merck-Sanofi Pasteur Laboratories, Spanish National Health authorities, and the regional health authorities of the La Rioja province on behalf of Zuriñe Jiménez Guereño and her mother Doña Maria del Carmen Jiménez Guereño for injuries and disabilities suffered by Zuriñe after the administration of Gardasil.

The complaint states that Merck Laboratories failed to use an inert placebo during clinical trials, thereby manipulating data and marketing Gardasil under false pretences. Despite complaints of several young women with similar new medical conditions after Gardasil injections, the Spanish health authorities ignored calls for a moratorium on the use of Gardasil until the safety issues were resolved.

Both regional and national health authorities made no attempt to verify the accuracy of the safety data Merck submitted to gain approval for the widespread administration of Gardasil as a cancer preventative; nor did they make any attempt to inform the public that an already proven safe and effective means of controlling cervical cancer was already in existence.

The complaint goes on to say both national and local health authorities had adequate knowledge regarding the potential harmful effects of Gardasil and chose to recommend administration of the HPV vaccine anyway. The complaint alleges this showed an absolute disregard for the health and well-being of young Spanish girls.

According to the complaint, the attitude of the Merck pharmaceutical company and Spanish health authorities (both national and regional) before, during and after the administration of Gardasil shows they care nothing about the risk to which medical consumers expose themselves whenever Gardasil is used.

The complaint states, prior to administration, no one was concerned about possible adverse reactions to the vaccine. When adverse reactions did occur, those who experienced them were treated with contempt leaving them in a state of helplessness. There was allegedly not one single official inquiry about the girls’ post-Gardasil conditions even though they were healthy prior to being injected with Gardasil.

An outcry from the public calling for a moratorium on the use of Gardasil until safety issues were resolved was ignored by Spanish health authorities. Injections of Gardasil continued despite the damage left behind.

According to Attorney Don Manuel Sáez Ochoa, (claiming) a possible exemption arguing that they did not know at the time of processing, the dangers of the vaccine (Gardasil) is laughable……Frankly this attitude seems clearly malicious and constitutes the offense of injury as per Article 149.1 of the Criminal Code that states: To cause another, by any means or process, the loss or worthlessness of an organ or principal member, or a sense, impotence, sterility, severe deformity, or severe somatic or mental illness, shall be punished with imprisonment of six to twelve years.

Charges contained in the official criminal complaint

Merck-Sanofi Pasteur, Spain’s National and Regional (La Rioja) health authorities are charged with the following:

  • fraudulent marketing and/or administration of an inadequately tested vaccine;
  • failure to inform the public about the potential risks of using Gardasil;
  • clear infringement of the right to informed consent;
  • ignoring new medical conditions in those who used Gardasil despite the similarity of their symptoms and the relatively short period of time between vaccine administration and the onset of symptoms;
  • ignoring established and new scientific evidence illustrating the potential harmful effects of Gardasil ingredients and manufacturing methods;
  • callous disregard for those suffering new medical conditions post-Gardasil;
  • failure to inform the public that HPV infections are simply one of the risk factors involved in the  development of cervical cancer;
  • failure to inform the public that 90% of all HPV infections clear on their own without medical intervention;
  • failure to inform the public about alternative methods of controlling cervical cancer; and criminal liability for the injuries resulting from the administration of Gardasil

Even if one assumes that Merck-Sanofi Pasteur and all of the government health officials were not aware of the potential risks and lack of proven benefit of Gardasil, there has been plenty of scientific and medical evidence provided since 2007 when the vaccine was approved for use in Spain.

Lawsuits in Australia against the Gardasil Vaccine

Naomi Snell, a 28-year-old woman in Melbourne, Australia, is leading a class-action civil lawsuit against drug maker Merck after suffering autoimmune and neurological complications following injections with the HPV vaccine, Gardasil.

After receiving the first of three doses of the vaccine, Naomi suffered convulsions, severe back and neck pain, and lost her ability to walk.

Doctors actually diagnosed her with multiple sclerosis, which was later retracted and labeled a neurological reaction to the vaccine.

Seven other women, who say they have suffered various physical problems, including anaphylaxis and miscarriage, after receiving Gardasil may also join the civil lawsuit, and this is likely only the beginning, as Gardasil is being implicated in a growing number of serious, permanent and sometimes deadly adverse reactions.

Tell your child’s doctor or health care professional if any of the following problems occur because these may be signs of an allergic reaction:

  • difficulty breathing
  • wheezing (bronchospasm)
  • hives
  • rash

Tell your child’s doctor or health care professional if your child has:

  • swollen glands (neck, armpit, or groin)
  • joint pain
  • unusual tiredness, weakness, or confusion
  • chills
  • generally feeling unwell
  • leg pain
  • shortness of breath
  • chest pain
  • aching muscles
  • muscle weakness
  • seizure
  • bad stomach ache
  • bleeding or bruising more easily than normal
  • skin infection

If you have ANY concerns relating to this or any other vaccine, the first thing you should do is contact your child’s doctor or health care professional right away if any of these symptoms concern you, even several months after your child gets the vaccine.

CONTACT OUR MEDICAL NEGLIGENCE SOLICITORS TODAY TO DISCUSS YOUR CASE

As medical negligence solicitors we can assess your claim efficiently and in a timely manner.

For more information or to arrange a meeting with one of our Medical Negligence Solicitors please contact Kathrin Coleman or call us on 01-5313800

MORE READING:

https://pompiliomartinez.wordpress.com/2016/03/04/motor-and-sensory-clinical-findings-in-girls-vaccinated-against-the-human-papillomavirus-from-carmen-de-bolivar-colombia/

http://www.irishtimes.com/news/crime-and-law/courts/high-court/court-told-of-horrendous-adverse-effects-of-hpv-vaccine-1.2414549

http://www.wexfordpeople.ie/news/wexford-woman-claims-cervical-cancer-vaccine-damaged-daughters-health-31531619.html

http://www.leagle.com/decision/In%20FDCO%2020150612900/McCULLOCH%20v.%20SECRETARY%20OF%20HEALTH%20AND%20HUMAN%20SERVICES

http://regret.ie/

http://www.comelook.org/