Merck is Sued for Injuries Caused by Gardasil

Merck is Sued for Injuries Caused by Gardasil

Sahara Walker was only 11 years old in 2013 when she received the Gardasil vaccine that drastically changed her life, according to the attorneys who filed a lawsuit in U.S. District Court for the Western District of Wisconsin against the New Jersey based pharmaceutical giant, Merck on Nov. 18, 2020. Prior to Gardasil, Sahara was a healthy young girl who achieved academic success in math, scoring in the top 97th percentile of Wisconsin students and was an active member in mathletes, advancing to the state competition.

After only one shot of Gardasil, together with the meningococcal and Tdap vaccines, Sahara’s health took a drastic turn for the worse. Within days of the shots, she suffered from headaches, vomiting, fatigue, cognitive impairment, excessive sleeping, body aches and fevers and, by the end of the month, she was bedridden and in a wheelchair. There were no more mathlete competitions as Sahara was left with no choice but to be homeschooled for the remainder of 6th grade through 12th grade.

‘My injuries from Gardasil have stolen so much from me’

Within a few years of that fateful day in 2013, Sahara was going to more than 50 doctor appointments a year and took as many as 55 pills a day. She currently receives Intravenous Immune Globulin (IVIG), which is a blood product made from pooling the serum of 1,000-15,000 plasma donors and takes 14 prescription medications. Sahara has been diagnosed with Neurocardiogenic Syncope (NCS), Postural Orthostatic Tachycardia (POTS), Orthostatic Hypotension (OH), Small Fiber neuropathy and Autoimmune Autonomic Neuropathy.1

Sahara stated:

My injuries from the Gardasil vaccine have stolen so much from me. Before the vaccine, the possibilities for my future were endless. Now, my life is full of accommodations and medical interventions. It’s not how any 19-year-old should have to live. I want to warn people of the potential for serious adverse reactions and let others who have been hurt know that they are not alone. I’m fighting for all of us.2

Sahara is far from alone in her suffering after receiving the Gardasil vaccine. There have been thousands of reports of young women being left with severe brain and immune system dysfunction, including hundreds of reports of deaths following Gardasil vaccinations.3 4 5 6 As of December 2020, there had been 45,710 reports of Gardasil vaccine reactions made to VAERS, with 7,017 reports of serious adverse events, including 789 that were life threatening, as well as 4,772 hospitalizations and 376 deaths after vaccination with Gardasil 4.7 In the year 2010 alone, there were 26 Gardasil-related deaths reported to VAERS.8

After Gardasil 4 was licensed by the FDA in 2006, the National Vaccine Information Center (NVIC) issued a series of reports in 2007 analyzing Gardasil adverse events being reported to VAERS.9 10 11 NVIC’s analyses revealed that there was a statistically significant increased risk of Guillain-Barre Syndrome (GBS) and other serious adverse events when Gardasil was simultaneously given with other vaccines, especially the meningococcal vaccine, Menactra. There was a 1,130 percent increase in GBS, a 674 percent increase in injuries from falls after loss of consciousness, a 234 percent increase in coordination and neuromuscular problems, a 118 percent increase in cardiac problems, a 114 percent increase in respiratory problems and a 30.1 percent increase in convulsions and central nervous system problems when the Gardasil and Menactra vaccines were given at the same doctor’s visit.12

Barbara Loe Fisher, co-founder and president of the NVIC, said:

Now we know from this report that there are more reactions and deaths associated with Gardasil than with another vaccine given in the same age group. It’s irresponsible not to take action.13

Merck’s action was to phase out the original Gardasil 4 vaccine and market Gardasil 9 in December 2014. Gardasil 9, which is supposed to protect against infection with 9 strains of HPV, has more than twice the amount of bioactive aluminum adjuvant.14 As of December 2020, there have been 14,025 reports to VAERS after vaccination with Gardasil 9, 787 with serious injury, 100 life threating, 550 hospitalizations and 31 deaths.15

Lawsuit Alleges Merck Knew Gardasil Was Defective

The lawsuit filed on behalf of Sahara Walker alleges that Merck was negligent, committed fraud and failed to warn patients posing “a substantial risk of significant harm to children and patients who were injected with the Gardasil HPV vaccine,” and that there were inherent manufacturing defects in the vaccine itself.16 The Complaint further alleges that Merck hid the inherent risks from the FDA and consumers and overstated the vaccine’s benefits, when there were no published studies demonstrating the vaccine prevented any type of cancer and that, “Merck negligently and fraudulently deprived parents and children of their right to informed consent.”

This assertion is supported by statements from one of the leading researchers of Gardasil vaccine, Diane Harper, MD, MPH, who has publicly stated that parents and young women should have more complete warnings prior to receiving the vaccine.17

According to the Complaint, Merck knew or had reason to know Gardasil is defective and ineffective, but instead of warning consumers about the dangers, the company wrongfully concealed information and further made false statements concerning the safety and efficacy of Gardasil.18

Routine Pap Smear Screening Successfully Prevents Cervical Cancer

There are over 200 types of Human Papillomavirus (HPV) with 12-18 strains (types) potentially associated with cervical cancer. Gardasil 4 claims to protect against four of those 200 strains with only two of the four strains associated with cervical cancer, while Gardasil 9 is said to protect against 9 strains.19 Current data shows that the vaccine is only effective for five years, however, children as young as 9 are being injected with Gardasil.20 There are questions about giving very young children a vaccine that may only confer five years of protection against cervical cancer, when the average age of cervical cancer diagnosis is 50 years old.21

Merck applied for fast-track status for Gardasil for the prevention of cervical cancer, even though the already available pap smear test is highly effective in preventing cancer when screening occurs on a routine basis as part of well care visits for women. Fast-track status is granted by the FDA to a manufacturer when there is an unmet need for a serious medical condition.22 Some health professionals have pointed out that there was no unmet need as far as detecting and preventing cervical cancer because the pap smear, which has no dangerous side effects, has been considered the most successful cancer screening test since it was developed in the 1920s and made a part of routine health care for women in the 1970s in the U.S.23

Studies Show Elevated Death Rate in Gardasil Clinical Trials

Vaccine manufacturers which receive a fast-track designation from the FDA may submit less data to the government prior to licensing and, in lieu of pre-licensure clinical trial data, can conduct “post-marketing” clinical studies after the vaccine is released for widespread public use.24 The Complaint alleges that Merck failed to disclose key material facts related the safety and efficacy of the vaccine both during the shortened clinical trial period and after the vaccine went on the market, and further alleges that Merck has never disclosed that Gardasil’s ingredients contain experimental viral DNA fragments (HPV LV1-DNA) that have never been approved by the FDA.25

The studies conducted during the fast-tracked pre-licensing period revealed an increase in the death rate of young women by almost double the national average in both the Gardasil group and the control group. The control group did not receive a true placebo but received the same bioactive aluminum adjuvant contained in Gardasil vaccine.

While the average death rate for young women aged 15-26 is 4.37 per 10,000 people, .23 percent of which can be attributed to cervical cancer, the death rate of the Gardasil study participants was 8.5 percent per 10,000. When looking at all of the studies Merck conducted on Gardasil, the death rate climbs to 13.3 percent per 10,000. Analysis of mortality date from Merck’s Gardasil trials suggests that a young woman is 58 times more likely to die following receipt of Gardasil vaccine than from cervical cancer.

Merck dismissed the increase in death rate among Gardasil study participants as “coincidence.”26 In 2019, Merck made $3.7 billion from global sales of Gardasil vaccine.27


Click here to view References:

1 Gardasil Attorneys Allege HPV Vaccine Caused Girl to Develop POTS. Baum, Hedlund, Aristei & Goldman Nov. 18, 2020.
2 Ibid.
3 Attkisson S. New Worries About Gardasil Safety. CBS News  Feb. 6, 2009.
4 Kotz D, CDC Takes Closer Look at Gardasil and Paralysis. U.S. News & World Report Mar. 20, 2009.
5 Chustecka Z. Case Reports of ‘Syndrome’ Appearing After HPV Vaccination. Medscape Sept. 18, 2015.
6 Tmoljenovic L, Colafrancesco S, Perricone C, et al. Postural Orthostatic Tachycardia With Chronic Fatigue After HPV Vaccination as Part of the “Autoimmune/Auto-inflammatory Syndrome Induced by Adjuvants”: Case Report and Literature Review. Journal of Investigative Medicine High Impact Case Reports Mar. 18, 2014.
7 Medalerts.
8 Lind P. U.S. Court pays $6 Million to Gardasil Victims. The Washington Times Dec. 31, 2014.
9 Debold V, Fisher BL. Human Papillomavirus Vaccine Safety: Analysis of Vaccine Adverse Events Reporting System Reports Part 1. Feb. 1, 2007.
10 Ibid.
11 National Vaccine Information Center. NVIC Analysis Shows Greater Risk of GBS Reports when HPV Vaccine Is Given with Meningococcal and Other Vaccines. Aug. 15, 2007.
12 Ibid.
13 See Footnote 3.
14 NVIC. What is the History of HPV Vaccine Use in America.
15 See Footnote 7.
16 Sahara Walker v. Merk & Co et al. Case: 3:20-cv-01048 Document #1 Nov. 18, 2020.
17 Attkisson S. Gardasil Researcher Speaks Out. CBS News Aug. 19, 2009.
18 See Footnote 1.
19 See Footnote 13.
20 See Footnote 14.
21 Key Statistics for Cervical Cancer. American Cancer Society July 30, 2020.
22 Fast Track. U.S. Food and Drug Administration Jan. 4, 2018.
23 Haelle T. Which Screening Prevents The Most Cervical Cancer? Go With Co-Testing. Forbes Sept. 14, 2018.
24 Parpia R. Lyme Disease Vaccines: Past and FutureThe Vaccine Reaction July 18, 2020.
25 See Footnote 13.
26 Ibid.
27 Ibid.

7 Responses to "Merck is Sued for Injuries Caused by Gardasil"

  1. Joy Metcalf   December 7, 2020 at 11:28 am

    I thought manufacturers were shielded from lawsuits, EVEN IF there was negligence? Though that was written into the original law, the USSC pointed out that the bill stated that vaccines were “unavoidably unsafe” and gave the manufacturers a complete pass.

    Reply
    • Julie AH   December 7, 2020 at 10:15 pm

      I believe the law is they can only be sued if it can be proven that they knew beforehand that the vaccine posed “a substantial risk of significant harm” and hid that information?

      Reply
    • Amanda   December 10, 2020 at 10:14 pm

      They cannot be sued if the vaccine is pet of the CDC recommended childhood vaccine schedule. That is why so many states were trying to make the HPV vaccine mandatory last year.

      Reply
  2. Amy   December 7, 2020 at 2:08 pm

    Went to conference years ago Cervical Cancer is cured by improving the local immunity. Some cases just used condoms to decrease the amount of bacteria brought into the system. Alternate Vitamin A and Vitamin D used intravaginally for a month with repeat Pap at 6 weeks. Some with more compromised and those with poor diets were encourage to eat better taking oral Vitamin C and eliminating sugar from the diet. No human especially children should have to suffer from vaccine damage.

    Reply
  3. sHelah HOCKMAN   December 7, 2020 at 2:46 pm

    If I had an adolescent child, I would not have her or him take Gardasil. It isn’t worth it, for what it apparently prevents.

    Reply
  4. Andy   December 13, 2020 at 11:17 am

    .23% of women that age die of cervical cancer. But what percentage of THAT is from cancers that Gardasil is supposed to protect from. I have read elsewhere that only 10% of cervical cancers are “covered” by the shot, and not the most common types.

    Reply
  5. Peter Groot   March 1, 2021 at 5:47 pm

    8.5 percent of 10,000 looks wrong. Per cent means out of 100. It probably should be 8.5 out of 10,000 which is .085%. All the “percent of 10,000” look wrong.

    Reply

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