Sisters' HPV vaccine injury claim heads to federal court

2013-11-07T09:00:00Z Sisters' HPV vaccine injury claim heads to federal courtDAVID WAHLBERG | Wisconsin State Journal | dwahlberg@madison.com | 608-252-6125 madison.com

Two sisters from Mount Horeb say a cervical cancer vaccine shut down their ovaries and almost certainly left them unable to get pregnant, a claim scheduled for a hearing Thursday and Friday in federal court in Washington, D.C.

Madelyne Meylor, 20, and Olivia Meylor, 19, say their premature ovarian failure came from the vaccine against human papillomavirus, or HPV.

It’s the first allegation that the vaccine caused the condition to reach a hearing through the National Vaccine Injury Compensation Program, said their attorney, Mark Krueger, of Baraboo.

Health officials recommend three doses of the vaccine against HPV, a sexually transmitted virus, for girls and boys ages 11 and 12 to protect against cervical cancer, throat cancer, genital warts and other conditions. Two brands are available: Gardasil, approved in 2006, and Cervarix, approved in 2009.

The vaccine injury program has awarded payments for HPV vaccine injuries in 68 cases for a total of at least $5.9 million, according to the federal government and Judicial Watch, a nonpartisan foundation. The program has dismissed 63 claims and 81 claims are pending.

About 22,000 adverse reactions from the HPV vaccine were reported nationally from June 2006 to March 2013, a period in which 57 million doses were distributed, according to the Centers for Disease Control and Prevention.

About 92 percent of the reactions, including the most common ones — fainting, dizziness and nausea — weren’t serious, the CDC said.

A 2011 study found that certain serious reactions — including seizures, stroke, potentially fatal allergic reactions and Guillain-Barre syndrome, an autoimmune disorder that can cause paralysis — were no more common among HPV vaccine recipients than in similar groups that didn’t get the vaccine, the CDC said.

The CDC and the Food and Drug Administration say the vaccine is safe and can help prevent many of the 18,000 cancers in women and 8,000 cancers in men caused by HPV each year.

But the Meylors said their Gardasil shots caused their ovaries to stop producing eggs. They also have premature menopause, marked by insomnia, night sweats and headaches, and almost certainly won’t be able to get pregnant, they said.

“I’ve always wanted a huge family, but I don’t know if that will be possible,” Madelyne said.

“People should look into the vaccine more and see if the benefits outweigh the risks,” Olivia said.

Madelyne, a UW-Madison junior, had her first menstrual periods at age 13, a few months before her first dose of HPV vaccine, according to a brief filed in her case.

Her periods were irregular and became more irregular after the second dose. After the third dose, at age 15, her periods stopped.

In 2010, at age 16, she was diagnosed with premature ovarian failure.

Olivia, a UW-Platteville sophomore, received three doses of HPV vaccine before having her first period at age 15, according to a brief in her case.

She had just one more period the next month. At 16, she was diagnosed with premature ovarian failure.

Tests for three possible genetic causes of the condition were negative for both women. They are taking birth control pills or using patches as hormone replacement therapy.

Their doctor told Olivia she has no chance of getting pregnant and Madelyne has less than a 5 percent chance, they said. Both could carry a baby conceived through infertility treatments, they said.

Merck, which makes Gardasil, refers to the condition as premature ovarian insufficiency, or POI.

“Merck has reviewed the post-licensure reports of POI after administration of Gardasil and has concluded that the evidence does not support a causal relationship to the vaccine,” the company said in a statement. “The cases have been reported to the U.S. FDA and other regulatory agencies. There have been no reports of POI in the clinical trials with Garsadil.”

Dr. Yehuda Shoenfeld, from Israel, plans to testify that the Meylors’ condition is an autoimmune disease caused by substances in the HPV vaccine, called adjuvants, designed to boost the body’s immune response. The phenomenon is known as Autoimmune Syndrome Induced by Adjuvants, or ASIA.

“There may be many young women who have been affected in this way who don’t know it,” said Krueger, the attorney.

The government will argue that the Meylors have typical premature ovarian failure unrelated to the HPV vaccine, according to U.S. Department of Justice briefs filed in both cases.

ASIA “is a syndrome that was first proposed by Dr. Shoenfeld in an article he authored in 2010,” the briefs say. “ASIA is not accepted by the medical community at large.”

Krueger said he doesn’t expect a decision immediately after the two-day hearing.

Joen Meylor, the sisters’ mother, said she trusted her doctor that Gardasil was safe. But when both daughters’ ovaries failed, “I started digging on the Internet and realized how harmful that vaccine is,” she said.

Whether the hearing results in a payment, “at least they’re going to have to look at us and make a decision,” she said.

Copyright 2015 madison.com. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

(39) Comments

  1. Crow Barr
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    Crow Barr - November 14, 2013 2:04 pm
    Sad, sad story, but we ALL have HeLa cells floating in us from any number of vaccines! Belated Thank You, Lacks family.
  2. HockeyTeam
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    HockeyTeam - November 11, 2013 4:38 pm
    It may be genetic predisposition to reaction from one or more of the vaccines ingredients. That is still irrelevant, however as the vaccine is still the causative factor.

    The case will hinge on whether they can show there was not proper warning of possible side effects given the literature at the time. Alternatively they could show that proper testing for health risks wasn't carried out by the makers of the injection.
  3. mottyk
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    mottyk - November 09, 2013 2:24 am
    Dr. Yehuda Shoenfeld et. al. published this in last July:
    Human Papilloma Virus Vaccine and Primary Ovarian Failure: Another Facet of the Autoimmune/Inflammatory Syndrome Induced by Adjuvants

    There are evidences that HPV vaccines can cause Auto immune diseases either by:
    a) adjuvants - autoimmune/ inflammatory syndrome induced by adjuvants (ASIA)
    b) the active ingredient. In this research: HPV-16L1.

    Both studies questions the whole process of testing and assuring the safety of vaccines both before licensing and after.
    1) In this regard, the fact that to date no solid tests or criteria have been established to determine whether adverse events are causally linked to vaccinations [6,16] should be a cause for concern.
    2) Finally, a further major bias in evaluating HPV
    vaccine safety comes from the fact that in all clinical
    trials for both Gardasil and Cervarix, safety outcomes
    were compared between vaccine recipients and
    those who received an aluminium adjuvant containing
    ‘placebo’.49,50 This practice is common in vaccine
    trials,61 despite much evidence showing that aluminium
    in vaccine relevant exposures can be toxic to
    humans,34,35,60 and therefore, its use as a ‘placebo
    control’ in vaccine trials can no longer be justified
  4. bnp
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    bnp - November 08, 2013 6:30 pm
    Few people know that the hpv virus is now the leading cause of throat cancer. Men are at a higher rate.
  5. milton's fried man
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    milton's fried man - November 08, 2013 12:54 pm
    Lots of guys get throat cancer for the same reason
  6. milton's fried man
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    milton's fried man - November 08, 2013 12:53 pm
    Henrietta Lacks got HPV from her husband most likely while still a young teen. Gave her the cancer that killed her
  7. milton's fried man
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    milton's fried man - November 08, 2013 12:52 pm
    Good luck with that lol
  8. milton's fried man
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    milton's fried man - November 08, 2013 12:51 pm
    When two sister have the same rare reaction to drug one has to wonder if it is a reaction vs genetics
  9. milton's fried man
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    milton's fried man - November 08, 2013 12:47 pm
    judicial watch is now non partisan? That would be funny if Wisconsin's pAper of record hadn't just said it. Instead it's just a sad reminder of what a worthless rag the state urinal has become.
  10. Twyla
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    Twyla - November 08, 2013 1:02 am
    What science? A bit of number crunching by the CDC?

    These HPV vaccines have wreaked havoc on some people's immune and nervous systems.

    Cervical cancer rarely kills when caught early via regular pap tests. And the risk of cervical cancer can be decreased by not smoking cigarettes.

    Looked at another way, chance of serious life-changing adverse reaction in a 12-year-old compared with chance of cervical cancer 40 years later.
  11. Twyla
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    Twyla - November 08, 2013 12:56 am
    Maybe they share a genetic susceptibility to harm from this vaccine.
  12. Twyla
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    Twyla - November 07, 2013 11:39 pm
    A similar report from the BMJ:
    Premature ovarian failure 3 years after menarche in a 16-year-old girl following human papillomavirus vaccination
    Premature ovarian failure in a well adolescent is a rare event. Its occurrence raises important questions about causation, which may signal other systemic concerns. This patient presented with amenorrhoea after identifying a change from her regular cycle to irregular and scant periods following vaccinations against human papillomavirus. She declined the oral contraceptives initially prescribed for amenorrhoea. The diagnostic tasks were to determine the reason for her secondary amenorrhoea and then to investigate for possible causes of the premature ovarian failure identified. Although the cause is unknown in 90% of cases, the remaining chief identifiable causes of this condition were excluded. Premature ovarian failure was then notified as a possible adverse event following this vaccination. The young woman was counselled regarding preservation of bone density, reproductive implications and relevant follow-up. This event could hold potential implications for population health and prompts further inquiry.

    Britt Fiste pleas for Unbiased Research on HPV Vaccines
    “I am not a coincidence”
  13. Twyla
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    Twyla - November 07, 2013 11:38 pm
    This study by doctors in Italy and Israel describes ovarian failure post-hpv vaccine:

    Human papilloma virus vaccine and primary ovarian failure: another facet of the autoimmune/inflammatory syndrome induced by adjuvants.
    All three patients developed secondary amenorrhea following HPV vaccinations, which did not resolve upon treatment with hormone replacement therapies. In all three cases sexual development was normal and genetic screen revealed no pertinent abnormalities (i.e., Turner's syndrome, Fragile X test were all negative). Serological evaluations showed low levels of estradiol and increased FSH and LH and in two cases, specific auto-antibodies were detected (antiovarian and anti thyroid), suggesting that the HPV vaccine triggered an autoimmune response. Pelvic ultrasound did not reveal any abnormalities in any of the three cases. All three patients experienced a range of common non-specific post-vaccine symptoms including nausea, headache, sleep disturbances, arthralgia and a range of cognitive and psychiatric disturbances. According to these clinical features, a diagnosis of primary ovarian failure (POF) was determined which also fulfilled the required criteria for the ASIA syndrome.
    We documented here the evidence of the potential of the HPV vaccine to trigger a life-disabling autoimmune condition. The increasing number of similar reports of post HPV vaccine-linked autoimmunity and the uncertainty of long-term clinical benefits of HPV vaccination are a matter of public health that warrants further rigorous inquiry.
  14. Twyla
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    Twyla - November 07, 2013 11:36 pm
    There have been a number of very serious adverse reactions to this vaccine reported in various countries. And, a key researcher has spoken out expressing doubts about whether the possible benefits of this vaccine outweigh the risks.

    An Interview with Dr. Diane M. Harper, HPV Expert


    The Truth About Gardasil

    Judicial Watch reports on Gardasil adverse reactions

    Gardasil and Unexplained Deaths

    There have been reports from all over the world of adverse reactions, including now in Japan:
    “Cervix vaccine issues trigger health notice”

    “Victims hit cervical cancer vaccines - Paralyzed teens, parents demand subsidized shots be eradicated”
  15. Twyla
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    Twyla - November 07, 2013 11:34 pm
    I'm so sad for these two beautiful girls and their family. May they go on to live happy fulfilling lives in spite of this. So unfair.
  16. Twyla
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    Twyla - November 07, 2013 11:33 pm
    This isn't a quack claim.
  17. Twyla
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    Twyla - November 07, 2013 11:31 pm
    57 million doses distributed -- of those, we don't know how many have actually been given. Three doses per person, so that cuts the number of recipients down by about 67%. And studies have shown that only 1% to 10% of adverse reactions are reported.
  18. chandra
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    chandra - November 07, 2013 7:02 pm
    When I was 18 i got the vaccination I am now 23....when I got my first HPV shot I felt fine, come the second shot I started to get dizzy and got nausea, when it came to the last and final shot I started to experience fainting, puking all the time, passing out, cramps so bad where I couldn't even get out of bed, and just missed a lot of school and I was always in and out of the doctors...the doctors did blood work and almost every other test they could think of..the doctors would not say it was from the shots, but why did I start feeling and get so sick after I got those shots? Finally the said it was IBS...to this day I ha r no been the same..I have not normal paps, worst cramps ever, server headache to where I end up puking and having to leave work. Reading this makes me think I should have my ovaries checked out...I don't recommend the shot to anyone!!!
  19. small town
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    small town - November 07, 2013 5:42 pm
    I'm a very close personal friends with his family and the mother has been working on this for years .if I had daughters I wish they would be just like those two they have hearts of gold.Seriously if you had two daughters that have the exact situation you're going to sit there and do nothing that's what it sounds like a lot of your comments come down to.I feel bad for your kids if you have any that you won't fight for them.
  20. CarolASThompson
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    CarolASThompson - November 07, 2013 2:41 pm
    Isn't our legal system wonderful, when people can get into court with quack claims like this, while tens of millions harmed by health fascist scientific fraud persecuting their lifestyles cannot. It's all run by the over-privileged 1% and this is what they want.
  21. rhivjylyh
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    rhivjylyh - November 07, 2013 2:08 pm
    I feel bad for these women and how this diagnosis affects their futures.

    That said, consider the likelihood of these two possibilities:

    1) The women both had an incredibly rare side effect from the HPV vaccine that is, in fact, so rare it hasn't been reported. And yet both of them have the same rare side effect.

    2) The women share an inherited genetic predisposition to premature ovarian failure. The article notes that the women were tested for three specific, known genetic causes of premature ovarian failure. But there is a constellation of other potential genetic causes that could cause premature ovarian failure.

    Neither one of these possibilities can be completely discounted, but genetics seems much, much more likely unless there is other genetic data not discussed in the article.
  22. array1
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    array1 - November 07, 2013 12:59 pm
    What is her husband has HPV?

    Also, studies have shown that abstinance only education is not as effective as teaching birth control in preventing teen pregnancy.
  23. BananaSplitz
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    BananaSplitz - November 07, 2013 10:55 am
    Wow. Way to assume the worst.
  24. PapaLorax
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    PapaLorax - November 07, 2013 10:45 am
    Science does not support a causal relationship so I would not just assume the adverse reactions here are related.
  25. MrNatural
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    MrNatural - November 07, 2013 10:07 am
    Luckily there there is no rape in the US.
  26. MrNatural
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    MrNatural - November 07, 2013 10:06 am
    3,939 women in the United States died from cervical cancer

    2010 The last year figures are available.
  27. MrNatural
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    MrNatural - November 07, 2013 10:04 am
    And what could possibly go wrong there?
  28. Juan Diego
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    Juan Diego - November 07, 2013 9:56 am
    First, kudos to these young women for going public about the effect of this drug on their bodies. Our daughter is 20 and we were told by our pediatrician years ago- probably about the same time the Meylors saw their doctor- that if she were abstinent and chaste (words much mocked today) there was no imaginable reason on earth why she would need such a vaccination. Turns out he was right.
    Witness the fruits of the "they're gonna do it anyway" mentality....
  29. Harvey
    Report Abuse
    Harvey - November 07, 2013 9:55 am
    Let's see - 22,000 cases of adverse reactions in over 57 million doses given. That means it is 99.97% safe. I wonder if I can think of things that are less safe. Hmmmm. Looked at another way, 22,000 adverse reactions over 7 years. Over the same 7 year span the American Cancer Society estimates 91,000 new cases of cervical cancer without the vaccine. Adverse reactions may make you sterile. The cancer has a high probability of killing you.
  30. array1
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    array1 - November 07, 2013 9:52 am
    I believe studies have shown that teaching abstinance is not as effective in preventing preganacy than teaching birh control. Personally, I'm totally against car accidents but I still opt for the insurance anyway.
  31. snootyelites
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    snootyelites - November 07, 2013 9:38 am
    There was an exact of case like this in Australia. The issue is establishing causation! Many teens go into menopause for variety of reasons. Gardasil could be a coincidence. Really unfortunate these girls have to suffer like this but cancer prevention aspect of Gardasil is overwhelming!

    About 60% or higher of Americans exposed one of many HPV strains. Gardasil will eventually prevail. Hopefully something better in the pipeline. This virus also establishes a clear connection between virus and cancer.
  32. PapaLorax
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    PapaLorax - November 07, 2013 8:10 am
    why get pollio vaccines? it is practically eradicated? Why chicken pox...rarely kills you?

    We do these things because science has shown it is better then not vaccinating...of course that isn't always the case on an individual level.
  33. retired
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    retired - November 07, 2013 7:15 am
    Wsj, can u keep us up to date on this issue.? Am curious how this turns out.
  34. lyla
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    lyla - November 07, 2013 12:58 am
    It is not because the child wants the vaccine, it's the physicians that push it when you take your child in for a physical. They "recommend" boys get it as well at age 13. I am totally against my two boys from getting the shot. Sorry array1 but I am teaching my sons to abstain from premarital sex.
  35. adamman
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    adamman - November 06, 2013 5:38 pm
    Ok, thank you thinkingoutloud. That was a reasonable explanation.
  36. Thinkingoutloud
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    Thinkingoutloud - November 06, 2013 5:21 pm
    The HPV shot has nothing to do with promiscuity and everything to do with protecting yourself from viruses that cause cancer. The shots only work before a person becomes sexually active...not after she or he has already become exposed to the virus. Yes, I said boys too. These viruses are carried by both males and females. So a pure and wholesome female disembarking from the Mayflower could marry an infected male and pay the price if not protected. Also, these viruses can be on fingers and in throats. They can be passed without intercourse.
  37. adamman
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    adamman - November 06, 2013 4:58 pm
    Okay, I just disembarked from the Mayflower. Still wonder why these girls need protection from a sexually transmitted disease. Answer the questions instead of ridiculing honest questions. Time for you to start your brain.
  38. array1
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    array1 - November 06, 2013 4:33 pm
    ummmmm.... the whole idea is to prevent cancer by a sexually transmitted virus in the first place. Time to get off the Mayflower, dude.
  39. adamman
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    adamman - November 06, 2013 4:04 pm
    Why do girls this young need the vaccine? Is it just because they want protection from promiscuity? Are they married? I think the lawsuit needs to be evaluated in relation to sexual choices people make. I know my position is controversial but people who live risky lifestyles should be held accountable.

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