The District Court in North Carolina sided with Merck & Co. and granted a summary judgment motion to dismiss plaintiff’s failure to warn claims in ongoing litigation between the pharmaceutical giant and young women injured by the Gardasil vaccine. The lawsuit alleged that Merck covered up the risks associated with the company’s blockbuster vaccine which claims to offer protection against cervical and other types of cancers associated with the human papilloma virus (HPV).1
Class Action Lawsuit Involved More Than 200 Gardasil Vaccine Injury Victims
Approximately 200 lawsuits filed against Merck for its Gardasil vaccine since 2022 had been consolidated into a class action lawsuit called the Bellwether Plaintiff cases in the Western District of North Carolina, Charlotte Division. The injured plaintiffs came from across the country stating that the vaccine caused serious injury and chronic poor health, including autoimmunity, encephalitis and neurological dysfunction, Postural Orthostatic Tachycardia Syndrome (POTS), development of diabetes, premature ovarian failure (POI), infertility, and death.2
Gardasil was fast-tracked to licensure by the U.S. Food and Drug Administration (FDA) in 2006 and first recommended by the U.S. Centers for Disease Control and Prevention (CDC) to be given to all 11-12-year-old girls. It was known at the time that Merck used an aluminum containing bioactive “placebo” in pre-licensure trials and only tested the vaccine in a small number of children under age 15.3
The class action lawsuit alleged manufacture defect, failure to warn and negligence.4
Merck filed a summary judgment motion to dismiss the failure to warn claims as it pertained to the vaccine causing POTS and POI. A summary judgment motion is brought when one party alleges that a trial is not necessary as the other side has no valid claims or defenses for the judge or jury to consider. The moving party argues that they are entitled to a judgment as a matter of law due to there being “no genuine issues as to any material fact”.5
In the summary judgment motion, Judge Kenneth Bell was tasked with deciding whether federal law allowed Merck to place warnings on the Gardasil vaccine’s label without the approval of the U.S. Food and Drug Administration (FDA). FDA approval is generally required when changes are made to a vaccine’s prescribing information.6
The court sought to answer the question of whether Merck, since its last disclosure to the FDA, received enough, “newly acquired information.that a scientist could reasonably conclude that there was a casual connection between taking Gardasil and contracting POTS or POI.”7
Court Concludes Merck Lacked the Authority to Add a Warning to Gardasil’s Label
The court was looking to see what evidence Merck had received since 2013, the latest time period that the plaintiff’s claim the warnings should have been provided, and whether that was enough evidence to warrant adding a warning to the vaccine label. The court found that by 2013, there was only one published case of verified POTS and only four verified cases of POI resulting from the vaccine. The court decided that there was not enough evidence to prove that there was a casual connection between the administration of the vaccine and those poor health outcomes. Since the court determined that Merck did not have newly discovered causation evidence, then FDA approval would be needed to change the vaccine label. Accordingly, the court found that Merck lacked the authority to independently add a new warning to the vaccine’s label.8
The plaintiff’s failure to warn claims were based on state law. Therefore, the court had to determine whether the state law claims were preempted by federal law. Generally, state law is preempted by federal law when there is a federal law on point that conflicts with state law because federal law overrides state law. Here, federal law under the Food, Drug and Cosmetic Act (FDCA) regulates what will appear on a drug or vaccine label. The FDCA regulation, “allow[s] only information for which there is scientific basis to be included in the FDA-approved label.”9
Once a label has been approved by the FDA, it generally may not be altered without further approval by the FDA unless it is established that there was enough newly acquired information leading qualified experts to conclude that there was a causal connection between the vaccine and the conditions that would be on the warning label. The plaintiffs bore the burden of proving that Merck received enough newly acquired information to warrant changing the label. The court concluded that plaintiffs did not establish that Merck had enough newly acquired information about Gardasil causing POTS or POI to warrant a label change after 2013.
The court found:
Federal law requires more than speculative inferences prior to adding dire warnings to lifesaving vaccines that discourage their use. The law requires reasonable scientific evidence of a casual association between the vaccine and the alleged harm… that evidence is lacking here. Therefore, Merck could not lawfully change the Gardasil label without prior approval from the FDA. Without that authority, federal and state law are in conflict and Bellwether Plaintiffs’ state law failure to warn claims are preempted.10
Plaintiffs intend to appeal the decision.11
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Click here to view References:1 Stempel J. Merck prevails in US safety litigation over Gardasil HPV vaccine. Reuters Mar. 11, 2025.
2 Coin J. Patients file lawsuits in Charlotte court alleging issues caused by Merck’s HPV vaccines. The Charlotte Observer Mar 11, 2024.
3 National Vaccine Information Center. Merck’s Gardasil Vaccine Not Proven Safe for Little Girls. June 27, 2006.
4 Munger L. Merck’s Gardasil Under Legal Scrutiny Despite Lack of Evidence to Support Suits. Biospace May 24, 2023.
5 Prevail Lawyers. A layman’s Guide to Summary Judgment. July 2, 2015.
6 In Re: Gardasil Products Liability Litigation. U.S. District Court of Western District of North Carolina Charlotte Division 3:220-MD-03036-KDB. Mar. 10, 2025.
7 Ibid.
8 Ibid.
9 Ibid.
10 Ibid.
11 Baletti B. Breaking: Federal Judge Hands Merck Win in Key Gardasil HPV Vaccine Case. Science, Public Health Policy and the Law.
14 Responses
you noticed they didn’t dismiss because there were no injuries.
they’re basically protected from liability from the injuries and hid behind regulations because they didn’t tell you that there could be injuries.
What a joke our system is.
It is a joke!!!! and the FDA is fraudulent. When are people going to learn to stay away from these vaccines. They are keeping people sick that is their motive
Since when can a company not put a warning without FDA approval? J&J very quietly took Levaquin [known as vitamin L and used as IV antibiotic in virtually every USA hospital] off the market when the lawsuits became too much. 4-5 BLACK BOX warning on Cipro and other FQ drugs but J&J was starting to be sued additionally for “delayed retinal detachment” ; which happened to at least two people I know personally.It destroys connective tissue body wide and they knew it for 40 years.
Hundreds of real world people harmed. A hypothetical as if judicial review for a situation ten years ago, not accounting for the ongoing harms or how the movement of vaccine awareness built over that time and there may be sufficient evidence now. Conveniently do not apply any retroactive enforcement. Lacking standing and the company does not have permission to warn of it’s own harms because not enough evidence was in at the time. Cycle everything back to the FDA and claim only qualified experts know anything worth while. Claim dismissed! Big pharma protected by the court systems again!
Who do you think these government regulators and judicial people actually work on behalf and actually care to honestly represent? You have only two choices; The citizens. Or the corporations.
These people are not experts. What they have been doing is not science. Justice delayed is justice denied. People, we’re on our own. Government regulatory authorities have not functioned properly for decades, probably never will. Find new better honest and impartial experts to rely on. Or as we like to say in our house; The very last place we turn to for any product or safety advisement is the government. Policy for sale. Looks like all the people with devastated health will have to drum up another six or seven digit legal funds pool, then beg the lawyers to try it again with a different retrospective date stamp. Maybe if they came with 2,000 or 20,000 people harmed, someone will notice. Not like the FDA could voluntarily take action now or anything… Again, they will not, because the government regulators do not represent the people, they function as a liability shield for pharmasuetical, big ag, and various other corporate entities.
In the real world; Case comes before the judge. Phone is ringing with paid lobbyists and highly compensated corporate lawyers. Judge reviews their investment portfolio. Makes a determination there is too much pressure, perhaps some form of compromising position made possible by this suit, backs into a legal ruling to sweep the whole thing away. Continues to count cash from the floor to the ceiling. Silently advises their own family to steer clear of the product in question. Let’s the plaintiffs down easy on a technicality. That’s just speculation of course but come on, logical challenge, the real world is knocking and will anyone answer? Trust the experts they said. Trust the courts and legal process they said. The alternative for the laymen is much more simple than all of this; Simply say no to all vaccines until the deeply entrenched corruption and incompetence is rooted out or washed away with time. Do not expect any meaningful change in your lifetime as long as the government money flows to these systems. Poisonous protectionism and perverse financial incentives made possible by your tax dollars appears hear to stay. Get with the notion of no taxation without representation, as that is what every plaintiff or person harmed by these systems is dealing with as the principal moral and primary legal issue at hand. Dismissed on a hypothetical based on historical dates, pretending new data is not present, as if justice is only possible under such limited circumstances. Who’s still buying this?
well said, and Exactly, it’s appalling, disgusting, greed for profit, they are all disgusting and should be tried by a Real Judge or at least someone with an ounce of compassion and dignity for fellow human beings. FRAUD AND CRIMES AGAINST HUMANITY IN THE NAME OF THE ALMIGHTY DOLLAR, crimes against the Ultimate Judge, GOD THE ALMIGHTY.
At least ten years ago I was listening to a local radio talk show. The guest was a physician who happened to have been my late wife’s OB at that time. The subject of the discussion was Gardasil. One woman called in and reported that her nineteen-year-old daughter had a reaction to a Gardasil injection which rendered her unable to drive a car any longer. The physician acted surprised and asked the mother if she had reported her daughter’s reaction to the drug company. The mother answered that she had not. The physician then said that is why these reactions are happening, because people are not reporting them to the drug company. That was a cop-out by trying to place blame on the mother. I was a practicing dentist at that time and was aware of reports of reactions to Gardasil which prompted me to tell my son not to allow his two daughters to get it. It seemed obvious that the physician was being paid to promote and not discredit Gardasil. That physician was prescribing Premarin to my wife after a study on Premarin had been discontinued because of too many side effects. The next caller was a retired physician who said that he was going to speak frankly because he no longer had ‘skin in the game’. He said that there were approximately 5000 cases of cervical cancer per year in the country and that the majority of those cases occurred in the lower socio-economic strata among women who did not seek preventive care such as pap smears. He went on to say that the drug companies were marketing Gardasil to millions of middle and upper-class women with full knowledge of those statistics. Cervical cancer should be fully preventable by taking appropriate precautions, and Gardasil should be unnecessary. It’s a repeat of the Vioxx debacle because the money is all that matters.
Judge totally political – practically a commercial for vaccines . . . bias
“Federal law requires more than speculative inferences prior to adding dire warnings to lifesaving vaccines that discourage their use. ”
“speculative inferences” . . . only a fraction report and the connection from treatment to injury is clear.
“dire warnings” . . . pretty dramatic, what about informed consent? Girls actually harmed . .
“lifesaving vaccines” . . . opinion, free choice? Only choice? Speculative inference, but apparently allowed for the judge’s personal viewpoint.
“Discourage their use”? – are you here to sell the product? Own pharma stock or pushing agenda? is it’s the courts job to encourage using a product?
My daughter suffered heart palpitations enough to send her to the hospital twice after receiving just one Gardasil shot in college. When she told me she had been given the shot, I told her not to get the next two and she listened – Thank God!
Christopher Eugene Bunch
12/5/03-8/14/18
On June 29, 2018, Christopher Bunch received the Gardasil vaccine at a routine doctor’s visit.
Within two and half weeks, he started complaining of a sore throat, and by July 31, he was complaining about a terrible sore throat and headache. (Sore throats and headaches are listed on the Gardasil 9 vaccine insert at common adverse effects.) https://www.facebook.com/photo?fbid=10232175465623417&set=a.1581927102147
Judges; definition: Self appointed dictators with no regard for the law, the boundaries of their districts, and the two branches of government that they don’t occupy. In other words, “glittering jewels of colossal arrogance”.
Protect big pharma. What more proof do they need? Why did Merck settle a lawsuit a $6B lawsuit, I believe in 2010, after which warnings of Epilepsy were placed on the labels. My daughter was healthy before she received the vaccines, she ended up with Tonic Clonic Seizures and will be on medicine for the rest of her life. The Dutch Scientist who was involved in this drug study, admitted that the vaccine was rushed to be put on the market. Too many of our kids have been harmed by this.
I do not understand why lawyers do not argue that the portion of the law that restricts law suits are unconstitutional. “All persons born or naturalized in the United States, and subject to the jurisdiction thereof, are citizens of the United States and of the State wherein they reside. No State shall make or enforce any law which shall abridge the privileges or immunities of citizens of the United States; nor shall any State deprive any person of life, liberty, or property, without due process of law; nor deny to any person within its jurisdiction the equal protection of the laws.”
Seventh Amendment
In Suits at common law, where the value in controversy shall exceed twenty dollars, the right of trial by jury shall be preserved, and no fact tried by a jury, shall be otherwise re-examined in any Court of the United States, than according to the rules of the common law.
I do not see anything in the above statement that gives Congress the authority to place limits on lawsuits that a citizen may bring. What do the other commenters see?
If your in your 30s like me it was given to us 2006 I was in high school they don’t care it’s population control by force sad
Amen, sister! Praying Kennedy will be an instrument for deliverance and justice ASAP!