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Children’s Health Defense (CHD) and several parents today filed a lawsuit in federal court challenging a Philadelphia law that allows minors to consent to vaccination without their parents’ knowledge, saying the legislation violates the constitutionally protected doctrine of informed consent and fundamental parental rights.

The lawsuit alleges the City of Philadelphia engaged in a “wink and a nod” practice of vaccinating children behind parents backs without informed consent for the past 15 years, under the cover of the 2007 General Minor Consent Regulation.

That rule allows children 11 and older to consent to vaccination without parental knowledge as long as they receive a “vaccine information statement” (VIS) for the administered shot.

It also absolves the vaccine administrator of liability if the minor gives consent.

On May 14, 2021, the city’s Department of Public Health also enacted an additional COVID-19 Minor Consent Regulation, allowing children ages 11 and up to consent to the COVID-19 vaccine available under Emergency Use Authorization.

Under that regulation, children could give consent if they received the U.S. Food and Drug Administration fact sheet because a COVID-19 VIS did not exist at the time.

Tricia Lindsay, attorney for the plaintiffs, told The Defender the fundamental rights of parents to direct the upbringing of their children are at stake in the case:

“The only time that a parent loses rights to their children is by a strict showing that they are not capable of taking care of their child.

“But here the government of Philadelphia is issuing a blanket statement and taking away parental rights without due process, and that is one of the greatest violations ever.

“They are using emergency powers and the excuse of concerns over ‘health and safety’ to justify it. But it’s camouflage. It’s a Trojan horse. They are using these buzzwords to justify their tyranny … which is what you call it when you remove a person’s fundamental rights without due process.”

Seven Pennsylvania parents joined CHD in suing the City of Philadelphia, its Department of Public Health and City Health Commissioner Cheryl Bettigole, M.D., MPH, alleging the regulations violate their rights.

The lawsuit, filed in the U.S. District Court for the Eastern District of Pennsylvania, said those regulations also “raise troubling issues of informed consent, freedom of religion, parental rights, and due process, implicating both the United States Constitution and the Constitution of the Commonwealth of Pennsylvania and other federal and Commonwealth laws.”

The plaintiffs are asking the court to declare Philadelphia’s 2007 and 2021 Minor Consent Regulations illegal and to stop them from being enforced.

CHD President Mary Holland told The Defender:

“It’s absurd to imagine that it is safe or desirable for 11-year-olds to make potentially life-altering medical decisions on their own without parental guidance, knowledge or consent. Philadelphia’s so-called consent policies violate state, federal and constitutional laws. I am happy that CHD is able to help put an end to these policies that actually endanger children’s health.”

National Childhood Vaccine Injury Act and VISs

Plaintiffs allege that Philadelphia’s regulations conflict with the consent requirements of the National Childhood Vaccine Injury Act of 1986 (NCVIA), the federal law that has primacy over conflicting local laws on such matters, according to the U.S. Constitution.

They also argue that the complicated requirements for seeking compensation — if someone is injured by a vaccine protected by the NCVIA — would be incomprehensible to most, if not all, children.

Under the NCVIA, vaccine manufacturers are protected from liability for a vaccine’s adverse effects if the vaccines are listed on its “Vaccine Injury Table.” The table lists covered vaccines, their recognized injuries and the timeframes within which those injuries must occur to be considered compensable.

Liability for injuries caused by vaccines listed on the table cannot be pursued in a regular court of law, but are instead compensated through the National Vaccine Injury Compensation Program (VICP).

The VICP also can provide compensation for an injury by a covered vaccine, even if the injury isn’t listed as compensable on the Vaccine Injury Table. However, the legal and administrative process is more complicated.

Even for listed injuries, it can be difficult to obtain compensation from the VICP. The backlog of cases is substantial and the proceedings are often drawn out by contentious expert battles.

The NCVIA mandates that the secretary of the U.S. Department of Health and Human Services create and publish VISs that detail the risks and potential adverse events associated with covered vaccines. Those sheets must be presented to children’s parents or legal guardians prior to vaccine administration.

The VIS is important, the complaint says, so that parents can recognize adverse events if and when they happen, and seek necessary medical treatment and also document such events in a timely manner, which is essential for seeking compensation through the VICP.

“If a parent is not aware of what their child has done,” Lindsay said, “then they don’t know what to look out for and they don’t know if the problem they are seeing is related to a vaccine.”

The NCVIA specifically mandated that VISs must be presented in a jargon-free and straightforward way that parents can understand.

The NCVIA doesn’t mention making them comprehensible to children, because the drafters of the NCVIA never imagined children would have to understand them on their own, the complaint alleges.

“The NCVIA simply does not contemplate that a child may be vaccinated without parental consent,” the complaint states. “Quite the opposite — the language of the NCVIA is clear that the VIS is provided to the parent who is able to offer informed consent on behalf of his or her child.”

But this law, the lawsuit alleges, removes parents from the equation altogether.

What about COVID vaccine injuries?

The COVID-19 vaccines are not covered by the NCVIA or the VICP.

Instead, under the Public Readiness and Emergency Preparedness (PREP) Act, people injured by a COVID-19 vaccine or “countermeasure” can seek compensation only under the Countermeasures Injury Compensation Program (CICP).

Since 2010, when the CICP approved its first claim, the program has compensated a total of 36 claims for vaccine injuries — six of those awards were for COVID-19 vaccine-related injuries.

The complaint also noted that COVID-19 vaccines available for 11-year-olds are still investigational. “Children are not capable of understanding the risks associated with a novel vaccine and cannot appreciate that there are no long-term studies of the safety or effectiveness of these vaccines,” the complaint states.

Lindsay said it was particularly concerning that Philadelphia specifically included the COVID-19 vaccines in the regulations and that the regulations continue to stand even though the Biden administration ended the COVID-19 public health emergency in May.

She said:

“Why would we extend this risk further to a novel vaccine, which we now know has many more problems? Why would we be signing up children to a mass experiment and taking away their guardian, the person that stands on the frontline, that’s there to protect them, to cover them, to guide them?

“It has nothing to do with the benefits of children because if it did, you would approach the guardian of that child, the person that is given the authority and has the responsibility of that child to see that that child is safe and allow them to make an informed decision as to what they deem best for their child.”

Can 11-year-old children give informed consent for medical interventions?

The complaint cites a long list of activities that are typically restricted for minors or restricted without parental consent in Pennsylvania.

For example, minors under the age of 21 cannot purchase alcohol or tobacco or enter a casino. A person must be 18 to enter into a contract or to register for the selective services without parental consent. One must be 16 to donate blood and 14 to consent to mental health treatment.

It is also illegal, the complaint notes, for pharmacists to administer vaccines to children 5 and older without parental consent.

According to the complaint:

“Philadelphia’s Minor Consent Regulations turn these requirements on their head. Rather than protecting children, Philadelphia’s Minor Consent Regulations let any child walk into a temporary vaccine ‘pop-up clinic’ or elsewhere on a whim, roll up her sleeve and receive a vaccine without her parents’ knowledge and even more importantly, her parents’ protective veil of consent. …

“The Minor Consent Regulations are a house of cards built on the unsupported, unsupportable and preposterous presumption that every Philadelphia child aged eleven and up is capable of true informed consent, that every child knows her own medical history, her family’s medical history, and can truly ascertain the potential serious risks and alleged benefits of a treatment, and can read and understand any written information — written for adults — presented to her without further explanation.”

The lawsuit alleges children likely cannot fully comprehend the VISs, let alone consent to the vaccines. Philadelphia children, it notes, have very low reading proficiency scores — only 34% of elementary students and 43% of high school students tested at or above the proficient level for reading.

It also raises concerns that no concrete proof a child-provided consent is even required.

This, the plaintiffs say, is in conflict with both the federal NCVIA and Pennsylvania law. The latter requires the written informed consent of a parent before a physician is allowed to perform medical or surgical procedures on a child.

The complaint cited the Troxel v. Granville Supreme Court case and a series of other cases that found “the interest of parents in the care, custody, and control of their children” is a constitutionally protected right.

Other minor consent lawsuits and struggles

When the pandemic began, most states had existing laws mandating parental consent for vaccination, with a few limited exceptions. But once the vaccines became available, some states and localities attempted to lower the age at which children could consent to vaccination on their own.

During Tennessee’s COVID-19 vaccination campaign, the state’s Department of Health invoked the “mature minor’ doctrine” to allow minors 14 and older to be vaccinated without a parent’s consent.

But in response to grassroots mobilization and testimony by CHD, Tennessee lawmakers in April passed a law requiring healthcare providers to obtain consent from a parent or legal guardian before vaccinating a minor.

In March 2022, CHD prevailed in a lawsuit against Washington, D.C., Mayor Muriel Bowser, the D.C. Department of Health (D.C. Health) and D.C. public schools after the U.S. District Court for the District of Columbia issued an order granting a preliminary injunction prohibiting the schools from enforcing the D.C. Minor Consent for Vaccinations Amendment Act of 2020 — a law that would have allowed children as young as 11 to be vaccinated without the knowledge or consent of their parents.

In that lawsuit, the D.C. District Court ruled in favor of CHD’s argument that the NCVIA pre-empted D.C.’s law that attempted to lower the age of consent for vaccinations to 11, and prevented the mayor of the District of Columbia, the D.C. Department of Health and D.C. public schools from enforcing the law.

The court, in that case, commented specifically on the intended function of the VIS:

“If Congress did not mean for the legal representative of a child to receive a VIS when his child receives a vaccine, then the phrase ‘the legal representatives of any child’ would be superfluous. All Congress would have needed to say is that a healthcare provider should give a VIS ‘to any individual to whom such provider intends to administer such vaccine.’ But it did not do that.”

In June, New York legislators also attempted to pass Senate Bill S762A, which would have allowed minors to be vaccinated without parental knowledge or consent. But grassroots efforts, including those undertaken by CHD, prevented that from becoming codified into New York state law.