“I do not wish to be the advocate of the anti-vaccine lobby…..but at least I feel we should use sound scientific argumentation and not let our standards be dictated by our desire to disprove an unpleasant theory” www.putchildrenfirst.org/media/2.20.pdf.
...... Thoma Verstraeten (Verstraeten was the co-author of the first of three studies offered by CDC to exculpate Thimerosal from developmental disorders. [Verstraeten et al. 2003 Pediatrics 112:1039] Verstraeten’s initial analysis showed correlations between Thimerosal and autism – and a host of other neurological disorders – comparable to the causal relationship between cigarettes and lung cancer. But when the 2003 study was published those relationships had disappeared.)
See Article 6:
".Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be express and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice."
At the very bottom of this page is a section that informs parents how to file a complaint with the Medical board if they did not receive Informed Consent before their child was vaccinated or proper care was not given to them after a vaccine reaction.
KNOW THE LAW
Can vaccines be 'safe' or 'effective' and "unavoidably unsafe" (Supreme Court) at the same time? Which is it? Just more/less safe and more/less effective? That's in part why congress wanted a balance between high uptake and compensation for those injured, resolving any scientific uncertainty in favor of over-compensation. Allowing parents the ability to have exemptions for their children must be protected because of ethics, informed consent, and the constitution. But that is not how the 1986 Vaccine Act played out when it was implemented.
On Tuesday, June 30, 2015, Governor Jerry Brown signed Senate Bill 277 (“SB 277”) into law, eliminating the “personal belief” exemption from the current mandatory immunization requirements. Under SB 277, beginning July 1, 2016, except when a child is excused for medical reasons by a licensed physician, public school districts and other educational institutions are prohibited from admitting a child for the first time, or admitting or advancing any student to the seventh-grade, unless the child has been vaccinated for specific diseases - unless they have an IEP.
The following are the diseases for which vaccination must be documented:
Haemophilus influenzae type b;
Pertussis (whooping cough);
Varicella (chickenpox); and any other disease deemed appropriate by the State Department of Public Health, taking into consideration the recommendations of the Advisory Committee on Immunization Practices of the U.S. Department of Health and Human Services, the American Academy of Pediatrics, and the American Academy of Family Physicians.
Students who filed with the school a letter or affidavit stating personal beliefs opposed to immunization prior to January 1, 2016, may continue to be enrolled until their next grade span. A “grade span” is defined as: birth to preschool; kindergarten and grades 1 to 6, inclusive, including transitional kindergarten; and grades 7 to 12, inclusive.
Exemptions from vaccinations for medical reasons are permitted if the parent or guardian files with the school “a written statement by a licensed physician to the effect that the physical condition of the child is such, or medical circumstances relating to the child are such, that immunization is not considered safe.”
The statement must indicate the specific nature and probable duration of the medical condition or circumstances for which the physician does not recommend vaccination. The written statement must include an account of related family medical history.
SB 277 specifies that its provisions do not prohibit a student who qualifies for an individualized education program (“IEP”) from accessing any special education and related services required by his or her IEP.
The new law does not apply to students in a home-based private school or students enrolled in an independent study program who do not receive classroom-based instruction.
“Compulsory Vaccination”, as in school exclusions have been found constitutional. This is the interpretation of the law by attorney Robert Krakow (www.krakowlaw.com), who further explains the lead cases.
The lead cases are Workman v. Mingo, 2011 4th Circuit Court of Appeals (WV),and Phillips v. City of New York, which is a 2015 Second Circuit (NY) case. Phillips dealt primarily with exclusion of school during an outbreak but in dicta compulsory vaccination was affirmed by citation to Jacobson, the 1905 Supreme Court case authored by Justice Harlan. There is another Second Circuit 2012 case called Cavaziel and a number of other cases. None found any problem with compulsory vaccination.
There is an argument that a parent's right to refuse compulsory vaccination is a “fundamental right” that requires “strict scrutiny” under the due process clause of the 14 Amendment to the U.S. Constitution. “Strict Scrutiny” is a concept of Constitutional law that was fully developed after the 1905 Jacobson decision (most notably in Korematsu in 1944) so the concept has not been directly considered by the Supreme Court in the context of vaccination, although later Supreme Court decisions have upheld compulsory vaccination. The 4th Circuit Workman decision rejected the "fundamental right" argument, stating:
"As in Boone, “the question presented by the facts of this case is whether the special protection of the Due Process Clause includes a parent's right to refuse to have her child immunized before attending public or private school where immunization is a precondition to attending school.” Boone, 217 F.Supp.2d at 956. We agree with other courts that have considered this question in holding that Workman has no such fundamental right. See Zucht, 260 U.S. at 176–77, 43 S.Ct. 24; Boone, 217 F.Supp.2d at 956; Bd. of Educ of Mountain Lakes v. Maas, 56 N.J.Super. 245, 264, 152 A.2d 394, 404 (N.J.Super.Ct App.Div.1959).”
Workman v. Mingo Cnty. Bd. of Educ., 419 F. App'x 348, 355 (4th Cir. 2011) The argument has yet be made to the Supreme Court that a parent’s right to refuse compulsory vaccination is a fundamental right, requiring strict scrutiny. If a court agreed that a vaccine mandate affected a fundamental constitutional right the government would have to show (1) a compelling governmental interest in in the vaccine mandate to achieve the statutory purpose, (2) that the vaccine mandate is sufficiently narrowly tailored to the statutory objective and that (3) the vaccine mandate is the least restrictive means of achieving the statutory objective. While it may seem obvious to those of us who oppose mandatory vaccination that these arguments should be successful, especially when no public health emergency has been demonstrated to exist and in light of new considerations affecting the implementation of vaccine policy (such as evidence of fraud by vaccine manufacturers or regulators, the inefficacy of vaccines to achieve a public health objective, or the risk of of harm from vaccines, which has been hidden by manufacturers and regulators), attorny Krakow is aware of no judicial decision recognizing this argument as invalidating vaccine mandates.
In California there is the Protection of Humans in Medical Experimentation Act, and many have asked if vaccines are not an experiment?
The statute defines “medical experiment” as “the practice or research of medicine in a manner not reasonably related to maintaining or improving the health of the subject or otherwise directly benefiting the subject.”
"However objectionable or offensive it may be" states Krakow, "it is clear that any court would exclude approved vaccination from classification as a “medical experiment” because vaccination is “reasonably related to maintaining or improving the health of the subject or otherwise directly benefiting the subject."
West's Ann.Cal.Health & Safety Code § 24174
§ 24174. Medical experiment
"As used in this chapter, “medical experiment” means:
(a) The severance or penetration or damaging of tissues of a human subject or the use of a drug or device, as defined in Section 109920 electromagnetic radiation, heat or cold, or a biological substance or organism, in or upon a human subject in the practice or research of medicine in a manner not reasonably related to maintaining or improving the health of the subject or otherwise directly benefiting the subject.
(b) The investigational use of a drug or device as provided in Sections 111590
(c) Withholding medical treatment from a human subject for any purpose other than MAINTENANCE or improvement of the health of thesubject."
And yet, the FDA has never safety tested or evaluated the vaccine schedule as a whole. Can the FDA preempt when they never "empted?"
That would require a court ruling.
The exact language of relating to the medical exemption reads as follows:
"120370. (a) If the parent or guardian files with the governing authority a written statement by a licensed physician to the effect that the physical condition of the child is such, or medical circumstances relating to the child are such, that immunization is not considered safe, indicating the specific nature and probable duration of the medical condition or circumstances, including, but not limited to, family medical history, for which the physician does not recommend immunization, that child shall be exempt from the requirements of Chapter 1 (commencing with Section 120325, but excluding Section 120380) and Sections 120400, 120405, 120410, and 120415 to the extent indicated by the physician’s statement."
So, a medical statement based upon the family history or individual medical condition(s) where it is decided that vaccine "is not considered safe" is also very broad. Attorney Jim Moody asks what is safe because there is nothing to compare "safe" to. The use of the word "circumstances" again seems quite broad and "considered safe" seems to encompass traditional informed consent doctrine according to Moody.
Since there is no baseline safety data on the vaccine schedule, that is, there have been no safety studies looking at any issues related to giving multiple vaccines at once, over time, repeated boosters of combined vaccine, etc. how does a physician determine what is safe... safe compared to what?
That is why vaccines are experiments and require Informed Consent just like any other experiment but this has never been brought to a court of law for a ruling but it sure needs to be.
The US Supreme Court has already stated that vaccine's adverse side effects are unavoidable - and unavoidable is fairly unambiguous.
Since there is not even minimal data to determine if the vaccine schedule is safe would that alone be enough to justify an exemption? Moody argues it would be, because essentially not only does this raise scientific/medical questions (the lack of safety data in a law that makes "safe" the determining factor for medical exemptions), but other issues, because there are no other approved FDA regulated pharmaceutical interventions are permitted that have no safety data behind them. Without baseline safety data... who or what is to determine what safe means? SB 277 has clearly given that determination to the individual physician.
When the Supreme Court states vaccine's adverse side effects are
"unavoidable" can a physician then take it upon themselves to say
they are safe or specifically they are safe for their patient without
This takes us back to Moody's opinion that this
safety issue quandary can only be addressed by Informed
Consent. Remember, the Supreme Court has opined "...the Act
eliminates manufacturer liability for a vaccine's "unavoidable adverse
Informed Consent means you and yours have the option to
decline consent. California has no problem with that but your
child can't go to school or stay in school once they hit a grade
span (coercion) without a medical exemption - an exemption
that (again) makes safety the key determining factor. Therefore,
just based on the safety issue alone, every child in the state of
California would be eligible for a medical exemption based on the
way the law is now written if for no other reason that when there is
coercion (your child can't go to school unless...) there is no
Informed Consent, and the paradox or Catch-22 of SB277 is that
it is unconstitutional without Informed Consent, but SB 277
eliminates Informed Consent with the coercion of stopping children
from going to school if you do not consent to have them
vaccinated. Of course, a new law can't be practically found to be
unconstitutional until a judge says it is no matter how
unconstitutional it may be.
Was this a bad law created for greed not need?
The answer to that question seems all too obvious when you realize the pharmaceutical companies have no liability - literally a get out of jail for free card and an ATM all in one. Why make a drug where someone can sue you when you can make a vaccine and make a lot of risk free money even if the vaccine is a stinker.
But back to the law...
The Bonilla letter (below) is in response to Attorney Krakow's letter, signed by almost 200 attorneys nationwide, opposing SB277. The legal provisions that are intended to protect medical exemptions are amendments that facilitated passage of the bill in the legislature.
The 4th and 5th bullet points in Rep. Bonilla’s letter point to amendments that will supposedly “protect” medical exemptions.
• Remove the word "contraindicate" from the bill to specify that a physician is not required to adhere to the
Center for Disease Control (CDC) recommendations for what conditions are "contraindicated" for
vaccines. Removing this term further reinforces and makes it clear that doctors can use their own sound,
professional judgment when determining an exemption.
• Allow doctors to consider family medical history as a condition for providing a medical exemption, to help
prevent a sibling of a child who suffered adverse effects from being required to comply with the
There is also Rep Bonilla's point about not denying services to children with disabilities.
The question is will medical exemptions be respected or will doctors supporting them be scrutinized, pressured, condemned, disciplined and vilified?
It is all about implementation, which is why the inflexibility of SB277, in its one size fits all no-choice health policy, is dangerous for America.
America does not have a public health emergency from the diseases we have vaccines for. It is experiencing a public health emergency from entities, such as Lyme. According to Krakow, our nation is experiencing an emergency in defending the attack on civil liberties, religious freedom and democratic principles. SB277 does more damage to the fabric of our society than a few measles infections ever will.
Krakow is concerned "the authorities" will NOT permit liberal implementation of those medical exemption provisions.
"In theory, if SB277 is properly implemented, there should be as many or more medical exemptions as there were PBE or religious exemptions, if health professionals are free to exercise their medical judgment. I doubt the authorities will allow this, so there has to be a way to deal with the inevitable confrontation that will ensue. This is analogous to the public health authorities' argument that parents’ exercise of religious exemptions were not genuine, and the resulting effort to eliminate religious exemptions because they were supposedly being abused. This is an argument that has been raised in New Jersey, where there is continues to be a legislative fight over a bill restricting exemptions."
Now, Moody feels that FDA approval of a vaccine as safe
and effective may trump state tort law under what's called
the 'comment k' principle (see below) in the restatement of
torts, but not necessarily the law of informed consent, which
is a separate obligation imposed for ethical reasons on doctors.
Thus, a doctor could be required to say, "this vaccine, or
the entire schedule, has been approved by the FDA, but we
still have no scientific data on the overall risk of the
schedule [baseline data on chronic health of unvaccinated]
for purposes of comparison, and we never tested even one
vaccine against a true placebo.. So, even though I can legally
prescribe this vaccine, or the entire schedule, I must also
tell you that the risks are unknown, the schedule is
experimental, and you may wish to decline on ethical reasons."
Since the FDA never considered or tested the "schedule as a whole,"
there would arguably be no FDA preemption.
The idea behind controversial 'comment k' in torts is that individual firms
should not have to pay in tort for risks they are unable to manage. Moody's
answer, contrary to the sloppy decision by the court, would be that this is a
matter of proof and jury instruction, i.e., a company can in fact 'manage' the risk of Hg (mercury) because as the Hilleman memo points out way back in 1991, there are safer alternatives. Some risks of 'unavoidably unsafe' products the companies or docs just can't do anything about and there is an argument that these costs should be socialized, i.e. borne by society as a whole. Here again, my preference would still be to allow the tort but let companies shift this risk to all purchasers by insurance, as is the customary solution for most products liability cases, as it still places an incentive on companies to make safer products, a perfectly appropriate incentive to place on pharma.
The infamous comment k comes from the restatement, second edition, of torts, 1963, section 402A:
Comment k provides as follows: “Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.” Restatement 353–354.
The short answer is that if Congress wanted to eliminate all state liability back in 1986 it surely would have said so, especially since this was a key part of the compromise, preserving existing remedies with the additional overlay of a no-fault federal option, between the goals of full and generous compensation for all injured for the greater good vs. reasonable liability protection for companies. But until the Obama-inspired Bruesewitz defeat in the Supreme Court is reversed not sure anything can be done about this.
Legal Remedies for Vaccine Injury?
Vaccine manufacturers enjoy unprecedented legal protection against design defect claims brought by vaccine injury claimants.
Manufacturers also are shielded from discovery by the requirement that vaccine injury claimants must first file their claims with a government compensation program, the Vaccine Injury Compensation Program. The NVICP applies the strictest statute of limitations against claimants who are under the age of majority - 3 years, whereas in most state minors can file claims until they turn 21 years of age. These protections blunt the utility of the legal system for people who are vaccine injured.
The liability protection enjoyed by the vaccine manufacturers has served to allow dismissal of large class actions filed by the vaccine injured. Thus, the most powerful legal tool that allows claimants who individually lack legal firepower, to bring claims as a group, thus mustering the resources to conduct sophisticated investigations, hire the best qualified expert witnesses, and survive onerous legal processes while they extract critical secreted information from the manufacturers. Without class actions, only the wealthiest individual claimants can afford to sue a pharmaceutical giant and take on their high-powered well-financed law firms.
Bottom-line: Vaccine manufacturers enjoy the greatest legal protection against lawsuits in the history of American jurisprudence.
While the vaccine-injured can, technically, claim for manufacturing defects, these are almost impossible to pursue unless claimants are privy to the details of the production process. Vaccine manufacturers do not make this kind of information available, nor can individual claimants afford to bring claims to investigate manufacturing problems. Unless there is independent monitoring of manufacturing processes that alerts consumers to defects - something that in reality does not exist, the availability of such claims is all but meaningless.
VACCINE COURT Regulatory negligence, criminal obstruction, and denialism
Stanford Report, July 6, 2015 Stanford professor has found that the federal Vaccine Injury Compensation Program has not lived up to its original goals of providing "simple justice" to children injured by vaccines. Lengthy delays and an adversarial tone characterize the program.
The Omnibus Autism Proceedings were established by SM Golkiewicz OAP General Order #1 in July of 2002.
Epidemiology studies ruled back then because it was a part of the petitioners burden of proof until the Althem and Capazano decisions from the circuit in 2006 and 2007. So, what the CDC did was to fake a bunch of exonerating epidemiology studies and get them published in authoratative medical journals while blocking petitioners' access to anything that might help the kids, e.g. destroying the Verstrateen databases documentd in the 2006 Institute of Medicine report, the now-admitted destruction of the Destefano documents a need to block the successful use of FOIA as a tool of discovery of government wrongdoing [which had led to release of the original Verstrateen documents discussed at the infamous Simpsonwood meeting], and the Department of Justice blocking any access by petitioners to the Vaccine Safety Database to conduct alternative studies, even though taxpayer funded and for the express purpose of assessing safety and injury.
It is one of the least well kept secrets among scientific and medical elites that vaccines can cause autism, even UK's Rutter admitted this in a 1994 article on the non-genetic basis for ASD. One of the 'dirty' secrets of the deliberate obstruction of justice is that the OAP special masters do NOT regard previous cases on causation as precedent in vax court, pretty much contrary to a thousand years of anglo-american due process. Their argument is that one-off cases based on unique medical records do not make for 'science' so they just ignore these. Now, since OAP, they will use any words or thuggery [brokering settlements] to avoid the 'autism' word in decisions lest it fuel further rebellion.
In case you are not aware, this is the purpose of the Vax court: "The Vaccine Act established the Program to compensate vaccine-related injuries and deaths. § 300aa-10(a). “Congress designed the Vaccine Program to supplement the state law civil tort system as a simple, fair and expeditious means for compensating vaccine-related injured persons. The Program was established to award ‘vaccine-injured persons quickly, easily, and with certainty and generosity.’” Rooks v. Sec’y of Health & Human Servs., 35 Fed. Cl. 1, 7 (1996) (quoting H.R. Rep. No. 908 at 3, reprinted in 1986 U.S.C.C.A.N. at 6287, 6344)."
In the below case a child died in 2011, one day after being injected with 7 vaccines, yet 4 years later this case has finally been adjudicated, not compensated (there is no compensation for the killing of a child via vaccines), one can clearly see that there is nothing simple, fair, or expeditious about this process, nor does the Program award vaccine-injured (in this case vaccine-killed) persons quickly, easily and with certainty and generosity.
Here is the conclusion reached by the Vax court: "In this case, I have concluded, after review of the evidence, that it is more likely than not that the vaccines played a substantial causal role in the death of J.B. without the effect of which he would not have died. The role of inflammatory cytokines as neuro-modulators in the infant medulla has been well described and is likely the reason for a significant number of SIDS deaths occurring in conjunction with mild infection. I have concluded that it is more likely than not that the vaccine-stimulated cytokines had the same effect in this vulnerable infant during sleep."
Robert F. Kennedy, Jr. and attorney Rolf Hazlehurst have petitioned the Inspector General of the Department of Justice (DOJ) to investigate possible legal misconduct by two federal government lawyers who they allege withheld and misrepresented evidence in the Autism Omnibus Proceeding (AOP), provided by Dr. Andrew Zimmerman, a key government witness, that showed that vaccines can cause autism.
The Autism Omnibus Proceeding (AOP) was an action by the vaccine court that lumped together more than 5000 claims that autism was caused by vaccine injury. All 5000 cases were to be decided by 6 selected test cases. Nearly all the cases in the AOP were dismissed in 2009. Zimmerman, who is regarded as perhaps the world's leading pediatric neurologist in autism research, had provided a report on Child Doe 77, one of the test cases in the Omnibus Proceeding, stating that in his professional opinion, vaccines caused Child Doe 77's autism, and could cause autism in other children who had a pre-existing mitochondrial condition. Subsequently, the Child Doe 77case was settled by the government, and it did not serve as a precedent for any other cases, even though it had been specifically selected as a test case.
Attorneys Vincent Matanoski and Lyn Ricciardella represented the DOJ in the AOP and never disclosed the analysis prepared by Zimmerman of Child Doe 77 to the attorneys for the 5000+ petitioners as required by the rules of the vaccine court. Matanoski and Ricciardella are alleged to have engaged in additional actions to keep the Zimmerman report and settlement of the Child Doe 77 case hidden from the petitioners and the public.
The alleged cover-up was revealed by Dr. Zimmerman in a deposition taken for a medical malpractice case against the doctor who administered vaccines to Yates Hazlehurst, the child of Rolf Hazlehurst. Yates Hazlehurst was one of the test cases in the AOP. In the Hazlehurst malpractice suit deposition Zimmerman revealed that Yates Hazlehurst's regression into autism mirrored that of Child Doe 77 and would have been germane to deciding the Hazlehurst case in the AOP. If the allegations are founded there would be grounds to reopen the cases dismissed in the AOP, and other cases dismissed in the vaccine court.
Serious investigation into the DOJ attorney's alleged misconduct is necessary.
Failure to Provide Consent for Vaccination or Failure to Provide Care for Vaccine Reactions: How to file a complaint with the Medical Board
If you and your child (or children) were not given proper informed consent, or were treated unfairly, improperly, or unprofessionally surrounding the issue of vaccination and vaccine reactions, you have the right to file a complaint with the state medical board*.
*There are statutes of limitation for filing a complaint; this varies from state to state. In CA, complaints must be filed within 10 years after a child reaches adulthood, or around age 28. For adults, a complaint must be filed within about 6 years of when the negligence occurred.
There are two main areas of complaint:
1. Failure to provide proper informed consent prior to vaccination, which applies to most vaccinated people 2. Failure to provide proper care after a patient suffers a moderate to severe vaccine reaction, which applies to some vaccinated people ____________________________________________________________________________
FAILURE TO PROVIDE INFORMED CONSENT AND EXPLAIN THE RISK OF ADVERSE REACTIONS
A. Doctors are required to provide informed consent for all medical treatments and procedures, including vaccination. If your doctor failed to discuss the full risks of vaccination with you prior to giving vaccines, then you did not receive informed consent.
Informed consent is almost never taking place. As you will read below, there are several steps that need to take place for certain vaccines. I have little doubt that the vast majority of health care providers and not following these guidelines. They have no liability if something goes wrong and as a practical matter if a parent receives a Vaccine Information Statements (VIS forms) from the CDC the vast majority of vaccine providers consider this adequate Informed consent; however, it is not.
All vaccine manufacturers provide Package Inserts (PIs) which detail ingredients, instructions, and warnings for the vaccine. Most PIs contain explicit instructions for doctors in the Patient Counseling section. (Note: language may vary; the following example is from the Daptacel brand of DTaP):
Inform the parent or guardian of the following: The potential benefits and risks of immunization with Daptacel The common adverse reactions that have occurred following administration of Daptacel or other vaccine containing similar components. Other adverse reactions can occur. Call healthcare provider with any adverse reactions of concern.
Physicians are required by federal law (National Childhood Vaccine Injury Act of 1986) to give parents the CDC Vaccine Information Statements (VIS forms) prior to vaccination. These forms are typically given immediately before vaccination as a way of providing informed consent. However, if your doctor failed to give you adequate time to read the material, ask if you understood the material, or give you the opportunity to ask questions about the information, then you did not receive informed consent. VIS forms only provide limited information and do not include the more detailed warnings and risks from the manufacturers found in the Package Inserts. Many vaccine PI's provide the following instructions to doctors (language varies):
“Before administration of [particular vaccine], health care providers should inform the parent or guardian of the benefits and risks of the vaccine…The health care provider should inform the parent or guardian about the potential for adverse reactions that have been temporally associated with the vaccine and other vaccines containing similar components.” (Patient Counseling Section of Act-HIB brand by Sanofi Pasteur, Pediarix brand of DTaP/Polio/HepB vaccine, Infanrix brand of DTaP vaccine by Glaxo Smith Kline, and Vaqta brand of Hepatitis A vaccine by Merck).
Because this list of "temporally-associated adverse reactions" is extensive for every vaccine, it is rarely discussed by doctors even though instructed specifically by the manufacturer in the PI. Temporally-associated adverse reactions are not included in the CDC VIS forms, so patients remain uninformed about these risks.
B. Additionally, manufacturers of some vaccines advise doctors to ask patients about adverse reactions to previous vaccines prior to giving these vaccines:
The Varicella PI states in the Patient Counseling Section (page 12):
"Question the patient, parent, or guarding about reactions to previous vaccines."
The Recombivax HB brand of Hep B vaccine and Vaqta brand of Hep A vaccine state in the Patient Counseling Section:
"Question the vaccine recipient, parent or guardian about the occurrence of any symptoms and/or signs of adverse reaction after a previous dose of hepatitis B (or Hep A) vaccine."
If your doctor or an office staff member failed to ask about reactions to any prior vaccines before giving doses of Varicella vaccine, Hepatitis A vaccine, or Hepatitis B vaccine, then proper procedure and precautions as recommended by the vaccine manufacturer were not followed and your child was put at risk.
C. If your child was given the MMR II vaccine, there are some additional Informed Consent steps required prior to administration. The MMR II vaccine PI has a separate Patient Information form that states: "You should read it before you or your child receives the vaccine. If you have any questions about the vaccine after reading this leaflet, you should ask your health care provider. This is a summary only. It does not take the place of talking about MMR II with your doctor, nurse, or other health care provider."
The MMR II Patient Counseling form also lists some warnings about who should not get the MMR vaccine, including teens/adults who are pregnant or plan to get pregnant within the next three months (this live virus vaccine can cause birth defects). The doctor is also instructed to ask you about any of the following, as these can increase the risk of adverse reactions to the vaccine: • A history of seizures or a brain injury • Active untreated tuberculosis • An allergic reaction to any other vaccine • A low platelet count • Allergy to eggs (vaccination is still allowed, but a patient should be warned about the greater risk of an allergic reaction)
Failure to allow you to read the MMR Patient Counseling form, ask questions, and discuss concerns with your doctor means that proper Informed Consent was not given.
D. There are three other unique circumstances that warrant extra informed consent. These specific risks are highlighted in the Warnings and Precautions section of these PIs:
• Those who are allergic to eggs: Not only is the MMR a risk, but the flu vaccine Package Insert clearly warns in the Patient Information Sheet that people who are allergic to eggs should not receive a flu vaccine (unless it is one of the new egg-free formulations). • Infants born prematurely: all injected treatments, including vaccines, pose a higher risk of Apnea (stop-breathing spells) in infants who were born prematurely. Doctors are advised in most vaccine PIs to give careful consideration to a baby's medical status and risks versus benefits when vaccinating ex-premie babies. • Infants with ongoing gastrointestinal disorders: the rotavirus vaccines (Rotarix and Rotateq) have specific warnings in the PIs against giving this oral vaccine to infants with active GI problems, including acute vomiting, acute or chronic diarrhea, failure to thrive, history of abdominal surgery, and any congenital abdominal defects.
FAILURE TO PROVIDE PROPER CARE AFTER A VACCINE REACTION
A. Failure to evaluate your child in person after a significant reaction reported over the phone. If you contacted your doctor's office over the phone regarding a moderate to severe vaccine reaction, and your doctor did not advise you to come into the office or go to an ER right away for an evaluation, then your doctor did not follow the warnings and instructions of the vaccine manufacturer. It is now common practice for office staff to reassure parents over the phone that a vaccine reaction is “normal”, “expected”, and “not a cause for concern”; and they generally will not advise an in-person medical evaluation. This may be proper procedure for mild reactions like fussiness, slight fever, and mild swelling and redness at the injection site. But all moderate to severe reactions, like hives, lethargy, seizures, fever of 105 degrees, inconsolable crying lasting 3 hours or more (encephalitis), and even extended changes in the child’s behavior or personality warrant prompt in-person medical attention.
B. Failure to document adverse events following vaccination. All adverse events that occur after vaccination are supposed to be documented in your child's medical record, regardless of whether or not your doctor or the medical staff personally believe the event was related to vaccination. The fact that your doctor does not agree that the reaction was related to vaccination does not release him or her from the responsibility to accurately document the adverse event in your child's medical record.
The American Medical Association's Principles of Medical Ethics (see link below) details a physician's ethical responsibility in two ways: First, to report adverse events in medical care, and second, that a physician "need not be certain of, or does not need to even believe in a reasonable likelihood of, a causal relationship between a treatment and an adverse event" in order to be ethically responsible to report that event. In fact, almost all vaccine Package Inserts advise physicians to "instruct the patient, parent, or guardian to report any adverse reactions or any symptoms of concern to their healthcare professional."
The polio vaccine PI (Sanofi Pasteur- IPOL brand) specifically says:
"Reporting by parents or guardians of all adverse events after vaccine administration should be encouraged. Adverse events following immunization with vaccine should be reported by healthcare providers to [VAERS]." Page 18, Reporting of Adverse Events
The HIB vaccine PI (Sanofi Pasteur- ActHIB brand) states:
"Vaccine recipients and guardians must report any adverse reactions upon administration of the vaccine to their healthcare provider…" Page 19
Unfortunately, many physicians do not document adverse reactions according to manufacturer and federal guidelines. Example: an infant has an encephalitis-type reaction (inconsolable crying lasting 3 or more hours), and the parents report this reaction to the doctor, either by phone call, during an immediate return visit, or a subsequent check-up. The doctor, however, only documents "parents report that the baby was fussy after the last vaccines." In fact, encephalitis is listed as one of many potentially-severe reactions which are mandated by federal law to be reported to the government. (See VAERS reporting below).
A doctor’s failure to document a vaccine reaction puts the child in danger of suffering a repeated or more severe reaction later under another doctor’s care. Parents may not be informed enough to know that a reaction is moderate or severe, so it is the doctor's responsibility to make sure reactions are properly documented to facilitate accurate communication with future health care providers.
C. Failure to conduct and/or document a detailed neurologic exam after an adverse event. Infants who suffer a neurological reaction, such as extreme lethargy, inconsolable crying for 3 or more hours (encephalitis), seizure, sudden loss of developmental skills, extreme personality changes, or any other reaction involving the nervous system should undergo a complete neurological exam by a physician to document their current neurological status and to check for neurological injury. Such symptoms should always be considered a potentially-serious medical problem because infection, trauma, brain tumor, stroke, medication overdose, accidental poisoning, and vaccination can all be potential causes of neurological injury. It is the duty of every physician to thoroughly evaluate such complaints regardless of the initially-suspected cause. Failure to take such symptoms seriously, perform an exam, or failure to document the findings of an exam, constitutes negligence on the part of the physician.
D. Failure to advise you to report the reaction to VAERS. Vaccine manufacturer PI's recommend that physicians advise their patients to report adverse events following vaccination to www.vaers.hhs.gov. Doctors are also mandated by law to report certain severe adverse events. The VAERS reporting form states:
"Health care providers and manufacturers are required by law (42 USC 300aa-25) to report reactions to vaccines listed in the Table of Reportable Events Following Immunization." (Page 1, in fine print)
These include anaphylaxis, brachial neuritis (dysfunction of the nerves in the arm), encephalopathy (brain injury), encephalitis (the most common of these mandatory reportable events after a Pertussis-containing vaccine or an MMR vaccine), chronic arthritis,
thrombocytopenia purpura (bleeding complications), paralytic polio, or any events categorized as a contraindication listed in the manufacture's package insert. See below for a complete list of mandatory reportable events.
E. Failure to inform you about the risk of repeated or worsened adverse reactions following a moderate to severe reaction. In the Warnings and Precautions section of every Product Insert, vaccine manufacturers advise physicians to carefully consider the benefits and risks before administering a repeated vaccine after certain moderate to severe reactions have occurred. These reactions include fever greater than or equal to 105 degrees F, collapse or shock-like state within 48 hours of a dose, persistent inconsolable crying lasting more than or equal to 3 hours within 48 hours of a dose, seizures with or without fever within 3 days, and history of GuillainBarre syndrome (temporary muscle weakness/partial paralysis) within 6 weeks of a vaccine.
EXAMINING YOUR CHILD'S MEDICAL RECORDS
1. Read the medical record to determine what your doctor wrote in the chart about providing informed consent for vaccinations. See if your doctor documented that the CDC VIS forms were provided to you (usually in the check-up section or the section where all vaccines are recorded together). Also note whether or not your signature or initials are present next to such documentation. If there is no documentation that VIS forms were provided, and you have no recollection of being given these forms, then you should inform the medical board of these facts. It is common practice for electronic medical records to automatically include a statement saying that VIS forms were provided to the patient. If you are certain that this was not the case, then you should inform the medical board.
2. Read through the visits that involved a vaccine reaction. If you called the office about a reaction, confirm that this was documented accurately. If the doctor saw your child in person for the reaction, confirm that what the doctor wrote down matches your child's reaction and see if the doctor documented a neurological exam. If you reported the reaction to your doctor at the next check-up, confirm that what the doctor or nurse wrote down matches the information that you gave them. If the reaction was moderate or severe, did the doctor warn you about the risks of repeating that vaccine again during the next checkup? Then compare this written information to what you remember about your visits and your child's reaction. Report any discrepancies or missing information in your board complaint.
3. Find what brands of vaccines were given to your child so you can investigate the proper Package Inserts and attach them to your complaint. The medical record is required to either list the brand name of the vaccine or the manufacturer. If only the manufacturer is listed, you will still be able to find the right PI by looking on the FDA website and finding the one that matches the manufacturer listed in your medical records. If you aren't sure, you can contact your doctor's office and ask what brands of each vaccine they use. You may also see lot numbers of the vaccines given to your child, and an online search of that vaccine and lot number should tell you what brand and manufacturer it is.
4. Send any pertinent pages from the medical record, with references to these pages in your complaint, to the medical board. You may write notes or highlight any part of the medical record to draw attention to these facts; the board will also obtain their own unmarked copy of the records directly from your doctor.
NOTE: You may submit a complaint without reviewing your medical records if your recollection of events is clear enough
SUBMIT YOUR COMPLAINT, WITH ALL SUPPORTING DOCUMENTS, TO YOUR STATE MEDICAL BOARD (hard copy preferred)
Find your specific medical board online and carefully read all instructions as you submit your complaint. Include copies of the pertinent pages of your child's medical record and any supporting documents listed below, such as the Vaccine PI Patient Counseling instructions and other sections, CDC VIS forms that you refer to in your complaint, VAERS information, the AMA statements on medical ethics and the statement of physician's duty from the National Vaccine Injury Act. Keep a photocopy of your entire file.
Note: while you can submit a medical board claim online, it may be more effective to send your claim as a hard copy.
The Medical Board of California website: Medical Board of California Central Complaint Unit 2005 Evergreen Street, Suite 1200 Sacramento, CA 95815
For all other State Medical Boards: here is a link to the Federation of State Medical Boards directory of State Medical and Osteopathic Boards:
SUPPORTING DOCUMENTS FOR YOUR COMPLAINT
Vaccine Package Inserts (PIs)
The FDA website lists the package insert for every vaccine licensed in the United States here: FDA Listing of Package Inserts. Find the name brand of each vaccine your child was given on the right hand side of this list, click on the particular vaccine, and you will find a link to the PI. The following sections contain specific details on risks that should have been disclosed to you as part of your Informed Consent regarding vaccine reactions: Patient Counseling Information, Adverse Reactions, Warnings and Precautions, Contraindications
National Childhood Vaccine Injury Act of 1986
This federal law mandates that patients be given VIS forms prior to vaccination, and the standard of care for informed consent is to allow patients time to understand and ask questions about these forms and about vaccines. The specific wording of this section of the law can be found here: National Childhood Vaccine Injury Act, under section D, Health Care Provider Duties:
"Each health care provider who administers a vaccine set forth in the Vaccine Injury Table shall provide to the legal representatives of any child or to any other individual to whom such provider intends to administer such vaccine a copy of the information materials developed pursuant to subsection (a) of this section, supplemented with visual presentations or oral explanations, in appropriate cases. Such materials shall be provided prior to the administration of such vaccine." For more information on the National Childhood Vaccine Injury Act, click here.
VAERS (Vaccine Adverse Events Reporting System) Table of Reportable Events Following Vaccination
Visit the VAERS website for more information on reporting vaccine reactions. Make sure to REPORT your child's vaccine reaction even if your doctor has not or will not. This link contains the list of the most severe vaccine reactions which a doctor is mandated by federal law to report, and, if such a reaction occurs, to make sure your child is not given that vaccine again.
American Medical Association Code of Medical Ethics
This code states the following about Informed Consent:
"The patient's right of self-decision can be effectively exercised only if the patient possesses enough information to enable an informed choice…The physician's obligation is to present the medical facts accurately to the patient…The physician has an ethical obligation to help the patient make choices from among the therapeutic alternatives consistent with good medical practice…Informed Consent is a basic policy in both ethics and law that physicians must honor…Physicians should sensitively and respectfully disclose all relevant medical information to patients."
Here you can view and print the AMA policy. This second AMA document details a physician's responsibility to report adverse events even if he or she doesn't believe the treatment (vaccine) caused the reaction:
These VIS forms provide the bare minimum level of “informed consent” that your doctor is obligated to make sure you receive before giving your child vaccinations. It highlights only some of the most important moderate and severe reactions to watch out for.