RESOLUTION 

Physician and Parent Decisions Regarding Immunizations (RN 19 23370) 

This measure would express the need for the laws of the State of California to reflect the foundational importance of the physician-patient relationship, the importance of the concept of informed consent, acknowledgment of ongoing advances in medicine, the breadth of approaches to medical care, including the administration of vaccines, and the use of precautionary principles when discerning the role of government as it may impact the health of individuals, including determining the appropriateness of providing a medical exemption from immunization requirements. 

WHEREAS, The State of California intends to protect and preserve the doctor-patient relationship as the foundational bedrock of an effective health care system;

WHEREAS, California intends to protect the right of individuals to be free to consult with their doctor and trust their doctor’s professional judgement and discernment when it comes to medical decisions for their family members; 

WHEREAS, Licensed medical doctors must be free to exercise professional judgment and conscience and to have the legal right to practice their profession of medicine and surgery protected, including providing vaccine medical exemptions for their patients;

WHEREAS, Vaccines carry risks that can be greater for some than others, including injury or death from complications;1 

WHEREAS, Section 300aa-10 of Title 42 of the United States Code established the Vaccine Injury Compensation Program (VICP) under the National Child Vaccine Injury Act of 1986 as an administrative alternative to a civil action, acknowledging that vaccines can cause injury and death and that federal compensation may be paid to individuals for an injury or death following receipt of a federally licensed and recommended childhood vaccine with the presumption of causation if the evidence demonstrates that there is no other plausible biological explanation for the injury and death;2 

WHEREAS, In September 2019, the United States Health Resources and Services Administration reported that approximately $4,200,000,000 in compensation has been paid to over 6,500 vaccine-injured individuals and families, and two out of three applicants were denied federal compensation;3 and 

WHEREAS, According to subsection (b) of Section 300aa-22 of Title 42 of the United States Code, a vaccine manufacturer cannot be held liable in a civil action for damages arising from a vaccine-related injury of death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects, even though the vaccine was properly prepared according to federal Food and Drug Administration (FDA) licensing standards and was accompanied by FDA-approved directions and warnings;4 and 

WHEREAS, In 2011, the United States Supreme Court interpreted subsection (b) of Section 300aa-22 of Title 42 of the United States Code, as It applies to manufacturer design defects, holding in Bruesewitz v. Wyeth LLC (2011) 562 U.S. 223, that the National Childhood vaccine Injury Act preempts all design defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects:5 and 

WHEREAS, According to Section 300aa-11 of title 42 of the United States Code, a health care provider administering the vaccine is not civilly liable for harm to the patient caused by the administration of the vaccine;6 and 

WHEREAS, The National Academy of Medicine also published physician committee reports pursuant to Section 313 of Public Law 99-660, acknowledging that there are significant gaps in vaccine safety science, including the need for more biological mechanism studies and methodologically sound epidemiological studies;7, 8, 9 and 

WHEREAS, The National Academy of Medicine published physician committee reports pursuant to Section 313 of Public Law 99-660, evaluating evidence in the medical literature and confirming that vaccines can cause injury and death and that there are individual genetic, biological, and environmental susceptibilities to vaccine reactions that have not been fully defined by science and prevent doctors from accurately predicting who will be harmed by vaccination;7, 8,10 and 

WHEREAS, Section 300aa-25 of Title 42 of the United States Code requires health care providers administering vaccines to record in a patient’s permanent medical record information for each vaccine; vaccine administration dates; vaccine manufacturer and lot information for each vaccine; and the name, address, and title of the individual administering the vaccine; and the occurrence of any adverse vaccine event set forth in the Vaccine injury Table and the occurrence of any contraindicating reaction to a vaccine as specified in the manufacturer’s package insert;11 and 

WHEREAS, Section 300aa-25 of Title 42 of the United States Code mandated the creation of the Vaccine Adverse Event Reporting System (VAERS), to be coadministrated by the federal Centers for Disease Control and Prevention (CDC) and the FDA, and required health care providers to report injury, harm, or any adverse event from the vaccine. Additionally, VAERS is publicly accessible and patients may also enter adverse event reports into the system. As of August 14, 2019, there have been 732,671 vaccine adverse event reports since its inception in 1990;11,12 and 

WHEREAS, It is estimated that only between 1 and 10 percent of all serious health problems, hospitalizations, injuries, and deaths that occur after vaccinations given to children or adults are ever reported to VAERS;13 and 

WHEREAS, The ethical principle of informed consent to treatment is recognized internationally under the World Medical Association (WMA) Declaration on the Rights of the Patient14, the WMA Medical Ethics Manual15, the WMA Declaration of Helsinki of 196416, the United Nations Universal Declaration of Human Rights of 1948 (UDHR)17, and the Nuremberg Code (1947)18, as a human right requiring the voluntary consent by individuals and parents or guardians of minor children, prior to medical treatment; and 

WHEREAS, Inflexible implementation of “one-size-fits-all” vaccine mandates places a disproportionate and unequal risk burden on those individuals who are biologically, genetically, or environmentally at higher risk for suffering harm from vaccination; and 

WHEREAS, The Wingspread Statement on the Precautionary Principle states: “Where an activity raises threats of harm to the environment or human health, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically. In this context the proponent of an activity, rather than the public bears the burden of proof. The process of applying the Precautionary Principle must be open, informed and democratic, and must include potentially affected parties. It must also involve an examination of the full range of alternatives, including no action;”19 and 

WHEREAS, The National Academy of Medicine has reported that it can take up to 17 years for a new best practice to reach the average physician and surgeon. It is prudent to give attention to new developments not only in general medical care, but also in the actual treatment of specific diseases;20 now, therefore, be it 

Resolved by the Assembly of the State of California, the Senate thereof concurring, That the laws of the State of California should reflect the foundational importance of the physician-patient relationship, the importance of the concept of informed consent, acknowledgment of ongoing advances in medicine, the breadth of approaches to medical care, including the administration of vaccines, and the use of precautionary principles when discerning the role of the government as it may impact the health of individuals, including determining the appropriateness of providing a medical exemption from immunization requirements. 

References:

1. Vadalà, Maria, Poddighe, Dimitri, Laurino, Carmen, and Palmieri, Beniamino. “Vaccination and autoimmune diseases: is prevention of adverse health effects on the horizon?” EPMA Journal. Sep 2017. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5607155/?fbclid=IwAR27H0DBoJ2ihHMZiAR1F0cdqmUG7pA3PbAyVXjmhsqnKTefDCrXCrg_i_I

2. “Title 42-The Public Health and Welfare Chapter 6A-Public Health Service Subchapter XIX-Vaccines Part 2-National Vaccine Injury Compensation Program.” Office of the Law Revision Counsel: United States Code, https://uscode.house.gov/view.xhtml?req=(title:42%20section:300aa-10%20edition:prelim).

3. “HRSA Data and Statistics.” Health Resources & Services Administration, Oct. 2019, www.hrsa.gov/sites/default/files/hrsa/vaccine-compensation/data/data-statistics-october-2019.pdf.

4 “U.S. Code Standards of Responsibility.” [USC02] 42 USC 300aa-22: Standards of Responsibility, 2020, https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300aa-22&num=0&edition=prelim

5 “Title 42-The Public Health and Welfare Chapter 6A-Public Health Service Subchapter XIX-VaccinesPart 2-National Vaccine Injury Compensation Program.” [USC02] 42 USC 300aa-23: Trial, 2020, https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300aa-23&num=0&edition=prelim.

6 “Title 42-The Public Health and Welfare Chapter 6A-Public Health Service Subchapter XIX-Vaccines Part 2-National Vaccine Injury Compensation Program Subpart a-Program Requirements.” 42 USC 300aa-10: Establishment of Program, 2020, https://uscode.house.gov/view.xhtml?req=(title:42%20section:300aa-10%20edition:prelim).

7 “Title 42-The Public Health and Welfare Chapter 6A-Public Health Service Subchapter XIX-VaccinesPart 1-National Vaccine Program.” [USC02] 42 USC 300aa-1: Establishment, 2020, https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300aa-1&num=0&edition=prelim.

8 IOM (Institute of Medicine). 2013. The childhood immunization schedule and safety: Stakeholder concerns, scientific evidence, and future studies. Washington, DC: The National Academies Press. https://www.nap.edu/read/13563/chapter/9#130.

9 “‘The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies.’” National Academies Press: OpenBook, 2013, https://www.nap.edu/read/13563/chapter/2#5. 

10 “‘The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies.’” National Academies Press: OpenBook, 2013, https://www.nap.edu/read/1815/chapter/2#8. 

11 “Title 42-The Public Health and Welfare Chapter 6A-Public Health Service Subchapter XIX-Vaccines Part 2-National Vaccine Injury Compensation Program Subpart c-Assuring a Safer Childhood Vaccination Program in United States.” [USC02] 42 USC 300aa-25: Recording and Reporting of Information, 2020, https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300aa-25&num=0&edition=prelim 

12 “Vaccine Adverse Events Reports 1990 - 2020.” Search Results from the VAERS Database, 2020, https://medalerts.org/vaersdb/findfield.php?action=Find&TABLE=ON&GROUP1=APPY.

13 Lazarus, Ross. “Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS).” The Agency for Healthcare Research and Quality, 2010, https://healthit.ahrq.gov/sites/default/files/docs/publication/r18hs017045-lazarus-final-report-2011.pdf.

14 “WMA - The World Medical Association-WMA Declaration of Lisbon on the Rights of the Patient.” The World Medical Association, 2015, https://www.wma.net/policies-post/wma-declaration-of-lisbon-on-the-rights-of-the-patient/.

15 “WMA - The World Medical Association-Medical Ethics Manual.” The World Medical Association, 2015, https://www.wma.net/wp-content/uploads/2016/11/Ethics_manual_3rd_Nov2015_en.pdf

16 “WMA - The World Medical Association-WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects.” The World Medical Association, 2013, https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/20132013/. 

17 “Universal Declaration of Human Rights.” United Nations, United Nations, 1948, https://www.un.org/en/universal-declaration-human-rights/.

18 “Nuremberg Code.” United States Holocaust Memorial Museum, 1949, https://www.ushmm.org/information/exhibitions/online-exhibitions/special-focus/doctors-trial/nuremberg-code. 

19 “Precautionary Principle, Understanding Science in Regulation.” The Science and Environmental Health Network, 1998, https://www.sehn.org/precautionary-principle-understanding-science-in-regulation. 

20 “Business and Professions Code - BPC Division 2. Healing Arts [500 - 4999.129] Chapter 5. Medicine [2000 - 2529.6].” California Legislative Information, 2006, http://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?lawCode=BPC§ionNum=2234.1