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Vaccines and the Law

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Where mandatory childhood immunizations are concerned, questions of public health, personal belief, and the dictates of law now collide on an alarmingly regular basis. Here’s a primer on the essentials of state and federal law on the subject.

Generations of American school children have been taught about the heroic achievement of Dr. Jonas Salk, who developed the first successful polio vaccine in the 1950s. In the early 1950s, an average of 25,000 annual cases of paralytic polio, with their often devastating consequences, occurred in the United States.

Culminating years of grassroots mobilization by the March of Dimes in raising funds for vaccine research, a widely publicized national field trial of the Salk vaccine was conducted in 1954. On April 12, 1955, when the results of a scientific review of the successful field trials were announced at the University of Michigan, Americans gathered around radios—judges even reportedly suspended court proceedings so everyone in the courtroom could hear—to listen with anxious anticipation to the results. Writer Frank Deford recalled the scene in his fourth grade classroom: “[W]e were safe again… Outside, we could hear car horns honking and church bells chiming in celebration. We had conquered polio.”1

After the polio vaccine became prevalent, the annual rate quickly dwindled and polio was effectively eliminated in the country by 1979.2 Now, as polio rates have risen in certain regions in Africa and the Middle East, significant concern has been raised that polio could be reintroduced by travelers to the United States. How can this be, given the availability of a cheap and effective vaccine? Simply put, more and more parents are delaying or skipping vaccinations for their children.

In light of the current public attention given to questions over vaccine rates, it is worth reviewing some of the areas in which vaccines, and decisions about whether they should be administered, are addressed in the law.

Mandatory Vaccination Laws

In 1905 the United States Supreme Court ruled, in Jacobson v. Massachusetts, that states can enforce compulsory vaccination laws. In doing so, the high court explained that constitutional liberties must sometimes give way to the common welfare: “[T]he police power of a state must be held to embrace, at least, such reasonable regulations established directly by legislative enactment as will protect the public health and the public safety.”3 A local vaccination ordinance excluding children from public school without proof of vaccination was upheld as within the government’s police powers in 1922.4

The United States Supreme Court addressed the vaccination issue as part of a free exercise of religion decision in Prince v. Massachusetts, which upheld a child labor conviction for the guardian of a nine-year-old girl selling religious literature. The Court stated in dictum that “[t]he right to practice religion freely does not include liberty to expose the community or the child to communicable disease or the latter to ill health or death.”5 A law that is neutral and of general applicability need not be justified by a compelling state interest even if it has the incidental effect of burdening a particular religious practice.6

While states can constitutionally require children to be vaccinated in order to attend public school, states can go beyond what the constitution requires and allow exemptions for religious or other bases.7 To the extent states permit some form of exemption, it can lead to litigation over the interpretation of the application state’s law and regulations, and whether the exemption provisions are applied in a neutral manner.8

Minnesota Requirements and Opt-Outs

Minnesota Statute §121A.15 states that a child two months of age or older may not be enrolled in school or child care unless the school or facility receives a statement from a physician or clinic that the child has been or will be immunized for various viruses (including measles) after the age of 12 months. This statement must include a record of the month and year of each received.

After the age of 18 months, no child may attend or continue attendance unless their primary scheduling of immunizations for diphtheria, tetanus, pertussis, polio, and hepatitis B has been completed, with a statement of confirmation by a physician or clinic. For children reaching seven and older, there must be a confirmed schedule specifying three or four doses of several kinds of immunizations.

Exemptions. A person does not have to be immunized if: (1) a physician signs a statement to the administrator stating that immunization is contraindicated for medical reasons or that laboratory confirmation of the presence of adequate immunity exists.9 Alternatively, immunizations shall not be required if a child’s parent or guardian (or the emancipated person) submits a notarized statement to the school or child care administrator stating the person has not been immunized as prescribed as prescribed in Minn. Stat. §121A.15, subdivision 1 because of the conscientiously held beliefs of the parent or guardian of the minor child or of the emancipated person. In addition, if a person is not a Minnesota resident and is enrolled in an online course or program without an instructor or classroom attendance, the immunization requirements do not apply. The statute also sets forth a set of immunizations that, if not done by a certain age, are not required. (A bill pending before the 2015-16 Minnesota Legislature—HF 393/SF 380—would modify Section 121A.15 and require a statement from a health care provider that the pros and cons of immunization had been reviewed with the person applying for the personal belief exemption.)

Until recently, all states except West Virginia and Mississippi allowed some form of religious or philosophical exemption.10 In June 2015, California enacted a law eliminating the personal belief exemption for existing specified immunization requirements.11 Minnesota’s requirement for a notarized form falls in the more stringent end of the exemption policy continuum.12 Neighboring states North Dakota and Wisconsin, as well as several other states, have more lenient requirements—with only the parent’s signature required. About half of the states are in between the two approaches, requiring a health care professional’s signature.

The No-Fault “Vaccine Court”

State regulations mandating vaccination would be of little consequence if a steady supply of vaccines were not available. Another area in which the government has expressly advanced the nation’s public policy in favor of promoting vaccine development and use is tort liability against vaccine manufacturers. The National Childhood Vaccine Injury Act of 1986 (Public Law 99-660) (Vaccine Act) created the National Vaccine Injury Compensation Program (VICP). The VICP was established to ensure an adequate supply of vaccines, stabilize vaccine costs, and establish an accessible and efficient forum for individuals found to be injured by certain vaccines.13 The Vaccine Act was passed following a scare in the 1980s over the pertussis portion of the diphtheria–pertussis–tetanus (DPT) vaccine. DPT vaccine makers, fearing an onslaught of large jury awards over (later discredited) claims of potential neurological harm, had ceased production, and officials feared the loss of herd immunity.14

The VICP establishes a no-fault administrative alternative to the traditional tort system for resolving vaccine injury claims. This process is sometimes commonly referred to as “Vaccine Court.” The VICP is funded through the Vaccine Injury Compensation Trust Fund. The Trust Fund is funded by a $0.75 excise tax on each dose of vaccines recommended by the Centers for Disease Control for routine administration to children.

A person injured by a vaccine (or parent, legal guardian, or legal representative of an estate) may file a claim with the U.S. Court of Federal Claims. An injury must have lasted for more than six months after the vaccine was given, or resulted in a hospital stay or surgery. Claims must be filed within three years after the first symptom of the vaccine injury, or within two years of a death and four years after the start of the first symptom of the vaccine injury that resulted in the death.15

The VICP publishes a Vaccine Injury Table16 as a starting-point for determining whether compensation is appropriate. The table lists injuries/conditions presumed to be caused by vaccines, and time periods in which the first symptom of these injuries/conditions must occur after receiving the vaccines. If the first symptom of these listed within the table occurs within the published timeframe, it is presumed the vaccine was the cause of the injury or condition unless another cause is found. If the reported injury/condition does not fall within the table presumptions, the applicant must demonstrate that the vaccine caused the injury/condition through medical records or opinion, which may include expert witness testimony.17

Compensation varies depending on the injury. It can include as much as $250,000 for pain and suffering, plus lost earnings, legal fees, and reasonable costs of past and future care. In the event of a death, the statute provides for compensation to the estate.18 The Act provides that “[i]t shall be the ethical obligation of any attorney who is consulted by an individual with respect to a vaccine-related injury or death to advise such individual that compensation may be available under the program.”19

The VICP is an alternative to the tort system for resolving vaccine injury claims. The Vaccine Act preempts claims against vaccine manufacturers for vaccine-related injuries or deaths if they resulted from unavoidable side effects even though the vaccine was properly prepared and accompanied by proper directions and warnings.20 A vaccine is presumed to be accompanied by proper directions and warnings if it complied with Federal Food and Drug Act requirements, unless clear and convincing evidence demonstrates a failure to exercise due care or the manufacturer engaged in intentional or fraudulent withholding of adverse information.21

Under the Vaccine Act, persons with claims of vaccine-related injuries or deaths resulting from covered vaccines must first exhaust their remedies under the VICP before they can pursue legal actions against vaccine administrators.22

The Vaccine Act’s liability protections to vaccine administrators are not absolute. There are instances when a vaccine administrator who gives a covered vaccine is not protected from liability by the Act, such as when an individual files a claim and is requesting damages of $1,000 or less. In addition, the VICP may be able to pursue its own action against a vaccine administrator using its subrogation rights after paying a petitioner for a vaccine-related injury.23

Given the liability limitations found in VICP, litigation has ensued testing the extent to which VICP preempts tort claims brought outside the VICP. The Supreme Court in Bruesewitz v. Wyeth, 562 U.S. 223 (2011), considered whether the VICP preempts all vaccine design defect claims against vaccine manufacturers.24 The petitioners in Bruesewitz sued after their daughter received Wyeth’s DTP vaccine. Their suit in Vaccine Court was dismissed for failure to prove a link between the vaccine and the child’s seizures and developmental problems. Their subsequent Pennsylvania state court case was removed to federal court. The 3rd Circuit held the vaccine design defect claims were preempted by the VICP.

The case before the Court came down to the interpretation of the specific statutory language regarding preemption. U. S. C. §300aa-22(b)(1), provides that “[n]o vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side-effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.” Design defects are not specifically addressed in the statute. In a 6-2 decision issued in 2011, the high court held that the Vaccine Act’s structure and that of vaccine regulation in general meant the Vaccine Act necessarily “preempts all design-defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects.”

Given the scope of Vaccine Act preemption, some claimants have sought, with some success, to argue that the Vaccine Act does not preempt claims against manufacturers of a component within a vaccine injection beyond the active vaccine component. For example, in 2006 the 5th Circuit Court of Appeals held that claims against the manufacturers of Thimerosal, a vaccine preservative, were not preempted by the Vaccine Act.25 The 5th Circuit previously stated in Moss v. Merck that “Thimerosal, when used as a preservative, is a component of a vaccine rather than an adulterant. Nonetheless, its status as a vaccine component no more makes Thimerosal a ‘vaccine’ than does the inclusion of a piston under the hood of an automobile make that object an ‘engine.’”26

Other legal protections have been implemented to provide tort immunity to facilitate administration of pandemic vaccines. In 2005, President Bush signed into law the Public Readiness and Emergency Preparedness Act (PREPA).27 PREPA states “a covered person shall be immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure” if a public health emergency has been declared by the Secretary of the Department of Health and Human Services. “Covered person[s]” include those who manufacture, prescribe, distribute administer, and dispense vaccination countermeasures targeted at the subject of the declared public health emergency.

When Parents Cannot Agree

Making the decision whether to vaccinate a child can be complicated enough when two parents in the same household weigh the pros and cons. That decision, and other custodial decisions, can become more difficult when the parties are not working together as a team in a committed relationship. Legal custody in Minnesota gives the right to the parent or parents to make decisions regarding a child’s upbringing, specifically including “education, medical care, and religious training.”28 Joint legal custody means that the parents have “equal rights and responsibilities” to makes these “major decisions.” The court in an action for custody shall apply a rebuttable presumption that joint legal custody is in the child’s best interests, unless domestic abuse has occurred between the parents, in which case the court shall use a rebuttable presumption that joint legal custody is not in the child’s best interests.29

Joint custody requires parents to work collaboratively to reach decisions on the types of important decisions that encompass legal custody. Of course, joint legal custodian parents cannot always agree on such decisions. When this occurs, the court is required to break the impasse by determining which outcome is in the minor child’s best interests.30 Should a child become physically or emotionally endangered as a result of impasse between custodial parents leading to an inability to make custodial decisions, the Court could consider this factor in determining whether a modification of a prior joint custody award is warranted. A joint custody arrangement may be modified when parents continue to battle over decisions concerning their minor child and this conflict creates an environment of instability for the minor child caught in the middle.31

If the parent choosing medical direction is the sole legal custodian, that parent is empowered to make custodial decisions unless it is against the child’s best interests and/or an endangerment. Minnesota Statute section 518.18 provides that custody may be modified, if it is in the best interest of the child, where circumstances have arisen since the prior order such that the present environment endangers the child’s physical or emotional health.32

There are limited reported cases referring to immunization in Minnesota which list it among several factors that play into a parent’s evaluation as caregiver. The gist from these cases is that a parent is not an effective caregiver if they do not keep up-to-date with their child’s vaccinations; however, this is only seen as a function of disorganization and parental torpor.33 There are many other cases in which the court depicts favorable parenting skills in its determination of custody and parenting time where the parent brought their children in for regular check-ups and immunization.34

Conclusion

The law provides a number of incentives and mandates regarding immunizations. These carrots and sticks span areas of public health, education, administrative law, and tort liability. Other areas of the law can ask courts to make findings on whether a parent’s failure, intentional or inadvertent, to arrange for a child’s vaccinations may speak to his or her parental fitness. In light of the resurgence of once-thought-defeated communicable diseases, and the ongoing discussion over vaccination rates that keeps the issue in the news, the ways the law intersects with these issues will likely gain future scrutiny as well.


The Honorable PATRICK ROBBEN is a judge on the Hennepin County District Court.  He currently serves as the assistant presiding judge in the Family Court Division.

ALISON GRAFSGAARD is a 2015 University of St. Thomas School of Law graduate who plans a career in family law in the Twin Cities. 


 

Notes

1 David Oshinsky, Polio: An American Story, Oxford University Press (2005).

2 Vaccine Information Statements: Polio VIS, Centers for Disease Control, http://www.cdc.gov/vaccines/hcp/vis/vis-statements/ipv.html

3 Jacobson v. Massachusetts, 197 U.S. 11, 25 (1905).

4 Zucht v. King, 260 U.S. 174 (1922).

5 Prince v. Massachusetts, 321 U.S. 158, 166-67 (1944).

6 Church of the Lukumi Babalu Aye, Inc. v. City of Hialeah, 508 U.S. 520, 531 (1993).

7 See, e.g., Phillips v. City of New York, 775 F.3d 538, 543 (2d Cir. 2015).

8 Marjorie Shields, “Power of Court or Other Public Agency to Order Vaccination Over Parental Religious Objection,” 94 A.L.R. 5th 613 (2001).

9 Minn. Stat. §121A.15, subd. 3(c).

10 Chris Kirk, “How Tough Are the Vaccination Laws in Your State?” SLATE, (2/4/2015), http://www.slate.com/articles/health_and_science/medical_examiner/2015/02/map_of_vaccination_laws_by_state_personal_belief_exemptions_measles_and.html 

11 2015 Cal. Legis. Serv. Ch. 35 (S.B. 277) (WEST).

12 Kevin Hooker, Note, “Exemptions to Vaccine Mandate: The Problem and Possible Remedies,” 14 Hous. J. Health L. & Pol’y 263, 266 (2014).

13National Vaccine Injury Compensation Program, Health Resources and Services Admin., http://www.hrsa.gov/vaccinecompensation/index.html.

14 Stephen D. Sugarman, “Cases in Vaccine Court — Legal Battles over Vaccines and Autism,” New Eng. J. Med. 1281 (2007).

15 Limitation on actions, 42 U.S.C. §300aa-16.

16 Vaccine Injury Table, 42 U.S.C. §300aa-14.

17 Id. §300aa-14; See also Definitions, 42 U.S.C. §300aa-33 (defining “vaccine-related injury or death”).

18 Compensation, 42 U.S.C. §300aa-15.

19 Establishment, 42 U.S.C. §300aa-10.

20 Standards of responsibility, 42 U.S.C. §300aa-22(a).

21 Id. §300aa-22(a).

22 Authority to bring actions, 42 U.S. C. §300aa-21.

23 Petition for compensation, 42 U.S.C. §300aa-11 (barring civil action for damages “in an amount greater than $1,000); Subrogation, 42 U.S.C. §300aa-17.

24 Bruesewitz v. Wyeth, 562 U.S. 223 (2011).

25 Holder v. Abbott Laboratories, 444 F. 3d 383 (5th Cir. 2006).

26 Moss v. Merck, 381 F. 3d 501 (5th Cir. 2004).

27 Public Readiness and Emergency Preparedness Act, 42 U.S.C. §247d–6d.

28 Minn. Stat. §518.003, subd. 3(a) (2014).

29 Minn. Stat. §518.17, subd. 2 (2014), amended by 2015 Minn. Sess. Law Serv. Ch. 30 (S.F. 1191).

30 Novak v. Novak, 446 N.W.2d 422, 424–25 (Minn. Ct. App. 1989) review denied (Minn. 12/1/1989) (addressing school choice dispute).

31Andersen v. Andersen, 360 N.W.2d 644, 646 (Minn. Ct. App. 1985).

32 Minn. Stat. §518.18 (2014).

33 Matter of Welfare of A.R.G.-B., 551 N.W.2d 256, 262 (Minn. Ct. App. 1996) (excusing delay of immunizations, suggesting it was due to mother’s grief over a child’s death and assuming she will have children immunized following the court date); Matter of Welfare of D.J.N, 568 N.W.2d 170 (Minn. Ct. App. 1997) (suggesting failure to provide proof of immunizations was a sign of bad parenting).

34 See, e.g., State v. Salazar, 504 N.W.2d 774 (Minn. 1993); SooHoo v. Johnson, 731 N.W.2d 815 (Minn. 2007).

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