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November
2019
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04:36 PM
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It is flu season again...Do you know where the vaccine court is?

Vol. 75, No. 5 / September - October 2019

Summary

Elimination of communicable diseases through vaccination has been “one of the greatest achievements of public health in the twentieth century.”

by Firooz Namei[1]

Elimination of communicable diseases through vaccination has been “one of the greatest achievements of public health in the twentieth century.”[2]Do You Know Where the Vaccine Court Is?

 

 

 

 

Although widespread use of vaccination began in the twentieth century, it actually dates to 1796 when Dr. Edward Jenner demonstrated its efficacy by inoculating a 13-year-old boy with the cowpox virus. Once he discovered that exposure to a pathogen causes the immune system to fight the disease, medical science expanded its vision: the historical focus of treating illness was no longer sufficient; prevention and eradication also became an essential part of medicine.[3]

The systematic implementation of the smallpox vaccine culminated in the global eradication of smallpox by 1979.[4] A disease that once killed at least 30 percent of its victims and blinded and scarred those lucky enough to survive, had completely disappeared all over the world.[5] In the United States, at least eight other diseases have been eliminated by vaccines: polio, typhoid fever, yellow fever, rubella, mumps, tetanus, Haemophilus Influenza Type B, and rabies.[6]

The control of infectious diseases in the United States is a result of widespread vaccination shortly after a baby is born – before he or she leaves the hospital. Every state requires proof of vaccination before a child can enroll in school or pre-school.[7] These vaccines include: measles, mumps, rubella, diptheria, whooping cough, tetanus, chickenpox, polio, hepatitis A and B, rotavirus, pneumococcus, Haemophilus Influenzae, and meningococcal disease. The near-universal administration of these vaccines has drastically changed children’s life expectancy. In the seventeenth century, one-third of all children died before age 15; today in the West, that figure is less than one percent.[8]

The vaccination requirements provide for exceptions for individuals who have religious or moral objections to vaccination.[9] These exemptions, along with widespread misinformation on social media about a nexus between vaccination and autism, have resulted in many eschewing vaccinations for their children. The consequences of this reluctance to vaccinate were dramatically demonstrated in 2015 when a measles outbreak that began at Disneyland sent more than 100 people to the hospital.

After the outbreak, California lawmakers closed a loophole that allowed parents to opt out of vaccinations for personal beliefs.[10] Vaccinations not only help the individual inoculated, they protect those whose immune systems are compromised and newborn babies by creating “community” or “herd” immunity.

In recent years, parents with autistic children searching for “scientific answers” latched onto a flawed study by a British physician.[11] His idea had superficial plausibility: If all children are vaccinated and some develop autism after they are vaccinated, then vaccines cause autism. Although this theory was debunked by science, by data, and by human experience, the idea has persisted. Many parents of autistic children filed claims for compensation; their claims were consolidated and tried in the Vaccine Court, where 19 experts testified: five on behalf of the Petitioners and 14 on behalf of the Secretary of the Department of Health and Human Services. The court held that vaccines do not cause autism.[12]

Although vaccines are hailed “as one of the greatest medical and public health accomplishments,” and millions are vaccinated without any adverse reactions, a small number of people who are inoculated suffer serious and debilitating side effects.[13] “In the 1970s and 1980s vaccines became, one might say, victims of their own success. [The vaccines] had been so effective in preventing infectious diseases that the public became much less alarmed at the threat of those diseases and much more concerned with the risk of injury from the vaccines themselves.”[14] By the early 1980s there was a substantial increase in product liability suits against vaccine manufacturers – between 1978 and 1981, for instance, there were only nine product liability suits filed against vaccine manufacturers. By the mid-1980s there were over 200 per year.[15]

To ensure the availability of vaccines after the two domestic vaccine manufacturers stopped making them, Congress enacted the National Childhood Vaccine Injury Act (“NCVIA”) in 1986 to establish a no-fault compensation program “designed to work faster and with greater ease than the civil tort system.”[16] The Supreme Court in Bruesewitz described the NCVIA as “quid pro quo”: It provides manufacturers protection from liability in exchange for their contribution to a fund to compensate injured claimants.[17] But what the manufacturers actually do is charge an excise tax on each vaccine dose administered. They do not contribute anything to the fund.[18]

Under the NCVIA, a claim for compensation for any injury alleged to have resulted from a recommended vaccine must be brought in the U.S. Court of Federal Claims in Washington, D.C. The NCVIA requires an injured claimant to first exhaust his or her remedies in the Court of Federal Claims before seeking other remedies against the manufacturers or providers. The NCVIA makes it almost impossible for an individual to bring a subsequent lawsuit against the manufacturer if injury or death was “unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”[19] “A claimant who wants to take his or her chance with a jury must first received a final decision from a Special Master of the Vaccine Court and formally reject it.”[20]

When an injury occurs, a claimant has three years from the first manifestation of the injury or two years from the time of death to file a claim for compensation.[21] Although the D.C. Circuit had previously held that this statute of limitations is strictly applied and was not subject to equitable tolling, it later reversed itself in an en banc decision and held that equitable tolling may be available in certain circumstances; the Supreme Court affirmed.[22]

The petition for compensation must state that the vaccine either caused an injury from which the claimant had not suffered before, or the vaccine significantly aggravated a pre-existing condition.[23] The Vaccine Rules originally adopted by the judges of the U.S. Court of Federal Claims and the guidelines adopted by the Special Masters provide a roadmap for practitioners and the Vaccine Court. The Rules require that the petition for compensation should be a short and plain statement of the facts and state the grounds for compensation, including whether the injury claimed is listed in the Vaccine Injury Table.[24]

What distinguishes a Vaccine Court claim from a products liability case is the Vaccine Injury Table. This table is the substantive law that determines the outcome of most cases. All vaccines covered by the NCVIA are listed on the table, along with “recognized” injuries that are presumptively related to the vaccine. For each listed injury a time limit is set from the time a vaccine is administered and the onset of the injury.[25] The original table adopted by Congress contained MMR (measles, mumps, and rubella), DTP (diptheria, pertussis, and tetanus) and the two polio vaccines, IPV and OPV.[26] The current table now also includes Hepatitis A and B, seasonal flu vaccines, meningoccal, pneumococcal conjugate, varicella (chicken pox), human papillomavirus, and rotovirus.[27]

When the medical records, submitted with the petition, reveal that a specified injury occurred in the specified time frame after vaccination, a presumption is created that the vaccine caused the injury. The petition does not need to submit expert medical opinion that the vaccine did in fact cause the injury.[28]

Once the presumption attaches, the burden shifts to the Secretary of the Department of Health and Human Services to show by a preponderance of the evidence that another cause, unrelated to the vaccine, was the source of injury.[29] The Secretary must present expert testimony to overcome the presumption and cannot rely on an idiopathic (unknown) cause.[30]

When an injury is not in the Table (off-Table)), an alternative means exists to demonstrate that the injury was “caused in fact” by the vaccination.[31] Since the presumption of injury provided by listing in the Table is not present in such cases, the petitioner has the burden to show that vaccination caused the injury.[32] Showing the causation in fact is the same standard as the burden in a tort case: preponderance of evidence.[33]

In cases where the injury is not in the Table, the issue of causation becomes very contentious. There are no biological markers to prove that a vaccine was the cause of the injury. A diagnosis that an injury resulted from vaccination is “bereft of complete and direct proof of how vaccines affect the human body.”[34] These cases are also difficult because the practitioners do not have their usual allies: the treating physicians. Most physicians invariably refuse to cooperate in the litigation of vaccine cases because they think such cases discourage vaccination. One must rely on experts at the universities and research centers.[35]

Another unique attribute of the NCVIA is that an attorney may not charge the client fees for services in connection with such a petition, but a court may award attorneys’ fees and costs, even in an unsuccessful petition brought in good faith.[36]

Counsel should not be reluctant to represent an injured client merely because the Vaccine Court is in Washington, D.C. In a Table injury case, there is no need for counsel to leave the office. Hearings are conducted over the phone and all filings are done electronically.

Regardless of attorneys’ opinion about the efficacy of vaccinations, Congress has established a forum where a claimant injured by vaccines can be compensated. Since the Vaccine Court was established in the 1980s, claimants have recovered more than $3.9 billion in compensation for vaccine injuries.

Reprinted with permission of the Kentucky Bar Association.

Link to Vaccine Injury Table in PDF Format

Vaccine Table

Endnotes

1 Firooz Namei is a 1982 graduate of the University of Cincinnati College of Law and is the managing partner of McKinney & Namei LPA, a litigation firm in Cincinnati. The author is grateful to Jocelyn dos Anjos for her medical and journal research.

2 Bruesewitz v. Wyeth LLC, 562 U.S. 223, 226 (2011), citing Centers for Disease Control, achievement in public health, 1900-1999: impact of vaccines universally recommended.

3 Ian Bailey, 4 Journal of Medical Biography 63-70 (1996).

4 Frank Fenner et al., Smallpox and Its Eradication (World Health Organization 1988).

5 Smallpox Fact Sheet, World Health Organization, 2001.

6 Williem G. Van Panhuis et al., Contagious Diseases in the United States from 1888 to the Present, 22 New Eng. J. Med. 2152 (2013).

7 Jacobsen v. Massachusetts, 197 U.S. 11 (1905) The Supreme Court upheld the constitutionality of imposing a criminal conviction for failure to vaccinate against smallpox.

8 Hannah Newton, The Dying Child in Seventeenth-Century England, 136 Pediatrics 218-20 (2015).

9 Timothy J. Aspinwall, Religious Exemption to Childhood Immunization Statutes: Reaching for a More Optimal Balance Between Religious Freedom and Public Health, 29 Loy. U. Chi. L.J. 109 (1997).

10 Soumya, Karlamangla & Rong-Gong Lin II, Vaccination Rate Up After Exemptions Tightened, L.A.Times, April 13, 2017.

11 Clyde Haberman, A Discredited Vaccine Study’s Continuing Impact on Public Health, N.Y. Times, February 1, 2015.

12 King v. Secretary of Health and Human Services, No. D3-584V, 2010 WL 892296 (Fed. Cl. Spec. Mstr., March 12, 2010).

13 Bruesewitz v. Wyeth LLC, 562 U.S. 223, 226 (2011), citing Centers for Disease Control, achievement in public health, 1900-1999: impact of vaccines universally recommended.

14 Id. (citations omitted).

15 Id.

16 Shalala v. Whitecotton, 514 U.S. 268, 269 (1995).

17 131 S. Ct. at 1080.

18 Derry Ridgeway, No Fault Vaccine Insurance: Lessons from the Vaccine Injury Compensation Program, 24 J. Health Pol. Pol’y L.59, 62 (1999).

19 42 U.S.C. § 300aa-22(b)(1). See also Brueswitz, 562 U.S. at 239, holding that this provision barred all claims based on design defects.

20 U.S. Ct. of Fed. Claims Vaccine R 12(a), 42 U.S.C. § 300aa-11(a)(1).

21 42 U.S.C. § 300aa-16(a).

22 Sebelius v. Cloer, 569 U.S. 369, 133 S. Ct. 1886 (2013).

23 Whitecotton v. Secretary of Health and Human Services, 81 F.3d 1099, 1107-08 (Fed. Cir. 1996).

24 U.S. Cl. Vaccine Rule 2(c)(1).

25 42 U.S.C. § 300aa-14(a).

26 Id.

27 L. A. Grohskopf et al., Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices – United States, 2018-19 Influenza Season, 67 MMWR Recomm Rep. 1 (2018).

28 42 U.S.C. § 300aa-11 (c)(1).

29 42 U.S.C. § 300aa-13(a)(1)(B).

30 42 U.S.C. § 300aa-13(a)(2)(A); Doe v. Secretary of Health and Human Services, 83 Fed. Cl. 157, 159 (2008).

31 42 U.S.C. § 300aa-13(a)(1)(B); §300aa-11(c)(1)(ii).

32 Athens v. HHS, 418 F.3d. 1274, 1278 (Fed. Cir. 2005).

33 Id. at 1279.

34 Id. at 1280.

35 The Vaccine Bar has created a list of researchers who are very helpful in guiding/educating an attorney litigating a vaccine case.

36 Sebelius v. Cloer, 569 U.S. 369 (2013).