SC Lawyer, May 2010, #5. An Overview of the National Childhood Vaccine Injury Act.

• Author: By Miles E. Coleman

South Carolina Lawyer

2010.

SC Lawyer, May 2010, #5.

An Overview of the National Childhood Vaccine Injury Act

South Carolina Lawyer May 2010 An Overview of the National Childhood Vaccine Injury Act By Miles E. Coleman Introduction

It is difficult to overstate the importance of vaccinations to modern health and quality of life. In the two centuries since Edward Jenner pioneered the smallpox vaccine in 1796, vaccinations have been credited with the virtual eradication of smallpox, polio, measles and diphtheria. Today, vaccination is a nearly universal and inescapable part of life. The average American child receives nearly 24 vaccinations in the first two years of life, and adults are frequently vaccinated for overseas travel or new diseases like H1N1, the so-called swine flu virus. See American Academy of Pediatrics, 2010 Immunization Schedules, http://www.aap.org/immunization/IZSchedule.html.

The individual and societal benefits of this immunization regimen are vast. The Centers for Disease Control estimates that the childhood vaccinations administered in any given year prevent 14.3 million cases of disease and 33,500 premature deaths over the course of those children's lifetimes. See Press Release, Centers for Disease Control and Prevention, Most U.S. Parents are Vaccinating According to New CDC Survey Vaccine Coverage Rates for Children Remain High (Sept. 4, 2008), available at http://www.cdc.gov/media/pressrel/2008/r080904.htm. Unquestionably, vaccines rank among mankind's greatest achievements in public health and are of great benefit to the vast majority of individuals. In rare instances, however, vaccines can cause serious injury. This article will explore the legal mechanism designed to easily, quickly and generously reward those injured by vaccinations.

Historic background

Throughout the 20th century, as vaccination schedules prescribed more and earlier immunizations, there was a growing awareness of the potential dangers of vaccinations and an accompanying resistance to immunization. In response, Congress passed the National Childhood Vaccine Injury Act of 1986 ("Vaccine Act" or "the Act"). Congress acknowledged the potential dangers of vaccination and the possible disastrous effect of the growing trend of tort litigation against vaccine manufacturers:

While most of the Nation's children enjoy greater benefit from immunization programs, a small but significant number have been gravely injured. These children are often without a source of payment or compensation for their medical and rehabilitative needs, and they and their families have resorted in greater numbers to the tort system for some form of financial relief. At least in part as a result of this increase in litigation, the prices of vaccines have jumped enormously. The number of childhood vaccine manufacturers has declined significantly. In certain areas, the level of immunization against some preventable diseases has decreased while the incidence of those diseases has increased. H.R. Rep. No. 90-908 at *4. Designed as a simpler alternative to traditional tort litigation, the Act establishes "a Federal 'no-fault' compensation program under which awards can be made to vaccine-injured persons quickly, easily, and with certainty and generosity." Id. at *3.

Statutory structure

The Vaccine Act, codified at 42 U.S.C. §§ 300aa-1 to -34 (2006), establishes a comprehensive scheme for compensating vaccine-injured persons and for improving the safety and effectiveness of immunizations. Many of these provisions-establishing committees, imposing administrative requirements and the like-are of little concern to injured parties or their attorneys. Of more interest to parties seeking recovery, the Vaccine Act creates a program "under which compensation may be paid for a vaccine-related injury or death," id. at § 300aa-10(a),and establishes a trust funded by a tax placed on designated vaccines from which a prevailing claimant may recover. See 26 U.S.C. § 9510 (2006). The Act also establishes within the U.S. Court of Federal Claims an Office of Special Masters consisting of up to eight special masters appointed to four-year terms. 42 U.S.C. § 300aa-12(c).

The Vaccine Act is the mandatory first resort for a vaccine-injured person. Only after reaching a final judgment under the Vaccine Act may a claimant decline the result and elect to pursue a civil suit in state or federal district court. Id. at § 300aa-21. Any subsequent civil action is essentially governed by state law, id. at § 300aa-22(a), including the applicable statute of limitations, id. at § 300aa-21(c), which is tolled pending the outcome of the Vaccine Act suit. Id. at § 300aa-16(c). The Act also places limitations on a subsequent civil action, stating that a vaccine manufacturer is not liable for any injury that "resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings." Id. at 300aa-22(b)(1). This provision, which purports to preempt state law claims based on design defect, is being challenged in two cases pending before the U.S. Supreme Court. Bruesewitz v. Wyeth, Inc., 561 F.3d 233 (3d Cir. 2009); Am. Home Prods. Corp. v. Ferrari, 668 S.E.2d 236 (Ga. 2008).

Of particular interest to practicing attorneys, the Act imposes an ethical obligation on any attorney consulted about a vaccine-related injury to advise the client of the potential of recovery under this program. 42 U.S.C. § 300aa-10(b). Additionally, and somewhat remarkably, the Act provides for the payment of the claimant's reasonable attorneys' fees and costs even if claimant loses, so long as the claim was brought in good faith. Id. at § 300aa-15(e)(1).

Typical litigation life cycle

A suit under the Vaccine Act is initiated by service on the Secretary of Health and Human Services and by filing with the Court of Federal Claims a petition containing specific allegations required by Section 300aa-11(c). The suit must be filed within three years after "the occurrence of the first symptom or manifestation of" an injury and, for an allegation of a vaccine-induced death, within two years after the date of death and four years after the first symptoms. Id. at § 300aa-16(a).

The petition is assigned to one of the special masters, who oversees the submission of evidence: usually the claimant's medical records as well as articles from medical and scientific journals. The court's rules of evidence and discovery "provide for a less-adversarial, expeditious, and informal proceeding" and "include flexible and informal standards of admissibility of evidence." Id. at § 300aa-12(d)(2). This evidence-gathering phase culminates in a hearing, often lasting several days, in which the special master serves as the fact finder. Such hearings typically include the testimony of the claimant, a treating physician and expert witnesses.

The special master then considers the entire record, including any diagnoses or conclusions in the medical record, and determines if the claimant has shown by a preponderance of the evidence that his injury was caused or aggravated by a vaccine. If the special master fails to issue a decision on entitlement within 240 days after the petition was filed, the claimant may elect to withdraw his claim and bring a civil action, though claimants seldom do so. See id. at § 300aa-21(b). The special master's decision, and any other published opinion or order, is initially filed under seal with a 14-day period for either party to request redactions before being made public.

If a claimant prevails on a claim of entitlement to compensation, the special master determines damages in accord with statutory mandates. See 42 U.S.C. § 300aa-15. A claimant may recover for actual and future medical expenses, loss of future earnings and a capped amount for pain and suffering. In the case of a death caused by a vaccine, the claimant's estate receives an automatic $250,000. Punitive damages are not available. As noted previously, regardless of the outcome, the claimant receives reasonable attorneys' fees and costs so long as the claim was brought in good faith. An attorney may not charge any fee above or in addition to the amount deemed reasonably and awarded by the special master. Id. at § 300aa-15(e)(3).

Though the Vaccine Act includes deadlines to promote an efficient resolution to claims, in reality proceedings are often stayed at the claimant's request while developing the case. Additionally, plaintiffs will often request a stay pending the outcome of an omnibus proceeding-a device whereby a special master uses a test case to resolve an issue common to multiple cases. This allows the special master to hear evidence, make findings and issue an opinion in the test case, often regarding a theory of causation. Although the parties in the other cases are not bound by the outcome of the test case, they may rely on the expert opinions and the evidence offered in the test case. Accordingly, while an expedited individual case could be resolved in approximately one year, it is not uncommon for cases to linger six or eight years as a result of simple stays or pending the result of an omnibus proceeding.

If either party wishes to appeal a decision of a special master, the party has 30 days to file a motion for review with the Court of Federal Claims, which reviews such cases in an appellate-like capacity. The parties submit briefs and give oral argument before a single judge. On review, the court has a wide variety of procedural options:

We may sustain the decision, set aside the decision and issue our own findings of fact and conclusions of law, or remand to the special master. [] We may set aside only those findings of fact and conclusions of law that are "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law." [ ] This standard of review applies differently to different aspects of the special master's decision: findings of fact are reviewed under the deferential "arbitrary and capricious" standard, legal conclusions under the "not in accordance with law" standard, and discretionary rulings for an "abuse of discretion."Hennessey v. Sec'y of HHS, 91 Fed. Cl. 126, 132 (2010) (internal citations omitted). If either party desires further review, it may appeal to the U.S. Court of Appeals for the Federal Circuit within 60 days of the decision by the Court of Federal Claims. Ultimately, appeal to the U.S. Supreme Court is available, though it is extraordinarily rare for the high court to grant certiorari. But see Shalala v. Whitecotton, 514 U.S. 268 (1995).

Substantive law issues

The Vaccine Act provides two routes to recovery for a petitioner seeking compensation. Under the easier method, known as a "table injury," the claimant need only show he received a vaccination listed on the Vaccine Injury Table and suffered one of the corresponding listed injuries within the prescribed period. See id. at § 300aa-14. Upon this showing, the vaccine is presumed to have caused the injury. The other route, called an "off-table" case, does not receive a presumption of causation. Rather, the claimant must prove that the vaccination caused the alleged injury.

Most litigation concerns off-table cases, in which the petitioner is required to show that (1) while within the United States, he received a vaccine listed on the Vaccine Injury Table, (2) the vaccine caused or significantly aggravated an illness, disease, disability or condition, and (3) the effects of that injury lasted more than six months or resulted in surgery or death. Id. at § 300aa-11(c). There is rarely any dispute over the first or third requirement. Rather, the issue is usually the second element: causation. In Althen v. Secretary of HHS, the Federal Circuit set out a three-prong test for establishing causation in an off-table claim:

Concisely stated, [petitioner's] burden is to show by preponderant evidence that the vaccination brought about her injury by providing: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury. 418 F.3d 1274, 1278 (2005). The first prong is theoretical and asks whether the vaccine in question can cause the injury alleged. The second prong applies the theory and asks whether the vaccine did cause the injury. The third prong focuses on whether the symptoms occurred in an appropriate time frame, neither too soon nor too long after the vaccination. Taken together, the three prongs must show by a preponderance of the evidence that the vaccination was a "but-for" cause of the harm.

The Federal Circuit has frequently reiterated the inherent uncertainty of vaccine causation and has consistently acknowledged a relaxed standard of proof in such cases. The relaxed preponderant evidence standard reflects the uncertain nature of "a field bereft of complete and direct proof of how vaccines affect the human body." Id. at 1280. Although this standard is relaxed, it is not entirely limp. The Vaccine Act does not demand scientific certainty but is not satisfied by mere speculation. Rather, a petitioner's theory must be persuasive, plausible and supported by sound and reputable medical and scientific evidence.

Conclusion

The Vaccine Act provides a simplified and expedited way to compensate vaccine-injured plaintiffs without endangering the public health benefits of widespread immunization. Vaccine litigation, though somewhat specialized, is certainly no more complex than traditional tort litigation. Additionally, while the compensation may not be lucrative, it is guaranteed. Proving vaccine causation can be a scientifically intense inquiry; however, case law reiterating the relaxed "preponderant evidence" standard encourages compensating worthy claimants.

For additional reading

De Bazan v. Sec'y of HHS, 539 F.3d 1347 (Fed. Cir. 2008)

Pafford v. Sec'y of HHS, 451 F.3d 1352 (Fed. Cir. 2006)

Capizzano v. Sec'y of HHS, 440 F.3d 1317 (Fed. Cir. 2006)

Althen v. Sec'y of HHS, 418 F.3d 1274 (Fed. Cir. 2005)

Knudson v. Sec'y of HHS, 35 F.3d 543 (Fed. Cir. 1994)

Miles Coleman is a law clerk to Judge Eric Bruggink at the U.S. Court of Federal Claims in Washington, D.C.

SIDEBAR

Omnibus Autism Proceeding

On March 12, 2010, three special masters simultaneously released their opinions in the Omnibus Autism Proceeding (OAP), concluding there was insufficient evidence to support a causal link between vaccines and autism. King v. Sec'y of HHS, No. 03-584V, 2010 WL 892296 (March 12, 2010); Dwyer v. Sec'y of HHS, No. 03-1202V, 2010 WL 892250 (March 12, 2010); Mead v. Sec'y of HHS, No. 03-215V, 2010 WL 892248 (March 12, 2010). These three test cases represented approximately 5,000 pending petitions alleging that thimerosal, a mercury-containing preservative used in vaccine prior to 1999, contributed to the development of autism. These decisions follow the special masters' rulings one year earlier rejecting the claim that thimerosal, acting in combination with the measles-mumps-rubella vaccine, could cause autism.

The three most recent opinions total more than 600 pages, exhaustively detailing the credentials and testimony of the dozens of expert witnesses, thousands of pages of medical records, and the 1,200 medical and scientific articles filed into the record. The three special masters considered the same evidence and testimony, but conducted their analysis individually. Ultimately, all three reached the same conclusion, namely that petitioners' theory lacked sufficient support to show their condition was caused or significantly aggravated by any vaccine. The petitioners are expected to seek reconsideration of the rulings and eventual review by the Court of Federal Claims.