http://www.hrsa.gov/osp/vicp/mindec02.htm

53rd Meeting of the Advisory Commission
On Childhood Vaccines (ACCV)
and Conference Call
December 4, 2002

Minutes

Members Present
Elizabeth J. Noyes, MA
Lois Ann Swartzlander, RN
Thomas P. Gallagher, J.D.
John R. Schreiber, M.D.
Eileen Seemayer
Barry R. Sugarman, J.D.

Public Participants Present
David Blake/Department of Justice
Amanda Buxbaum/National Vaccine Information Center
Greg Chernick/Wilmer, Cutler & Pickering
Dack Dalrymple/ Dalrymple & Associates
Adam Eckstein/The Pink Sheet
Jeff Francer/Arnold & Porter
Arnold Gale, M.D./Stanford University
Claire Hannan/Association of State and Territorial Health Officials
Sam Kanji
Bronwen Kaye, Wyeth
Raymond MacDougall/Sabin Vaccine Institute
Peter Meyers/George Washington University School of Law
Michael Milmoe/Department of Justice
Geoffrey Peterson/Aventis Pasteur
Bruce Roberts/Robertson Roberts
Carol Ruppel/Every Child By Two
Charlene Shapiro/Wilmer, Cutler & Pickering
Mary Sherrett/ASA
Paul Strain/Venable, Baetjer & Howard, LLP

Ex Officio Members Present
Norman Baylor, Ph.D.
Barbara Mulach, Ph.D. for
Carol A. Heilman, Ph.D.
Ben Schwartz, M.D.

Executive Secretary
Thomas E. Balbier, Jr., Director, Division of Vaccine Injury Compensation (DVIC), Office of Special Programs (OSP), Health Resources and Services Administration (HRSA)

Principal Staff Liaison
Cheryl A. Lee, DVIC, OSP, HRSA

Introduction and Opening Remarks

Ms. Elizabeth Noyes welcomed the members to the 53rd quarterly meeting. The minutes of the September 4, 2002 meeting were approved.

Institute of Medicine's Report, SV40 Contamination of Polio Vaccine and Cancer, Kathleen Stratton, Ph.D.

On October 22, the Immunization Safety Review Committee (Committee) released its fifth report, entitled, SV40 Contamination of Polio Vaccine and Cancer.The Committee examined the hypothesis that exposure to polio vaccine contaminated with simian virus 40 (SV40) causes certain types of cancer. The Committee's charge was to assess both the scientific evidence regarding the hypotheses under review and the significance of these issues for society.

Some of the polio vaccine administered from 1955 - 1963 was contaminated with SV40. The virus came from the monkey kidney cell cultures used to produce the vaccine. Most, but not all, of the contamination was in the inactivated polio vaccine (IPV). Once the contamination was recognized, steps were taken to eliminate it from future vaccines. Between 1959 - 1961, experimental lots of oral polio vaccine (OPV) contaminated with SV40 were administered to about 10,000 people participating in clinical trials. Tests of stored samples of the IPV that had been administered in the United States from May through July in 1955 found varied levels of SV40 contamination with some vaccine showing no contamination. From this data, it is estimated that 10% - 30% of IPV contained live SV40 and that similar percentages of the approximately 98 million Americans who had been vaccinated by 1961 were exposed to SV40.

The Committee reviewed the epidemiologic evidence on the association between exposure to polio vaccines containing SV40 and the subsequent development of cancer. Upon this review, the Committee found studies examining cancer incidence or mortality. Also included in the Committee's review were studies of cancer occurring in children who may have had a prenatal exposure to SV40 through vaccination of their mothers.

The Committee reviewed the studies in the following three categories: cancer incidence, cancer mortality, and cancers following prenatal exposure to SV40-containing vaccine. For cancer incidence, the Committee reviewed five ecologic studies and two controlled studies. The five ecologic studies were: Fisher et al., 1999; Geissler, 1990; Olin and Giesecke, 1998; Strickler
et al., 1998; and Strickler et al., 1999. The two controlled studies were Innis, 1968 and Stewart and Hewitt, 1965.

For cancer mortality, the Committee reviewed the following two ecologic studies: Fraumeni et al., 1963, and Strickler et al., 1998. They reviewed one uncontrolled study (Carroll-Pankhurst et al., 2001), and two follow-ups to the study--Fraumeni et al., 1970; and Mortimer et al., 1981.

All of the studies that the Committee reviewed concerning cancer incidence or cancer mortality and exposure to polio vaccine containing SV40 have substantial limitations. Many of theses studies were ecologic in design. In an ecologic study, the unit of analysis is a group. Because the joint distribution of the study factors and disease within each group are unknown, it is difficult to make causal inferences regarding the association between an exposure and disease at the individual level.

Most of the epidemiologic studies on polio vaccine containing SV40 and cancer are subject to misclassification bias because of a lack of detailed and specific information about the level of SV40 contamination in individual vaccine doses. These studies were also limited by the rarity of the tumors thought to be associated with exposure to SV40.

Studies of cancer mortality are confusing due to improvements over time in the effectiveness of treatments, which may produce a decline in mortality rates that is unrelated to the incidence of the cancer. If the associations suggested by some studies in this body of weak epidemiological evidence are true, the absolute risks for additional cancer cases or deaths are small and cannot necessarily be attributed solely to exposure to SV40-contaminated polio vaccine. Based on these limitations, the Committee concluded that the evidence is inadequate to accept or reject a causal relationship between SV40-containing polio vaccines and cancer.

The Committee focused on reviewing the biological evidence with an eye toward additional research that might be needed to better understand the putative role that exposure to SV40 from polio vaccines might have in cancer. The Committee reviewed the evidence on biological mechanisms related to this hypothesis through the following three key questions: (1) Is SV40 a transforming virus; (2) Can SV40 cause cancer in humans under conditions of natural exposure; and (3) Is contamination of the polio vaccine with SV40 responsible for SV40 infection in humans?

The first question was, "Is SV40 a transforming virus?" Evidence suggested that SV40 could produce oncogenic transformation of cells that comes from four sources: rodents, nonhuman primates, cell culture studies, and humans. The earliest studies of SV40 were conducted with rodents and showed that administration to neonatal and weanling hamsters causes cancers. A seminal study (Eddy et al, 1961) demonstrated that injection of extracts of rhesus monkey kidney-cell cultures into newborn hamsters was followed by the occurrence of neoplasms in approximately 70% of the animals. Despite the limitations in their applicability to humans, these animal systems are notable in that the tumors were seen, and the human cancers were associated with the presence of SV40 or viral fragments in rodents.

Cells transformed by SV40 have been shown to grow in humans and become tumors. In a study by Jensen and colleagues (1964), persons terminally ill with cancer received implants of either homologous or autologous tissue via subcutaneous injection. When cells transformed by SV40 were implanted, nodules of undifferentiated tumor cells developed. This study provides evidence from contrived clinical conditions that cells transformed by SV40 can develop into undifferentiated tumors in a human host. Therefore, the Committee concluded that the biological evidence is strong that SV40 is a transforming virus.

The second question was, "Can SV40 cause cancer in humans under conditions of natural exposure?" There is a theoretical basis for the existence of mechanisms by which SV40 could cause cancer in humans. The principal lines of evidence for the operation of specific mechanisms are that SV40 acts in ways consistent with tumorigenesis and that DNA sequences consistent with SV40 have been detected in several types of human tumors.

Data on the association between SV40 and human tumors are inconsistent. A growing body of clinical studies reported the detection of SV40 DNA in several types of tumors. The most notable and well studied of these is mesothelioma. In addition, SV40 DNA has been detected in bone cancers, and in non-Hodgkin's lymphoma. However, other studies report an inconsistency or absence of SV40 in mesotheliomas, osteosarcomas, and brain tumors.

The conflicting results in the detection of SV40 have led to questions about technical aspects of the detection of the virus. There are questions as to whether positive findings are the result of overly sensitive, but nonspecific tests that are detecting other viruses or SV40 from laboratory contamination, or whether negative findings arise from a lack of sensitivity in the detection methods used.

The detection of SV40 in tumors does not demonstrate a causal relationship. SV40 could be a passenger virus, infecting the cells, but causing no pathology. Findings from studies examining SV40 in mesothelioma demonstrate a great deal of variability which precludes the ability at present to draw conclusions regarding the frequency with which SV40 can be detected in specific neoplasms and/or normal tissues in humans. Therefore, the Committee concluded that the biological evidence is of moderate strength that SV40 exposure could lead to cancer in humans under natural conditions.

The third question was, "Is contamination of the polio vaccine with SV40 responsible for SV40 infection in humans?" In the United States, potentially contaminated IPV was administered between 1955 and 1963. Because the process for inactivating the live polio virus could be expected to kill some of the SV40, some vaccines were likely exposed to a mixture of the live and killed virus while others were exposed only to killed SV40. Thus, exposure to IPV between 1955 and 1963 cannot be equated with exposure to live SV40 or, by extension, to infection with SV40.

There is additional uncertainty about the possible contribution of vaccine-based SV40 exposure to SV40 infection and carcinogenesis because of the age of which vaccines were exposed. Because the incidence of ependymomas is highest in children under age 5 and osteocarcoma is most common in adolescents, contemporary evidence of SV40 in such tumors does not provide a direct link to exposure to contaminated IPV between 1955 and 1963. But with the long latency period for mesothelioma, exposure to contaminated IPV remains a possibility.

Other sources of exposure to SV40 may also exist. A limited number of people have been exposed to SV40 through other vaccines, including an experimental live-virus vaccine against respiratory syncytial virus and a licensed inactivated adenovirus vaccine that was administered to military recruits.

The measures of infection remain problematic. The serology data is unclear, in part, because of concerns about cross-reactivity with certain viruses. The Committee concluded that the biological evidence is of moderate strength that SV40 exposure from the polio vaccine is related to SV40 infection in humans.

The Committee concluded that the evidence is inadequate to accept or reject a causal relationship between SV40-containing polio vaccines and cancer. The Committee also concluded that concerns about exposure to SV40 through inadvertent contamination of polio vaccines are significant because of the seriousness of cancers as the possible adverse health outcomes and because of the continuing need to ensure and protect public trust in the nation's immunization program.

The Committee does not recommend a policy review of polio vaccine by any of the national or federal vaccine advisory bodies, on the basis of concerns about cancer risks that might be associated with exposure to SV40, because the vaccine in current use is free of SV40. The Committee does recommend that appropriate Federal agencies develop a Vaccine Contamination Prevention and Response Plan. The Committee also recommends the development and use of sensitive and specific standardized techniques for SV40 detection.

The Committee further recommends that once there is agreement in the scientific community as to the best detection methods and protocols, pre-1955 samples of human tissues should be analyzed for presence or absence of SV40 in rigorous, multi-center studies. The Committee recommends further study of the transmissibility of SV40 in humans.

Until some of the technical issues are resolved, the Committee does not recommend additional epidemiological studies of people potentially exposed to the contaminated polio vaccine.

Discussion of VICP Provisions in the Homeland Security Act of 2002:
Emily Marcus Levine, J.D.

Ms. Emily Marcus Levine, J.D. presented an overview of sections 1714-1717 in the Homeland Security Act of 2002 (P.L. 107-296) affecting the National Vaccine Injury Compensation Program (VICP) and on section 304 which provides liability protection to health care providers administering the smallpox vaccine under certain circumstances.

On November 25, 2002, the President signed into law the Homeland Security Act (HSA). There are two vaccine liability issues in the HSA that affect the VICP. The first issue is modifications to the National Childhood Vaccine Injury Act of 1986 (Act), as amended, which incorporates several sections of the March 21 version of, "Improved Vaccine Affordability and Availability Act" (S. 2053), introduced by Senator William Frist, (R-TN). The second issue is smallpox liability.

Prior to the enactment of the HSA, the Act's definition of manufacturers extended only to manufacturers of vaccines on the Vaccine Injury Table (Table). This definition did not include manufacturers of components of ingredients in these vaccines.

In HSA, Section 1714, "The Clarification of Definition of Manufacturer," amends the definition of manufacturer to include manufacturer of any components or ingredients of vaccines on the Table. This change extended the Act to allow liability protection for vaccine-related claims against manufacturers of thimerosal.

In HSA, Section 1715, "Clarification of Definition of Vaccine-Related Injury or Death," clarifies the definition of "vaccine-related injury or death." It states that a preservative that was intentionally used as a component of a vaccine is not an adulterant or contaminant. It also states that any component or ingredient that is listed in a vaccine's product license application and product label is not an adulterant or contaminant. Therefore, thimerosal would be not considered an adulterant or contaminant of a covered vaccine under the Act. In the Department's view, this section was a mere clarification of preexisting law.

Prior to the enactment of the HSA, the Act did not provide a definition for a vaccine. Section 1716 of HSA, "Clarification of Definition of Vaccine," provides the following definition of a vaccine, "any preparation or suspension, including but not limited to a preparation or suspension containing an attenuated or inactive microorganism or subunit there of or toxin, developed or administered to produce or enhance the body's immune response to a disease or diseases and includes all components and ingredients listed in the vaccine's product license application and product label." This provision makes it explicit that a preservative listed in a vaccine's product license and product label is included in the definition of a covered vaccine. This provision requires claims alleging injuries from a thimerosal component of a covered vaccine to be pursued initially through the VICP before other civil litigation can be pursued.

Several proposals in S. 2053 that would affect thimerosal civil actions were included in the HSA. For example, in section 203, "Jurisdiction to Dismiss Actions Improperly Brought," would have prohibited awards in civil actions for claims where an individual had not proved that any physical injury had occurred. In Section 202, "Equitable Relief," would have extended the Act to apply claims seeking equitable relief.

There are other proposals in S. 2053 that were not specifically targeted to addressing thimerosal claims, but were targeted toward making the VICP more efficient and generous. First, Section 207, "Increase in Award in the Case of a Vaccine-Related Death and for Pain and Suffering, " would have increased the $250,000 award for death and the $250,000 award for pain and suffering to $350,000. Second, Section 212, "Extension of Statute of Limitation," would have extended the statute of limitations for a vaccine-related injury from 36 months to 6 years, and upon death, extended from 48 months to 6 years after the onset of the first symptoms or significant aggravation of the injury from which death resulted.

The enactment of the HSA did not affect the Act or state law statute of limitations provisions. The Act has two statute of limitation provisions that may affect thimerosal claims. One provision states that the date the civil action was dismissed would be considered the date the VICP petition was filed for purposes of calculating the statute of limitations under the Act. This gives petitioners the benefit of this time period, so long as the petition is filed within one year from the date that the civil action was dismissed.

Under the Act, the statute of limitation provision specifies that the state law statute of limitations provision will be tolled during the pendency of the VICP claim. If a proper VICP petition is filed, the limitations period under state law will be stayed with respect to the civil action brought for the same injury/death claim from the date the VICP petition is filed, and until the date the VICP petitioner elects to reject the VICP judgment.

The HSA provisions apply to all actions or proceedings pending on or after the date of enactment, unless a court of competent jurisdiction has entered judgment (regardless of whether the time for appeal has expired).

Smallpox Liability

In HSA, Section 304, "Conduct of Certain Public Health-Related Activities," includes smallpox liability protection and countermeasures. It also includes the Secretary of Health and Human Services' (HHS) obligations, along with the Secretary of Homeland Security, to set priorities and develop strategies for research and development relating to counter measures against terrorist threats.

Section 304 authorizes the Secretary of HHS to issue a declaration for a set period of time to administer smallpox countermeasures to a group of individuals. The declaration has to be published in the Federal Register, and once it is finalized, it will provide liability protection to healthcare providers administering the smallpox vaccine. This group of individuals would be deemed "covered persons" and "employees of the Public Health Service." If an individual sustains an injury they believe resulted from the smallpox vaccine, they would be able to bring a lawsuit under the U.S. Federal Tort Claim Act (FTCA). This would be the only lawsuit an injured could file for an injury from smallpox vaccine.

If the Secretary of HHS does not issue a declaration and someone received the smallpox vaccine, or if the person were not covered by the declaration, the injured person would have the rights he/she would normally have under current law to seek legal redress.

Under HSA, a "covered person" includes the following four categories of individuals: manufacturers and distributors of a covered countermeasure; healthcare entities under whose auspices countermeasures were administered; a qualified person who administered the counter- measure (this would be a licensed healthcare professional/other person authorized to administer countermeasure under State law where administered); and any agent/employee of any person in the above categories. These covered persons are shielded from liability because they would be protected under FTCA, which is the exclusive remedy for seeking damages for smallpox vaccine related injuries and deaths.

The U.S. is liable for a claim arising from the administration of a covered countermeasure, including the smallpox vaccine, if certain requirements are met. The countermeasure had to be administered by a qualified person. It had to be administered for the purpose of preventing or treating smallpox. It also had to be administered during the effective period of the Secretary of HHS' declaration, and the injured person had to be within the category of person that the Secretary of HHS recommended receive the countermeasure.

The HSA also covers liability for non-vaccine recipients. If someone suffers an injury by being in close contact with someone who received the smallpox vaccine, then for the purposes of the HSA, he/she is treated as if he/she received the smallpox vaccine. The non-vaccine recipient would have to contract vaccinia during the effective period of the Secretary of HHS declaration or within 30 days thereafter. In the alternative, the injured person would have to reside with a vaccine recipient or reside with a vaccine recipient who was a covered person under the Secretary of HHS declaration, and the non-vaccine recipient would have to contract vaccinia after that date. Under certain circumstances, the U.S. can oppose or deny a claim.

The HSA makes clear that in order for a legal action to proceed against the U.S. under the FTCA, the U.S. Attorney General would have to make a certification that the action was filed against a covered person, and that action was based on a claim alleging injury/death arising from administration of covered countermeasure. This certification would establish facts for determining certain jurisdictional issues.

The HSA does not specifically impose any limitations on damages under the FTCA, or under state law. The FTCA incorporates state law provisions on damages, but punitive damages would not be allowable.

Update on Thimerosal Litigation: Luke Sobota, J.D., Wilmer, Cutler & Pickering

Luke Sobota is an associate attorney with the firm of Wilmer, Cutler and Pickering. Mr. Sobota stated that he is not the counsel of record in any of the thimerosal related lawsuits and that his discussion would not reflect the positions of any party in these lawsuits.

In June, there were 67 thimerosal lawsuits filed. Currently, there are 190 thimerosal related lawsuits filed in state and Federal courts. Out of these cases, there are 12 putative class actions, which purport to represent 175 million individuals who have received a vaccine containing the preservative thimerosal. None of these putative class actions lawsuits have been certified.

These lawsuits have been filed against vaccine manufacturers, manufacturers and distributors of thimerosal, and doctors and other administrators of the vaccines.

The complaints filed in these lawsuits fall into three categories. First, children alleging autism or other neurodevelopmental disorders that they claim were caused by thimerosal. Second, children who have received a vaccine containing thimerosal, but do not currently have an injury. These plaintiffs are seeking future medical monitoring of their health. Third, parents and other third parties alleging injuries arising out of the child's vaccine related injury or death (derivative claims).

Most of the courts have been willing to permit these derivative claims filed by parents to continue in state court notwithstanding the VICP. Although the remedies available differ among the state courts, they have recognized that parents might be eligible to receive compensation for loss of consortium, loss of services of the child, lost wages, and medical expenses.

On November 5, Federal Judge Sarah Vance permitted a derivative claim filed by a vaccinated child's parents to go forward under state law. The parents in that case alleged that the manufacturers of vaccines and thimerosal were negligent in failing to adequately test the vaccines, in failing to consider alternatives to thimerosal as a preservative, and in failing to adequately warn of potential dangers.

The court's ruling that the claims could go forward was interesting in two respects. First, the child never filed a petition with the VICP, and sought no relief in this case. The only claims filed in this case were the parents' derivative claim for loss of consortium, intentional infliction of emotional distress, and lost wages. The court held that the parents' claims for loss of consortium and lost wages could go forward.

Second, the court held that there was no need to wait for the child to file a petition with the VICP, even though the VICP would ordinarily decide whether or not the vaccines caused the child's alleged injuries. The court instead held that it would independently make that causal determination in the process of resolving the merits of the parents' derivative claims.

Other courts have ruled that the parents' derivative claims should be stayed until the VICP has resolved the child's underlying petition. These courts have noted that parallel claims could result in inconsistent decisions and could frustrate the Act's purpose of sparing the vaccine industry from the expenses of duplicative litigation.

All of the courts addressing direct cases filed by children alleging thimerosal related injuries have held that they must first be brought under the VICP before going into state or Federal court. These courts have rejected the plaintiff's argument that thimerosal is not covered under the Act because it is an "adulterant or contaminant" intentionally added to the vaccine. However, these decisions do not mean that these cases will be filed with the VICP. Plaintiffs have developed other theories to keep their cases in state court and out of the VICP.

In Leroy v. HHS, the U.S. Court of Federal Claims held that thimerosal is antithetical to an "adulterant or contaminant" because it prevents corruption of the vaccine. The court further held that thimerosal is a constituent part of the vaccine's suspension or preparation; and therefore, covered by the VICP.

Even though the state and Federal courts appear to agree that thimerosal is a constituent part of a vaccine and therefore, covered by the VICP, it does not mean that these cases will now be filed in the VICP. These court decisions only address one of several bases that plaintiffs have asserted for not filing under the VICP.

For example, some courts have held that parents' derivative claims can continue in state court notwithstanding the VICP. These derivative claims often present the same legal issues and sometimes even seek the same type of damages that the VICP would address with respect to the underlying petition. In addition, plaintiffs have amended their complaints to evade the VICP by seeking damages of less than $1,000 or by seeking medical monitoring.

The vast majority of courts in the thimerosal lawsuits have not addressed these issues and the decisions that were made by some courts are subject to further appellate review.

Report on the Division of Vaccine Injury Compensation (DVIC): Thomas E. Balbier, Jr.

On October 18, DVIC moved from the Parklawn Building in Rockville, Maryland to the East-West Towers Building in Bethesda, Maryland. Our new mailing address is 5600 Fishers Lane, Room 16C-17, Rockville, Maryland, 20857 and our phone and fax numbers will remain the same.

There has been a huge influx of cases filed. In Fiscal Year (FY) 2002, there were 953 claims filed. This increase is due to thimerosal and autism cases being filed. In FY 2003, 160 claims have been filed thus far.

The annual total for awards paid for post-1988 cases has changed over the years. In FY 2001, the total paid was almost $84 million. In FY 2002, the total was $56.9 million, and so far in FY 2003, $12.2 million has been paid.

Beginning in January 1999, DVIC developed an initiative in partnership with the Office of the General Counsel (OGC), Department of Justice (DOJ), and the U.S. Court of Federal Claims (the Court) to expedite the adjudication of the remaining pre-1988 claims. As of November 18, only 6 claims remain to be adjudicated.

The Vaccine Injury Compensation Trust Fund (Trust Fund) balance is $1.8 billion. The amount of money received in the Trust Fund from October 1, 2001 through September 30, 2002 was $176 million. The interest income earned was $74 million, and the excise tax collected was $102 million.

On October 3 and 4, the VICP held a Strategic Planning Retreat (the Retreat) at the Hyatt Regency Hotel in Bethesda, Maryland. The Retreat was facilitated by the Vantage Human Resources Services, Incorporated (Vantage). Approximately, 55 VICP stakeholders attended the Retreat. The stakeholders in attendance were: 15 staff from the Health Resources and Services Administration; 2 staff from the Office of the General Counsel; 7 members of the ACCV; 5 parents of children who had filed claims under the VICP; 7 attorneys representing petitioners and vaccine companies; 3 representatives of vaccine companies, 9 individuals representing medical organizations; 5 representatives of parent or consumer interest groups; and 1 individual from the Clerk's Office of the U.S. Court of Federal Claims.

The participants provided valuable comments on the draft strategic plan, and on the draft implementation and communication plans for the strategic plan. The VICP Strategic Planning Workgroup (the Workgroup) developed the strategic plan. Comments received from the participants stated that the Retreat provided an opportunity for a frank discussion of issues and challenges facing the VICP, as well as a forum for presenting potential solutions to these challenges. All the participants expressed an interest in continuing their involvement in the strategic planning process until its completion in December. The participants also expressed sincere hopes that some positive changes will occur as a result of their efforts.

The next major activities of the Workgroup will be to obtain comments on the draft plan from the ACCV members and other participants this afternoon, and review and incorporate appropriate comments into the final strategic plan.

There has been lots of legislative activity. On September 5, Ms. Elizabeth J. Noyes, ACCV Chair, sent a letter to Tommy Thompson, Secretary of Health and Human Services
(the Secretary) recommending changes in various provisions in the "Improved Vaccine Affordability and Availability Act" (H.R. 5282). This bill is the House version of S. 2053, and was introduced by Representatives Jim Greenwood (R-PA) and Edolphus Towns (D-NY).

On September 18, the House Committee on Government Reform held a hearing titled "Continuing Oversight of the National Vaccine Injury Compensation Program." Chairman Dan Burton conducted this hearing as a follow-up to the VICP hearings held on November 1 and December 12, 2001. The purpose of the hearing was to discuss the cases of petitioners, Ms. Janet Zuhlke and Mr. Thad Rogers. The hearing consisted of two panels. The first panel consisted of Ms. Zuhlke and Mr. Rogers. They testified about their experiences in seeking
compensation through the VICP. Mr. Ron Homer, an attorney representing Mr. Rogers was also a member of this panel. The second panel consisted of Mr. Paul Clinton Harris, Jr., Deputy Associate Attorney General, DOJ, and Mr. William Hobson, Director, Office of Special Programs, HRSA. They were asked their views on the "National Vaccine Injury Compensation Improvement Act of 2002" (H.R. 3741).

On September 18, Daniel J. Bryant, Assistant Attorney General, DOJ, sent a letter to Rep. Dan Burton (R-IN), Chairman of the House Committee on Government Report, expressing DOJ's views on the "National Vaccine Injury Compensation Program Improvement Act of 2002" (H.R. 3741).

On November 25, the President signed into law the Homeland Security Act of 2002 (HSA), which established the Department of Homeland Security. The HSA includes provisions from the "Improved Vaccine Affordability and Availability Act," a bill introduced by Senator William Frist (R-TN) on March 21, 2002. Sections 1714 -1717 revise the definition of a manufacturer, clarify the definition of a vaccine-related injury or death, and adds the definition of a vaccine. These sections would require future and pending civil lawsuits to first be filed with the VICP. Presumably, this would remove from the state courts future and pending individual and class action lawsuits alleging that thimerosal and/or covered vaccines caused autism.

In HSA, Section 304 provides liability protection to health care providers and hospitals administering the smallpox vaccine, and the manufacturers of this vaccine through the Federal Tort Claims Act if the Secretary issues a declaration that a bioterrorist threat makes it advisable to implement a countermeasure, such as administration of the smallpox vaccine. Under this section, the only recourse for individuals filing claims or actions alleging injuries from the smallpox vaccine would be to sue the U.S. in Federal court although State laws would apply. This section would not allow claims alleging injuries or deaths from the smallpox vaccine to be filed with the VICP.

In September, the U.S. General Accounting Office released a report entitled, "Ensuring an Adequate Supply Poses Continuing Challenges." This report addresses the following issues: the recent childhood vaccine shortages; what factors have contributed to the vaccine shortages; and what strategies are Federal agencies considering to help mitigate disruptions in the vaccine supply.

On October 8-9, Dr. Geoffrey Evans, Medical Director, represented the Health Resources and Services Administration (HRSA) at the National Vaccine Advisory Committee (NVAC) meeting in Washington, D.C. Agenda topics included: payment rates by Medicare for vaccine administration, vaccine supply shortages, and smallpox vaccine policy. In addition, Dr. Evans co-chaired the Subcommittee on Vaccine Safety and Communications, and reviewed the Centers for Disease Control and Prevention's (CDC) smallpox vaccine communication plan and future topics for the Institute of Medicine Immunization Safety Review Committee. Ms. Noyes, ACCV liaison to NVAC, provided a briefing on the VICP Strategic Planning Retreat, and an update thimerosal-related litigation.

On October 16-17, Dr. Evans attended the CDC's Advisory Committee on Immunization Practices meeting in Atlanta, Georgia, and provided an update on the VICP.

On November 8, Commander Carol L. Konchan presented an overview of the VICP to approximately 225 participants at the Annual Kansas Immunization Conference in Topeka, Kansas. The conference was sponsored by the Kansas State Nurses' Association. The presentation included the history of the VICP, as well as the general process of filing a claim with the VICP.

On September 23, Ms. Elizabeth Rezai-zadeh joined the VICP as a HRSA Scholar. She has completed a B.S. degree in Microbiology and a M.P.H. in Epidemiology at the University of South Florida in Tampa.

On October 21, Lieutenant Nichole Chamberlain joined the VICP as a Program Analyst in the Policy Analysis Branch. She has a Bachelors degree in Nursing. Formerly, she worked in HRSA's Office of Peer Review as a Program Analyst.

Effective November 17, Ms. Doris Cooper, Program Analyst, Program Operations Branch, was promoted from a Grade 9 to a Grade 11.

On November 13, the 20th Annual 2002 HRSA Awards Ceremony was held and two VICP staff received distinguished awards. Mr. Ward Sorensen, Chief, Program Operations Branch, received the Administrator's Award for Excellence for his extraordinary contributions over a decade of development, implementation, and evolution of the VICP. Ms. Carole Marks, Management Analyst, Program Operations Branch, received the Administrator's Special Citation Award for extraordinary contributions in the design, conversion, and implementation of the VICP's internal data system.

On November 29, Ms. Judy Ceresa left the VICP after 8 years of invaluable service to join HRSA's Office of Rural Health as a coordinator of grants.

Report of the Department of Justice (DOJ): Mark Rogers, J.D., Acting Deputy Director for the Torts Branch, Civil Division

Mr. Mark Rogers gave an update on autism and other cases currently being handled at DOJ.

DOJ has been working on an ongoing initiative to review all the 1997 and older docket number cases (hereinafter referred to as "Project 97"). DOJ is looking at various methods to complete the adjudications of these cases. These methods include: working with the Special Masters to reconsider the possibility of settlement in these cases; locating additional medical records, and encouraging petitioner's counsel to respond more quickly.

At the start of Project 97, there were 70 such cases at DOJ. In the past 8 months, 41 cases were resolved, with 29 cases still pending. Thirteen of these cases are awaiting attorney's fees, and fifteen cases are pending resolution before the Special Master.1

DOJ has been focusing on settling cases fairly and quickly. Over the past 18 months, 71 cases have been settled. This number represents over half of the cases compensated during this period. Forty percent of the cases were settled within a year of being filed; 21 percent were settled within two years of filing; and 25 percent were settled within three years of filing. The average time to process the settlement of a case is approximately 11 weeks, and DOJ has been working with the Special Masters to ensure that the process takes no more than 15 weeks.

DOJ has also been resolving cases using Alternative Dispute Resolution (ADR). This method is being used instead of litigation to resolve a case. A Special Master who is not assigned to the case acts as a mediator between the parties to resolve the case. Over the past 18 months, DOJ has participated in 18 ADR resolutions. This is compared to just 17 ADRs in the first ten years of the Program.

In the past year and a half, DOJ has had only 5 hearings on the amount of damages that should be awarded. There are 5 cases on appeal to the U.S. Court of Federal Claims (Court), and one of these cases was appealed by DOJ. Currently, there are no appeals pending at the U.S. Court of Appeals for the Federal Circuit.

Currently, there are approximately, 1,000 petitions filed alleging injuries due to thimerosal. These cases are currently moving on the track of an omnibus autism proceeding. This proceeding gives anyone who has a claim alleging autism the opportunity to opt into the proceeding, and consolidates the cases for purposes of processing. Most of these cases are being filed without medical record documentation.

The specific inquiry in individual cases will be stayed until the general questions are answered.

Currently, the autism cases are in the discovery phase. This phase involves producing relevant documents to support a position in the case. DOJ developed a Motion For Protective Order to clarify the rules for production of documents submitted to a Special Master. A party in a Vaccine Act proceeding may not disclose information to a person who is not a party in the proceeding without the express written consent of the person submitting the information. The Motion for a Protective Order sought to have this ordinary protection extend to the Omnibus proceedings.

Mr. Rogers stated that the number of autism cases will stress the VICP's capability to handle these cases, and that DOJ will move these cases along as fairly and less litigiously as possible.

Update from the U.S. Court of Federal Claims: Gary Golkiewicz, J.D., Special Master

Chief Special Master Golkiewicz reported that he would give a broad overview of activities of the U.S. Court of Federal Claims (Court).

The Special Masters have been working diligently to resolve the pre-1988 cases. The Court is down to one pre-1988 case, and it is currently tied up with Medicaid issues.

The use of ADR in resolving cases has been successful as parties in the case become more comfortable with the process. The Court has encouraged parties to utilize ADR for more than just settling cases. ADR can be used to assist parties in closing communication gaps, gathering information, narrowing issues, resolving collateral issues, and preparing the case for trial.

Last spring, a Process Committee (the Committee) was formed by the Court to review, evaluate, and suggest changes in the litigation process. The Committee consists of Court representatives, DOJ representatives, Petitioners' Counsel, Chief Special Master Gary Golkiewicz, Thomas Gallagher, J.D., Vito Caserta, M.D., Deborah Harris, J.D., and Emily Marcus Levine, J.D. The Committee's views on the litigation process will be taken into consideration for changes in the Court's procedural guidelines.

In 2000, there were 350 hepatitis B cases filed. The Court has categorized these cases into ten groups. Four of these groups represent approximately 100 cases. The remaining six groups of cases are stayed until supporting documentation can be found. Special Master Golkiewicz stated that his priority at the Court would be to monitor the progress of both groups of cases.

The Court has formed another committee to discuss the best methods for handling autism cases. Chief Special Master Golkiewicz established two governing principles at the start of the committee that will affect the handling of autism claims. The first principle is the Court cannot litigate thousands of cases individually. There are insufficient resources available to review the individual petitions and medical issues. Second, the causation issue will be determined to be decided in two years.

Chief Special Master Golkiewicz issued the "Autism General Order #1" (the Order), as a result of the tremendous efforts from this committee. This order discusses the process and timeframes for procedures leading to a decision in an autism case.

The autism proceedings started on July 3, 2002 and a decision will be issued no later than July 3, 2004. Special Master George Hastings is overseeing the autism proceedings. Chief Special Master Golkiewicz is assisting by working with attorneys to work out disagreements, accepting new ideas for better case strategy, and listening to complaints. Most importantly, Chief Special Master Golkiewicz is working to see what cases or categories of cases are candidates for settlements.

The autism cases will also be assisted by medical experts, who will provide scientific information and medical theories to help the Court understand the litigative risks, and determine if settlement is a possibility.

There have been several difficulties in processing the autism claims. First, the Respondents have challenged the Order relating to the completeness of a petition. They have moved to dismiss the case based on an incomplete petition. The National Childhood Vaccine Injury Act of 1986, as amended (the Act), states that petitioners shall file a complete petition. A ruling on a response to this motion will be issued later this month.

Second, the Act states that Special Masters must issue a decision on a petition no later than 240 days. At the close of this period, the petitioner has the option to continue in the VICP or withdraw their petition. If a petitioner elects to continue in the VICP, but later withdraws their petition, a question arises if they have a right to do so, or is it irrevocable that they continue in the VICP. The Act is silent on this issue.

Lastly, the biggest issue the Court is facing is causation. This issue dictates how much information is needed, defines the nature of the proceedings, and whether a case can be decided based upon medical records, witnesses, doctors, or medical experts. The Act does not provide help in defining "causation." The Act states that it must be shown that the vaccine caused the injury. The Appellate Court has dealt with some causation-in-fact issues, but there is no case, which presents the issue of standards to be applied in a causation-in-fact case.

Chief Special Master Golkiewicz stated that when the VICP started 14 years ago, virtually all the cases were litigated as vaccine injury Table cases. These types of cases were easy to decide because the proof of injury was a straightforward factual determination. Now, virtually all cases are litigated as causation-in-fact cases. These cases raise many issues and petitioners must prove their injury using traditional tort standards that the vaccine in fact caused the injury. He stated that the change in how causation is determined impacts every facet of litigation in the VICP.

Discussion on the National Vaccine Injury Compensation Program's Revised Draft Strategic Plan: Ana Rodriquez, Ed.D.

Ms. Ana Rodriquez, Ed.D. has a doctoral degree in organizational development from the University of Massachusetts. She has advised other programs in the Federal government in organizational development. She has been extremely involved with the VICP in developing their Strategic Plan. Ms. Rodriquez requested comments on the VICP's strategic themes and objectives from the ACCV and other participants. The comments received are provided below.

Theme 1 - Develop a consistent standard for determining off-Table cases.

Mr. Barry Sugarman, J.D. commented that using a term to imply a relaxed standard for determining off-Table cases would be a benefit to petitioners.

Dr. Arnold Gale commented that it would be easier to establish a standard that would make it easier for the VICP to be understood by all parties, i.e. Special Masters and attorneys.

Mr. Peter Meyers, J.D. reiterated that the standard should be a somewhat relaxed standard to create a more generous type of compensation program.

Ms. Deborah Harris, J.D. commented that the standard needs to be changed to be more consistent and specific.

Mr. Thomas Gallagher, J.D. stated that the increase in causation-in-fact cases have occurred because the guides to interpretation have been changed for Table cases. The causation-in-fact cases have a more difficult burden of proof, and this defeats the intent of Congress to compensate individuals in a fair manner.

Dr. Rodriquez stated that after considering the comments on Theme 1, it might be changed to: "Develop a more relaxed and consistent standard for determining off-Table cases."

Objective 1.5 - Establish limits of legal discovery

Mr. Sugarman commented that it would be unfair to limit discovery to petitioners with non-Table case injuries because it would limit their rights, and they carry the burden of proof in proving their case.

Ms. Jackie Noyes stated that legal discovery should be limited, but not less restrictive than what is currently set.

Theme 2 - Structure the National Vaccine Injury Compensation Program (VICP) to be responsive to evolving science, medicine, and policy actions.

Ms. Noyes stated that the word "structure" in Theme 2 could be replaced with "assure." She stated that keeping "structure" in the sentence implies that the VICP is not responsive to evolving science, etc.

Objective 2.3 - Advocate for the exploration of other funding options for research into vaccine-related injuries.

Dr. John Schreiber suggested that it might be useful to request research funds for the National Institute for Allergies and Infectious Diseases at the National Institute for Health to conduct research on vaccine related injuries.

Objective 2.1 - Decrease the number of claims that are not brought on a "reasonable" basis, perhaps by establishing a more specific definition of "reasonable."

Ms. Noyes stated that this objective was negative, and implied that claims should be reduced.

Dr. Schreiber stated that this objective should be changed to: "Establish a more specific definition of "reasonable."

Mr. Gallagher stated that language in objective 2.1 needs to refer to bringing a case on a good faith basis after an examination of the medical records, and after consultation with physician, and if there is a reasonable basis to believe that there is an injury associated with a vaccine.

Dr. Rodriquez reported that objective 2.1 might be changed to, "Increase the number of cases that are based upon a reasonable basis, as long as they are meritorious and based upon a scientific basis."

Theme 3 - Simplify the process sufficiently enough to make it understandable to the claimants, attorneys, physicians, special masters and others.

Ms. Noyes stated that this theme implies that the information that is sent out on the VICP is not understandable or sufficient enough. She stated that this theme indicates that some sort of measure is needed to indicate how well the VICP is understood. She further stated that simple language is needed for people to understand it.

Dr. Gale stated that since he was a part of the VICP Draft Strategic Planning Workgroup, they discussed that communication can always be improved to explain the VICP and let the public know that the VICP is here to serve them.

Objective 3.1 - Identify key indicators of a lack of knowledge of misinformation regarding how the VICP functions.

Mr. Sugarman stated that this objective should be deleted in its entirety because it overlaps with Theme 4. He stated that a marketing research strategy could be done to identify the key problems in publicizing the VICP.

Dr. Rodriquez stated that Theme 3 might be changed to, "Streamline the process to make it more user friendly or understandable to the claimants, attorneys, physicians, and special masters." She stated that objective 3.1 may be deleted, and that objectives 3.2 and 3.3 may also be deleted because they are very similar.

Theme 4 - Increase knowledge about the VICP among all stakeholders. The Strategic Planning Workgroup acknowledges that communication about the existence of the VICP, while necessary, is potentially frightening to people. It is vitally important to communicate to the public the message that, while vaccines are essentially safe, the VICP's goal is to compensate the small number of people who suffer a significant adverse event to covered vaccines.

Ms. Lois Swartzlander commented that she objected to the phrase "small number of people" because the numbers of vaccine-injured people are growing, and some parents might be offended by this phrase.

Dr. Schreiber stated that "potentially frightening" should be removed. He said that it could be implied that the VICP is frightening. He stated that is important to make parents aware of the VICP, as well as to make them aware of the effects of the diseases if vaccines are not administered.

Ms. Eileen Seemayer stated that it is important that physicians communicate to new parents the existence of the VICP, especially during the child's first year of life.

Objective 4.2.2 - Partnering with healthcare providers, advocacy groups, government agencies, and public organizations to assure vaccine benefits and risks and information about the VICP ("who to turn to on those rare occasions when something goes wrong)" are given to parents, or those adults taking a vaccine, all the time the vaccine is being considered/administered, and to increase and improve the distribution of the Vaccine Information Statements to vaccine recipients or their parents in the case of a minor child.

Dr. Schreiber stated that the bar associations need to be listed in this objective because they need to be made more aware of the existence of the VICP.

Ms. Swartzlander stated that the word "rare occasions" should be deleted because when a vaccine injury occurs it does not feel like a rare occasion at the time.

Dr. Rodriquez stated that Theme 4 might be changed to: "Increase knowledge about the VICP among all the stakeholders. The Strategic Planning Workgroup acknowledges that it is vitally important to communicate to the public that while vaccines are essentially safe, the VICP's goal is to compensate people who suffer a significant adverse event to covered vaccines." She stated in Objective 4.2.2 "state and local bar associations" may be added to the partnering groups. Also in this objective, the word "rare" may be deleted.

Theme 5 - Recognize and address the growing threat posed by bioterrorism.

Ms. Noyes asked if this theme was in place because someday the bioterrorist drugs will be covered under the VICP. She also stated that Theme 5 should be moved to the end of the theme list because the Homeland Security Act of 2002 addresses smallpox liability, and the VICP is not mentioned in the bill.

Ms. Tamara Overby stated that Theme 5 was created in case the VICP would someday have to cover bioterrorist drugs.

Dr. Schreiber asked if someday the VICP would be engaged to assist with smallpox liability. He stated that the VICP was designated to compensate children injured by childhood vaccines. He added that smallpox injuries could deplete the Trust Fund.

Ms. Bronwen Kaye stated that a smallpox compensation program could be modeled after the VICP. She stated that the VICP personnel could assist with the smallpox claims because of their expertise, and this new program could have a different funding source.

Mr. Dack Dalrymple, J.D. commented that another possibility for a smallpox compensation program would be that the President could create an emergency compensation program if a smallpox outbreak were to occur, and base it upon how many people are injured and an appropriate economic response.

Ms. Carol Ruppel suggested deleting Theme 5. She stated this theme is misleading, and that the strategic plan is meant to strengthen the issues in the VICP.

Objective 5.2 - Define the risks posed by a potential bioterrorism attack.
Objective 5.3 - Collect, maintain and analyze data regarding such vaccines, reported adverse events, and the infections themselves. Utilize appropriate data.

Dr. Schreiber stated that objectives 5.2 and 5.3 should be deleted because 5.2 defines the risk posed by a potential bioterrorism attack and the VICP should not be involved. He stated that objective 5.3 deals with analyzing and collecting data vaccines and adverse events, and that the VICP is not a data collection agency that follows adverse events.

Dr. Rodriquez reported that Theme 5 may be moved to the end as Theme 9, and that Theme 5 may be change to: "Recognize and address the potential role of the VICP and the growing threat posed by bioterrorism." She also reported that the objectives under Theme 5 need to be reviewed to possibly be change and more generalized.

Theme 6 - Encourage the continued preservation of the Vaccine Injury Compensation Trust Fund to ensure funds are available to pay awards to claimants who have been found to be eligible for compensation.

Ms. Seemayer commented that the word "encourage" needs to be deleted from Theme 6.

Ms. Overby stated that the word "encourage" is used because most people do not know that the Department of Treasury controls the Trust Fund. She stated that the use of funds in the Trust Fund must be monitored by the VICP to keep track of the balance and to ensure that it is being used as intended by Congress.

Mr. Balbier stated the word "preservation" in Theme 6 implies that the goal would be not to pay out funds. He stated that the VICP has no control over the collections and investments in the Trust Fund, but the VICP does provide input to the Department of Treasury on investments.

Mr. Gallagher stated he did not agree with "preservation" either. He stated that the Trust Fund should continue to be used to compensate legitimate claims.

Dr. Rodriquez stated that Theme 6 might be changed to "Maintain the integrity of the vaccine injury compensation Trust Fund."

Theme 7 - Streamline administrative handling of the claims to facilitate a less time consuming process.

Ms. Noyes questioned if Theme 7 should be combined with Theme 3 since the topic matters are similar. Dr. Schreiber concurred.

Ms. Overby commented that Theme 7 could be an objective under Theme 3. She stated that Theme 7 relates to the process of the claim, whereas Theme 3 deals with all the steps involved in processing a claim.

Dr. Rodriquez noted that Theme 7 would be reviewed by the Workgroup to give it a new title to distinguish it from Theme 3.

Objective 8.1 - Convene a conference, sponsored by the ACCV and attended by all stakeholders, to consider, based on an improved VICP, whether:

Ms. Noyes asked if a workgroup should be formed to review and discuss the current vaccine litigation issues (e.g., thimerosal cases).

Dr. Schreiber commented that he would be very interested in a conference or workgroup to address increases in civil litigation and thimerosal injuries, and send suggestions to the Secretary of HHS.

Mr. Balbier stated that he did not agree it was necessary to have a conference over a particular vaccine issue when workgroups of the ACCV have been formed to hash out difficult and contentious issues.

Dr. Schreiber stated that in Theme 8, the phrase "thimerosal-related injuries" should be deleted. He said that there is no data that supports injuries related to thimerosal.

Dr. Rodriquez stated that there are no changes to Theme 8. Objective 8.1 will be further discussed and maybe reworded at a later time. She also stated that forming a workgroup would be considered.

Objective 8.1.1 - it would be more beneficial to all stakeholders, as a national health policy, to eliminate all civil litigation based on vaccines

Mr. Gallagher commented that Objective 8.1 and its subcategories are unconstitutional. He stated that it would be unfair to take away the right of the individual to sue a vaccine manufacturer if they are not satisfied with the VICP award.

Mr. Sugarman concurred with Mr. Gallagher's comment that is unconstitutional to take away a right of an individual to seek other legal remedies. He stated the mission of the VICP is not to legislate the due process in other U.S. courts.

Ms. Kaye stated that the purpose of the objective is to convene a group and discuss the different themes, while deciding what to keep and what to change.

Dr. Schreiber stated that it is not the VICP's purview to change the process of civil litigation. He further stated that the purview of the VICP should be to maintain vaccine supply and protect children against diseases.

Objective 9.2 - Extend the statute of limitations to at least six years.

Ms. Noyes stated that objective 9.2 has already been addressed by the ACCV, and is part of the legislative proposals.

Ms. Overby stated that they are looking at processes that have not taken place yet under the VICP, so it can be included as a strategic objective.

Objective 9.3 - With input from the ACCV, consider restructuring the entire claims process so that the determination of whether an injury is vaccine related is an entirely administrative process.

Ms. Overby gave an example of administratively processing claims. She stated the Veterans' Affairs uses guidelines to determine if someone is entitled to compensation.

Dr. Geoffrey Evans stated the Veterans Affairs uses an administrative process for processing Agent Orange Program claims. He stated that this program is streamlined and less adversarial with a large number of individuals being compensated using a relaxed standard.

Ms. Seemayer commented that she would rather have a lawyer handle a claim instead of an administrative process of filling out paper work.

Mr. Sugarman stated it is important to have a lawyer litigating on the claimants' behalf because they have a right for their story to be told and tried by a judge. He said the administrative process takes that right away.

Dr. Rodriquez stated that objective 9.3 may be reconsidered at a later time, and Objective 9.2 may be either eliminated or restated to ensure it meets the need of the VICP. She also stated that objective 9.7 would be reconsidered.

Ms. Overby stated the next steps of the Strategic Workgroup would be to review the suggestions from the ACCV members and participants, and revise the strategic plan accordingly. The revised plan will then be sent out to the ACCV, participants at the Strategic Planning Retreat, and other interested parties in the VICP for review.

Nomination of ACCV Vice-Chair

On December 31, Ms. Swartzlander's term will expire. Ms. Noyes called for nominations to replace Ms. Swartzlander as Vice-Chair. Ms. Swartzlander nominated Dr. Schreiber, and the ACCV voted all in favor of Dr. Schreiber as the newly appointed Vice-Chair. His first meeting in this capacity will be March 5, 2003.

Elizabeth J. Noyes, M.A.
ACCV Chair
Lois Ann Swartzlander, RN
ACCV Vice-Chair
Thomas E. Balbier, Jr.
Executive Secretary, ACCV