Source: https://www.ebcala.org/unanswered-questions/vaccine-epidemic
Timestamp: 2019-04-23 16:09:38+00:00

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1 The 1986 National Childhood Vaccine Injury Act acknowledges that vaccine injury or death may be “unavoidable even though the vaccine was properly prepared and accompanied by proper directions and warnings.” 42 U.S.C. 300aa-22(b)(1). The “unavoidable” language in the Act is from the Restatement (Second) of Torts that applies to “products which, in the present state of human knowledge, are quite incapable of being made safe.” Restatement (Second) of Torts Section 402A, comment k (1965).
2 According to the Centers for Disease Control and Prevention, “[y]ears of testing are required by law before a vaccine can be licensed. Once licensed and in use, vaccines are continuously monitored for safety and efficacy,” www.cdc.gov/vaccine-safety/Vaccines/Index1.html.
3 The National Childhood Vaccine Injury Act of 1986, 42 U.S.C. 300aa-1 et seq.
4 42 U.S.C. § 300aa- 14; see also www.hrsa.gov/vaccinecompensation/table.htm.
5 HHS information on vaccine injury compensation, www.hrsa.gov/vaccinecompensation/statistics_report.htm.
6 For example, Dr. Martin Smith, the President of the American Academy of Pediatrics, wrote in an article about the 1986 act to his members that “[t]his was the best compromise settlement . . . that could be reached.” Martin H. Smith, National Childhood Vaccine Injury Act, Pediatrics 82 (1988):264. From a different perspective, Barbara Loe Fisher, President of the National Vaccine Information Center, said in an address to the Advisory Commission on Childhood Vaccines about the work of parents in crafting the 1986 Act, “[w]e believed we were participating in the development of a law which would give—in the words of the then AAP Chairman—‘simple justice to children,’” www.nvic.org/injury-compensation/vaccineinjury.aspx.
7 Remarks of Robert Krakow at American Rally for Personal Rights, Chicago, IL, May 26, 2010, www.americanpersonalrights.org.
8 See note 5 for HHS information.
9 The Omnibus Autism Proceeding was a set of six test cases chosen from approximately 5,000 petitions to determine whether vaccines caused autism in those cases. The cases lasted approximately eight years, presenting thousands of pages of science and testimony and tens of witnesses on two theories, that the mercury-containing preservative thimerosal causes autism alone and that thimerosal together with the measles-mumps-rubella vaccine causes autism, www.uscfc.uscourts.gov/sites/default/files/autism.background.2010_0.pdf.
10 To be sure, there is evidence that individual Special Masters exercise appropriate independence. Our critique is directed to the VICP as an institution and not to the performance of individual Special Masters.
11 Information on the Vaccine Safety Datalink at the CDC website, www.cdc.gov/vaccine-safety/Activities/VSD.html.
12 Institute of Medicine, “Vaccine Safety Research, Data Access, and Public Trust,” www.iom.edu/Reports/2005/Vaccine-Safety-Research-Data-Access-and-Public-Trust.aspx, noting that the CDC’s handling of the VSD thimerosal data suffered from a “lack of transparency,” that datasets “were not archived in a standard manner,” and “are not available for reanalysis,” and that CDC officials should “seek legal advice” regarding possible violations of the Federal Data Quality Act. The critical VSD information is allegedly available offshore in the archives of a private healthcare provider. The Special Masters of the Court of Federal Claims presumably could have issued subpoenas for this information but did not. For a detailed discussion of the VSD and the possible thimerosal-autism link, see David Kirby, Evidence of Harm: Mercury in Vaccines and the Autism Epidemic: A Medical Controversy (New York: St. Martin’s Press, 2005).
13 Althen v. Secretary of HHS, 418 F.3d 1274 (Fed. Cir. 2005).
14 Concession agreement linked to David Kirby,“Government Concedes Vaccine-Autism Case in Federal Court—Now What?” Huffington Post, February 25, 2008, www.huffingtonpost.com/david-kirby/government-concedes-vacci_b_88323.html.
15 Compensation decisions at the Court of Federal Claims website, Child Doe/77 v. Secretary of HHS, 2010, www.uscfc.uscourts.gov/sites/default/files/CAMPBELLSMITH.%20DOE77082710.pdf.
16 Hazlehurst v. HHS, Court of Federal Claims, 2009, ftp://autism.uscfc.uscourts.gov/autism/vaccine/Campbell-Smith%20Hazlehurst%20Decision.pdf; and Hazlehurst v. HHS, U.S. Court of Appeals for the Federal Circuit, 2010, www.cafc.uscourts.gov/images/stories/opinions-orders/09-5128.pdf.
17 The Special Master in the VICP admitted DOJ’s expert report of Dr. George Bustin without admitting the underlying data verifying his expert report. This data was crucial to the final decision that Michelle Cedillo’s autism was not caused by the measles virus. The judges of the U.S. Court of Appeals for the Federal Circuit acknowledged that the lack of underlying data for the Bustin report was “troubling,” but did not require that the data be produced in part because the formal rules of civil procedure do not apply. Cedillo v. HHS, 2010 5004, (Fed. Cir. August 27, 2010), www.cafc.uscourts.gov/images/stories/opinions-orders/10-5004.pdf.
18 In the Omnibus Autism Proceeding, DOJ frequently referred to Dr. Andrew Wakefield’s character and laboratory, although he was not a party to the litigation and had no direct relevance to it. DOJ had Dr. Chadwick testify because Dr. Chadwick had worked in Dr. Wakefield’s laboratory, although he had no knowledge about the laboratory where Michelle Cedillo’s measles biopsy laboratory analyses were actually done. Cedillo v. HHS, 2009 WL 331968 at 56. Similarly, in closing arguments DOJ’s lead attorney Vincent Matanoski stated that “all the strands through these cases come back to him [Andrew Wakefield]. He presented bad science.” Cedillo Transcript, June 26, 2007, 2898-99 at A599– A600.
19 Daubert v. Merrell Dow Pharmaceuticals, Inc., 43 F.3d 1311 (9th Cir. 1995).
20 Althen v. Sec’y of HHS, 418 F.3d 1274, 1280.
21 Rebecca Estepp, parent of child in the Omnibus Autism Proceeding and vaccine safety advocate, as quoted in Coalition for Vaccine Safety press release, www.coalitionforvaccinesafety.org/press.htm.
22 See, e.g., Carolyn Gallagher & Melody Goodman, “Hepatitis B Triple Series Vaccine and Developmental Disability in U.S. Children Aged 1-9 Years,” Toxicology and Environmental Chemistry 997 (2008); Kara L. McDonald et al., “Delay in Diphtheria, Pertussis, Tetanus Vaccination Is Associated With a Reduced Risk of Childhood Asthma,” Journal of Allergy and Clinical Immunology 121 (2008):626.
23 Transcript of oral argument, Bruesewitz v. Wyeth, No. 09-152, October 12, 2010, 30, www.supremecourt.gov/oral_arguments/argument_transcripts/09-152.pdf.

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