Vaccines and the

The National Vaccine Injury Compensation Program

Katherine Davenport

Food and Drug Law

Third Year Written Work Requirement

Harvard Law School

April 10, 2000

Table of Contents

Introduction ................................................................................. 2

1. The Food and Drug Administration: Regulation of Vaccines

and Vaccine Manufacturers .................................................... 5

1. History of the FDA Regulation of Vaccines

and Vaccine Manufacturers ................................................... 5

1. The Review of Biological Products .......................................... 6

1. FDA Regulation of Vaccines and Vaccine Manufacturers ............... 8
2. FDA Regulation and Licensing of Vaccine Manufacturers ......... 9
3. FDA Regulation of Vaccines ............................................. 11
4. FDA Regulation of Vaccine Labeling ................................... 12
5. FDA Monitoring of Adverse Events .................................... 12

1. Conclusion: Limited Effect of FDA Regulation ........................... 14

1. How Do We Confront the Adverse Effects of Vaccination?

One Alternative: The Civil Tort System ..................................... 15

1. Theories of Liability ........................................................... 15

1. Failure of the Tort System .................................................... 17

III. The National Vaccine Injury Compensation Program .................... 21

1. The Design of the NVICP .................................................... 22

1. Location of the NVICP in the Court of Federal Claims ............... 22

2. The Special Masters ........................................................ 24

3. Petitioners Under the NVICP ............................................. 25

4. The Vaccine Injury Table ................................................. 27

a. Listed Vaccines ........................................................ 27

b. Burden of Proof ........................................................ 29

c. Revision of the Table ................................................. 30

1. The NVICP Proceedings ..................................................... 32

1. Conduct of Proceedings ................................................... 32

2. Petition Content ............................................................. 33

3. Experts ....................................................................... 34

1. Compensation Recoverable .................................................. 36

1. Financing of Compensation ............................................... 36

2. Conventional Damages .................................................... 37

3. Costs of Proceedings ....................................................... 38

a. Attorneys’ Fees ......................................................... 38

b. Fees of Experts ......................................................... 41

4. Process for Appeals ......................................................... 42

1. Program Statistics .............................................................. 43

1. Petitions Filed ............................................................... 43

2. Adjudication ................................................................ 44

3. Awards ...................................................................... 44

IV. The Liability of Vaccine Manufacturers after the National Vaccine

Injury Compensation Program ................................................ 45

1. NVICP Limitations on Manufacturer Liability ............................ 45

1. Unavoidable Side Effects ................................................. 45

2. Statutory Presumption of Due Care in Packaging and Warning ...... 47

3. Direct Warnings ............................................................. 48

4. Punitive Damages ........................................................... 51

1. Restriction on Evidence from the NVICP ................................... 51

V. Has the NVICP Achieved Its Goals? Proposals for Reform .............. 53

1. First Goal: Protecting the Vaccine Supply and

Reducing Vaccine Litigation ................................................. 53

1. Second Goal: Compensating Injured Vaccinees ........................... 55

1. Length of NVICP Proceedings ............................................ 56

2. Adversarial Nature of Proceedings ....................................... 58

3. Loss of the Presumption of Vaccine Injury .............................. 60

1. Eradicating the Tension Between the Two Goals of the NVICP ........ 62

1. Eradicating the Tension Between the NVICP and the

Safety Goal of the Vaccine Act .............................................. 62

Conclusion .................................................................................. 65