Bioterrorism brings vaccine issue to Congress.

Americans have started to speak about life as pre- or post-September 11. Suddenly, there is a new world order that seems out of order. Life in the nation's capital, in particular on Capitol Hill, is certainly not back to business as usual, despite the urging of political leaders to resume a "normal" routine.

At this writing, Congress is beginning to grapple with the issue of bioterrorism--a subject not under urgent consideration before September 11. Indeed, Congress has already passed a host of bills specifically responding to issues that have arisen in the wake of the terrorist attacks.

Some include important civil justice provisions. The Air Transportation Safety and System Stabilization Act, for example, limited the liability of the airlines involved in the September 11 attacks and created a special fund for victims.

The most recent antiterrorism legislation is a bill still being drafted at press time by Sens. Edward Kennedy (D-Mass.) and Bill Frist (R-Tenn.), the Bioterrorism Preparedness Act of 2001. Among other things, it seeks to strengthen the development of new countermeasures against bioterrorism and to protect existing ones. One of its primary goals is to facilitate the production of vaccines.

The legislation would create a Bioterrorism Vaccine Compensation Program that would function as an alternative to the tort system for those who suffer injury or death as a result of receiving a covered vaccine. The program would be modeled after the National Vaccine Injury Compensation Program, created in 1988 to compensate individuals or families of individuals injured by childhood vaccines.

Before that program was established, manufacturers of the DPT (diphtheria, pertussis, tetanus) vaccine told Congress that liability exposure was threatening to drive them out of business. Companies that make vaccines to protect against diseases used in bioterrorism are beginning to make similar claims.

The bill offers some protection from lawsuits to manufacturers of vaccines specifically "developed as a priority countermeasure ... to treat or prevent infections by a biological pathogen" and "administered for such use by order or recommendation of the secretary [of health and human services] to respond to the use or threatened use of a biological agent."

Procedures for filing petitions and holding hearings under the new program would be identical to those of the childhood vaccine program, and a claimant's eligibility for compensation and the amount of the award would be determined in a similar way. As in the childhood vaccine program, claimants in the new program would be allowed to reject an award and file a civil lawsuit seeking damages.

The most noticeable difference between the two programs would be the funding mechanism. For vaccines administered on or after October 1, 1988, awards are paid from the Vaccine Injury Compensation Trust Fund, which is financed by an excise tax on manufacturers of vaccines covered by the program. Funding for the Bioterrorism Vaccine Compensation Program would come through the regular appropriations process, meaning that Congress would have to vote annually on the funding.

Lessons learned

The new program, if enacted, might benefit from lessons learned about the childhood vaccine compensation effort.

In the 13 years since that program started, some claimants have said they found the compensation process difficult. An article published this year in Consumer Reports quoted a law professor with the vaccine-injury law clinic at George Washington University saying that the government aggressively pursues technical loopholes during the claim process and "fight[s] everything to the bitter end." (Vaccines: An Issue of Trust, Consumer Rep., Aug. 2001, at 17.)

On November 1, Rep. Dan Burton (R-Ind.), chair of the Committee on Government Reform and another critic of the childhood vaccine compensation program, held a hearing to address its problems. In his opening statement, he said the system was designed to provide quick, generous compensation "without a lot of legal fighting" but that "cases drag on for 6 or 8 or 10 years."

Burton and a bipartisan group of House members earlier this year started looking for a way to fix these problems. They introduced their bill, the Vaccine Injured Children's Compensation Act of 2001 (H.R. 1287), in March.

Among other things, H.R. 1287 would ease the burden-of-proof requirement for petitioners seeking compensation for vaccine-related injuries. To deny a claim, the government would be required to prove by clear and convincing evidence that an illness, injury, or death was due to factors unrelated to the vaccine. It would also liberalize provisions relating to the statute of limitations and the award of attorney fees, which also would benefit petitioners.

If liability protection is to be offered to bioterrorism vaccine manufacturers, any improvements made to the childhood vaccine compensation program could help claimants in the bioterrorism compensation plan, since the two programs are so closely linked.

Kristin Loiacono is media relations coordinator for ATLA.