Protection for Eli Lilly?
Many commentators have criticized the inclusion in the Homeland Security bill of "language protecting Eli Lilly from litigation involving vaccines". The current stories in the news reflexively identify Eli Lilly and Company as the beneficiary of this supposed freebie, although the language in the bill does not identify that company or single out its products for special treatment. Even those sources which are more careful still identify the companies as "vaccine manufacturers like Eli Lilly". The fact that all news sources are in lockstep on this point is intriguing.
Fairly characteristic of complaints by non-media sources is the comment of Jeanne D'Arc, who moans that this is "a measure that has absolutely nothing to do with security". Wrong. Consider the facts:
- Congress passed a Vaccine Compensation plan way back in 1986 [42 USC 300aa-10 et seq] because drug companies were unwilling to continue to manufacture essential vaccines without some form of protection. If polio vaccines and MMR vaccines are not available, we will see a return of many childhood diseases.
- The new proposal extends the plan to companies which manufacture certain components of the vaccines - see below.
- Neither the original law nor the new proposals bars lawsuits. Instead, claims are handled under a special claims procedure in the Court of Claims under the Vaccine Compensation Act, under which damages that are proven to be caused by the vaccine are awarded regardless of fault and which reimburses all medical costs as well as up to $250,000 for noneconomic damages, plus an award of attorneys' fees. The program is paid for by a special assessment against vaccine manufacturers.
- The Vaccine Injury Compensation Program is mandatory but not binding. If the injured person still wishes to pursue court action after the Court of Claims proceeding, he can reject the award and do so. The reality, however, is that most claimants will be satisfied with the award, particularly when they learn that they will have to prove either fault or a product defect if they resort to the courts.
- The United States was the victim of a widely publicized act of biological terrorism in the Fall of 2001, and fears a similar or more wide-ranging attack using smallpox or other biological agents in the future.
- Neither anthrax vaccines nor smallpox vaccines would be covered under the VICP as it currently stands.
Sorry, Jeanne D'Arc. This has everything to do with our domestic security. It is essential for the people of this nation that these vaccines be made available, and that they be manufactured now. If Congress determines that including these agents in the Vaccine Compensation system will promote that important aim, I don't see why they should not do it. This is not payback for a favored industry. The well-being of the American public is at issue.
There is a further fact that none of the news reports has disclosed. The Lilly component in question is thimerosal, which is a mercury-based product which has been alleged but not proven to be related to childhood autism. The Department of Health and Human Services has already determined that claims for autism or other conditions related to this agent are covered under the VICP, because it does not consider thimerosal an "adulterant or contaminant". The VICP does not apply to adulterants or contaminants found in vaccines. (HHS does note at the cited page that this issue is still under consideration by the Court of Claims.)
Links of interest:
As the NVIC site suggests, the claim and compensation system may not be perfect and perhaps should be improved. The basic idea behind this litigation alternative, though, is sound.
8:05:02 AM 
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