2011.03.05 Q'uo on Vaccines

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Just to note, the reasonable alternative design is not strictly required in some states, but given that design defect products liability is usually negligence related (a reasonable person would not have designed it that way), its very difficult to win the negligence argument without putting forth a good alternative design that was known and readily useable by the designer even in states where it is not strictly required.

I agree with should do something and I think the #1 solution is empowering people and the people hurt by making manufacturers liable. 

Screening isn't a bad suggestion, but I have little faith in regulators now that industry these days is so organized and has such a heavy influence on them (EPA, FCC), and there's little incentive for manufacturers to do it. Interestingly I think if you held manufacturers liable it would jumpstart the manufacturer's interest in figuring out screen if they had trouble figuring out the design aspect. So while I personally wouldn't hold my breath that screening mandated by regulators would solve a lot of these problems, I would be totally for such a suggestion of screening.

Here's where I would suggest to look:  at the timeline of development of scientific knowledge and research methods as compared to the approval and release of vaccines.

OK first, I would say that we have to make sure that the term "design" is meant to also include the methodologies and approval process themselves.  I would say you cannot really separate the vaccine itself, from the scientific and legal processes themselves that are used to ensure its safety.  I would then build an argument adhering to this somewhat expanded, but reasonable, definition.  

I would argue:  For vaccine X approved in year Y, even if there was no reasonable alternative design available, based upon:

1.  What was scientifically known, or reasonably known, at the time;
2.  What types of scientific tests were available based upon technology available at the time; and
3.  What types of investigational models themselves were available, based upon available research methods, statistical models, and computer hardware/software at the time.

Nevertheless, at year Z, (1), (2), and/or (3) such information/methods (1a, 1b, 1c...2a, 2b, 2c...3a, 3b, 3c...) became available that would have given us the ability to conduct new research into the risk factors for vaccine harm, and for ways to mitigate or eliminate those risks.

But we did not do this.  And again, even though this is still not due to negligence on the part of the companies- who were only following the laws, but as a society as represented by our government, we should have done something differently.  We should have updated the design to include regular investment in, an active pursuit, of this information.

And so... if we are to make this argument... perhaps reasonable alternative design is still strained.  Maybe we should look away from tort law completely?

Or maybe not... even if you fail, you succeed in getting that argument out into the public record, and creating something newsworthy around it.

Nevertheless, IF this is the case, then why not just propose amendments to the existing law, which require vaccine manufacturers to actively research these things, and to contribute their findings to a pooled resource which can then be mined to find out how we can best identify those babies at risk?

How much money would that really take to get going, if measured in terms of wrongful death awards.  10 wrongful deaths?  100?

Sure... Big Pharma has its lobbyists.  But if something like that were to be proposed... what is there to lobby against?  Why would they even want to?  The cost would be a drop in the bucket in terms of their overall expenses.  Especially if they pool resources.  Those people at those companies... they are parents too.  They want to do the right thing.  They want to look good.  Why would they fight it?

Who- in their right mind- would come out against such a proposal?  Heck forget fighting with the companies, make the government pay for it.  It would be easy to find the money.  Its value is about 1 brick's worth of a $3.1 billion border wall. You know... to protect our innocent babies.  Who doesn't like babies?