nos-trum. pronunciation: \nos'-trum\. noun. Etymology: Latin, neuter of noster our, ours.
1. a medicine of secret composition recommended by its preparer but usually without scientific proof of its effectiveness.
2. a usually questionable remedy or scheme.
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Wednesday, October 13, 2010

Supreme Court Vaccine Case: If You Can't Show Cause, Can You Sue Anyway?

A new vaccine case before the Supreme Court is being characterized as a "product liability" issue.  But the problem is that the plaintiff has never shown that the vaccine caused the problem.

This is an interesting twist, both in the law and in the science.  The facts are these (quotation from the Washington Post (Oct 13) :
"We are talking about trying to eliminate some of the most horrifying and horrible incidents of injury to vaccines that we compel children to take," said David C. Frederick, a Washington lawyer.  He represents the parents of Hannah Bruesewitz, 18, who began to have seizures as an infant after receiving the third of five scheduled doses of Wyeth's Tri-Immunol diphtheria-pertussis-tetanus vaccine. The company, now owned by Pfizer, has taken the drug off the market.  ...The National Childhood Vaccine Injury Act of 1986 said all such claims must first go to a special tribunal commonly called the "Vaccine Court." The tribunal ruled against the Bruesewitzes, saying they had not proved that the vaccine caused Hannah's problems. The couple then sued under Pennsylvania tort law. But federal courts said the suit could not proceed, because federal law prohibits claims against "design defects" in vaccines.  The question before the Supreme Court is whether that is correct, or whether Congress left some remedy for those who say injury or death could have been avoided if the manufacturer had offered a safer vaccine [my note:  say what?  how did we go from "didn't cause" to "injury could have been avoided"?]
Note that while the case is about remedies for a product that was later replaced by a different vaccine, the parents have never shown in their suits that the daughter's seizure disorder was caused by the vaccine.

Where did the issue get transformed?  

I have a problem with suing for treatments that have been superseded.  It reminds me of the heart valve replacement suit a couple of years ago.  Prior to the 1960's people with bad heart valves mostly just...died.  Then a hardware device came along that allowed replacement of the valve, extending doomed patients' lives.  It worked like a ping pong ball in a small birdcage; the flow of blood out of the heart would push the ball away from the base of the cage allowing blood to flow.  The ping pong ball would then be pushed back to the bottom of the cage, plugging the hole and stopping blood from flowing back into the heart.  Anybody who knows about back-flow valves in plumbing can see how it works.  (My description is way over-simplified, but you get the idea.)  Not elegant, but it did the job.  After more than two decades, the frame of the cage, after about a billion heart beats pounding it, began to crack in some cases.

So, these folks, who got an extra couple of decades of life, sued...alleging a product defect.

The point is, you get the best available at the time...and if better comes along later, should you be able to sue retroactively? (This is risky surgery, you don't just replace an artificial valve like buying a new car)

The vaccine suit is similar (but, still, it shouldn't even be credited, since there's no proof of harm).  The vaccine in question was superseded by a vaccine that's less likely to cause febrile seizures.  The new product had been introduced at the time of this child's birth (if I understand the facts correctly), but the data was not yet complete on whether it was safer or not, and the old vaccine was still available. 

Why no proof of harm?  Many vaccines cause fever.  About 15% of kids are vulnerable to seizures from fever.  These are almost always harmless, and they grow out of that vulnerability.  And any febrile illness can cause these seizure episodes, not just vaccines.  But there's little evidence that they precipitate a lifelong seizure disorder.  And many children have lifelong seizure disorders, caused by neurological problems, birth defects, etc...nothing to do with vaccines.

This is what the parents failed to show in their previous suits.  And, by the way, the issue of "forcing" vaccines on people was decided in the courts a hundred years ago; yes, the government has an obligation to protect the public by not allowing people to spread contagion.

I guess ultimately this case is about sympathy.  Sympathy for the child and their family:  "Can't we find a way to compensate them for this tragedy?"  Because it is a tragedy:  the daughter requires extended care, medication, and support...the kind of situation that can financially break even the wealthiest.

One final consideration.  The 1986 law that shielded vaccine manufacturers from liability, and set up a vaccine court to decide compensation, was an effort by Congress to stem the tide of companies who were cancelling vaccine production because they were getting sued all the time.  That court has worked; it has compensated many thousands of people, awarding millions.  At the same time, it cuts out the frivolous and unproved cases.

So, should we overturn a mechanism that compensates those who are truly harmed, and protects vaccine production?  Shortages have occurred in the past for exactly the reason that the law was written.

The media article seems to think the justices have mixed feelings.  But if we go back to the pre-1986 situation, there may be consequences we don't want.

Doc D

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