February 23, 2011

Antixvaxxers lose another one

I actually agree with Nino Scalia! Once in every 10 blue moons, eh? Whoa.

As to the why of agreement?

He was part of a 6-2 majority dismissing a vaccine-related suit against Pfizer's Wyeth unit.

I don't buy Sonia Sonomayor's counterclaim:
Sotomayor said the ruling “leaves a regulatory vacuum in which no one ensures that vaccine manufacturers adequately take account of scientific and technological advancements when designing or distributing their products.”
No, no, no. Theoretically, at least, the FDA still has that role. How well it does it is another issue. She's also wrong in claiming the law establishing the vaccine court didn't intend consequences like this.

More on the case and its background here. While this isn't guaranteed to keep antivaxxers out of either federal or state court systems on spurious claims, it will certainly help.

For people who believe as Sotomayor does, and have the power to do something, fine. Start by giving better funding to the FDA. Beyond that, look at what's good about the current vaccine court structure and ask if it can't be translated to other science-heavy legal cases which are susceptible to tort abuse. (It happens, trial lawyers, setting aside the BS of the GOP.)

For example, whether from bomb testing dust or uranium mining dust or poor reactor management, perhaps all cases of radiation sickness should have a similar court. At the same time, each guilty finding should have mandatory punitive damages if it's part of a pattern.

Anyway, Orac has (as I had hoped and expected) now posted much more about this case.

Now, a lot of antivaxxers will claim this is stopping state-level lawsuits. No.

As for the state court issue nothing's changed there. The original 1986 law precluded suits from starting in state court. Orac note this. ALL this ruling did was state that the Court says the 1986 law pre-empts initial state court action on design-defect claims as well as on other claims where initial action at state court level was already pre-empted. So, it stops nothing; rather, it clarifies what was already stopped.

Was the majority's ruling a proper one? Here's what 42 U. S. C. §300aa–22(b)(1), the relevant section of the National Childhood Vaccine Injury Act, says:
No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.
Subsection 2 goes on:
For purposes of paragraph (1), a vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material respects with all requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and section 262 of this title (including regulations issued under such provisions) applicable to the vaccine.
So, design defects, it seems, were meant to be heard by the court. There is one exception.

Sub-subsection A of subsection 2 says that if a plaintiff shows:
(B)y clear and convincing evidence that the manufacturer failed to exercise due care notwithstanding its compliance with such Act and section (and regulations issued under such provisions).
In other words, willful negligence suits can still proceed, unless the new ruling invalidated them, too.

Full SCOTUS ruling here (PDF).

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