Monday, March 8, 2010

Vaccine injury at the US Supreme Court

Flickr Photo by dbking
A vaccine injury case is being heard by the US Supreme Court and it has the potential to change how the vaccine program works in this country. The primary issue in the case is whether vaccine makers can be sued directly in civil court for defects in their their products.

As matters stand now, if a person thinks they have been injured by a covered vaccine, they are required to file a claim with the National Vaccine Injury Program, otherwise known as vaccine court. This is a special venue that was created by the National Childhood Vaccine Injury Act of 1986 and was meant to provide a no-fault, swift, flexible, and less adversarial alternative to the traditional court system.

Under this system, the Department of Health and Human Services (HHS) takes the place of the vaccine manufacturer as the counter party and responds to claims of injury from vaccine.  A claim is handled in one of two ways. If an injury occurs within a certain amount of time after the vaccine is administered and is on the Vaccine Injury Table, then the assumption is that the vaccine caused the injury and it is up to HHS to prove that it wasn't.  If an injury does not fall on this table, then it is up to the person filing the claim to prove that the injury was more likely than not caused by the vaccine. The exact method of proving this varies, but normally requires showing a biologically plausible mechanism whereby the vaccine could cause the injury as well as showing a relationship between the vaccine being administered and the injury.

If all goes well, a person will file a claim, the claim will be quickly processed by the vaccine court, and, assuming the injury was found to be caused by the vaccine, the person will be compensated for their injury. But what happens if a person is not satisfied with their award or if the court rules against them?  The ruling can be appealed to the U.S. Court of Federal Claims but if the appeal is rejected, or if the person so chooses, they can take their claim to civil court and file suit directly against the vaccine manufacturer.

At least, that's the theory. In practice I don't think anyone has ever successfully brought a claim against a vaccine manufacturer in civil court because of how the National Childhood Vaccine Injury Act has been interpreted by the courts.  This brings us to the current case.

The case before the Supreme Court is Bruesewitz v. Wyeth and at issue is whether vaccine manufacturers are liable for defects in their products or failing to take action to improve the safety of their products. From SCOTUSBlog -

Title: Bruesewitz v. Wyeth
Docket: 09-152
Issue: Whether Section 22(b)(1) of the National Childhood Vaccine Injury Act of 1986 — which expressly preempts certain design defect claims against vaccine manufacturers “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 warning” — preempts all vaccine design defect claims, regardless whether the vaccine’s side effects were unavoidable.
In this case, the parent say that their daughter Hannah suffered a series of seizures after receiving the third dose of the DTP vaccine in 1992. She was later diagnosed as having a residual seizure disorder and developmental delay. In April 1995, her parents filed a claim with the vaccine court alleging that it was the DTP vaccine that caused the injury and asking for compensation.

One month prior to their filling, HHS removed "residual seizure disorder" from the vaccine injury table for DTP which shifted the burden of proof from HHS to the family. When the case was finally heard seven years later, in 2002, the special master hearing the case rejected the parents' claims because they failed to prove that the DTP was responsible for their daughter's injuries.

Hannah's parents rejected the finding and filed suit in civil court on the grounds that the vaccine maker knew that the vaccine was problematic, knew that the specific vaccine lot caused many injuries (a "hot" lot), and had a safer vaccine available yet failed to bring it to market. The vaccine manufacturer, Wyeth, asked for, and was granted, summary judgment on the grounds that the National Childhood Vaccine Injury Act granted the company immunity from being sued for defects in their vaccine.

The parents appealed the ruling to the Third Circuit court where the summary judgment against them was upheld, which brings us to the case before the Supreme Court.

The issue before the court is whether Congress, when it passed the National Childhood Vaccine Injury Act, intended to grant vaccine manufacturers blanket immunity from being sued for defects in their products. Was the vaccine court meant to be the sole way of recovering damages from injuries caused by vaccines?

Be aware that I am oversimplifying the issue somewhat and there are other issues that I am not mentioning.  The documents in the case are well over a hundred pages long and go into greater detail than I am able.  If you are interested in the full details, I suggest reading the briefs that are referenced above.

I would like to highlight one other aspect of the case though.  There is another case, Am. Home Prods. Corp v. Ferrari, where the Georgia  Supreme Court ruled in a different way from the 3rd Circuit.  In this case, the Georgia court ruled that vaccine manufacturers do not have automatic immunity and that each case must be decided on its own merits.

The Georgia ruling only applies in the state of Georgia, and the case was dismissed by the plaintiffs before it could be appealed to the US Supreme Court so it is unclear what the precedent of this ruling is.  But the US Supreme Court may have decided, in part, to hear the current case to resolve the difference of opinion between the Georgia Supreme Court and the 3rd Circuit.

Depending on how the US Supreme Court decides the case, there could be far reaching consequences.

The first possibility, and the least satisfying, would be if the court ruled only on the specifics of the current case and did not address the broader issue. If this happens, the split between the 3rd Circuit and the Georgia Supreme Court would stand and the underlying issue would remain unresolved.

The next possibility is that the court will find that vaccine manufacturers cannot be sued for defects in their products in civil court and that the vaccine court is the only venue for such claims. This would mean that vaccine manufacturers would effectively have no liability for damages caused by their products since they have no part in the vaccine court nor do they pay the damage awards themselves - these are paid for by a surcharge on every shot.

I don't like this option and I think that most people can agree that removing the possibility of liability from a six billion dollar industry is not a very good idea. One of the checks that keeps companies honest is the threat of lawsuits and if those are removed I think the results would not be good.  And when you combine the greater potential for problems with the fact that vaccines are increasingly becoming mandatory, I think you can see that there would be an inevitable backlash against the system.

The other possibility is problematic as well. If the court rules that vaccine makers can be liable for defects in their products, then there will be a huge number of lawsuits filed. Remember the 5,000 or so claims in the autism omnibus that are still pending in vaccine court?  If vaccine manufacturers are liable, I would be willing to bet that all of these claims would jump to civil court and create a large mess for these companies.

On the flip side here, it would be interesting to see what the discovery process, something that is not available in vaccine court, would turn up from these companies. I am positive that they have researched the autism-vaccine connection and it would be most interesting to see what they have found.

Regardless of the decision, one thing seems certain.  The current vaccine court system does not appear to be working all that well.  Claims are not handled in a quick manner (there is a backlog of about 7,000 cases) and the table of vaccine injuries is not being maintained well.

But, more importantly, it seems that some of the participants in the process are more interested in protecting the vaccine program overall than they are in awarding compensation to children injured by their shots.  That is how we get results like the one in the Bailey Banks case where the special master came up with the absurd notion of a "non-autistic" form of PDD-NOS to avoid saying that a vaccine lead to autism (hint PDD-NOS is, by definition, a form of autism).

I honestly can't say which way this case is going to go, but it should prove to be interesting.

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