Oct 12 2010

Vaccine Suit to be Heard by Supreme Court

The US Supreme Court is about to hear a case involving an alleged vaccine injury. This one does not involve thimerosal, MMR, or autism – it involves neurological injury allegedly from an older version of the DTP vaccine. However, this case would have implications for the many autism-related claims being made.

The case is not about the facts of the claim – whether or not the DTP actually caused any injury in this case, that of Hannah Bruesewitz, but rather about the vaccine court and the ability of parents to bring suits against vaccine manufacturers.

In 1986 the National Childhood Vaccine Injury Act created a special court, the vaccine court, the purpose of which was to provide an alternate method for determining who deserves compensation for a possible vaccine injury. The vaccine court functioned to protect both citizens and vaccine manufacturers. It provides an expedited route to compensation, with a generously low threshold for evidence. For certain listed injuries, compensation is automatic.

The vaccine court also provides protection for vaccine manufacturers, because it puts barriers in the way for those families who want to bypass the vaccine court and sue companies directly. The concern is that without such protections vaccine manufacturers would not be able to function – it would simply cost them too much money to constantly defend themselves from suits, and they would always be at the mercy of a quirky jury decision.

There is precedence for this. In the 1980s lawsuits began to emerge claiming that silicone breast implants were causing cancer and autoimmune disease. This led to many settlements, some in the millions of dollars, against silicone manufacturers, including  multi-million dollar settlements. The capper was a class action lawsuit that was settled for 3.4 billion dollars.

As a result of these lawsuits Dow Corning filed for bankruptcy, and silicone manufacturers Dow Corning, Bristol-Myers Squibb, and Bioplasty stopped producing silicone for implants by the end of 1992. In essence, the silicone breast implant industry was destroyed by lawsuits.

All of this was happening at a time when the scientific evidence was coming in strongly against any connection between silicone implants and chronic disease, such as autoimmune disease.

Imagine the same scenario playing out in the vaccine manufacturing industry – lawsuits shutting down vaccine companies even as scientific evidence is coming in showing that vaccines do not cause the alleged injuries. This would have unacceptable public health ramifications.

The situation is even worse for vaccines, because there is an organized and highly motivated anti-vaccine movement. They would like nothing better than to shut down the vaccine industry with harassing lawsuits.

This is the issue now at stake in the Supreme Court case – was the National Childhood Vaccine Injury Act intended to prevent lawsuits against vaccine manufacturers? Actually, the suit deals with a specific kind of suit, that dealing with manufacturing defects. It is already clear that the act was meant to prevent or minimize lawsuits dealing with known risks and side effects from vaccines. Essentially, as a society we accept that vaccines are a public good but come with a small risk. So we put a small tax on all vaccines and use that money to compensate those who are unlucky and get a side effect.

But does this mean that vaccine producers are immune to liability no matter what they do? What if they knowingly produce a bad vaccine, or make a mistake in manufacturing? Now we are not talking about an unavoidable rare side effect, but a manufacturing error. This is the precise issue of the Supreme Court case.

The parents bringing the suit allege that the vaccine company, now part of Pfizer, kept producing an older version of  the DTP vaccine even when a newer and safer version was available (this newer version is now in use). This, they argue, makes the company liable for injuries from the older and less safe vaccine.

While the facts of the claim are not at issue, it is instructive to review them. The claim is that the older whole cell pertussis vaccine, part of the diptheria, tetanus, pertussis vaccine (DTwP) has been largely replaced with the DTaP vaccine, which contains an acellular pertussis component. This change was partly due to rare cases of neurological disease (seizures and encephalopathy) following DTwP being given, as in this case.

However, scientific evidence did not support an actual link between DTwP and neurological injury. A 1990 review found:

There clearly is an increased risk of a convulsion after diphtheria-tetanus-pertussis immunization but no evidence that this produces brain injury or is a forerunner of epilepsy. Studies have also not linked immunization with either sudden infant death syndrome or infantile spasms.

In 1993 the Institute of Medicine conducted their own review of the evidence and concluded.

The committee concluded that the evidence is insufficient to indicate either the presence or absence of a causal relationship between DTP vaccine and permanent neurological damage.

But a later (1994) extensive population-based case control study found:

This study did not find any statistically significant increased risk of onset of serious acute neurological illness in the 7 days after DTP vaccine exposure for young children.

As far as I can find, that seems to be the last of the major studies of DTwP and neurological injury.

But, as the silicone implant case demonstrates, having the science on your side is not enough to protect companies from serious financial harm due to law suits, even to the point of destroying an industry.


The results of this case will be very interesting to follow. I don’t know all the details of the case (what the company knew at the time and their decision-making process – details that may become relevant), but my review of the scientific evidence indicates that, once the dust had settled it seems as if there is no causal connection between DTwP and neurological injury.

That question aside, the legal issue is whether or not parents can bypass the vaccine court and sue companies directly for alleged manufacturing defect. This is a tough question, and will likely require a delicate balance of two competing interests. On the one hand, we want companies to be motivated by the threat of suit to adhere to the best manufacturing processes possible and to produce the safest vaccines possible. On the other hand, we don’t want frivolous, misguided, or even malicious suits to threaten a much-needed industry.

The case may hinge on the interpretation of the intent of the Vaccine Injury Act – not what the law should be, but what the law actually states. This, of course, may lead to a legislative battle to pass a new law that will strike the proper balance of accountability and protection that the vaccine industry requires.

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