I haven’t written much about this before, at least not in this context, but vaccine scares are nothing new, nor is execrably fear mongering journalism about vaccines. Those of you who read Paul Offit’s Autism’s False Prophets or Arthur Allen’s Vaccine probably know about a particularly egregious example of both that occurred in the early 1980s and concerned the DTP (diptheria-pertussis-tetanus) vaccine. In 1982, the local NBC affiliate in Washington, DC aired a special report entitled DPT: Vaccine Roulette. Indeed, Vaccine Roulette was the prototype of the muck-raking, sensationalistic sort of documentary that we’ve come to know and hate, showing children who were thought to have suffered brain damage due to the DPT vaccine and making it sound as though this was a common event, when later investigations demonstrated that it was not. Still, the DPT vaccine did produce severe neurological reactions, and the scare over it sparked by DPT: Vaccine Roulette resulted in a rash of lawsuits that endangered the vaccine supply.
As a result, lawsuits proliferated, and there were several large jury awards. Due to the fear that litigation would drive vaccine manufacturers either out of business or into giving up manufacturing vaccines due to liability concerns, Congress was driven to “do something.” These fears were not unfounded. All but one DPT manufacturer stopped making it, and the last one threatened to do so. In order to safeguard the vaccine supply in 1986 Congress passed the National Childhood Vaccine Injury Act (NCVIA). This law established a no fault compensation system for children injured by vaccines. To administer the compensation, the NCVIA established a Vaccine Court, administered by the Office of Special Masters in the U.S. Court of Federal Claims. Claims against vaccine manufacturers can’t be initially filed in state or federal court; they have to go through the Office of Special Masters, where special judges known as Special Masters adjudicate the claims. It is just this court that I blogged so copiously about in 2008 and early 2009 as a result of the Autism Omnibus action, in which the Special Masters of the Vaccine Court instructed representatives for the 5,000 or so children in the action to choose their best cases as “test cases” for the claim that vaccines caused autism. All three test cases lost.
It shouldn’t be thought that the Vaccine Court didn’t compensate children with legitimate cases of injury due to vaccination. It did compensate many children over the last 22 years. It does so by, as I have pointed out before, using looser rules of evidence and not requiring the Daubert standard for scientific testimony and evidence. There is also a list of “table injuries” that are assumed automatically to be due to vaccine injuries. Compensation covers medical expenses, legal expenses loss of future earning capacity, and others. Even for unsuccessful claims, legal expenses are often covered. Unsuccessful claimants can sue in federal court after losing in Vaccine Court, but this is generally rare.
Several plaintiffs have tried over the years to bypass the Vaccine Court for what I consider to be obvious reasons: More money. Although vaccine court is relatively fast and fair, it caps pain and suffering damages at $250,000, which, as you can imagine, most lawyers don’t find too appealing, even though certain lawyers like Clifford Shoemaker have made quite the living off of bringing actions in vaccine court. It looks, however, as though we will soon know whether the Vaccine Court is Constitutional and whether parents can bypass it, as next year the Supreme Court will be hearing a case asking just that:
The justices Monday agreed to decide whether drug makers can be sued outside a special judicial forum set up by Congress in 1986 to address specific claims about safety. The so-called vaccine court has handled such disputes and was designed to ensure a reliable, steady supply of the drugs by reducing the threat of lawsuits against pharmaceutical firms.
The questions in the latest case are whether such liability claims can proceed, if the vaccine-related injuries could have been avoided by better product design, and if federal officials had approved another, allegedly safer drug. Oral arguments in the dispute will be held in the fall.
Interestingly, even though the Third Circuit Court of Appeals ruled for the vaccine manufacturer, concluding that the legislative history of the NCVIA indicated a clear intent by Congress to preclude suing for claims of preventable injuries due to poor design, the case appears to be going to the Supreme Court because vaccine manufacturers and the Obama Administration requested it:
A federal appeals court eventually ruled for Wyeth, now owned by Pfizer Inc., concluding that all design-defect claims were barred under statute. Despite that victory, the company urged the high court to hear the case, saying it seeks final resolution on broader legal questions. The Obama administration also urged review and is supporting the company and the federal law in question.
The case boils down to three questions:
- whether the Act preempts all design defect claims against the manufacturer of a vaccine
- whether the plaintiffs demonstrated that the manufacturer failed to adequately warn the plaintiffs of the risks associated with the vaccine
- whether the plaintiffs provided sufficient evidence of a manufacturing defect to survive the defendant’s motion for summary judgment.
I can understand why Wyeth Laboratories might ask for a clarification from the Supreme Court, but it’s a risky move. The court had already ruled in its favor resoundingly, writing:
“If we interpret the Vaccine Act to allow case-by-case analysis of whether particular vaccine side effects are avoidable, every design defect claim is subject to evaluation by a court,” Smith wrote in an opinion joined by Judges Theodore A. McKee and Joseph F. Weis.
Which is, of course, true.
The question all appears to boil down to what is known as the “preemption clause” of the NCVIA. Under that clause, vaccine manufacturers cannot be held responsible for injuries, deaths, or side effects that “were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.” The question remains what the word “unavoidable” means, with the plaintiffs arguing that an injury due to a design or manufacturing defect of a vaccine is avoidable. The court concluded that Congress had intended to preempt all suits against vaccine manufacturers based on on design defect claims.
Given conflicting rulings and the specter of other cases, apparently Wyeth wanted clarity. The question is: What kind of clarity will it get? If the Supreme Court upholds the Third Circuit Court’s ruling, then the Vaccine Court will continue to function as before, which it has done well for 24 years. If, however, the Supreme Court rules that product defect cases can bypass the Vaccine Court, look for the floodgates to open to a slew of lawsuits claiming that some aspect of vaccine design was defective, leading to their causing autism, neurological injury, autoimmune diseases and a variety of other claims of “vaccine injury. The situation has the potential to degenerating into 1985 all over again.
In the meantime, I dread what the anti-vaccine propaganda machine is likely to do with the Supreme Court’s decision to take the case. No doubt it will ramp up a propaganda campaign and file a bunch of amicus briefs to the court. If there’s one thing the anti-vaccine movement has wanted to do over the last 10 years, it’s to destroy the Vaccine Court and allow open season on vaccine manufacturers. This is particularly ironic, given that the grande dame of the anti-vaccine movement, Barbara Loe Fisher, was involved in the passing of the original. However, because the Vaccine Court doesn’t compensate everyone and, as the results of the Autism Omnibus test cases demonstrate, is fairly good about not compensating truly frivolous claims, lately Fisher has become hostile to the NCVIA that she helped to pass, while the rest of the anti-vaccine movement has never liked it.
My prediction is that this will be the next Autism Omnibus case for the anti-vaccine movement. they will, more than anything else, want Bruesewitz to win, because that will open the floodgates. Trial lawyers also want Bruesewitz to win, as well. It’s a high stakes gamble for both sides. If Bruesewitz loses, the NCVIA is safe for the foreseeable future, and the anti-vaccine movement won’t be able to do a thing about it. If Bruesewitz wins, the anti-vaccine movement will be able to orchestrate a flood of lawsuits, and the vaccine supply, already tenuous enough as it is, will be in as much danger as it was 25 years ago.