Vaccine injury and compensation

The comment thread for my post last week about how philosophical vaccine exemptions in California are endangering herd immunity is rapidly approaching 500 comments as I write this and may well surpass that number by the time this post “goes live” in the morning. I mention this because buried in the comment thread are a number of comments by our old “friend,” that anti-vaccine-sympathetic pediatrician to the stars, Dr. Jay Gordon doing what Dr. Jay does best and basically making a fool of himself on matters of vaccine science through his preference for anecdote over sound epidemiology and clinical trials, his utter insistence that his 30 years of clinical experience trump the aforementioned sound epidemiology and clinical trials (hint to Dr. Jay: they don’t), and going about his usual job of insisting that vaccines cause autism and that, despite his extreme distrust of vaccines, his advocacy of not vaccinating for some common childhood diseases because he imagines the vaccines to be more dangerous than th disease, and his consorting with leaders of the anti-vaccine movement like Jenny McCarthy, he really and truly is “not anti-vaccine.”

His denials fool no one, least of all me.

The reason I bring up Dr. Jay is because, round about comment #389 in the seemingly endless thread, Dr. Jay wrote:

Just tweeted: AND today’s brand new judicial decision must not be exaggerated to the detriment of calm discussion either: http://bit.ly/9kZFhm

Correlation does not prove causation even if I agree with this individual MMR decision. I just think that side-effect-denialists need to calm down, too.

I’ll give Dr. Jay credit for “talking the talk” when it comes to giving lip service to the mantra of “correlation does not necessarily equal causation,” but unfortunately he never seems to be able to “walk the walk” and stop asserting baldly that “vaccines cause autism” or likening vaccine manufacturers to tobacco companies. Leaving aside for the moment my intense desire, barely held in check, to mock Dr. Jay for his transparent and laughably inappropriate attempt to hijack the term “denialist” for the side of pseudoscience, an attempt so hilariously inapt that I really did laugh when I read it, it turns out that over the last couple of days Dr. Jay is not alone in seemingly wanting to rub my nose in this particular decision, which was reported in the U.K.’s The Daily Mail over the weekend. Basically, it is the story of a young man named Robert Fletcher in the U.K. who is severely disabled and has been awarded £90,000 in compensation by the governement’s Vaccine Damage Payment Unit for having been injured by the MMR vaccine back in the early 1990s.

Before I discuss the case in more detail, I’m going to say something that may surprise some who read here. I don’t have much a problem with this ruling. Not really. In fact, the main problem I have with this ruling is not that it was made, but rather that it took so damned long to make it and the payout was paltry. You see, Dr. Jay is laying down what I like to refer to as a steamy, drippy turd of an argument when he claims that there is a such thing as a “vaccine injury denialist.” None of us who make it our business to refute the pseudoscience claiming that vaccines cause autism deny that vaccines can on occasion cause actual injury. Rather, what we argue, based on good science and strong clinical trials data, is that such injuries are rare and that they do not include among them autism, asthma, and the veritable panoply of various conditions that anti-vaccine zealots claim to be due to “vaccine injury.”

Not that science has any persuasive effect on anti-vaccine zealots and their fellow travellers (like Dr. Jay), who would have you believe that being vaccinated is extremely dangerous and that it causes all sorts of problems, the worst of which is autism. As I’ve discussed on this blog hundreds of times over the last five years, sometimes in utterly nauseating (to some) detail, neither vaccines nor their various components, have been linked to autism. They just haven’t, and it’s not as though a link hasn’t been sought by real scientists and physicians in multiple large epidemiological studies over the last dozen years. Researchers have looked for such a link and haven’t found it. More than a decade later, there is still no credible scientific or clinical evidence (and Wakefield’s or Hewitson’s execrable “science” doesn’t count) that vaccines cause or are correlated with autism and a lot of credible evidence that they are not, Dr. Jay’s confident pontifications notwithstanding.

However, there can be (and are) vaccine reactions. No one is denying that. And because vaccination is in essence a social pact, in which by vaccinating we all take an infinitesimally small risk for a very large benefit, when a child suffers an adverse reaction there should be compensation. Indeed, that’s just what we have here in the U.S. with the Vaccine Court, which I’ve written about many times before. As I’ve pointed out (for example, here), because of rising litigation that jeopardized the vaccine program and threatened to drive pharmaceutical companies out of the vaccine business, Congress passed the National Childhood Vaccine Injury Act of 1986 (Public Law 99-660), which created the National Vaccine Injury Compensation Program (VICP). The idea was to create an alternative to the tort system through which people injured by vaccines could be quickly compensated through what is in essence a no-fault system. True, litigants claiming vaccine injury, if denied compensation by the Vaccine Court, can still sue in conventional courts, but all claims for compensation for vaccine injury in the U.S. must first go through the VICP and the Vaccine Court. In addition, the standards of evidence in the Vaccine Court of the VICP are arguably lower than what would be required to obtain compensation through conventional federal courts. For example, in the Vaccine Court the Daubert rules for the admission of scientific testimony from expert witnesses do not apply. Virtually all scientific testimony is allowed, which is, by the way, how such awful testimony was allowed in the Autism Omnibus test cases on behalf of the complainants.

Further streamlining of the system occurred in 2005, when the United States Court of Appeals for the Federal Circuit ruled that an award should be granted if a petitioner either establishes that a “Table Injury” of injuries that are generally accepted as potentially being caused by vaccines) occurred or proves “causation in fact” by proving the following three prongs:

  • a medical hypothesis causally connecting the vaccination and the injury;
  • a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and
  • a showing of a proximate temporal relationship between vaccination and injury.

Compensation is virtually automatic for so-called “table injuries” (i.e., known injuries that science attributed to vaccines listed on the Vaccine Injury Table) within the correct time frame. Also, compensation can be awarded if plaintiffs can meet a standard of evidence showing a 51% or greater chance that the plaintiff was injured by the vaccine in question. Indeed, as one lawyer who represents cases in front of the vaccine court put it:

“There is a difference between scientific proof and legal proof,” Conway said. “One is 95 percent certainty, and the other is . . . 50 percent and a feather.”

In other words, the award of compensation does not mean that a scientific link was found, only that a court of law thinks it more likely than not that a specific set of health problems is due to vaccine injury, no more, no less. A legal finding of causation does not necessarily imply a scientific finding of causation, no matter how much anti-vaccine activists trumpet rulings compensating children for vaccine injury as vindication of their pseudoscientific views that vaccines cause autism. Indeed, this ruling doesn’t even “prove” that MMR can cause brain damage, a contentious scientific question whose answer is not at all clear.

Finally, the VICP will reimburse plaintiffs for legal fees and court costs even if they lose in Vaccine Court. Indeed, certain unscrupulous lawyers (cough, cough, Clifford Shoemaker) have taken advantage of this feature of the Vaccine Court and racked up some very impressive billings representing complainants in front of the Vaccine Court. In other words, here in the U.S. at least, as little as the anti-vaccine movement believes it and would prefer to believe a conspiracy theorist view in which they are the downtrodden speakers of truth to power beaten down by The Man, the entire system bends over backwards to give complainants the benefit of the doubt. That the complainants for the test cases for the Autism Omnibus could not prevail, even in the relatively friendly venue of the Vaccine Court, should be evidence enough of just how weak their cases were, particularly given that the test cases were presumably the strongest cases the Omnibus lawyers could come up with. That point was driven home recently when the appeal for the first test case, that of a child named Michelle Cedillo, to the Federal Circuit Court, was denied, a ruling that was not unexpected and in which I take no pleasure but that was completely appropriate.

Now back to Robert Fletcher’s unfortunate case. As his mother told The Daily Mail:

Robert is nearly 19 but mentally he is like a 14-month-old toddler. He can’t stand unaided and he is doubly incontinent.

‘He can’t speak except to say “Hi, Mum” or “Hi, Daddy”.

‘We chop up his food and have to anticipate all his needs. He is prone to various illnesses and last week suffered around 40 severe epileptic seizures.

‘In April this year, we thought we’d lost him. He contracted a chest infection and had to go to hospital for several days.

‘He is such a lovely boy. When he’s not ill, he’s so cheerful and seems to take everything on the chin. In between seizures he says “Hi, Mum” and tries to kiss me.

My heart goes out to the Fletchers; it must be incredibly trying to have to deal with such a set of disabilities day in and day out. Moreover, I have no problem with the government finding legal causation. It’s almost irrelevant if on a strictly scientific basis the MMR vaccine caused Robert’s condition. There’s enough of an appearance that it did that, on a legal grounds and a societal basis, he should be given the benefit of the doubt and compensated. In fact, I agree with Mike Stanton that compensation took far too long and that the amount awarded was far too little. Mike makes a rather fascinating comparison between the U.K.’s vaccine compensation system and that of the U.S. The results are not favorable to the U.K.:

Again, the contrast with the USA could not be greater. Statistics about vaccine claims, verdicts and compensation paid are readily available on government websites. The UK government admitted to paying £3.5 million in compensation over the previous 8 years in 2005. The USA has paid out nearly $2 billion to 2,472 claimants over the past 21 years. They meet the legal costs of all claims whether upheld or not. The American Way seems to be to admit that vaccine injuries are a rare but unfortunate occurrence and to make the no fault compensation programme as transparent and user friendly as possible. By contrast the UK government is secretive, mean spirited and places obstacles in the path of potential claimants in a misguided attempt to bolster the vaccination programme. But insisting that vaccines are safe rather than being honest about the risks and benefits has not led to greater vaccine take up. On the contrary, whenever the government dismisses people’s fears instead of taking them seriously its “we know best” attitude merely reinforces people’s doubts.

Of course, the cost of the American system is widespread abuse by certain lawyers, who know they’ll be paid, win or lose. To me that is an acceptable price to pay to make the compensation system fair and relatively fast. True, some lawyers are not satistified because they can’t ever expect the truly large “lottery jackpot”-sort of pay-off from a Vaccine Court ruling. That’s the reason why some of them are arguing that the pre-emption of regular courts in vaccine cases by the Vaccine Court is unconstitutional.

Mike also makes a rather provocative observation that, had Jackie Fletcher been compensated in a timely fashion back in the 1990s, perhaps Andrew Wakefield would not have found such fertile ground for his anti-vaccine pseudoscience. Remember, Jackie Fletcher is the woman who formed JABS, which is in essence the British version of the NVIC or Generation Rescue. Whether this is true or not is, of course, impossible to say. Alternate history scenarios are fun to argue but impossible to prove one way or the other. It does, however, appear undeniable to me that the British system is neither fair nor transparent, and that can’t help but decrease confidence in the vaccination system, regardless of how safe vaccines are. After all, only 100% safety, which is unachievable for any intervention, would guarantee that there will not be the occasional child who suffers an injury due to vaccination. Like both Mike Stanton and Kev Leitch, I believe that such children deserve prompt, fair compensation.

Predictably, the anti-vaccine movement is crowing over this ruling, citing it as vindication. The anti-vaccine crank propaganda blog Age of Autism, for instance, has two stories up already, one entitled UK Vaccine Injury Win: MMR Caused Brain Damage and Vaccine Injury: The Fletchers and Cedillos – a Tale of Two Families. In one of these posts, Teresa Conrick struggles mightily to try to argue that, really and truly, the Fletcher decision means that vaccines cause autism after all:

Jacki and John Fletcher are warrior parents who have persevered in their care and legal case for Robert, now 18 years old. Jackie, in a recent email to Anne Dachel, here at Age of Autism, revealed that Robert suffers from a severe seizure disorder, with an inflamed oesophagus, brain damage and has some minor autistic traits. The award stressed epilepsy as the result of his injury. That is great news but for the thousands still waiting with children and teens also injured by the MMR, the lack of the word, “autism”, is baffling. Welcome UK parents, to our world, too. Here in the states, we also have heard those words, “but not autism.”

Whether it is severe autism or minor autism, isn’t “autism” a set of behaviors?

Uh, no. Nice try, though.

Of course, Autism is more than just a “set of behaviors,” but even if autism were nothing more than a set of behaviors I would retort that, for example, ADHD is a “set of behaviors” too, but that does not mean ADHD is the same thing as autism. Ditto any number of neurodevelopmental disorders. Claiming that the rare neurologic injuries that can be caused by vaccines are “the same thing” as autism based on such an argument is specious reasoning at best, disingenuous at worst. Still, such posts are revealing. Age of Autism claims that it is all about “autism advocacy,” but in the end its merry band of propagandists are all about the vaccines, and so are its readers. They are anti-vaccine to the core. To them, autism is “vaccine injury,” and that’s it. No amount of science will convince them otherwise.

Injuries and complications that can be scientifically shown to be due to vaccines deserve compensation that is prompt, fair, and not onerous to obtain, even at the cost of letting sleazy lawyers take advantage of the system. Meanwhile, scientists should (and, the pharma conspiracy mongering of the anti-vaccine movement notwithstanding, do) work to make vaccines as safe as possible, so that such injuries are as rare as possible. Unfortunately, there will likely never be such a thing as a vaccine that is 100% absolutely safe; all that can be reasonably requested are vaccines whose benefits and safety far exceed a tiny risk of complications and a system that compensates those injuries. Although the ethical issue of how much risk is acceptable and what frequency of vaccine injuries are tolerable in the vaccination program is complex and difficult, we should not lose site of the fact that vaccines do far more than good.