Liar, Liar, Pants on Fire

There is a certain lie that floats about anti-vaccine groups. Before I go on, let me be clear about my use of that word: "lie". Because of certain, um, frivolous proclivities among some of the folks who perpetuate this lie, I feel it behooves me to define just what I mean. In this post, I am going to use the term "lie" with it's definition of "a falsehood". It should not be construed, unless I explicitly state otherwise, that I am implying an intention to deceive on the part of the person uttering this lie. Suffice to say that, whether through deliberate action or mere misunderstanding, many among the anti-vaccine movement persist in forwarding this lie, this falsehood, as if it were truth.

Now what lie am I going on about? This: "the Supreme Court of the United States has completely shielded vaccine manufacturers from product liability". You've no doubt heard some version of this before, often in the form "parents can't sue vaccine manufacturers". As it is frequently stated by those opposed to vaccinations, this simply is not true. Some parents just repeat this because they read it somewhere and believed it. They haven't actually read the relevant documents to find out for themselves what's really going on. I don't blame them for that. It's sloppy thinking and intellectually lazy, but I'm not going to harp on it. I'd just recommend that they (temporarily) put aside their blinders, read the actual source documents and think for themselves. Don't even take my word for it.

Then there are those who ought to know better, and, I suspect, probably do. Whether they just really do not understand or are knowingly misrepresenting facts, there are those who hold themselves out as fierce advocates of informed consent who, if they were truly devoted to that, would actually present truth, rather than falsehood. People like Barbara Loe Fisher.

What prompted this post is something I read on Fisher's blog, Vaccine Awakening, the other day. Now, I don't make a habit of frequenting her site. I find her writings to be akin to those with paranoid delusions of grand conspiracies. They're not, I would say, my cup of tea (a nice cup of jasmine or Earl Grey, on the other hand...). But on a whim I took a look over there, stumbling on a post from November last year entitled Under Attack, NVIC Helps Americans Stand Up & Speak Out. It was there, under the heading "No Liability for Drug Companies & Doctors" that I read this:

I certainly didn't realize this.

That sounds bad, doesn't it? I mean, complete protection from product liability claims? No chance to sue doctors for malpractice? And the vaccine makers want to be able to force people to buy their products? With no exceptions? I certainly don't want that. The only problem for Fisher is that it is not true.

Where did she get this information? Well, she doesn't provide any support for the forced purchase bit, so I have to assume she's just making that part up. I mean, to begin with, "no exceptions" implies that not even medical exemptions would be allowed. I don't think even the most callous company would push for that, let alone be allowed to do so. As for the medical malpractice bit, neither of her citations (which, by the way, both go to information put together by her and her organization, the misnamed National Vaccine Information Center, rather than independent, original sources) mention anything about doctors being shielded from malpractice claims. My understanding on that point is that if a doctor follows all the appropriate directions for vaccine handling and administration, including taking into account the individual patient's current state of health, that they are not committing any sort of malpractice if the vaccine results in an adverse event. That is as it should be. If, on the other hand, they do not properly handle the vaccine (e.g., improper storage), do not administer it according to accepted standards or otherwise behave in a manner contrary to good medical practice, they can still be sued for malpractice. But, no actual source for her claim, so I'll just leave it at that.

The "product liability" bit, now. That I can address more fully, since we actually have available to us an original source upon which her claim rests. That's the lie that I was talking about. This particular gem stems from a misrepresentation of a Supreme Court case, Bruesewitz v. Wyeth (PDF). That link, which she doesn't include in her post, goes to the final ruling in the case. Take a moment to read it, or at least the first few pages, which summarize the decision.

By way of a little background, Hannah Bruesewitz, born in 1991, received, according to the approved vaccination schedule, a DTP immunization in April 1992, after which she suffered seizures and developmental delay. Her parents filed a claim in the Vaccine Injury Compensation Program in 1995. Though the judgment went against them, the Special Master still awarded them attorney's fees and costs. The Bruesewitzes, rather than appealing the decision, decided to reject the ruling and sue the vaccine manufacturer, Wyeth, in state court on a design defect claim. Their claim in state court was dismissed on the grounds that the National Childhood Vaccine Injury Act (NCVIA) preempts claims of design defects. The case then wound its way up to the Supreme Court, where the question was "whether a preemption provision enacted in the National Childhood Vaccine Injury Act of 1986 (NCVIA) bars state-law design-defect claims against vaccine manufacturers."

In a 6-2 decision, the Supreme Court ruled that NCVIA does preempt state design defect claims. What this means is that if a vaccine causes an injury despite the maker following all proper good manufacturing practices and including appropriate directions for its use, as well as reasonable warnings about the risks, then the claimant has to go through the Vaccine Injury Compensation Program first; they cannot just sue in state court from the get-go.

Without a good understanding of how to read legal text or judicial writing (i.e., just reading the ruling like one might read a newspaper article or novel, where one can make perfectly justifiable assumptions), I can understand how someone might get the impression that all claims against a vaccine manufacturer are barred from state court. It's wrong, but I do understand how one can come to that conclusion. So what does the ruling really mean? I'm not a lawyer, but I have run my ideas past several who have helped me clarify some of the nuances of the ruling.

Judicial decisions tend to be rather narrow in their focus. For instance, when it comes to products liability, there is a good deal more than just "design defect" claims. There are also manufacturing defects and labeling defects. Bruesewitz only declared that design defects are preempted by NCVIA; the other two types of defect are still open avenues for tort actions in state court. If an injury resulted from negligent manufacturing practices or labeling defects, the company can still be sued under state law, rather than through the Vaccine Court. Therefore, the claim that vaccine manufacturers are shielded from all liability (or even just all products liability) is demonstrably false. Anyone who says otherwise is lying (either through misunderstanding or deliberate deceit).

Beyond that, there is still another aspect implied by the anti-vaccine assertion: that all vaccine claims are barred from litigation. Like the products liability bit above, this, too, is false. The basis for the Bruesewitz ruling is the NCVIA. This is important for a couple reasons. First, that act only covers vaccines that are recommended for routine administration to children. If a vaccine is not part of the recommended childhood immunization schedule, then it is not covered by the Vaccine Injury Compensation Program. If it is not covered by VICP, then the Bruesewitz interpretation does not apply, and one can attempt to sue the manufacturer for product liability (on design, manufacturing or labeling defect claims) in state court.

The second aspect is the table of injuries. NCVIA has established a list of injuries that, if they occur within the listed time frame of receiving a vaccine, are assumed to be caused by the vaccine and are compensated by the program. If an injury is not listed, the claim must still go through the Vaccine Program first, in which case the petitioner must prove that the injury was caused by the vaccine. But if the court rejects the claim, the petitioner can either appeal to the U.S. Court of Appeals for the Federal Circuit, claiming that the Vaccine Court made a mistake, or file a claim in state court. In the former case, success will result in compensation from the program. In the latter, the claim is against the manufacturer.

The Bottom Line

The Bruezewitz ruling does not protect vaccine manufacturers from being sued. It does not protect them from all liability, nor does it even protect them from all product liability. There are still a number of different ways that companies can be sued. Furthermore, petitioners can still be compensated, even if an injury is not on the vaccine injury table, as long as they can prove that the vaccine was plausibly and more likely than not the causative agent for the injury.

So if you read or hear someone say that a vaccine manufacturer is protected from liability, know that they are lying (i.e., telling a falsehood), either intentionally or through misunderstanding or ignorance. Some of them, such as activists like Barbara Loe Fisher, should know better.