NVICP Tarsell decision not proof of HPV vaccine-related mortality – just legal errors

NVICP Tarsell decision

On September 25, 2017, Special Master Christian Moran from the National Vaccine Injury Compensation Program (NVICP), acting under a Court of Federal Claims decision that changed the legal standard for compensation, awarded compensation to Ms. Emily Tarsell for the tragic death of her daughter, Christina Tarsell. The family had blamed the tragedy on Gardasil. the HPV vaccine. Let’s review the facts and legal issues of the NVICP Tarsell decision.

A reading of the decision shows that the Special Master himself had serious doubts that the HPV vaccine had actually caused the death (and could probably have more strongly stated his doubts); however, he felt bound by a flawed decision of the Court of Federal Claims and compensated because of that guidance. The claimant’s theory that was used to claim that the vaccine caused the young woman’s death is also extremely far-fetched. It should not have fulfilled the plausible theory requirement even under the watered-down version ordered by the Federal Claims judge. The timing (i.e., cause and effect) was likely wrong – the Special Master thought the disease symptoms started before the administration of the vaccine – but for procedural reasons, he did not dwell on that issue.

While anti-vaccine websites present the Special Master’s award as proof that the death was caused by the administration of the vaccine, that is a serious misreading of the NVICP Tarsell decision. Ms. Christina Tarsell’s death is extremely tragic. But there is no good basis to claim that the HPV vaccine caused it.

There are three legal errors in the decision of the Court of Federal Claims judge, a decision that was then legally binding on the Special Master it was returned to for reconsideration:

  1. Reversing the burden of proof in relation to the timing of the alleged harm;
  2. relaxing the standard under which a medical theory is evaluated; and
  3. applying a de novo standard instead of an arbitrary and capricious standard to the Special Master’s findings of facts (which I’ll explain).

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European court vaccine decision – a legal analysis

European court vaccine decision

On June 21, 2017 the European Court of Justice (ECJ) decided a product liability case (N.W. et al v. Sanofi Pasteur MSD SNC, C-621/15) described by news articles as allowing plaintiffs to be compensated for alleged vaccine harms, even when there is no scientific evidence of a causal connection (in the most extreme versions, “with no proof”). This description is incorrect. More nuanced analyses were provided by Orac and Steve Novella, but I think they, too, did not exactly capture what the decision does. This post explains the European court vaccine decision.

Three take-home points are important:

  1. If there is no scientific consensus as to whether a vaccine causes a particular kind of injury, member state courts can allow plaintiffs to use circumstantial evidence to prove a vaccine injured them. Defendants, of course, can use scientific evidence to counter the plaintiff’s circumstantial evidence. This decision does not mean that science doesn’t matter in the courts or that anti vaccine activists can win even when the science is against them.
  2. Member courts cannot treat circumstantial evidence as creating a presumption of causation. The plaintiff bears the burden of proving the vaccine cause the injury, and each case must be examined on its facts.  For example, a temporal connection alone does not automatically mean there’s causation.
  3. In a referral like this, the ECJ does not reexamine the facts. It is answering the specific questions of law, and basing its decision on the description of the facts sent up from below. The ECJ was acting on a mistaken premise that the science, in this case, was unclear. That premise came from the lower courts, and the ECJ did not err in following it: it did not reexamine the facts, and did not decide the case in front of it, it only addressed a specific legal question. In the lower courts that now will be expected to rule according to the ECJ’s decision, Sanofi Pasteur – the defendant – should provide the scientific evidence, and we can hope the court, as did the Court of Appeals who ruled on the case last, will follow it. It’s unclear how the case will end.

This is a complex decision. To explain it, I will start with some background on product liability law and European Union law with respect to the European court vaccine decision. Then I will address this case, and then the ruling itself. If you are short of time you can skip the background and go directly to the case, but I think those who want to really understand this will benefit from it. Continue reading “European court vaccine decision – a legal analysis”

Vaccine injury compensation and mitochondrial disorders

Vaccine injury compensation and mitochondrial disorders

This post examines the treatment by the National Vaccine Injury Compensation Program (NVICP) of the first of two claims (see second one here) heard from those claiming vaccines cause more injuries than acknowledged in recent days. This article will focus on vaccine injury compensation and mitochondrial disorders – while the second one will cover an NVICP decision with respect to a form of an autoimmune syndrome.

The Special Master’s decisions – as many decisions in NVICP are – are long, complex, and examine the evidence closely and in detail. They address factual debates, expert disagreements specific to the case and expert disagreements on the science.

This post won’t cover them – that’s not my goal. All I will address are the Special Master’s conclusion about two hypotheses raised by those who believe vaccines injured their child (and also promoted by anti-vaccine organizations).

The NVICP (commonly called the Vaccine Court) is a no-fault program created by Congress to serve two goals: to protect the vaccine supply by offering limited liability protections to vaccine manufacturers and providers and to help those injured by vaccines – or even those who may have been so injured – be compensated more easily than in the regular courts.

As I addressed in the past, NVICP provides petitioners – as claimants are called – with substantial breaks compared to the regular courts. Petitioners do not have to prove a product defect or any kind of fault; the requirements for proving causation are relaxed; evidentiary rules are relaxed, allowing the introduction of evidence and experts that would not be allowed in a regular court.

NVICP is not, however, a benefits program. Its goal is not providing any parent with a child with a problem support. The United States certainly needs to offer more support to families of children with disabilities, but NVICP’s aim is different: it focuses on compensating injuries that may, at least, have been caused by vaccines.

To be compensated by an NVICP decision a petitioner does need to meet minimal standards suggesting a possible connection between a vaccine and an injury (a settlement does not require similar proof; parties settle for all kinds of reasons, including a view that the case isn’t worth litigating). At the very least a petitioner needs to show an injury, and provide expert testimony (expert testimony is generally needed when someone claims medical causation in the courts as well – that a medical act, device, drug etc. caused harm – with very narrow exceptions).

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