Left Brain Right Brain

As Ken has recently written, the Supreme Court has decided on the case of Bruesewitz v. Wyeth. This is not an autism case, but involves the rights to sue a vaccine manufacturer for design defect claims outside of the court system set up 25 years ago in the Vaccine Act.

Justice Scalia wrote the decision, with Justice Breyer submitting a concurring statement and Justice Sotomayor writing the dissent. It was a 6-2 decision, with Justices Sotomayor and Ginsberg dissenting and Justice Kagan not participating.

The parents had already brought their case to the Court of Federal Claims (“vaccine court”), which ruled against them. They did not accept the ruling and took their case to other courts. Eventually landing in the Supreme Court of the United States (SCOTUS). The U.S. Supreme court is an appeals court. As such, this case is an appeal of a lower court (Court of Appeals) ruling. The Supreme Court ruled:

For the foregoing reasons, we hold that the National Childhood Vaccine Injury Act preempts all design-defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects. The judgment of the Court of Appeals is affirmed.

The Court summarized a major part of the claim as:

Their complaint alleged (as relevant here) that defective design of Lederle’s DTP vaccine caused Hannah’s disabilities, and that Lederle was subject to strict liability, and liability for negligent design, under Pennsylvania common law.

The parents had argued that they could sue under a “design defect” argument, and “strict liability“.

Design defects are defined as:

In the law of products liability, a design defect exists when a defect is inherent in the design of the product itself. In a products liability case, a plaintiff can only establish a design defect exists when he proves there is hypothetical alternative design that would be safer that the original design, as economically feasible as the original design, and as practical as the original design, retaining the primary purpose behind the original design despite the changes made.

“Strict liability” “…applies when a defective product for which an appropriate defendant holds responsibility causes injury to an appropriate plaintiff.”

They claimed that the manufacturer of the vaccine can be sued because a safer vaccine could have been produced and avoided the injury.

Note that in this SCOTUS case, they aren’t arguing the facts of the case–whether the vaccine caused injury–just whether they had the right to sue in a civil court based on the “design defect” claim. SCOTUS did not rule one way or another on the injury claim that was rejected by the Court of Federal Claims.

As to the liability issue, Federal law states:

“[n]o vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side-effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”

Much language is spent on the meaning of the “if” clause and the “even-though” clause. Many words to discuss a short paragraph. One which I thought was quite clear. But I’m not an attorney.

In the Court’s discussion is this paragraph:

Design defects do not merit a single mention in the Act or in Food and Drug Administration regulations that pervasively regulate the drug manufacturing process. This lack of guidance for design defects, combined with the extensive guidance for the two liability grounds specifically mentioned in the Act, strongly suggests that design defects were not mentioned because they are not a basis for liability. The Act’s mandates lead to the same conclusion. It provides for federal agency improvement of vaccine design and for federally prescribed compensation,which are other means for achieving the two beneficial effects of design-defect torts—prompting the development of improved designs, and providing compensation for inflicted injuries.

Design defects are just not part of the equation in the Vaccine Act, and the Court decided that this is because the lawmakers intended it that way.

Does this mean that Americans have no recourse in vaccine injury claims? The claim has already been made, even as I was writing this post:

According to vaccine safety advocate Louise Kuo Habakus, “The Court is telling parents that they’re on their own. Parents know that 4 out of 5 cases of vaccine injury do not get compensation in the misnamed Vaccine Injury Compensation Program. The Supreme Court has slammed the courthouse doors shut.”

“Parents know that 4 out of 5 cases of vaccine injury do not get compensation in the misnamed Vaccine Injury Compensation Program.”

What a statement. I’ve never heard this statistic before. I guess I’m not a “parent” by the definitions of the self-styled “vaccine-safety” community. Or, maybe, just perhaps…the statistic is made up or manipulated and this is the time to try to get it into the national discussion.

Are the courthouse doors shut? Hardly. There is the Court of Federal Claims, which does compensate people by allowing Americans to petition the U.S. government directly. That is no small issue, by the way. Sovereign states can not be sued under normal circumstances.

Even aside from the Court of Federal Claims, is this 100% immunity from liability? I don’t believe so. Remember that phrase: “…even though the vaccine was properly prepared and was accompanied by proper directions and warnings”. What if a vaccine is not properly prepared? Or if it doesn’t have proper directions and warnings?

A legal term is used throughout the decision: “unavoidably unsafe products”. I was going to predict that this term would be used to scare people about vaccines. I can’t make that prediction, because it has already started. Again from Ms. Habakus:

Because the federal government recommends 70 doses of 16 “unavoidably unsafe” vaccines, and states compel 30-45 doses for school attendance, this issue affects all children.

Keep this in mind. Not vaccinating yourself or your child is an “unavoidably unsafe” decision. Also it is an “unavoidably unsafe” decision for others.

Justice Sotomayor wrote about “unavoidably unsafe” in her dissenting opinion, citing “… comment k of §402A of the Restatement of Torts (Second) (1963–1964)”. (comment k gets discussed much by both sides).

“Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.”

This is the entire point of the informed consent, by the way. If there is no chance of adverse events, there is no need to “inform” the patient about anything. I bring this up because informed consent is supposed to be a big issue for “vaccine-safety” groups.

Justice Sotomayor accuses the majority of writing a “policy driven” decision.

25Respondent notes that there are some 5,000 petitions alleging a causal link between certain vaccines and autism spectrum disordersthat are currently pending in an omnibus proceeding in the Court of Federal Claims (Vaccine Court). Brief for Respondent 56–57. Accord-ing to respondent, a ruling that §22(b)(1) does not pre-empt design defect claims could unleash a “crushing wave” of tort litigation that would bankrupt vaccine manufacturers and deplete vaccine supply. Id., at 28. This concern underlies many of the policy arguments inrespondent’s brief and appears to underlie the majority and concurring opinions in this case.

Perhaps I am naive, but I agree that such statements should not weigh into the decision. If these 5,000 petitioners have the right to sue, they should have that right.

Justice Sotomayor goes on to say:

In the absence of any empirical data, however,the prospect of an onslaught of autism-related tort litigation by claimants denied relief by the Vaccine Court seems wholly speculative.

It may be speculative, but is as good a speculation as you can get. Yes, if Bruesewitz had prevailed, there would be an onslaught of autism-related tort litigation.

Further, she states:

Trial courts, moreover, have considerable experience in efficiently handling and disposing of meritless products liability claims, and decades of tort litigation (including for design defect) in the prescription-drug context have not led to shortages in prescription drugs.

Which is a very strange statement in context. Yes, some autism-vaccine cases have been halted before they started in civil courts. But the entire basis for the Vaccine Act and the Court of Federal Claims taking on the vaccine issue is the claims that DPT was causing a huge wave of disability. A claim which was later found to be meritless, as later science showed no association. The litigation which prompted the Vaccine Act did lead to shortages and was well on its way to leaving the US without vaccine providers.

This all said, in the end it isn’t whether the court is right or wrong (as will no doubt be discussed at length in some circles). For practical purposes, what matters is that the court has decided. People are not able to take vaccine manufacturers to civil court on design defect claims.

With that and the end of the Omnibus Autism Proceeding, autism-vaccine litigation is essentially over. If some real evidence were to come forward which could make autism causation by vaccination a defensible idea, sure, cases would be heard again in the vaccine court. Until that time, legally as well as scientifically, the idea has had its day and it is time to move on.