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To my vaccine-concerned friends: stop saying that the Supreme Court decided that vaccines are “unavoidably unsafe.” It didn’t.

To my vaccine-concerned friends: stop saying that the Supreme Court decided that vaccines are “unavoidably unsafe.” It didn’t.

(2/14/2021 note: Because so many people have apparently misunderstood this in-the-weeds legal analysis of this Supreme Court decision, I have recently revisited the issue of the “vaccines are unavoidably unsafe” mantra in a recent post which might make it clearer for some. Here is the link. )

One of the things that drives me crazy is when nonlawyers misstate the law. I have been informed by some of my vaccine-concerned friends that the Supreme Court actually stated that vaccines are “unavoidably unsafe,” and use the Supreme Court finding to support their argument that people should not be forced into vaccination because even the Supreme Court acknowledged how unsafe vaccines are.

I’m here to tell you that it never happened.

The Supreme Court has never held or decided or even affirmatively stated as a proposition of medical fact that vaccines are “unavoidably unsafe.” Those who make that incorrect assertion have misread or misstated the Supreme Court’s decision in Bruesewitz v Wyeth, LLC, decided in 2011.

The legal issue decidedin Bruesewitz v Wyeth, LLC

The issue in the case was whether after an adverse decision from the federal vaccine court, the alleged vaccine-injured party could pursue a state law, design-defect lawsuit. The district court dismissed the lawsuit on preemption grounds, and the court of appeals affirmed. The Supreme Court, per a majority opinion by Justice Scalia, affirmed, holding that all state law, design-defect vaccine injury lawsuits were preempted by the 1986 federal vaccine act.

Before taking a closer look at the decision, a point about how lawyers analyze cases (which we call “legal method”) and how appellate courts write opinions.

The precedential rule of law established in a case is often called the holding. In Bruesewitz, the rule of law or holding is that any and all state court design defect vaccine injury lawsuits are preempted by federal law.

Anything other than the holding is called dicta, and would include the discussions which the majority and dissent opinion writers put into their respective opinions to show that the other side is wrong. And that’s what happened in this case, which gave rise to the incorrect notion that the Supreme Court decided or stated that vaccines are “unavoidably unsafe.”

Justice Scalia focused on the key language supporting preemption:

“the Act expressly eliminates liability for a vaccine’s unavoidable, adverse side effects: “No 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.”
(Page 5 of the opinion)

Here is a pdf of the opinion:


So, the vaccine statute does in fact suggest that some vaccines could have adverse effects which are unavoidable. But of course, all vaccine-concerned know that. What this language means is that as long as the vaccine was properly manufactured and proper warnings were given (and that means using the FDA approved labeling language, including warnings and contraindications) then a vaccine manufacturer can not be sued (outside of vaccine court) for any harm or side effects the vaccine caused.

One of the arguments which the vaccine-injured family made, which was adopted by the Supreme Court dissenters, was that the word “unavoidable” in the statute is a term of art, and refers to a comment in the Restatement of the Law on Torts.

We need to go sideways, times two, to explain:

What’s a Restatement?

Restatements are compilations the law by a group of legal scholars. They are like legal reference books which summarize the law on a given subject. They are not state specific. They relate the common or judge made law on a topic across the country. Restatements are not binding, but are frequently cited by judges, especially if there is no state case law on a legal point.

Products liability lawsuits

The easiest way to sue a product manufacture is to sue under a products liability theory because of strict liability, meaning you don’t have to show that the manufacturer was negligent.

There are three types or grounds for successful products liability cases: defective manufacturing, defecting warning, and defective design. It’s the third which was the basis of the vaccine injured plaintiff and the dissent’s argument.

Comment k to a Restatement section, states in effect that you can’t sue for products liability for “unavoidably unsafe products,” meaning, if there is no way to make the product safe or make a better designed product.

The dissent argued that because the vaccine statute used the word “unavoidable” that meant Congress intended to incorporate the “unavoidably unsafe products” concept from the Restatement section comment. (Note that Restatements don’t usually directly apply to, or interpret federal statutes, so to me the argument was pretty lame). With this and other arguments, the dissent tried to argue that not all vaccine design- defect lawsuits should be automatically preempted (and presumably only those where there is proof that the vaccine is “unavoidably unsafe,” and that would open the door to more involved litigation in this and all other similiar cases issue).

Scalia discussed this argument in his majority opinion and mentioned the “unavoidably unsafe products” language from the Restatement, discussed in the dissent’s opinion. Scalia said there was no indication that the authors of the statute intended that the statute be interpreted by the Restatement comment.

This oversimplifies things somewhat, but the important point is that while Scalia did quote the Restatement’s comment’s words, it was done in the context of the majority’s rejecting the application of the Restatement comment to the federal vaccine statute. (Scalia’s discussion of the Restatement comment is on pages 8-11. (I confess to having a hard time following some of his semantic points, but his esoterica is not relevant to my point in this post).

So, I’m thinking that if you’re using Bruesewitz to try to argue that even the Supreme Court acknowledged that vaccines are unavoidably unsafe, now would be a good time to stop.

Rick Jaffe, Esq.