Sunday, November 3, 2013

Vaccines and "Unavoidably Unsafe Products"

By Dorit Reiss

Those of us engaged in vaccine-related discussions online often hear vaccine critics claim the Supreme Court has declared vaccines “unavoidably unsafe” and thus incredibly dangerous. The critics are doubly wrong. First, the Supreme Court has said no such thing. Second, in the law’s eyes, an unavoidably unsafe product is not a “super-dangerous” product.  Quite the opposite, an unavoidably unsafe product is a product whose tremendous benefits justify the reasonable risks it poses.

What is an "unavoidably unsafe” product?

Normally, in the United States, a person only has to pay damages if they caused harm to someone else with fault—in other words, if they acted negligently or intentionally. In the area of products liability, however, the United States adopted a different approach.

In 1965 the American Law Institute published the Restatement (Second) of the Law of Torts, §402A. Section 402A was an attempt by the ALI – a nonprofit organization of lawyers, judges and academics - to rationalize a growing number of court decisions holding manufacturers and sellers of defective products liable to the consumers their defective products injure.  It adopted a standard of liability without fault when a business sells a product “in a defective condition unreasonably dangerous to the user or consumer or to his property.”

The qualification was important: not every product that causes harm is defective.  Well-made knives can cut fingers, and even the best whiskey can get you drunk!   To be defective, a product had to be unreasonably dangerous, either because it was poorly made, or because consumers weren’t aware of its dangers, or because a different design could have made the product safer.

Restatements are very influential (though not binding), and section 402A was quickly adopted by pretty much every state.

The Restatement’s drafters wanted to provide certain products with additional protection against liability, because although those products, too, carried risks, they provided especially high benefits.  The Restatement’s drafters expressed this idea in a comment to section 402A; namely, comment k:

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 last sentence is the important one: A vaccine whose benefits outweigh its risks is not unreasonably dangerous or defective – even if the risks are as frightening as those attributed to the Pasteur vaccine, let alone modern vaccines, with their much lower risks.

In retrospect, the Restatement’s drafters could have chosen better language to capture the idea that a product or a drug can be valuable even it if poses some risk to its users (and indeed, the drafters of the Restatement (Third) of Torts: Product Liability did away with the “unavoidably unsafe” language while preserving the same idea:   

Saying a product is “unavoidably unsafe” makes it sound like the product is a bad one, when what the drafters meant was precisely the opposite: the comment was meant to apply only to ethical drugs or vaccines, i.e. where the benefits outweigh the risks.  But courts understood.  Some courts (California, New York, Alabama) adopted comment k wholeheartedly, exempting all properly manufactured prescription drugs and vaccines from strict liability.  Others applied comment k selectively, requiring a case-by-case determination that there is no safer alternative design for a drug or vaccine before finding the risk unavoidable (Idaho, Colorado, Hawaii).  Some courts, inevitably, are unclear or take an intermediate position (Florida, Georgia, Indiana). 

The message comes through clearly: these products are beneficial enough that society wants to encourage their manufacturing. Therefore, while strict liability would be applied to most products, a manufacturer that prepared a drug or vaccine carefully and warned consumers of its risks should not have to pay for the side effects of a drug or vaccine whose benefits outweigh the risks unless that manufacturer can be shown to have been negligent.

In other words,  “unavoidably unsafe” is the opposite of “unreasonably dangerous” in the Restatement’s categorization. It justifies a more favorable treatment because of those products’ extraordinary benefits.

What Did the Supreme Court say in Bruesewitz?

Regardless of the real meaning of the term “unavoidably unsafe,” it is understandably disturbing to parents to hear that the Supreme Court described the vaccines given to their children using that scary term. Fortunately, it didn’t.

In a case from 2011, Bruesewitz v. Wyeth , the Supreme Court discussed whether the National Childhood Vaccine Injury Act of 1986 (NCVIA) preempts tort suits for product design defects at the state level. The NCVIA created an administrative compensation scheme, in many ways quicker and easier than a court procedure. The question was whether a plaintiff who claims that she was injured because the vaccine was designed in an unsafe manner is limited only to the special compensation scheme, or can also sue in state courts (specifically, plaintiff claimed that she should have been given the shot with the acellular pertussis vaccine, rather than the whole cell pertussis vaccine).

While section 402A of the Restatement (Second) Torts did not distinguish between types of defects directly, today’s product liability jurisprudence distinguishes between three types of defects a product might have. Manufacturing defects are situations where the product is not up to the standard set by the manufacturer itself: when it deviates from its intended design. In the vaccine content, an example is the infamous Cutter Incident, in which a polio vaccine supposed to contain an inactivated virus ended up containing a live virus, paralyzing 200 children and killing ten. The product was designed to have an inactivated virus; it had a live one; the manufacturer did not meet its own standards. For manufacturing defects, the courts apply strict liability.

Another type of defects is a design defect. Under this theory, a plaintiff must prove that there is an alternative design that is safer than the current design. In the vaccine context, plaintiff may claim that using the Oral Polio Vaccine (OPV) that includes a live virus and carries a small risk of paralysis is less safe than using the Inactivated Polio Vaccine (IPV) which does not carry that risk. To make a long story short, while some courts still talk about strict liability when handling these kinds of suits, they are currently handled under negligence principles.

The last type of defects is a warning defect, also handled under negligence principles. A warning defect, for example, would be not warning that a product needs to be stored in a certain temperature, or not warning against a risk.

The NCVIA clearly allows children injured by a vaccine to sue the manufacturer in the regular courts if the vaccine was poorly made or lacked appropriate warnings.  Does it also allow children to sue in state court if the vaccine was poorly designed?

The question was how to interpret §300aa-22(b)(1) of the act, which says:

“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.”

The plaintiffs – and two dissenting Justices – argued that when Congress used the word “unavoidable,” it meant to invoke comment k’s concept of the “unavoidably unsafe” product, as interpreted by courts applying it using a case-by-case approach.  Under this approach a product isn’t unavoidably unsafe if there’s a way to design the product that would eliminate the risk of side effects.  Therefore, the plaintiffs claimed Congress meant for plaintiffs to have the opportunity to sue a vaccine’s manufacturer if they could prove that an alternative design would have eliminated the risk of harm.

The majority of the Supreme Court, in a five-justice decision written by Justice Scalia, disagreed.   What Congress meant when it said manufacturers are not liable for side effects that were “unavoidable” was that manufacturers are not liable for the side effects of vaccines that are properly prepared and accompanied by proper directions and warnings.  As Justice Breyer explained in a concurring opinion, Congress deliberately decided that if plaintiffs could sue manufacturers over the way vaccines were designed, drug manufacturers threatened by frequent lawsuits would stop making needed vaccines. Congress was not willing to accept that result.

The majority opinion in Bruesewitz expressly rejected the idea that by using the word “unavoidably” Congress meant to invoke comment k:

“… there is no reason to believe that [the Act] was invoking [comment k]. The comment creates a special category of ‘unavoidably unsafe products,’ while the statute refers to ‘side effects that were unavoidable.’ That the latter uses the adjective ‘unavoidable’ and the former the adverb ‘unavoidably’ does not establish that Congress had comment k in mind. ‘Unavoidable’ is hardly a rarely used word. Even the cases petitioners cite as putting a definitive gloss on comment k use the precise phrase ‘unavoidably unsafe product’; none attaches special significance to the term ‘unavoidable’ standing alone.” 

The court is very clear: it’s rejecting the application of the term “unavoidably unsafe” to the Act.  Neither Congress nor the Court thinks vaccines are “unavoidably unsafe” in the way vaccine critics mean to suggest.


Comment k does use the Pasteur rabies vaccine to illustrate what it means by “unavoidably unsafe” and the dissenters in Bruesewitz v. Wyeth do rely on comment k to argue Congress meant for plaintiffs to have a chance to prove that an alternative design would have made the vaccine safer.  What the vaccine critics have missed -as Justice Breyer’s concurring opinion in Bruesewitz explains – is the principle behind comment k.  If a product – like a vaccine or a drug – is “unavoidably unsafe”, the product is NOT defective, and the product’s manufacturer is not liable for the products’ inherent risks (though the plaintiff may still be eligible for compensation through the administrative program). “Unavoidably unsafe” products are products that are so valuable – have so many benefits – that the risk associated with their use is justified.  If the Supreme Court had applied this term to vaccines, it would have reaffirmed what most scientists and doctors know: the benefits of vaccines far, far outweigh their small risks.

Author's Note: I am very grateful to the people who read my post for accuracy and for grammatical edits: Marsha Cohen, David Jung, David Levine, Kathy McGrath, Paul Offit, Robert Schwartz, Madeleine Ware, Alice Warning Wasney and Kelly Wessel. All errors are, of course, my own.

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