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.
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.
Conclusion:
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.
