Supreme Court Limits Lawsuits Against Vaccine Makers


Vaccine makers such as Pfizer (PFE) are breathing much easier today: The Supreme Court ruled they can't be sued for defective vaccine designs. That puts the kibosh on some 5,000 cases in which parents blame vaccines for their children's autism, and generally gives the pharmaceutical companies much more certainty about their potential liability. The decision was 6-2, with Justice Elena Kagan sitting out. Justices Sonia Sotomayor and Ruth Bader Ginsburg dissented.

When a product hurts someone, one possible way the victim can sue is to claim that the product was designed defectively. Claiming a defective design is the tricky, because products can be inherently dangerous, but still be good products -- chainsaws or cars, for example. While different courts use different tests to determine if a design was defective, the basic idea is to strike a balance between the product's usefulness as intended and the risks it creates.

Let's apply this to a hypothetical vaccine: Imagine it's possible to have a vaccine that has no side effects, but isn't particularly effective at preventing the disease it targets, and another formulation that's extremely effective at disease prevention, but does have side effects, including -- in very rare cases -- horrible ones such as brain damage or even death. Because of society's interest in promoting the use of effective vaccines -- when someone fails to immunize their child, both that child and other people are put at risk, particularly infants and the elderly -- Congress has emphatically endorsed vaccines that are effective but have some rare risks as the better design.

To prevent vaccine makers from being bankrupted by lawsuits over those rare but horrible side effects, Congress created a special vaccine compensation program for victims. If a victim's claim is rejected by that program, the victim can still sue under state law, claiming the vaccine was defective. In the case the Court just decided, the issue was whether Congress allowed all kinds of defective vaccine claims, or just claims a vaccine was defectively manufactured or defectively marketed (i.e.: that the maker failed to warn users of known risks.)

Justice Scalia: A Strict Constructionist and a Strict Grammarian

The court heard the case of Hannah Bruesewitz, who developed a seizure disorder and mental disabilities as an infant, shortly after being given Wyeth's DPT vaccine. (Wyeth is now part of Pfizer.) Her family's claim for compensation was rejected by the federal program, and they turned to state court, alleging the vaccine was defectively designed because Wyeth owned a different design that was safer, but chose not to market it. Wyeth disputes the claim that the other design was safer.

In deciding the Bruesewitz's claim was barred, the Court turned to the text and structure of the law creating the federal compensation program. Effectively the decision turned on what the three words "even though" and "unavoidable" meant in this context:

"No vaccine manufacturer shall be liable [for] a vaccine-related injury or death...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." (bold added)

Justice Scalia, a famous textualist, wrote the opinion. The majority decided that the language meant that only manufacturing and marketing defects, which follow the "even though", are allowed. If design defects were allowed, it should have said something like "properly prepared and designed and accompanied..."

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The dissent disagreed, arguing that the word "unavoidable" had a special meaning from a law treatise, which changed the analysis, and Congress hadn't clearly said it was preempting the state claims. Finally, the dissenters emphasized that shielding vaccine makers from design defect cases eliminates a powerful incentive for manufactures to keep improving their designs. As to the last argument, Scalia conceded the tort liability motive for design improvement was indeed eliminated by his opinion, but insisted the law provided other incentives.

Scalia, who has a reputation for witty, readable and caustic opinions, clearly reveled in parsing the sentence's structure as well as talking trash (in polite Supreme Court fashion) about Sotomayor and Ginsburg's dissent. For example, Justice Scalia noted that the "even though" clause is known as a "concessive subordinate clause by grammarians" and said things like "dissent's principal textual argument is mistaken ... We do not comprehend ... its reasoning."

Justice Scalia also took a passing swipe at Congress, noting that it had been unnecessarily wordy:

"Petitioners and the dissent contend that the interpretation we propose would render part of [the vaccine law] superfluous: ... ("the injury or death resulted from side effects that were unavoidable even though") is unnecessary. True enough. But the rule against giving a portion of text an interpretation which renders it superfluous does not prescribe that a passage which could have been more terse does not mean what it says."

At the end of the day, vaccine makers win. Society also wins -- especially if the vaccine makers' threats of withdrawing from the business if they lost this case were sincere. But the Bruesewitz family loses, painfully, as their now teenage daughter still suffers from the seizure condition and mental disabilities. And if the dissent is right, and manufacturers will fail to improve their vaccine designs as a result of the decision, we will all lose eventually as side effects that could have been reduced or eliminated continue to hurt people.