Before the High Court: Can Drug Companies Be Sued Over Vaccine Designs?

This term, the U.S. Supreme Court will decide if the parents of a girl who grew ill shortly after being vaccinated against diphtheria, tetanus and pertussis can sue the vaccine's manufacturer. Their claim: that the vaccine was defectively designed. It's an important question because 5,000 potential lawsuits alleging that vaccines caused autism lurk in the background, and vaccine makers threaten to stop producing the drugs if the suits are allowed.

The question under review: Did Congress forbid these lawsuits when it created a special court and compensation mechanism for people allegedly injured by vaccines?

The Bruesewitz family sued drugmaker Wyeth (now a part of Pfizer [PFE]) in the vaccine court after their then-6-month-old daughter Rebecca developed a seizure disorder and mental disabilities shortly after receiving a dose of Wyeth's DPT vaccine. The court denied the family's claim, ruling that they failed to prove the vaccine caused the seizures. Importantly, the vaccine court process did not allow for discovery from the vaccine maker.

The Bruesewitzes then turned to state court, where they sued Wyeth on the grounds that the vaccine was defectively designed, based on the claim that a safer vaccine was available, one that had been developed by Eli Lilly (LLY) in the 1960s and that Wyeth had acquired the rights to in the 1970s, but had chosen not to market.

Did a Safer Alternative Exist?

Wyeth disputes the family's characterization of the competing vaccine design as safer, noting that there's no evidence that it causes fewer neurological disorders than the vaccine now in use. The company also notes that it was only in 1996, four years after Rebecca was vaccinated, that it received approval for a safer vaccine for use in children under the age of 2.

To win in state court on their defective-design suit, the Bruesewitzes would have to prove that the vaccine injured their daughter. Moreover, the family would have to convince a jury first that a safer alternative existed, then persuade them that because it did, the design of the vaccine that Wyeth marketed was unnecessarily dangerous.

Rather than litigate the case on the merits, however, Wyeth pointed to the National Childhood Vaccine Injury Act of 1986, claiming that it preempted all state-law design defect cases for vaccines. Both the federal District Court and the Third Circuit Court of Appeals agreed, which led to the current Supreme Court appeal.

It All Depends on What "Unavoidable" Means

The core question is this: Is an injury caused by a vaccine "unavoidable" if it could have been prevented by a safer, available alternative? The National Childhood Vaccine Injury Act explicitly bars state claims over unavoidable vaccine injuries, but it doesn't define "unavoidable." Wyeth and its amicus allies -- which include the U.S. government -- contend that "unavoidable" injuries are those that result from the design of the vaccine, a design approved by the Food and Drug Administration.

By that logic, design defect claims are barred, although claims that the vaccine was manufactured badly or that parents weren't given proper warnings would still be allowed because those are avoidable. Vaccines, after all, are inherently dangerous to some small degree, though the danger is dwarfed by their success at preventing deadly childhood diseases.

The family and its allies, among them the striking team of conservative legal scholar Kenneth Starr (of Bill Clinton impeachment fame) and liberal legal scholar Edwin Cherminsky, contend that understanding the definition of "unavoidable" as categorically barring design-defect claims would render the word meaningless. Its purpose in the statute, they argue, is to allow people to show the injury could have been prevented -- in this case, by using a better vaccine design.

When the Third Circuit found for Wyeth on the issue, it declared that the meaning of "unavoidable" wasn't definitively answered by the statute itself, and it turned to legislative history to decide the question. However, Starr and Cherminsky pointed out that preemption is supposed to require a clear statement of congressional intent in order to preserve states' powers, making the relevance of legislative history questionable, especially when the statute itself doesn't make a clear statement. Even if legislative history is useful for preemption analysis, they continue, in this case it doesn't provide the kind of clear statement of intent that the Constitution requires.

Not Merely Hypothetical Consequences

Although the briefs focused on linguistic arguments about what "unavoidable" meant in light of the statute's structure and history, and whether that meaning was clear enough to trigger preemption of design-defect claims, the oral argument was more outcome-oriented, focusing on the consequences of each meaning of unavoidable.

If the family's meaning prevails, the justices were concerned that pharmaceutical firms would be driven to stop making vaccines due to the expense of defending design-defect cases (and paying out large judgments if they lost). If Wyeth's meaning wins, the justices were concerned that people who suffered injuries that were "avoidable" in a normal sense would not be compensated for them. Similarly, the justices were concerned that without the threat of design-defect lawsuits, companies that knew that safer designs existed would lack the incentive to develop or produce them, as the plaintiffs allege happened in Rebecca's case.

The immediate consequences of this decision aren't theoretical: If the Bruesewitzes' view wins out, some 5,000 people are likely to sue vaccine makers in state courts alleging defective vaccine design caused their children's autism, and vaccine makers warn that allowing defective-design suits could drive them out of the vaccine business.

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It's difficult to gauge how the court will rule in this matter: Its most recent cases in similar legal issues all went against preemption, but the narrow majorities in those cases included Justices David Souter and John Paul Stevens, both of whom have left the court. In Cuomo v. Clearing House Association, Justice Antonin Scalia joined his four liberal colleagues; inWyeth v. Levine, Justices Anthony Kennedy and Clarence Thomas joined the liberal wing; and in Altria Group v. Good, Kennedy again voted with the liberal wing.

So, not only did two consistent votes against preemption retire with Souter and Stevens, but one of their replacements -- Justice Elena Kagan -- won't participate in this case. Thus, for the family to win this case -- no preemption -- and assuming the justices vote roughly as they have in the past, not only must Justice Sonia Sotomayor vote with Justices Ruth Bader Ginsburg and Stephen Breyer, but two out of the trio of Justices Kennedy, Thomas and Scalia must join them. After Stevens retired, SCOTUSblog predicted that preemption might be one of the areas of law that shifted. This case will be a harbinger of how big that shift might be.