a pile of vaccine vials and a needle

Where Calls for Overturning Bruesewitz v. Wyeth Go Wrong

This week, legislators in Minnesota proposed a resolution calling on Congress and the President to legislate to overturn the Supreme Court’s decision in Bruesewitz v. Wyeth, 562 U.S. 223 (2011). Similar resolutions have been proposed in other states – and like them, this resolution is supported by legislators who are not anti-vaccine. You could support vaccines and yet have concerned about limits on access to courts and support broadening them. However, the phrasing of this specific resolution strongly suggests that its supporters suffer from misconceptions about our vaccine compensation scheme.

Bruesewitz v. Wyeth

The 1980ssaw a number of lawsuits against vaccines manufacturers, especially against manufacturers of DTP.  Although most of the lawsuits failed, a few won large jury verdicts. As a result, many manufacturers of vaccines left the market. By the end of 1984, only one manufacturer of DTP remained active, and the costs of the vaccine increased. People claiming vaccine injuries were not happy with the existing system – where compensation was hard to come by and uncertain – either. A rare coalition of interests led to the passage of the National Childhood Vaccine Injury Act. The act was a compromise – nobody was completely satisfied with it – but it provided a balance between the interests of the parties.[1]

Among other things, the act created the National Vaccine Injury Compensation Program (NVICP). The program balanced liability protections for manufacturers with substantial breaks for petitioners.

In 2011, a case before the Supreme Court examined the scope of these liability protections. In a 6:2 decision the Supreme Court interpreted the National Childhood Vaccine Injury Act to completely preempt design defects: for those claims, the only available forum is currently NVICP. Other claims need to start in NVICP, but can then be brought in state courts, if the claimant is not happy with the NVICP result.

The resolutions in question here call on the President and Congress to overturn Breusewitz. They would not have any direct effect by themselves, serving mostly as an appeal for the federal government to act. However, they reflect several misconceptions worth correcting.

What’s wrong with the resolutions?

First, these resolutions seem to assume that the Supreme Court’s decision in Breusewitz v. Wyeth, which interpreted Congressional law as limiting design defect claims to vaccine court only, wrongs people who claim vaccine injuries. That is not the case.

NVICP has two goals: protecting the vaccine supply (including stabilizing prices) and providing an easier compensation mechanism. It has done well in achieving both, as Anna Kirkland in her book points out. Claimants going through the program receive many breaks compared to litigants in civil courts:

  1. They do not have to provide evidence of design defect – or any defect.
  2. Causation standards are less demanding than in civil courts (let me know if you want me to elaborate).
  3. The rules of evidence are relaxed – claimants can use experts and bring in materials that would not be allowed in regular courts.
  4. Fees and costs are covered even if people lose. No contingency fee: the whole award goes to the claimant.

There are also things claimants give up. Discovery is limited (though not completely barred), and the statute of limitation of 3 years – a period usual in this context – also applies to children. But all in all, it’s a favorable system. It is not a wrong against the claimants.

And it has preserved the vaccine supply by limiting litigation. While for most types of claims, aside from the design defects, people can go to court after, few do, because it’s harder to win in court. However, several well-funded anti-vaccine organizations have brought lawsuits in recent years. A few of them may try to reopen the already litigated and determined issue of whether vaccines cause autism in courts(Dr. Kirkland’s book has an excellent discussion of these cases), or litigate other ill-founded claims. The risk is that opening that door could potentially bring us back to the 1980s, where manufacturers were leaving the market because of mostly unfounded lawsuits, because the cost of litigation was high.

A time where measles outbreaks are already showing that we may be in the danger zone in terms of the number of people protected by vaccines is a bad time to increase access problems.


Second, these resolutions say: “…our individual human rights should outweigh the profits of pharmaceutical companies, and individuals should have the ability to hold vaccine manufacturers liable for design defects that result in adverse side effects from vaccines;”

This seems to be premised on the view that there is an individual right to bring a specific claim against a company, and that the liability protections are only there to protect company profits (which, as was already pointed out, is not the case). There isn’t a general right to bring a specific suit, though. States limit rights to sue for policy reasons all the time. For example, Minnesota limited liability of landowners in statute  and liability to bystanders by court action:  California restricts liability of landowners to trespassers and liability for accidents from serving alcohol to intoxicated people(except minors). All states have statutes limiting liability for policy reason; there is no absolute right to sue. The federal government can also impose such limits.

In this case, for policy reasons, the federal government created a generous compensation scheme for people claiming harms from vaccines, and in exchange, limited their ability to sue manufacturers. It is well in line with other liability limits, and does not violate rights.

Further, phrasing it as “individual right v. corporate interests” ignores the fact that reducing the vaccine supply – the goal of liability protections – puts at risk children left unprotected from disease, and may harm community more broadly. It is not pharmaceutical companies who suffer when preventable diseases come back. It’s the people who get sick and the community that has to pay for containing the outbreak.

Third, these resolutions, suggesting that “the European Union has found a way to allow evidence-based lawsuits holding vaccine manufacturers liable without destabilizing the European health care system,” appears to draw on a misunderstanding of European law. There is no general European law about liability for vaccine harms. Some European states have partial or full liability protections. The decision that is the basis for the misunderstanding was examining a specific case from France, where some claims of vaccine injuries do go to the courts – but others are compensated by the government without access to court, in other words, a system that does not offer full court access for design defects. The decision focused on a specific evidentiary question analyzed by Professor Alex Stein on this very blog.

And note that although some specific European member states do allow lawsuits against vaccines manufacturers, assuming that that alone is a basis for the United States to move there is problematic. European tort law is very different from United States law in other ways that discourage litigation, and the European social services net is more extensive, reducing the need to litigate to cover basic needs and costs. To give one example of the difference, in many countries in Europe, there are no contingency fees – making lawsuits harder for those with less means, though there may be legal aid available. Further, in several countries experts would be appointed by the courts, removing expert battles. In other words, using the European system to justify a specific legal change in the U.S. needs to be done carefully. In this case, the differences suggest simply assuming that the approach in some (but not all) European states to the issue is not valid.

While, again, we may expect organic suits to be few, since few people who cannot prove their claim in vaccine court would find a lawyer willing to take their case to civil court, where the barriers to winning are higher, we have seen an increase in the organization of the anti-vaccine movement, and they have funded several (problematic) lawsuits over the past few years, for example, small FOIA requests against the Department of Health and Human Services (like here or here) later used to convince followers that vaccines are not supported by robust science. It is not far-fetched to be concerned about ill-founded lawsuit being brought to use for publicity or even intentionally to disincentivize vaccine manufacturing.

While not perfect, Anna Kirkland points out that NVICP offers a reasonable way to handle vaccine injuries, and a reasonable compromise between the interests involved. Part of that scheme are liability protections, and since 2011, the Supreme Court’s decision in Bruesewitz is part of that scheme. Well-intentioned legislators should not be led into fighting this scheme for the wrong reasons.

[1]This discussion is based on the book: ANNA KIRKLAND, VACCINE COURT: THE LAW AND POLITICS OF INJURY  (2016).


Dorit Reiss

Dorit Rubinstein Reiss is a professor of law at the University of California, Hastings College of the Law. Increasingly, her research and activities are focused on legal issues related to vaccines, including exemption laws and tort liability related to non-vaccination. She published law review and peer reviewed articles and many blog posts on legal issues related to vaccines. She received an undergraduate degree in Law and Political Science (1999, Magna cum Laude) from the Faculty of Law in the Hebrew University of Jerusalem. She received her Ph.D. from the Jurisprudence and Social Policy program in UC Berkeley. She is a member of the Parents Advisory Board of Voices for Vaccines, and active in vaccine advocacy in other ways. She is also a Member of the Vaccine Working Group on Ethics and Policy (http://vaccineworkinggroupethics.org/).

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