Legal scholar Dorit Rubinstein Reiss: Where calls for overturning Bruesewitz v. Wyeth go wrong

Bluestem was perplexed to see resolutions (SF 2781 and HF2825) introduced in the Minnesota legislature that would "memorialize the President and Congress to hold vaccine manufacturers liable for design defects that result in adverse side effects from vaccines."

Was this part of the anti-vaccine movement?

At Harvard Law School's Petrie-Flom Bill of Health blog, Dorit Rubinstein Reiss, a professor of law at the University of California, Hastings College of the Law and a member of the Parents Advisory Board of Voices for Vaccines, reviews the resolutions in a post 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:

They do not have to provide evidence of design defect – or any defect.

Causation standards are less demanding than in civil courts (let me know if you want me to elaborate).

The rules of evidence are relaxed – claimants can use experts and bring in materials that would not be allowed in regular courts.

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. . . .

Read the rest at the Bill of Health blog.

The Minneota Senate bill is authored by Anoka Republican Jim Abeler; Bruce Anderson; Michelle Benson; Mary Kiffmeyer ; and, Scott Jensen are co-authors. In the House, Lake Crystal New Republican Jeremy Munson is the chief author, along with eleven other Republicans and Eagan DFLer Sandra Masin.

Photo: A child with measles.

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