Importation of Novartis meningitis vaccine not likely to make U. liable

Princeton's plan to make a meningitis vaccine —called Bexsero —available to students in the near future likely has few legal ramifications for the University, despite the fact that the U.S. Food and Drug Administration has not yet approved the drug for use in the United States.

Since March, eight cases of meningococcal disease linked to the University have been reported. Following the seventh case, the University decided in coordination with the Centers for Disease Control and Prevention and the FDAto import the Bexsero vaccine and offer it to students and certain community members.

In order to receive the vaccine, students will have to sign an informed consent form that will likely go to great lengths to eliminate any legal risk the University might face should something go wrong during the implementation of the vaccination program, Associate Director of the Program in Law and Public Affairs and former professor of Health Law and Policy Leslie Gerwin said. This legal consent form has not yet been released to the public.

University General Counsel Peter McDonough was out of the office when contacted by The Daily Princetonian.University Spokesperson Martin Mbugua declined to comment Monday, noting that the consent form has not yet been approved or issued and that questions about the legal aspects of the form would be best answered by a legal expert.

The consent form will first need to be approved by the CDC's Institutional Review Board.

Although the University administration is encouraging students to get the vaccine, Gerwin said the University is unlikely to assume any sort of responsibility in the event of problems with the vaccine.

“The University is not liable … because you will sign an informed consent form. And that informed consent will probably be very long and detailed,” Gerwin said.

The one point of possible legal contention could come with regards to whether or not the University has given students enough data to actually be informed when consenting to receiving the vaccine. University administrators have given little information regarding the contexts of specific cases of meningitis that have broken out on campus, Gerwin said, adding that this withholding could potentially be raised as an issue in court.

Email alerts sent to the student body have included information regarding the diagnosed students' gender, when they developed symptoms and began to receive treatment, and some basic information on the location of the institutions where they were receiving treatment.

“The only legal challenge you would have is whether you had sufficient information to be informed,” Gerwin said.

Gerwin noted, however, that the Health Insurance Portability and Accountability Act, which protects the privacy of patient medical records, grants the University much leeway when it comes to withholding details of the outbreak in order to protect the privacy of the affected students. The University, Gerwin said, has to walk a fine line in determining the marginal benefit of providing more information to students interested in possibly receiving the vaccine.

Although the FDA has not yet approved the vaccine for general use in the United States, Gerwin noted that as far as legal issues go, the company behind the vaccine, Novartis, has followed established FDA protocol in its attempt to make Bexsero available to the University.

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Specifically, the FDA has worked with the CDC to approve Bexsero as a “treatment investigational new drug,” which, according to the FDA’s website, is a drug or vaccine “showing promise in clinical testing for serious or immediately life-threatening conditions.”

Gerwin also pointed to the European Union’s approval of the vaccine as promising evidence of the drug’s safety. She noted that even Britain’s Joint Committee on Vaccination and Immunisation, which recommended against adding Bexseroto its routine vaccination program this past July, did so not because the drug was unsafe in any way, but rather because it was not deemed cost-effective in the context of the country’s government-payer health system.