Red line heart rate on the screen indicates cardiac arrest.

Could Self-Operated Assisted Suicide Devices Be Coming to a Town near You?

By Matthew Chun

A scientist’s high-tech approach to assisted suicide is already available for use in Switzerland and is actively being campaigned for in the United Kingdom. . . Could the United States be next?

Dr. Philip Nitschke — nicknamed “Dr. Death” by some — has made it his mission to “demedicalize death” by removing doctors from the process of assisted suicide and bringing suicide devices directly into the hands of individuals seeking to end their own lives. To do so, Nitschke developed the Sarco device — a 3D-printed human-sized capsule that can be operated with a press of a button by a user inside to create an airtight lock and to release nitrogen gas, resulting in a “peaceful, even euphoric death” within minutes.

Having been launched in Switzerland in 2021, the Sarco is reportedly available for use in the country’s legal assisted suicide clinics. And to the outrage of many, Nitschke has recently begun campaigning for legislative backing of the Sarco in Scotland. Given these recent developments, one might wonder whether similar campaigns might make their way to the United States, and if so, whether or not they could succeed. While such campaigns may not be such a far-flung possibility given the current U.S. legal landscape, I believe the threat of new sui generis state legislation will ultimately prevent the introduction of self-operated assisted suicide devices in the U.S. for at least the foreseeable future.

The U.S. Legal Landscape

Under the U.S. system of health care federalism, the legal analysis of self-operated assisted suicide devices involves both federal and state considerations. While not exhaustive, this blog post explores some of the major legal issues likely to arise if a device like the Sarco were to be introduced into the United States.

Federal Considerations

FDA Approval

A natural place to begin is the U.S. Food and Drug Administration (FDA), which “regulates the sale of medical device products (including diagnostic tests) in the U.S. and monitors the safety of all regulated medical products.” Although it is questionable whether the FDA would ever approve the Sarco machine as a medical device, it turns out the FDA may not need to. Historically, the FDA has repeatedly refused to regulate compounded lethal drugs used for capital punishment, with its inaction largely being insulated from judicial review. And in 2019, the Justice Department asserted that the FDA does not even have the authority to regulate such drugs since “the FDCA’s regulatory framework for ‘drugs’ and ‘devices’ cannot sensibly be applied” to articles having an intended use not traditionally regulated by FDA (i.e., ending human life). For similar reasons, the Sarco — which has the sole intended use of ending human life — is unlikely to be subject to regulatory review by FDA.

Federal Legislation

Federal legislation is also unlikely to pose a meaningful obstacle to self-operated assisted suicide devices in the U.S. At the federal level, there are zero laws prohibiting assisted suicide. And in 1997, the Supreme Court unanimously held in Washington v. Glucksberg that while there was no constitutional right to physician-assisted suicide, legislation concerning the permissibility of physician-assisted suicide was a matter left for the states. Thus, if any legal obstacles could prevent the Sarco (or similar devices) from entering the U.S., they are likely to manifest at the state level.

State Considerations

As of May 2022, physician-assisted suicide is legal in ten U.S. states and the District of Columbia (either by law or by court ruling). However, in these jurisdictions, “[i]ndividuals must have a terminal illness as well as a prognosis of six months or less to live.” Thus, at least under these limited circumstances, it appears that the Sarco could be introduced in the U.S. as a means for implementing physician-assisted suicide.

The legality of the Sarco becomes much more uncertain though, if Dr. Nitschke’s ultimate goal is achieved of removing doctors from the process so that patients (who may not have any terminal illness) will “[n]o longer have to beg a panel of doctors to grant their final wish.” Under such circumstances, use of the Sarco to end one’s own life is unlikely to qualify as physician-assisted suicide at all.

Suicide has been legal in the United States since 1911. However, an increasing number of states have prohibited encouraging suicide. While it is, in theory, possible for the provider of a Sarco to be held liable under such statutes, this would likely be a legal issue of first impression. Previous cases about inciting suicide very rarely have found liability when only “verbal encouragement” was involved and when “the encourager was never in the presence of the suicide.” Moreover, none of these cases involved the liability of a corporate or other non-human entity such as a manufacturer or seller of a device. Finally, even if Dr. Nitschke could be held personally liable for the effects of the Sarco device, enforcement would likely be extremely difficult, requiring an assertion of extraterritorial jurisdiction to reach him in the Netherlands.

Rather than relying on existing laws, states opposing devices like the Sarco (or seeking simply to maintain the status quo) would likely have the most success by passing sui generis legislation prohibiting the manufacturing, selling, or importing of any self-operated assisted suicide devices. Such legislation would quell many of the legal uncertainties regarding such devices and likely would fall well within the regulatory power of the states as rationally related to “the state’s legitimate interest in protecting medical ethics, shielding disabled and terminally ill people from prejudice which might encourage them to end their lives, and, above all, the preservation of human life.

Conclusion

Given the many restrictions on physician-assisted suicide laws across the various states, it may be surprising how few legal obstacles the Sarco would appear to face in the current U.S. legal landscape. However, new state legislation prohibiting self-operated assisted suicide devices could be implemented at any time and poses the greatest hurdle for Dr. Nitschke’s dream. Therefore, for better or for worse, the credible threat of such targeted legislation makes it unlikely that we will see the U.S. product launch of the Sarco anytime soon.

Matthew Chun

Matthew Chun is a J.D. candidate at Harvard Law School and patent agent at Fish & Richardson P.C. He holds a DPhil in Engineering Science from the University of Oxford and a B.S. in Mechanical Engineering from the Massachusetts Institute of Technology. At Harvard Law School, Dr. Chun is Managing Editor of the Harvard Journal of Law and Technology and a Student Fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. All opinions expressed are solely his own.

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