The Right to Live,The Right to Thrive

Mallory E. McLaren, J.D.

Agenda Fundamental rights to determine what happens

to your body One’s right to reject treatment or die One’s right to self-determine medical treatment and

experimentation

The state of law and governance today Dissonance between the governmental interest to

“preserve life” and how it meets that goal

Pursuing biological resilience is more than just about law and courts

About me:

J.D. – Seton Hall UniversityB.A. - The Evergreen State College

Resiliency and regenerative biotechnology sector entrepreneur

Long-time advocate for trans* & intersex persons / gender identity inclusion and equality

Veganism & Vegetarian life choices / Animal welfare and liberation

Fundamental rights to end medical treatment in the U.S.A.1976: Removal of respirator could be removed at the family’s behestIn re Quinlan – NJ Supreme CourtSCOTUS certiorari denied

… then a legal “gray area” period concerning who by, and how, extraordinary measures are decided …

1990: “Clear and convincing evidence” of patient’s wishes are required for removal of life supportCruzan v. Director, Missouri Department of Health – U.S. Supreme Court

1997: Right to assistance in suicide is not a fundamental rightWashington v. Glucksberg – U.S. Supreme Court

Turning a new leaf: Assisted termination-of-life in the U.S.A. “Death with Dignity” legislation

Oregon 1997 (date of the law’s last challenge) Washington 2008 Vermont 2013 Oregon and Wash. require self administration of

life-ending drugs

Montana “decriminalized” assisted suicide in 2009 by state judicial precedent Doctors can use “assisted death” as an

affirmative defense if charged with a crime related to a terminal patient’s death

Turning a new leaf, globally Euthanasia in Belgium

Legislation in effect since 2002 Patients with psychiatric conditions – and even

children – can request voluntary euthanasia. Patients must have a “constant and unbearable

suffering” which is “incurable” Doctors administer the final treatment A national board requires doctors to account for

every euthanasia event administered Overwhelming public support exists in Belgium

for this law

But by the same token, shouldn’t we have the right to live?

Fundamental rights to self-determine treatment in the U.S.A.

2007: [The] Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach The D.C. Federal Circuit, which rules on

decisions and rulemaking of independent federal agencies like the FDA

Ultimately an en banc 8-2 decision SCOTUS certiorari denied

Abigail Burroughs Suffered from aggressive head and neck cancer Died in 2001

Human Clinical Trials Phase 1: Safety (including dosage and

side effects) The Abigail Alliance attempted to get drugs/therapies at this stage ⏎ Phase 2: Efficacy + Safety Phase 3: Large-scale drug trial monitoring:

side effects comparison to existing treatments gathering information on how to use the

drug/treatment in the safest manner

Fundamental rights to self-determine treatment in the U.S.A., cont’d. The Abigail Alliance’s argument:

The common law [criminal & tort] concepts of self-defense, necessity, and interference with rescue are broad enough to demonstrate the existence of the fundamental right for “persons in mortal peril” to “try to save their own lives, even if the chosen means would otherwise be illegal or involve enormous risks.”

In other words, activity that is self-defense + necessity + attempt to rescue oneself = protection as a fundamental right

A right to medicines

Fundamental rights to self-determine treatment in the U.S.A., cont’d. To prove a fundamental right under the 5th

Amendment’s substantive due process (SDP) clause:

1.  ”[D]eeply rooted in this Nation's history and tradition

2. “[I]mplicit in the concept of ordered liberty.”

If an SDP fundament al right is established, then strict scrutiny applies for the government to prove that both: A compelling state interest exists “Narrow tailoring” for the least intrusive means to serve

the compelling interest

Fundamental rights to self-determine treatment in the U.S.A., cont’d. A brief history of decisional privacy as a 5th Amendment fundamental

right:

1965: A specific right to use contraception from general right to be free from intrusion into “sacred precincts of marital bedrooms

Griswold v. Connecticut – U.S. Supreme Court 1973: A specific right to terminate a pregnancy from broader right to privacy Roe v. Wade – U.S. Supreme Court 1976: A right to determine extended family living arrangements from broader

constitutional protection for “the sanctity of the family” Moore v. City of East Cleveland - U.S. Supreme Court 

D.C. Circuit in Abigail Alliance:

“In any event, the Alliance's liberty claims are not grounded in the abstract notion of personal autonomy but rather in the specific right to act to save one's own life.”

Fundamental rights to self-determine treatment in the U.S.A., cont’d.

Re common law self-defense:

Unlike the cases in which the doctrine of self-defense might properly be invoked, this case involves risk from drugs. Because terminally ill patients cannot fairly be characterized as using reasonable force to defend themselves when they take unproven and possibly unsafe drugs ... [the Abigail Alliance] cannot draw support from the doctrine of self-defense.

Taking a drug is not self-defense in the classic sense because [in part] the tool Alliance patients want to use to save themselves may not actually save them

Fundamental rights to self-determine treatment in the U.S.A., cont’d. Re common law necessity:

The U.S. Supreme Court [has spoken]: under any conception of legal necessity ... The defense cannot succeed when the legislature itself has made a determination of values ... and that is precisely what the FDCA has done ... Congress has prohibited general access to experimental drugs ... and has prescribed in detail how experimental drugs may be studied and used by the scientific and medical communities.

Fundamental rights to self-determine treatment in the U.S.A., cont’d.

Re common law interference with rescue:

It is difficult to see how a tort addressing interference with providing “necessary” aid would guarantee a constitutional right to override the collective judgment of the scientific and medical communities expressed through the FDA's clinical testing process

Fundamental rights to self-determine treatment in the U.S.A., cont’d. The result of the Abigail Alliance case:

Affirmed the right of doctors and patients to make decisions about pre-approval [post phase II] drugs and therapies under narrow exemptions

...But also

Affirmed the FDA’s administrative power to prevent the procuring a drugs that had not only been proven safe, but also effective

What should have been argued Administrative Law “Chevron Doctrine”

Agencies perform their duties by way of “enabling acts” from Congress The enabling act’s plain meaning controls agency decisions generally But if no plain meaning is apparent, then an agency’s action must not

be arbitrary, capricious, or directly contradict the enabling act Strategy: make an argument that the FDA standing in the way of

people like Abigail Burroughs saving their own life is rooted in arbitrary, circular reasoning contradicts the FDA’s goal of promoting well-being because it leaves

terminally ill patients no meaningful options to assent to risk when attempting to self-preserve

Bodily autonomy Individual right to avoid physical frailty and premature death

A “meta” argument – more meta than a “right to medicines”

The Precautionary Principle The proponent of an activity, rather than the

public or government, should/must bear the burden of proof.

Or, in other words...

“I won’t be satisfied (with your evidence) until I say/feel I’m satisfied (with your evidence), and I’ll tell you when that is, and [your burden and standard of proof] is subject to increase at my whim.”

The Precautionary Principle, cont.’d.

The American Enterprise Institute’s view: A blanket “better safe than sorry” policy is wholly

arbitrary or incoherent, and leads to absurd outcomes

Becomes a “Trojan horse” pretext for other ideological crusades

When selectively applied to politically disfavored technologies and conduct it serves as a barrier to both technological progress and economic growth

See https://www.aei.org/publication/the-problems-with-precaution-a-principle-without-principle/

“This is not just about me. This is about so many others.”

-Abigail Burroughs

There’s hope! The 2015 American Cures Act

Approved by the U.S. House of Representatives by a 344-7 vote – awaiting the U.S. Senate’s vote

PDUFA V’s Patient Centered Drug Development Factors

Analysis of condition Current treatment options Benefits to patient, society, and science Risks to patient, society, and science Our ability to manage peril or risk

U.S. President Barack Obama’s 2015 State of the Union call for a “Precision Medicine Initiative”

The Right to Live The Right to Thrive

mallory@eternabiocapital.com https://www.linkedin.com/in/

malloryemclaren

QUESTIONS?COMMENTS?