Legal Update 2009: The Top 10 Legal Developments in Bioethics American Society of Bioethics + Humanities Annual Meeting | Washington, DC Thursday, Oct.

Legal Update 2009:

The Top 10 Legal Developments in Bioethics

American Society of Bioethics + Humanities

Annual Meeting | Washington, DC

Thursday, Oct. 15, 2:45 – 3:45 p.m.

• Lois Shepherd, J.D.Lois Shepherd, J.D. University of VirginiaUniversity of Virginia

• Nadia Sawicki, J.D. M.Be.Nadia Sawicki, J.D. M.Be. Loyola University Chicago School of Loyola University Chicago School of

LawLaw

• Mary Anderlik Majumder, J.D. Ph.D.Mary Anderlik Majumder, J.D. Ph.D. Baylor College of MedicineBaylor College of Medicine

• Erin Egan, M.D. J.D.Erin Egan, M.D. J.D. University of Colorado - DenverUniversity of Colorado - Denver

FormatFormat

• SpeakersSpeakers– 10 min10 min– 10 min10 min– 10 min10 min– 10 min10 min

• 20 min Q&A at the end20 min Q&A at the end

• Get the handoutGet the handout

Access to Access to Investigational Drugs Investigational Drugs outside Clinical Trialsoutside Clinical Trials

Lois Shepherd, J.D.Lois Shepherd, J.D.Center for Biomedical Ethics and Center for Biomedical Ethics and

HumanitiesHumanitiesSchool of LawSchool of Law

University of VirginiaUniversity of Virginia

Constitutional claimsConstitutional claims• Abigail Alliance v. Von Abigail Alliance v. Von

Eschenbach, 495 F. 3d Eschenbach, 495 F. 3d 695 (D.C. Cir. 2007)695 (D.C. Cir. 2007)

• Presented the issue of Presented the issue of an individual’s right to an individual’s right to access unapproved access unapproved drugs vs. FDA drugs vs. FDA regulation for public regulation for public health health

• Plaintiffs lost; but Plaintiffs lost; but that’s not the end of that’s not the end of the storythe story

Gunvalson v. PTC Gunvalson v. PTC Therapeutics Therapeutics 303 Fed. Appx. 128 (3303 Fed. Appx. 128 (3rdrd Cir. 2008)Cir. 2008)

– In Aug. 2008, federal judge In Aug. 2008, federal judge ordered drug company to give ordered drug company to give teenager with muscular teenager with muscular dystrophy access to still-dystrophy access to still-experimental drug. Patient did experimental drug. Patient did not meet eligibility requirements. not meet eligibility requirements.

– Claim based on promissory Claim based on promissory estoppel.estoppel.

– Third Circuit, on appeal vacated Third Circuit, on appeal vacated the lower court’s order: promise the lower court’s order: promise was not clear and definite; was not clear and definite; parents did not rely on the parents did not rely on the promise (2 elements missing). promise (2 elements missing).

Arguments pro and con Arguments pro and con

• For increased accessFor increased access– Post-Phase I drugs have Post-Phase I drugs have

already been tested for already been tested for safetysafety

– Terminally ill have no Terminally ill have no other options—safety is other options—safety is less of a concern for less of a concern for themthem

– Compassionate use (or Compassionate use (or Treatment IND use) Treatment IND use) programs are very programs are very limited (regulatory limited (regulatory obstacles; no obstacles; no incentives for mfrs)incentives for mfrs)

– Regulate (require Regulate (require attempts to access a attempts to access a trial); don’t bar accesstrial); don’t bar access

• Against increased Against increased accessaccess– Safety testing is not Safety testing is not

completecomplete– The terminally ill must The terminally ill must

be protected as well be protected as well (their desperation makes (their desperation makes them particularly them particularly vulnerable to abuse, esp. vulnerable to abuse, esp. when profit motive is when profit motive is involved)involved)

– Compassionate use Compassionate use programs existprograms exist

– Clinical trial enrollment Clinical trial enrollment will decrease; drug will decrease; drug approval process will approval process will slow down and be slow down and be muddiedmuddied

Trends in Advance Care Trends in Advance Care Planning Law?Planning Law?

National Health Reform National Health Reform • Tri-Committee Bill, Tri-Committee Bill,

HR 3200, Section HR 3200, Section 1233.1233.

• Reimbursement Reimbursement for “Advance Care for “Advance Care Planning Planning Consultations”Consultations”

• Not scripted Not scripted consultations, but consultations, but “shall “shall include. . . .”include. . . .”

State legislation relating to State legislation relating to advance care consultationsadvance care consultations

• California—requires providers to give California—requires providers to give certain information to patients certain information to patients following a diagnosis of terminal following a diagnosis of terminal illness if the patient indicates a illness if the patient indicates a desire to receive such information.desire to receive such information.

• Other states: considering trying to Other states: considering trying to increase number of living wills by increase number of living wills by tying to insurance in some way.tying to insurance in some way.

Legal Developments in Bioethics

Nadia N. SawickiAssistant Professor

Loyola University Chicago School of LawBeazley Institute for Health Law and Policy

North Carolina Court Limits State Medical Board’s Disciplinary Authority

N.C. Dep’t of Corrections v. N.C. Medical Board(North Carolina Supreme Court, 2009)

North Carolina Court Limits State Medical Board’s Disciplinary Authority

North CarolinaMedical Practice Act

The Medical Board may discipline physicians for “unprofessional conduct,” including “departure[s] from the ethics of the medical profession.”

North Carolina Court Limits State Medical Board’s Disciplinary Authority

North Carolina Lethal Injection Statute• The prison physician must be presentduring

execution of condemned inmates; and• The prison physician must certify the fact of

execution to the court.

AMA Code of Medical Ethics Opinion 2.06 “A physician, as a member of a profession dedicated to preserving life when there is hope of doing so, should not be a participant in a legally authorized execution.”

North Carolina Court Limits State Medical Board’s Disciplinary Authority

North Carolina Medical BoardPosition Statement, 2007

“[T]he Board will not discipline licensees for merely being “present” during an execution in conformity with N.C. Gen. Stat. 15-190. However, any physician who engages in any verbal or physical activity [beyond these requirements] that facilitates the execution may be subject to disciplinary action by this Board.”

North Carolina Court Limits State Medical Board’s Disciplinary Authority

N.C. Dep’t of Corrections v. N.C. Medical Board(North Carolina Supreme Court, 2009)

Issue: Did the Medical Board exceed its authority in adopting the 2007 Position Statement?

Held: Yes. The Position Statement is unenforceable.

North Carolina Court Limits State Medical Board’s Disciplinary Authority

• In promulgating its position statement, the Medical Board “improperly exceeded the authority bestowed upon it to regulate the practice of medicine.”

• The use of the word “present” in the lethal injection statute indicates the state’s expectation that the physician will provide “some sort of professional assistance” for which he is “uniquely qualified” during the execution process.

• It us “illogical” to think that the legislature intended that the physician be present only as an “uninvolved onlooker,” or as “a potted plant,” merely occupying space.

North Carolina Court Limits State Medical Board’s Disciplinary Authority

Implications of this decision?

• When larger policy issues are at stake, state courts are willing to restrict board authority, even without specific direction from the legislature

• Implications for physician involvementin national security efforts

State Courts Limit Abortion Disclosure and Consent Requirements

South Dakota statute, adopted 2005

• Biological disclosure: Abortion will “terminate the life of a whole, separate, unique, living human being”

• Relationship disclosure: “The pregnant woman has an existing [constitutional] relationship with the unborn human being” that abortion will terminate

• Medical risk disclosure: Must describe all “statistically significant risk factors” of abortion, including increased risk of suicide

State Courts Limit Abortion Disclosure and Consent Requirements

Planned Parenthood v. RoundsU.S. District Court for S.D., 2009

• Biological disclosure: Abortion will “terminate the life of a whole, separate, unique, living human being”

• Relationship disclosure: “The pregnant woman has an existing [constitutional] relationship with the unborn human being” that abortion will terminate

• Medical risk disclosure: Must describe all “statistically significant risk factors” of abortion, including increased risk of suicide

State Courts Limit Abortion Disclosure and Consent Requirements

Oklahoma Freedom of Conscience Act,adopted 2008

Medical provider may not perform an abortion unless he has first:• Performed an ultrasound;• “Display[ed] the ultrasound images so that the pregnant woman may view them;”• Provided a verbal description of what the ultrasound is depicting

State Courts Limit Abortion Disclosure and Consent Requirements

Oklahoma Freedom of Conscience Act,

adopted 2008Medical provider is liable in damages if he does not comply.

Note: A patient is permitted to “avert her eyes” or “refuse to look” at the ultrasound.

State Courts Limit Abortion Disclosure and Consent Requirements

NovaHealth v. HenryOklahoma District Court,

2009

• Freedom of Conscience Act is unconstitutional• Violates Oklahoma Constitution’s “single

subject” rule

Legislators vow to reintroduce the bill next term.

State Courts Limit Abortion Disclosure and Consent Requirements

Implications of these decisions?

• Wait and see approach• Track proposed legislation

Developments in Federal Stem Cell Research Policy

Mary A. Majumder, JD, PhDCenter for Medical Ethics and Health Policy

Baylor College of Medicine

Bush Administration Policy

• Derivation process was initiated prior to 9:00 P.M. EDT on August 9, 2001.

• Embryo was created for reproductive purposes and no longer needed.

• Informed consent must have been obtained for the donation of the embryo.

• Donation must not have involved financial inducements.

Dickey Amendment: Text

(a) None of the funds made available in this Act may be used for—(1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).

(b) For purposes of this section, the term ``human embryo or embryos'' includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

Omnibus Appropriations Act, 2009, Public Law 111-8, Sec. 509

Dickey Amendment

• Since 1996, passed every year without substantive change.

– No clarification of meaning/rejection of NIH interpretation permitting funding of research involving hESCs (Rabb memo, 1999).

– Sutherland on Statutes: Legislative adoption presumed conclusive when repeated reenactments follow a notorious practical interpretation.

http://stemcells.nih.gov

Parental Refusals of Medical Treatment

State Authority Protection of

Children(parens patriae)

vs.Parental Authority

Protection of Religious Liberty/

Minority Communities

HEW/HHS CAPTA Regs*

1974: A parent or guardian legitimately practicing his religious beliefs who thereby does not provide specified medical treatment for a child, for that reason alone shall not be considered a negligent parent or guardian; However such an exception shall not preclude a court from ordering that medical services be provided to the child, where his health requires it. (Interpreted as an eligibility requirement)

1983: Nothing in this part should be construed as requiring or prohibiting a finding of negligent treatment or maltreatment when a parent practicing his or her religious beliefs does not, for that reason alone, provide medical treatment for a child; provided, however, that if such a finding is prohibited, the prohibition shall not limit the administrative or judicial authority of the State to ensure that medical services are provided to the child when his health requires it.

*45 CFR Part 1340

Hauser Case• Child: 13 year-old with Hodgkin’s lymphoma• Charge(s): Medical neglect, contempt of court, deprivation of

parental rights (Minnesota)• Religious involvement: Nemenhah Band • Background: Judge ordered return to court to assess

progress; mom fled with child but returned voluntarily• Outcome: Back in parents’ custody; completed chemotherapy

and scheduled to start radiation this month

Worthington Case• Child: 15-month-old with pneumonia and a blood infection• Charge(s): Second-degree manslaughter, second-degree

criminal mistreatment (Oregon)• Religious involvement: Followers of Christ Church • Background: Aunt called authorities, but too late• Outcome: Jury found Carl Worthington guilty of criminal

mistreatment, and judge sentenced to 60 days in jail and 5 years probation; Raylene Worthington acquitted of all charges

Neumann Case• Child: 11-year-old in diabetic ketoacidosis • Charges: Second-degree reckless homicide (Wisconsin)• Religion: Unleavened Bread Ministries • Background: Aunt called authorities, but too late • Outcome: parents convicted in separate trials; on Oct. 6

sentenced to 10 years probation plus (delayed pending appeal) 6 months in jail in 30-day increments over the next 6 years (could have been 25 years).

Summing Up

• Growing prominence of New Age belief systems and Internet-based faith communities.

• Confusion created by religious exemptions.

• Juror difficulty in applying criminal laws to parents perceived as well-intentioned and caring.

• Issue of deterrence, especially in relation to sentencing.

Freedom of Speech and Physicians’ Prescribing Habits

Erin A. Egan, MD, JDUniversity of Colorado DenverLoyola University Neiswanger Institute for Bioethics and Health Policy

Issue Can a state ban sale of physicians’ prescribing information?

Why would they want to?

Physician prescribing information is collected from a variety of sources, most notably pharmacies, and compared with the AMA physician Masterfile to create a prescribing profile for individual physicians

Why Buy/Sell Information

Big business- 1.75 billion in 2006

Data can be tied to individual physicians or grouped by region or demographics

Physician pharmaceutical detailing- a huge investment- can be tailored to physicians

Can reinforce current prescribing habits, can try to influence changes in prescribing practices.

Where’s the Money? Decreasing access to physicians

“The Unbranded Doctor”

“Project Prescription”

Reps being banned from academic campuses

Providers increasingly unwilling to speak with detailers/reps

The coercive (malignant?) relationship between physicians and pharmaceutical companies

Commercial Speech Not all speech is free speech

Commercial speech is free speech

Commercial speech is protected under the constitution

So what is commercial speech

Precedents

Challenges to Free Speech in the Medical Arena

Tobacco and alcohol advertising bans

Direct to consumer marketing regulation

Dietary supplement labeling and marketing

Result- ban cannot be placed on commercial speech. Commercial speech is protected as long as it is accurate (disclaimer caveat for supplements)

Precedents Wouldn't be a legal talk without them

The Central Hudson Test

Central Hudson Gas and Electric Corp v. Public Service Commission 447 U.S. 557 (1980)

Commercial speech cannot be restricted unless the Government can show

The speech is false, misleading, or regards illegal activity

Regulation supports a valid public interest and no other means is sufficient

Other Cases Bigelow v. Virginia- since abortion is legal in New York, Virginia cannot stop

newspapers advertising the service

Virginia State Board of Pharmacy v Virginia Citizens Consumer Council- the state cannot stop pharmacies from advertising drug prices.

Other cases- state/ government cannot ban direct to consumer advertising, unlimited restrictions cannot be placed on tobacco and alcohol advertising.

Beef Jerky Sale of prescribing data is not “commercial speech”

The information is processed and packaged before it is soled

Prescribing information is to commercial speech what beef jerky is to beef

The processing and interpretation changes the information from free speech to a product

Disaster Response Law

Model State Health Emergency Powers Act (caveat of discussing model acts)

Model act, enacted in whole or in part in 38 states

Creates a disaster or emergency response framework

Who cares? Pandemic Flu- H1N1

Fortunately not a severe strain, but impact will be felt in numbers

50% of population to be effected?

Pediatric deaths for this season so far have exceeded all pediatric deaths from last year.

Individual experience

From 100 daily ED visits to 190 daily ED visits

More that 20 nurse/PCT’s absent or sent home daily

One half of all ICU beds taken by patients with confirmed or suspected H1N1

Tension Public good vs. individual liberties

Disaster must be declared by governor

Quarantine authority (enforceable by use of the militia, but failure to comply is a misdemeanor)

Appropriation of property, facilities, supplies, personnel as needed to promote the welfare of the state or region

Civil liability protection

Civil Liberties Inherently there will be some infringement on civil liberties

Civil liberties should be protected when possible, multiple attempts at safeguards to ensure least restrictive means employed

Issues- quarantine, vaccination, evaluation, treatment

Provider issues- failure to comply with any of the above (most significantly vaccination, but also in participation in response) could lead to loss of credentials or licensure

Legal Basis for Infringing on Civil Liberties

Jacobson v. Massachusetts- there are restraints that can be placed on every person for the common good

Development of individual autonomy and the penumbra of privacy

Consider Roe and Cruzan

What would the outcome be?

Standard of care Inherent implications for standard of care

Rationing of vaccine

Individual experience

1500 doses for a 500+ bed medical center and clinic network for providers and patients

All doses recombinant live vaccine, not appropriate for high risk patients or high risk providers

Priority given to providers, provider groups ranked

Clear inability to meet CDC guidelines for vaccination

Further Deterioration of the Standard of Care

Canceling elective clinic visits, surgery?

Triaging ventilators?

Triaging non-flu patients because of burden of flu patients?

On and on

Opinion Better to be wrong than uncertain

Transparency is the only way to maintain social order

Transprency is also the only way to approximate anything close to ethical practice

Fading of interest in solving this problem

Momentum after 9/11, Katrina

Momentum with H1N1 flu

Generating interim momentum to create valuable infrastructure