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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. University of Virginia Nadia Sawicki, J.D. M.Be.

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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.

    University of Virginia

  • Nadia Sawicki, J.D. M.Be.

    Loyola University Chicago School of Law

  • Mary Anderlik Majumder, J.D. Ph.D.

    Baylor College of Medicine

  • Erin Egan, M.D. J.D.

    University of Colorado - Denver


Format
Format

  • Speakers

    • 10 min

    • 10 min

    • 10 min

    • 10 min

  • 20 min Q&A at the end

  • Get the handout


Access to investigational drugs outside clinical trials

Access to Investigational Drugs outside Clinical Trials

Lois Shepherd, J.D.

Center for Biomedical Ethics and Humanities

School of Law

University of Virginia


Constitutional claims
Constitutional claims

  • Abigail Alliance v. Von Eschenbach, 495 F. 3d 695 (D.C. Cir. 2007)

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

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


Gunvalson v ptc therapeutics 303 fed appx 128 3 rd cir 2008
Gunvalson v. PTC Therapeutics 303 Fed. Appx. 128 (3rd Cir. 2008)

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

  • Claim based on promissory estoppel.

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


Arguments pro and con

For increased access

Post-Phase I drugs have already been tested for safety

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

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

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

Against increased access

Safety testing is not complete

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

Compassionate use programs exist

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

Arguments pro and con



National health reform
National Health Reform

  • Tri-Committee Bill, HR 3200, Section 1233.

  • Reimbursement for “Advance Care Planning Consultations”

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


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

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

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


Legal developments in bioethics

Legal Developments in Bioethics

Nadia N. Sawicki

Assistant Professor

Loyola University Chicago School of Law

Beazley Institute for Health Law and Policy


North carolina court limits state medical board s disciplinary authority
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 authority1
North Carolina Court Limits State Medical Board’s Disciplinary Authority

North Carolina

Medical 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 authority2
North Carolina Court Limits State Medical Board’s Disciplinary Authority

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 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.


North carolina court limits state medical board s disciplinary authority3
North Carolina Court Limits State Medical Board’s Disciplinary Authority

North Carolina Medical Board

Position 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 authority4
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 authority5
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 authority6
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
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 requirements1
State Courts Limit Abortion Disclosure and Consent Requirements

  • Planned Parenthood v. Rounds

  • U.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 requirements2
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 requirements3
State Courts Limit Abortion Disclosure and Consent Requirements

Oklahoma Freedom of Conscience Act,

adopted 2008

Medical 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 requirements4
State Courts Limit Abortion Disclosure and Consent Requirements

  • NovaHealth v. Henry

  • Oklahoma 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 requirements5
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

Developments in Federal Stem Cell Research Policy Requirements

Mary A. Majumder, JD, PhD

Center for Medical Ethics and Health Policy

Baylor College of Medicine


Bush administration policy
Bush Administration Policy Requirements

  • 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
Dickey Amendment: Text Requirements

(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
Dickey Amendment Requirements

  • 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.




State Authority Requirements

Protection of Children

(parens patriae)

vs.

Parental Authority

Protection of Religious Liberty/ Minority Communities


Hew hhs capta regs
HEW/HHS CAPTA Regs* Requirements

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
Hauser Case Requirements

  • 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
Worthington Case Requirements

  • 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
Neumann Case Requirements

  • 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
Summing Up Requirements

  • 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
Freedom of Speech and Physicians’ Prescribing Habits Requirements

Erin A. Egan, MD, JD

University of Colorado Denver

Loyola University Neiswanger Institute for Bioethics and Health Policy


Issue
Issue Requirements

  • 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
Why Buy/Sell Information Requirements

  • 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
Where’s the Money? Requirements

  • 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
Commercial Speech Requirements

  • 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
Challenges to Free Speech in the Medical Arena Requirements

  • 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
Precedents Requirements

  • 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
Other Cases Requirements

  • 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
Beef Jerky Requirements

  • 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
Disaster Response Law Requirements

  • 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
Who cares? Requirements

  • 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
Tension Requirements

  • 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
Civil Liberties Requirements

  • 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
Legal Basis for Infringing on Civil Liberties Requirements

  • 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
Standard of care Requirements

  • 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
Further Deterioration of the Standard of Care Requirements

  • Canceling elective clinic visits, surgery?

  • Triaging ventilators?

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

  • On and on


Opinion
Opinion Requirements

  • 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


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