Legal Update 2009 The Top 10 Legal Developments

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 • Speakers – 10 min • 20 min Q&A at the end • Get the handout

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 • Abigail Alliance v. Von • • Eschenbach, 495 F. 3 d 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) – 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

Trends in Advance Care Planning Law?

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 • 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 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 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 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 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 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 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. 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 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 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 Requirements Nova. Health 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 Requirements Implications of these decisions? • Wait and see approach • Track proposed legislation

Developments in Federal Stem Cell Research Policy Mary A. Majumder, JD, Ph. D Center for Medical Ethics and Health Policy Baylor College of Medicine

Bush Administration Policy • Derivation process was initiated prior 9: 00 P. M. EDT on August 9, 2001. to • 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. 289 g(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 h. ESCs (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, JD University of Colorado Denver Loyola University Neiswanger Institute for Bioethics and Health Policy

Issue l Can a state ban sale of physicians’ prescribing information? l Why would they want to? l 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 l Big business- 1. 75 billion in 2006 l Data can be tied to individual physicians or grouped by region or demographics l Physician pharmaceutical detailing- a huge investment- can be tailored to physicians l Can reinforce current prescribing habits, can try to influence changes in prescribing practices.

Where’s the Money? l Decreasing access to physicians l “The Unbranded Doctor” l “Project Prescription” l Reps being banned from academic campuses l Providers increasingly unwilling to speak with detailers/reps l The coercive (malignant? ) relationship between physicians and pharmaceutical companies

Commercial Speech l Not all speech is free speech l Commercial speech is protected under the constitution l So what is commercial speech l Precedents

Challenges to Free Speech in the Medical Arena l Tobacco and alcohol advertising bans l Direct to consumer marketing regulation l Dietary supplement labeling and marketing l Result- ban cannot be placed on commercial speech. Commercial speech is protected as long as it is accurate (disclaimer caveat for supplements)

Precedents l Wouldn't be a legal talk without them l The Central Hudson Test l Central Hudson Gas and Electric Corp v. Public Service Commission 447 U. S. 557 (1980) l Commercial speech cannot be restricted unless the Government can show l The speech is false, misleading, or regards illegal activity l Regulation supports a valid public interest and no other means is sufficient

Other Cases l Bigelow v. Virginia- since abortion is legal in New York, Virginia cannot stop newspapers advertising the service l Virginia State Board of Pharmacy v Virginia Citizens Consumer Council- the state cannot stop pharmacies from advertising drug prices. l Other cases- state/ government cannot ban direct to consumer advertising, unlimited restrictions cannot be placed on tobacco and alcohol advertising.

Beef Jerky l Sale of prescribing data is not “commercial speech” l The information is processed and packaged before it is soled l Prescribing information is to commercial speech what beef jerky is to beef l The processing and interpretation changes the information from free speech to a product

Disaster Response Law l Model State Health Emergency Powers Act (caveat of discussing model acts) l Model act, enacted in whole or in part in 38 states l Creates a disaster or emergency response framework

Who cares? l Pandemic Flu- H 1 N 1 l Fortunately not a severe strain, but impact will be felt in numbers l 50% of population to be effected? l Pediatric deaths for this season so far have exceeded all pediatric deaths from last year. l Individual experience l From 100 daily ED visits to 190 daily ED visits l More that 20 nurse/PCT’s absent or sent home daily l One half of all ICU beds taken by patients with confirmed or suspected H 1 N 1

Tension l Public good vs. individual liberties l Disaster must be declared by governor l Quarantine authority (enforceable by use of the militia, but failure to comply is a misdemeanor) l Appropriation of property, facilities, supplies, personnel as needed to promote the welfare of the state or region l Civil liability protection

Civil Liberties l Inherently there will be some infringement on civil liberties l Civil liberties should be protected when possible, multiple attempts at safeguards to ensure least restrictive means employed l Issues- quarantine, vaccination, evaluation, treatment l 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 l Jacobson v. Massachusetts- there are restraints that can be placed on every person for the common good l Development of individual autonomy and the penumbra of privacy l Consider Roe and Cruzan l What would the outcome be?

Standard of care l Inherent implications for standard of care l Rationing of vaccine l Individual experience l l All doses recombinant live vaccine, not appropriate for high risk patients or high risk providers l l 1500 doses for a 500+ bed medical center and clinic network for providers and patients Priority given to providers, provider groups ranked Clear inability to meet CDC guidelines for vaccination

Further Deterioration of the Standard of Care l Canceling elective clinic visits, surgery? l Triaging ventilators? l Triaging non-flu patients because of burden of flu patients? l On and on

Opinion l Better to be wrong than uncertain l Transparency is the only way to maintain social order l Transprency is also the only way to approximate anything close to ethical practice l Fading of interest in solving this problem l Momentum after 9/11, Katrina l Momentum with H 1 N 1 flu l Generating interim momentum to create valuable infrastructure