New dispute over frozen embryos

Just in time for Monday's 4th Bioethics class, here's a Dallas Morning News article on the dispute in Austin over the disposition of frozen embryos, involving a divorcing couple and their interrupted plans for an IVF pregnancy. (The article exemplifies one of my pet peeves about journalists' tangential (at best) understanding of legal process. In its last paragraph, the article states, "Arguments before the Texas Supreme Court in the Roman case have not yet been set," but nowhere this statement does the reporter ever say what the outcome was at the trial court level (Family Court? Probate Court? In what county?) or the intermediate appellate level.)

This is a replay of the famous Tennessee Supreme Court case, Junior Davis v. Mary Sue Davis, which was the first case to say that, absent extraordinary circumstances, the ex-spouse who wants to avoid parenthood should ordinarily be allowed to do so:

In summary, we hold that disputes involving the Disposition of preembryos produced by in vitro fertilization should be resolved, first, by looking to the preferences of the progenitors. If their wishes cannot be ascertained, or if there is dispute, then their prior agreement concerning Disposition should be carried out. If no prior agreement exists, then the relative interests of the parties in using or not using the preembryos must be weighed. Ordinarily, the party wishing to avoid procreation should prevail,
assuming that the other party has a reasonable possibility of achieving parenthood by means other than use of the preembryos in question. If no other reasonable alternatives exist, then the argument in favor of using the preembryos to achieve pregnancy should be considered. However, if the party seeking control of the preembryos intends merely to donate them to another couple, the objecting party obviously has the greater interest and should prevail.

Most courts have followed the Tennessee court's lead in this arena.

As for the Texas case, here is the appellate court' s opinion (the husband won: "We hold that the embryo agreement provides that the frozen embryos are to be discarded in the event of divorce. By awarding the frozen embryos to Augusta, the trial court improperly rewrote the parties’ agreement instead of enforcing what the parties had voluntarily decided in the event of divorce. Accordingly, the trial court abused its discretion in not enforcing the embryo agreement. ") and a link to the Supreme Court's docket sheet in Roman v. Roman. Petitioner's reply brief on the merits is due June 15th, though the parties in this case have received many extensions of time during their year at the Supreme Court; all told, the case has been kicking around for almost 5 years (nearly as long as the Romans' marriage lasted). More to follow . . . .

Health Lawyers News, June 8

From the folks at American Health Lawyers Association comes this week's issue of Health Lawyers News:

Top Stories

• More Questions Surface About FDA's Response To Avandia Risks
  The House Oversight and Government Reform Committee held a hearing June 6 to probe the Food and Drug Administration’s (FDA's) role in evaluating the safety of the diabetes drug Avandia. Full Story
• House Passes Stem Cell Bill
  The House cleared June 7 a bill (S. 5) aimed at expanding research opportunities on embryonic stem cells in a 247-176 vote. The Senate cleared the measure in April by a vote of 63-34. Full Story

Articles & Analyses

• The Medicare Competitive Bidding Program For Durable Medical Equipment, Prosthetics, Orthotics, And SuppliesBy Carol Loepere, Elizabeth Carder-Thompson, Bob Hill, and Debra McCurdy, Reed Smith LLP
• Proposed Inpatient PPS Rule To Impact Specialty Hospitals: CMS Continues To Implement Its “Strategic And Implementing Plan For Specialty Hospitals”, By Thomas E. Dowdell and Lara E. Parkin, Fulbright & Jaworski, LLP

Current Topics

• Antitrust
  U.S. Court In Tennessee Refuses To Dismiss Nurses’ Claims Alleging Hospitals Conspired To Depress Wages
• Arbitration/Mediation
  Arkansas High Court Upholds Denial Of Medical Corporation’s Motion To Compel Physician To Arbitrate Claims In Employment Dispute
• EMTALA
  U.S. Court In Virginia Holds State Hospital's Agreement To Comply With EMTALA Did Not Waive Virginia's Sovereign Immunity
• ERISA
  1. U.S. Court In Missouri Finds ERISA Preempts Plan Beneficiaries' Suit Against HMO For Charging Copays In Violation Of State Law
  2. Eighth Circuit Reverses Lower Court Decision Upholding Health Plan Insurer’s Retroactive Rescission Of Plan Participant’s Coverage
• Food and Drug Law
  1. FDA Creates Communications Advisory Committee
  2. Health Subcommittee Will Mark Up Pharmaceutical, Device Bills Next Week
• Fraud and Abuse
  1. Eleven Arrested In Alleged $5 Million Billing Scheme For HIV Infusion Treatments
  2. Update
  3. U.S., Texas Reach $15 Million Settlement With Hospital District To Resolve FCA Claims
• Health Information Technology
  New Coalition Will Lobby For Immediate Deployment Of Health Information Technology
• Health Policy
  Business Roundtable Releases Principles For Healthcare Reform
• Healthcare Spending
  NGA-NASBO Reports Stable Fiscal Conditions For States In FY 2007, But Projects Increasing Strain On Budgets In FY 2008
• Hospitals and Health Systems
  Texas Supreme Court Finds Hospital May Not Maintain Lien Against Patient For Charges Not Covered By Workers Comp
• Individual/Patient Rights
  Sixth Circuit Strikes Down Michigan Abortion Law
• Insurance
  Maine High Court Rejects Payors’ Challenge To Calculation Of “Cost Savings” From Health Program Used To Set Offset Payments
• Medicaid
  OIG Finds AMPs For Most Drugs Remained Fairly Stable In Quarterly Comparison
• Medicare
  U.S. Court In District Of Columbia Stays Hospitals’ Action Seeking Reopening Of Medicare Cost Reports
• News in Brief
  AMA Consortium Approves 10 New Physician Quality Measures
• Physicians
  1. Physician Survey Finds Medicare Payment Cuts Will Affect Access, Care, AMA Says
  2. Oklahoma High Court Reinstates Physician’s Suit Against Hospital, Finding Peer Review Statute Does Not Provide Blanket Immunity
• Quality of Care
  Study Shows Pay-For-Performance Initiative Did Not Result In Significant Improvement For Heart Attack Patients
• Tax
  1. Ohio High Court Finds Provider Of Hospice And In-Home Nurse Services Entitled To Property Tax Exemption
  2. Indiana Tax Court Finds Taxpayer Failed To Show Medical Facility Was Used Predominantly For Charity, Denies Property Tax Exemption

Table of Contents © AHLA, 2007. Reprinted by permission.

On the day before the House passed the stem-cell funding bill (S. 5 passed in the Senate on April 11), which Pres. Bush has promised to veto, there was interesting, potentially revolutionary (but potentially not) news on the stem-cell science front: Skin cells from mice have been reprogrammed to act as stem cells. If that carries over to humans and the results are consistently reproducible, we're looking at a way to avoid using embryonic stem cells, thus mooting the pro-life objection against destroying an embryo (even one you created as a clone of yourself) to obtain a fresh supply of stem cells. Here are some links and summaries from AHLA:

• NBC Nightly News (6/6, lead story, 3:05, Williams) led its broadcast with "an amazing piece of science" having to do "with medicine," as well as "with a hugely divisive political issue, embryonic stem cells and their potential to cure the sick and disabled." NBC (Bazell) added, "This is indeed an astounding and elegant piece of scientific research. It's not going to end the debate about embryonic stem cells, but it could be a big step in that direction."


• The CBS Evening News (6/6, story 3, :30, Couric) noted that "researchers say they have found a way to make stem cells out of ordinary skin cells in mice. If the technique works in humans, scientists might using human embryos. Experts believe stem cells could be used to treat diseases ranging from diabetes to Parkinsons."


• The Chicago Tribune (6/6, Kaplan) reports, "If the discovery applies to human cells -- and researchers are optimistic that it will -- it would offer a straightforward method for creating a limitless supply of cell lines tailor-made for patients without any ethical strings attached. ... 'This is truly the Holy Grail -- to be able to take a few cells from a patient, say a cheek swab or some skin cells, and turn them into stem cells in the laboratory,' said Dr. Robert Lanza, an embryonic stem-cell researcher and head of scientific development at Advanced Cell Technology Inc. in Worcester, Mass., who was not involved in the research. 'It would be like turning lead into gold.'"


• In a front-page article, USA Today (6/7, 1A, Vergano) says that "the findings, by three teams publishing in the journals Nature and Cell Stem Cell, mean the reprogrammed cells may offer a non-controversial way...to make rejection-free tissues for transplant patients. But research still hasn't shown that the same cells will work in humans too, the study's authors say."


• The Wall Street Journal (6/7, Naik) runs a similar report under the headline "Stem-Cell Breakthrough May Ease Ethical Debate." On its front page, the New York Times (6/7, A1, Wade), meanwhile, says that "the technique seems likely to be welcomed by many who have opposed human embryonic stem cell research. It 'raises no serious moral problem, because it creates embryoniclike stem cells without creating, harming or destroying human lives at any stage,' said Richard Doerflinger, the United States Conference of Catholic Bishops' spokesman on stem-cell issues."


• The Christian Science Monitor (6/6, Spotts) adds, "many researchers say that progress in the U.S. has been hampered by limits...Bush imposed on federally funded human embryonic stem-cell research nearly six years ago." But "the limits also have prompted some labs to hunt for alternate ways to derive cells."


• In a front-page article, the Washington Post (6/7, A1, Weiss) reports, "Acutely aware that their new work could undermine that key political goal, the scientists cautioned that their success with mouse cells does not guarantee quick success with human cells." They "called for Congress to pass the bill, which would give federally funded researchers access to embryos slated for destruction at fertility clinics. 'A human is not a mouse, so a lot more work has to be done,' said Marius Wernig, who led one team with Rudolf Jaenisch of the Whitehead Institute for Biomedical Research in Cambridge, Mass."
  
• Along those lines, the New York Times (6/7, A32, Pollack) runs another story titled: "A Long, Uncertain Path For New Cell Technique."

TB quarantines are usually a local matter, rarely federal

That's what last night's AP story on Drew Speaker reported. True enough, and this case illustrates that local authority is still pretty much hit-or-miss. Maryland officials claimed not to have the authority to detain or quarantine him, but as the AP reports, many state and local jurisdictions do. Speaker was being kept in quarantine pursuant to a federal order -- the first in 44 years -- but that order lapsed Saturday night, when it was replaced by a local Denver order.

• CDC's Division of Tuberculosis Elimination has some good information about the case.


• The ACLU has published some comments on the Speaker case. Although it says there is no indication that federal law has been violated by his quarantine, the group emphasizes the need to get judicial review of Speaker's continued detention. It also has links to its comments on the CDC's proposed rule on quarantining travelers (70 Fed. Reg. 71892-71948 (Nov. 30, 2005)).

Top SSRN downloads in public health law

Here are the top 10 SSRN downloads in public health law as of the end of May:

• Why Evolutionary Biology is (So Far) Irrelevant to Law
  U of Texas Law, Public Law Research Paper No. 89, U of Texas Law, Law & Econ Research Paper No. 81
  Brian Leiter and Michael Weisberg , University of Texas at Austin - School of Law & Department of Philosophy and University of Pennsylvania Date
  Posted: March 23, 2006Last Revised: February 7, 2007
  Working Paper Series 844 downloads
• Privacy's Other Path: Recovering the Law of Confidentiality
  George Washington University Law School Public Law Research Paper No. 249, Washington University School of Law Working Paper No. 07-03-02, Georgetown Law Journal, 2007
  Neil M. Richards and Daniel J. Solove , Washington University School of Law and George Washington University Law School
  Date Posted: March 13, 2007
  Last Revised: April 5, 2007
  Accepted Paper Series
  758 downloads
• Tort Reform and Accidental Deaths
  Emory Law and Economics Research Paper No. 05-17, Emory Public Law Research Paper No. 05-29
  Paul H. Rubin and Joanna Shepherd , Emory University - Department of Economics and Emory University - School of Law
  Date Posted: August 11, 2005
  Last Revised: February 27, 2006
  Working Paper Series
  600 downloads
• Toward a Theory of a Right to Health: Capability and Incompletely Theorized Agreements
  Yale Journal of Law & the Humanities, Vol. 18, pp. 273-326, 2006
  Jennifer Prah Ruger , Yale University - School of Medicine
  Date Posted: September 28, 2006
  Last Revised: March 30, 2007
  Accepted Paper Series
  589 downloads
• The Case Against Smoking Bans
  U of Missouri-Columbia School of Law Legal Studies Research Paper No. 2006-11, Missouri Environmental Law and Policy Review, Vol. 13, 2006
  Thomas Andrew Lambert , University of Missouri at Columbia - School of Law
  Date Posted: April 24, 2006
  Last Revised: July 7, 2006
  Accepted Paper Series
  562 downloads
• Does Medical Malpractice Reform Help States Retain Physicians and Does it Matter
  Jonathan Klick and Thomas Stratmann , Florida State University College of Law and George Mason University - Buchanan Center Political Economy
  Date Posted: November 19, 2003
  Last Revised: December 19, 2005
  Working Paper Series
  527 downloads
• Database of State Tort Law Reforms (DSTLR 2nd)
  Northwestern Law & Econ Research Paper No. 06-08
  Ronen Avraham , Northwestern University - School of Law
  Date Posted: May 17, 2006
  Last Revised: December 8, 2006
  Working Paper Series
  488 downloads
• Rethinking Equal Access: Agency, Quality, and Norms
  Global Public Health, Vol. 2, No. 1, pp. 78-96, 2007
  Jennifer Prah Ruger , Yale University - School of Medicine
  Date Posted: January 18, 2007
  Last Revised: March 30, 2007
  Accepted Paper Series
  343 downloads
• Stem Cell Research and the Law
  UCLA School of Law Research Paper No. 06-05
  Russell B. Korobkin and Stephen R. Munzer , University of California, Los Angeles - School of Law and University of California, Los Angeles - School of Law
  Date Posted: January 28, 2006
  Last Revised: February 8, 2006
  Working Paper Series
  324 downloads
• Toward a Human Rights Framework for Intellectual Property
  Vanderbilt Public Law Research Paper No. 06-03, U.C. Davis Law Review, Vol. 40, p. 971, 2007
  Laurence R. Helfer , Vanderbilt University - School of Law
  Date Posted: March 21, 2006
  Last Revised: April 12, 2007
  Accepted Paper Series
  318 downloads

Groopman on medical error: it's not all about systems

There's an interesting blog post by Rob Cunningham over at Health Affairs, ostensibly about Jerome Groopman's new book, How Doctors Think. Here's a sample:

[T]he subtlety of the cognitive biases associated with diagnostic error in Groopman’s work and other studies suggests a daunting re-education challenge. Greater reciprocity in doctor-patient relations is a part of the answer that is consistent with many IT champions’ vision of patient-centered care. Other problems are not nearly as well recognized. Mark Graber and colleagues, cited above, found “premature closure,” or the inclination of physicians to settle on a diagnosis before they have gathered enough information or considered all the alternatives, to be the single most common source of cognitive failure. But there are a whole slew of other mental and behavioral weaknesses that may enter into the clinical encounter and drive it into a ditch.

The bottom line, according to Groopman, is that doctors often don’t ask the right questions and don’t listen carefully enough when the patient answers. . . .

It's an interesting problem, and not just for medical schools and training programs. Earlier in the blog post, Cunningham referred to "rushed patient encounters and imperious, overconfident practitioners [as] merely the most obvious symptoms of what can go wrong." I don't know what legislators and regulators can do about imperious and overconfident practitioners, but it's certainly worth asking what systemic conditions have contributed to the rushed patient encounters, as well as other health-care ills -- e.g., "an apparent decline in physicians’ clinical skills, driven at least in part by increasing dependency on high-tech diagnostic tools and financial incentives to see more and more patients."

When we get the health care system we deserve, we also get the practitioners (and practices) we deserve, as well.

Meanwhile, Groopman made an appearance on the Colbert Report recently. Here are the (somewhat predictable) results:

Shouldn't someone at his publisher's have told Dr. Groopman he was going onto a comedy show?

Art Caplan on Dr. Death's release and legacy

I'm glad Art sees this guy the same way I do. Here are some nuggets:

• I believed Kevorkian was a very dangerous killer [in 1994], and I still believe it now. He helped dozens of depressed and disabled people die without trying very hard to convince them to live.


• Kevorkian believes in suicide on demand. He thinks that doctors have an obligation to help anyone who decides that their life is not worth living, whatever their reason. Some of the 130 people he helped die had no terminal illnesses. Some were clearly depressed. Others had histories of mental illness. Only a few got any counseling. Kevorkian helped them all to die.


• Kevorkian’s problem was and is that he likes death way too much. The enthusiasm he brought to his cause was always deeply troubling. No doubts, no ambivalence, ever seemed to cross his mind as he dispatched his victims. The fact that he helped some to die within hours of meeting them, the fact that he would turn a disabled man’s death into a national spectacle by giving a tape of his murder to "60 Minutes" — never mind that they used it! — and the fact that he never seemed to try particularly hard to talk those who came to him out of their decision to die made him morally suspect then and hardly worth hearing from now.

As Caplan points out, the carefully crafted Oregon Death with Dignity Act has resulted in relatively few actual suicides, while at the same time providing the encouragement to develop more effective (and available) palliative care programs. On balance, I am still against legalizing physician-assisted-suicide, but public opinion is slowly swinging in favor of legalization and Oregon has demonstrated that, at least in a state like Oregon, it's possible to avoid the abuses that people like me have worried about.

SSRN: Top health law downloads

End-of-month (or beginning-of-month) recap of the top 10 SSRN downloads in health law (look for public health law rankings tomorrow):

• Safe Storage Gun Laws: Accidental Deaths, Suicides, and Crime
  Yale Law School, Law & Economics Working Paper No. 237
  John R. Lott Jr. and John E. Whitley , State University of New York - Department of Economics and University of Adelaide - School of Economics
  Date Posted: May 22, 2000
  Last Revised: June 10, 2002
  Working Paper Series
  9111 downloads


• Abortion and Crime: Unwanted Children and Out-of-Wedlock Births
  Yale Law & Economics Research Paper No. 254
  John R. Lott Jr. and John E. Whitley , State University of New York - Department of Economics and University of Adelaide - School of Economics
  Date Posted: May 16, 2001
  Last Revised: June 5, 2001
  Working Paper Series
  6030 downloads


• Stability, Not Crisis: Medical Malpractice Claim Outcomes in Texas, 1988-2002
  Journal of Empirical Legal Studies, Vol. 2, pp. 207-259, 2005, Columbia Law and Economics Working Paper No. 287, U Illinois Law & Economics Research Paper No. LE05-002, U of Texas law, Law and Econ Research Paper No. 030
  Bernard S. Black , Charles Silver , David A. Hyman and William M. Sage University of Texas at Austin - School of Law , University of Texas at Austin , University of Illinois College of Law and University of Texas at Austin
  Date Posted: October 25, 2005
  Last Revised: March 19, 2007
  Accepted Paper Series
  1682 downloads


• Abortion and Original Meaning
  Yale Law School, Public Law Working Paper No. 119
  Jack M. Balkin , Yale University - Law School
  Date Posted: August 21, 2006
  Last Revised: October 2, 2006
  Working Paper Series
  1485 downloads


• What the Publisher Can Teach the Patient: Intellectual Property and Privacy in an Era of Trusted Privication
  Stanford Law Review, Vol. 52
  Jonathan Zittrain , University of Oxford - Oxford Internet Institute
  Date Posted: March 9, 2000
  Last Revised: March 26, 2007
  Accepted Paper Series
  1300 downloads


• TRIPs, Pharmaceuticals, Developing Countries, and the Doha 'Solution'
  U Chicago Law & Economics, Olin Working Paper No. 140
  Alan O. Sykes , Stanford Law School
  Date Posted: February 19, 2002
  Last Revised: March 7, 2002
  Working Paper Series
  1250 downloads


• Unintended Consequences of Medical Malpractice Damages Caps
  NYU Law Review, Vol. 80, pp. 391-512, May 2005
  Catherine M. Sharkey , Columbia University - Columbia Law School
  Date Posted: February 17, 2005
  Last Revised: June 1, 2005
  Accepted Paper Series
  971 downloads


• Bayh-Dole Reform and the Progress of Biomedicine
  Law and Contemporary Problems, Vol. 66, No. 1
  Arti K. Rai and Rebecca S. Eisenberg , Duke University School of Law and University of Michigan Law School
  Date Posted: November 23, 2002
  Last Revised: February 6, 2003
  Accepted Paper Series
  901 downloads


• Incentives in Nonprofit Organizations: Evidence from Hospitals
  Simon School of Business Working Paper No. FR 00-02
  James A. Brickley and R. Lawrence Van Horn , University of Rochester - Simon School and Owen Graduate School of Management, Vanderbilt University
  Date Posted: February 14, 2000
  Last Revised: April 2, 2002
  Working Paper Series
  826 downloads


• The TRIPS Agreement, Access to Medicines and the WTO Doha Ministerial Conference
  FSU College of Law, Public Law Working Paper No. 36 and QUNO Occasional Paper No. 7
  Frederick M. Abbott and Florida State University College of Law and Illinois Institute of Technology - Chicago-Kent College of Law
  Date Posted: October 8, 2001
  Last Revised: October 15, 2001
  Working Paper Series
  744 downloads

Tubercular lawyer's world-wide travel raises public health questions

"Drew" Speaker, and every public-health office and official he encountered in the past couple of weeks, are now at the center of a serious controversy. The best single story that summarizes what we know so far appeared in this morning's New York Times. In addition to a full account of Speaker's travels and discussions with public-health officers, John Schwartz asks all the right questions:

1. "Why would a well-informed person aware of medical concerns get on an airplane after receiving a diagnosis of a disease that could be fatal to others?"
   
2. "Why would he flee from health authorities once the diagnosis became even more grave?"


3. "How could the man’s father-in-law, an expert in tuberculosis at the C.D.C., accede to the trip?"


4. What does this saga tell us about the legal and practical gaps in our ability to limit the public's exposure to an infected individual, especially one with a motive -- whether benign or malicious -- to be evasive?


5. How much freedom -- of movement, from surveillance -- will Americans tolerate in order to limit their exposure to infectious disease?

One of the more interesting lessons of this story revolves around Speaker's decision -- which he admits, "In hindsight, maybe it wasn't the best decision" -- to ignore the CDC's instruction not to fly home from Rome on a commerical airliner:

He said that when he was contacted by a representative of the Centers for Disease Control in Rome, he was told that he could not fly home unless he chartered a plane — at a cost of $100,000 — and that he should check into a local hospital. “I felt very abandoned,” he said, emphasizing that he firmly believed he could not infect others. He said he feared he might end up “stuck in an Italian hospital indefinitely, where I could die.”

As Michael Osterholm, an epidemiologist who directs the Center for Infectious Disease Research and Policy at the University of Minnesota, observed:

“Short of a military state where you have 24/7 surveillance on someone, you have to count on the good will of the individual.

He called this a fact of life in an open society, one that could lead to major problems in an outbreak of pandemic influenza, in which many people would probably be boarding planes knowing they were sick to get away from an epidemic. “They would say, ‘I want to make sure I get out,’ ” whatever the risk to others. In that kind of situation, he said, the public health system would inevitably be unable to keep up.

There are a couple of AP stories today that add to what we know about Speaker:

• TB Lawyer Called 'Pillar' of Community photo
  ATLANTA (AP) - The story of how Andrew Speaker met his future bride still draws laughs from his friends. The young attorney met Sarah Spence Cooksey, an aspiring lawyer, at an Atlanta pub and handed her his fancy business card. When she called, she asked for "Mr. Speaker." But the man she ended up...


• TB Patient Faces 2 Months in Hospital photo
  DENVER (AP) - The man quarantined with a dangerous strain of tuberculosis will likely spend up to two months in a hospital while he receives a battery of antibiotics and is evaluated for possible surgery, his doctors said. Andrew Speaker is the first infected person quarantined by the U.S....

The most comprehensive coverage of this story seems to be over at the Harvard Public Health School's World Health News site. Here are the stories they've featured:

• Man With TB Apologizes for Putting Others at Risk
  Lawrence K. Altman and John Holusha (The New York Times, June 1, 2007)
  "The Atlanta lawyer who flew on crowded airplanes while infected with a dangerous form of tuberculosis said today he did not think he presented a danger when he flew and he apologized to his fellow passengers." See also: TB Treatment a 'Challenge,' Doctor Says (The Atlanta Journal-Constitution, June 1, 2007)


• Agent at Border, Aware, Let In Man With TB
  Lawrence K. Altman (The New York Times, June 1, 2007)
  "The man with a dangerous form of tuberculosis who flew to Europe for his wedding and honeymoon was identified yesterday as a 31-year-old Atlanta lawyer. Department of Homeland Security officials said he re-entered the country from Canada when a customs agent let him pass despite knowing that the man was being sought by health authorities." Free registration required.
  
• Case of TB Traveler Reveals Holes in Global Disease Control
  Elisabeth Rosenthal (International Herald Tribune, May 31, 2007)
  "The U.S. health authorities failed to notify their Italian counterparts that an American tourist with an extremely dangerous form of tuberculosis was staying in a Rome hotel this month until he was leaving the country, Italian officials said Thursday. That time lapse allowed him to leave Rome and fly to Prague and Montreal, potentially exposing dozens of people to an often lethal germ."


• TB Patient's Father-in-Law a CDC Microbiologist
  (Associated Press, May 31, 2007)
  "The honeymooner quarantined with a dangerous strain of tuberculosis was identified Thursday as a 31-year-old Atlanta personal injury lawyer whose new father-in-law is a CDC microbiologist specializing in the spread of TB and other bacteria."


• Near Misses Allowed Man With Tuberculosis to Fly
  Lawrence K. Altman and John Schwartz (The New York Times, May 31, 2007)
  "A series of 'understandable' near misses accounted for a Georgia man’s odyssey to Europe in which he might have exposed fellow passengers on a series of commercial flights to an exceptionally dangerous form of tuberculosis, federal officials said [Wednesday]." Free registration required.


• Isolating an Evasive TB Patient
  Editorial (The New York Times, May 31, 2007)
  "Congressional oversight committees ought to examine whether health officials dropped the ball -- and what steps can be taken to ensure that patients infected with deadly contagious diseases protect others from infection." Free registration required.


• Earlier:
  CDC May 29 Media Relations Telebriefing Transcript
  Atlantan Quarantined with Deadly TB Strain (The Atlanta Journal-Constitution, May 30, 2007) Free registration required.
  CDC Warns of Possible TB Exposure on Atlanta-Paris Flight (The Atlanta Journal-Constitution, May 29, 2007) Free registration required.

Dr. Death out of prison

I can't let the moment pass without acknowledging the release -- after 8 years in the Michigan prison system -- of Jack Kevorkian, a former pathologist who performed active euthanasia (a/k/a "murder") on a patient, filmed it, and allowed "60 Minutes" to air the event (AP, courtesy of Forbes). ("60 Minutes" will broadcast an interview with Mike Wallace this Sunday.)

He's a ding-bat, to be sure. Even many proponents of physician-assisted suicide cringe at the mention of his name. In the name of physician-assisted suicide ("PAS"), he helped strangers, not patients, kill themselves without ensuring that they were terminally ill, without assessing their mental state, and without seriously exploring less drastic means of addressing the concerns that led these citizens to seek out Kevorkian's services. Most, if not all, of the safeguards built into the Oregon Death With Dignity Act were routinely ignored in his quest for publicity for his cause. He shone a spotlight on an issue that needed to be examined and debated, but the way he did it might well have set the PAS movement back years, if not more. The New York Times has a good article on Kevorkian and the status of PAS around the country.

Dutch reality tv program -- "Big Donor Show" -- a hoax

Wouldn't you know: One of the stories that lured me out of semi-retirement and back to HealthLawBlog -- the one about the Dutch tv network that was about to air a show featuring a terminally-ill patient interviewing three candidates in kidney failure to decide which one would get her kidney -- turns out to be a hoax by the network, designed to pressure government officials to reform organ-transplantation laws in the Netherlands. According to the AP (courtesy of The Washington Post), the terminally-ill patient was simply a role played by a Dutch actress (Leonie Gebbink, looking none-too-ill in her publicity shot).

It appears that organ-transplant officials the world over are a pretty conservative lot, adverse to publicity that could be seen as sensationalistic in any way, and of course there was plenty about this "show" not to like. But count this episode as one of many that illustrate the widespread feeling of frustration that "business as usual" isn't getting the job done in the organ-transplant field. The waiting-list statistics at UNOS tell a pretty grim tale:

• there are currently 96,047 registered patients on various waiting lists


• over the past 5 years, waiting-list registrations have skyrocketed for livers, kidneys, and lungs; the number of transplants has increased modestly, and the number of patients who died waiting for a transplant has either gone up modestly (livers and kidneys) or stayed about the same (lungs) despite heroic efforts to increase donations; for hearts, the number of deaths on the list has gone down slightly, but not because of an increase in the number of transplants, which has stayed about the same:

[click to enlarge]

Historians of organ transplantation may well look back on 2007 as the year of the first big crack in the facade. I am thinking of HHS' opinion earlier this year that the prohibition against buying and selling organs (42 U.S.C. § 274e) would not be violated by paired exchanges of living donor kidney transplants. This is the situation when A donates a kidney to D in exchange for C's donation of a kidney to B, where A would otherwise be a living related donor to B, and C would otherwise be a living related donor to D, but for A-B and C-D incompatibility. (A variation on this theme occurs when a living related donor who is incompatible with a family member on the waiting list donates to a stranger, in exchange for which the patient on the waiting list receives some priority on the waiting list, which may substantially shorten his or her waiting time.) Every first-year Contracts student can spot the valuable consideration in these arrangements, but DOJ said the practice does not violate federal law. It can only be a matter of time before the supposed distinction between mutual promises (or the performance thereof) and the exchange of cash for a promise (or performance thereof) will crumble.

Health Lawyers News, June 1

From the folks at American Health Lawyers Association comes this week's issue of Health Lawyers News:

Top Stories

• CMS Implements New Marketing, Education Requirements For PFFS Plans
  Abby L. Block Director of the Centers for Medicare and Medicaid Services’ (CMS’) Center for Beneficiary Choices sent a memo May 29 to Medicare Advantage (MA) Private fee-for-service (PFFS) plans reminding them that CMS is requiring new outreach processes to ensure beneficiaries and providers are informed about the distinctive features of Medicare PFFS plans. Full Story
  
• Baucus, Grassley Urge IRS To Update Reporting Forms For Nonprofits
  Senate Finance Committee Chairman Max Baucus (D-MT) and Ranking Member Charles Grassley (R-IA) sent a letter May 25 to Treasury Secretary Henry Paulson urging him to update Form 990 and Form 990 PF that nonprofits file with the Internal Revenue Service (IRS) in order to gain greater transparency into the workings of tax-exempt organizations including charities. Full Story

Articles & Analyses

• Unionized Hospital Denied Antitrust Exemption In Nurses’ Suit, by Mark A. Hutcheson, Douglas C. Ross, Mary E. Drobka, and Charles S. Wright, Davis Wright Tremaine, LLP

Current Topics

• Criminal Law
  D.C. Circuit Upholds Restitution Order Against Podiatrist Who Pled Guilty To Medicare Fraud


• Fraud and Abuse
  Sixteen Individuals Charged With Defrauding Medicare Of $101 Million In DME Billing Scheme


• Update


• Healthcare Access
  California Appeals Court Voids County’s Income Eligibility Cap For Subsistence Medical Care


• Hospitals and Health Systems
  1. Florida High Court Finds Hospital Has No Duty To Ensure Staff Physicians Have Malpractice Insurance
  2. Florida Appeals Court Finds Hospital Owed No Duty of Care To Man Who Fainted After Viewing His Wife’s Emergency Treatment


• Individual/Patient Rights
  Second Circuit Finds Intended Organ Recipient Had No Property Right In Donated Kidney Because Of Incompatibility


• Long Term Care
  House Panel Investigating Deceptive Practices In Long Term Care Insurance Market


• Medicaid
  1. President Signs Supplemental War Spending Bill With SCHIP Funding And Moratorium On Medicaid Rule
  2. CMS Issues Final Rule On State Medicaid Financing Arrangements
  3. Ninth Circuit Upholds Oregon Plan Charging Individuals In Medicaid Expansion Group Higher Copays Than Other Medicaid Recipients


• Medicare
  1. CMS Proposes Non-Coverage Of LADR For Medicare Recipients Over 60
  2. CMS Releases Measures For Evaluating Financial Health Of Suppliers Participating In New DMEPOS Competitive Bidding Program
  3. CMS Clarifies Policy Relating To Part D Special Transition Period For Retroactive Enrollment
  4. GAO Finds Most Employers Continued Retiree Drug Coverage, Opted For
  Subsidy


• News in Brief
  1. PhRMA Adds Drug Safety Information To Its Website
  2. AHRQ Adds New Web Tool For Healthcare Quality Report Cards


• Patient Safety
  Baucus,Grassley Introduce Bill Directed At Improving Research On Pharmaceutical Safety And Effectiveness


• Physicians
  1. Tennessee High Court Holds Information Otherwise Available From Original Sources Is Discoverable But Not From Peer Review Committee
  2. Ohio High Court Strikes Down Rule Barring Anesthesiologist Assistants From Performing Epidural And Spinal Procedures


• Tax
  Eleventh Circuit Holds Medical Residents May Qualify For FICA Exemption

Table of Contents © AHLA, 2007. Reprinted by permission.

NIH creates and confers new AID research awards

This is a little late in hitting the usually up-to-the-moment HealthLawBlog (!), but it's still worth noting. NIH has created the NIH World AIDS Day Awards to recognize truly brilliant, trail-blazing work by researchers and program managers whose contributions to AIDS research have probably saved the lives of millions. One of the recipients this past year was Bob Yarchoan (who, I am proud to say, was a college classmate of mine). Here's what the award citation said about Bob:

A joint award to Robert Yarchoan, M.D. and Hiroaki Mitsuya, M.D., Ph.D. of the National Cancer Institute — for their individual and combined achievements, groundbreaking discoveries and innovative and original scientific contributions that have significantly advanced HIV treatment research. Their landmark clinical studies, demonstrating that AZT could result in partial restoration of the immune response and temporary clinical benefit, established the first treatment for HIV infection and launched the era of effective therapy for HIV/AIDS. Their work significantly advanced this field, directly impacting on the development of new and better strategies to prevent and treat HIV disease in this country and around the world.

Congratulations, Bob!

China's ex-regulator of food and drug gets death penalty

And I thought we took food and drug regulation pretty seriously over here! This is from the AP (courtesy of The Boston Globe), and thanks for the tip to Peter Leibold, the EVP at American Health Lawyers Association:

China's former top drug regulator was sentenced to death Tuesday for taking bribes to approve untested medicines, as the country's main quality control agency announced its first recall system targeting unsafe food products.

The developments are among the most dramatic steps Beijing has publicly taken to address domestic and international alarm over shoddy and unsafe Chinese goods -- from pet food ingredients and toothpaste mixed with industrial chemicals to tainted antibiotics.

The Beijing No. 1 Intermediate People's Court convicted Zheng Xiaoyu for taking bribes in cash and gifts worth more than $832,000 when he was director of the State Food and Drug Administration, the official Xinhua News Agency said. The court then issued the death penalty, the report said.

Dutch reality tv: who will get my kidney?

According to AP this morning (courtesy of the Chicago Sun-Times), the BNN television network in The Netherlands plans to go forward with its reality program, "Big Donor Show," in which a terminally ill 37-year-old woman will interview and choose from among three transplant candidates. The network says they intend the show to serve as a public-service message about the number of Dutch patients (2,000) who die each year while waiting for a kidney transplant. Really? It's not about the cruel exploitation of desperate, dying people in order to boost ratings? Really? Really?

Emergency research protocols expand

It was controversial when the FDA amended its version of the Common Rule (21 CFR Part 50) in 1996 to add a provision that allows for emergency research when true informed consent isn't possible (§ 50.24) -- the first time human subjects could be legally enrolled in research without their consent. The FDA defended the move as a modest exception for the relatively rare instances in which research would be stymied because of the impossibility of obtaining consent that would otherwise be required. As an article in yesterday's Washington Post makes clear, such research is getting considerably less rare, renewing the decade-old debate about whether the FDA's exception is really needed or is encouraging, as BU's George Annas says, " lazy investigators not wanting to try to get informed consent in situations where it is difficult to get it, so they say it is impossible."

Department of full disclosure: I have been a member of a consultation group in Dallas in connection with the emergency research discussed in this article ("Clinical Trial of the Active Compression-Decompression (ACD) and Inspiratory Threshold Valve (ITV) Devices vs Standard CPR").

California health reform

Ned Spurgeon (Utah and visiting distinguished chair at McGeorge this semester) has done a really nice piece on California health reform. It's been posted by Elizabeth Ann Weeks (Kansas) on the Jurisdynamics blog page.

Living with an incurable genetic disease

The N.Y. Times ran a remarkable story last Sunday describing the life changes that occur when a person chooses to learn whether she has the genetic condition -- Huntington's Disease (or HD) -- that killed her grandfather and afflicts her cousin. Is it a good idea to find out, or is it an invitation for sorrow, stigmatization, and loss of insurability? The issues are explored sensitively and in detail in this article, which I didn't see last Sunday as I prepared for and gave a talk to The Institute for the Humanities at Salado on, of all things, medical privacy and the uses to which genetic information may be put. Thanks to college classmate Rick Goggans, M.D., for pointing this one out to me!

Links to HD resources (provided by The Times):

• Huntington’s Disease Society of America


• Hereditary Disease Foundation


• Huntington’s Disease Advocacy Center

Fen-phen lawyers defrauded plaintiffs, court rules

Physicians, other health care professionals, hospitals, and other health-care entities take their lumps here with some regularity, so it is perhaps only fitting that I should note this story from yesterday's N.Y. Times:

W. L. Carter knew there was something fishy going on when he went to his lawyers’ office a few years ago to pick up his settlement check for the heart damage he had sustained from taking the diet drug combination fen-phen.

The check was, for starters, much smaller than he had expected. And his own lawyers threatened to retaliate against him if he ever told anyone, including his family, how much he had been paid. “You will be fined $100,000, you will go to jail and you will be sued,” Mr. Carter recalled them saying.

Mr. Carter was right to have been suspicious. The lawyers defrauded their clients, a state judge has ruled in a civil case, when they settled fen-phen lawsuits on behalf of 440 of them for $200 million but kept the bulk of the money for themselves. Legal experts said the fraud might be one of the biggest and most brazen in legal history.

This week, several clients testified before a federal grand jury that has begun to investigate potential criminal wrongdoing arising from the settlement.

“It enrages me,” said Sonja Pickett, a retail manager, who testified Thursday before the grand jury. “They robbed us.”. . .

The basic facts are not in dispute. When the clients sued the drug maker, they agreed to pay the lawyers 30 percent to 33 percent of any money that was recovered, plus expenses. In this case, that would have left the 440 clients to divide perhaps $135 million.

But the clients received only $74 million. An additional $20 million went to a questionable “charitable fund.” The rest — $106 million — went to lawyers. Though amounts of the individual settlements remain sealed, court papers suggest they were from $100,000 to $5 million. On average, plaintiffs received less than 40 percent of what the settlement agreement specified, instead of the roughly 70 percent to which they were entitled.

Had the lawyers merely taken what they were contractually entitled to, they would have become very rich men, said Tracy Curtis, a mortgage loan officer who is also suing her former lawyers. “They could have taken the high road,” Ms. Curtis said. “They would have made plenty of money.”

There's more, and it's all ugly. Shameful.

Federal bill prohibiting genetic discrimination analyzed by Congressional Budget Office

H.R. 493 (the "Genetic Information Nondiscrimination Act of 2007") would broadly prohibit genetic discrimination by employers (including states and their political subdivisions), unions, employment agencies, and insurers. It has 221 co-sponsors, which is more than enough (assuming they all vote for the bill in the form in which it hits the floor and after amendments, if any) to pass in the House. Here's the Congressional Research Service's summary of the bill:

• Amends the Employee Retirement Income Security Act of 1974 (ERISA) and the Public Health Service Act to expand the prohibition against discrimination by group health plans and health insurance issuers in the group and individual markets on the basis of genetic information or services to prohibit: (1) enrollment and premium discrimination based on information about a request for or receipt of genetic services; and (2) requiring genetic testing. Sets forth penalties for violations.


• Amends title XVIII (Medicare) of the Social Security Act to prohibit issuers of Medicare supplemental policies from discriminating on the basis of genetic information.


• Extends medical privacy and confidentiality rules to the disclosure of genetic information.


• Makes it an unlawful employment practice for an employer, employment agency, labor organization, or training program to discriminate against an individual or deprive such individual of employment opportunities because of genetic information. Prohibits the collection and disclosure of genetic information, with certain exceptions.


• Establishes a Genetic Nondiscrimination Study Commission to review the developing science of genetics and advise Congress on the advisability of providing for a disparate impact cause of action under this Act.

For a more detailed discussion of the bill, go to H. Rept. 11-28 (Part I), March 5, 2007. Also, a number of states already have similar laws on their books. The National Conference of State Legislatures has a handy list of such laws (last updated Nov. 2006 (employment) and June 2005 (insurance)).

Yesterday, the CBO published its cost estimate for H.R. 493. Over 10 years, the federal treasury would be out about $2 million (because premiums for some of the new insureds would be tax-deductible) and the CBO estimates increased outlays of about $2 million (assuming appropriations are approved) for the Departments of Labor, Treasury, and HHS. There will be additional state and private-sector mandates in connection with the anti-discrimination law, but CBO figures the cost will be low for the states and below the threshold in the Unfunded Mandates Reform Act for the private-sector actors.

If there's a surprise in any of this, it might be in the estimated number of citizens expected to benefit from this law: 600. Is there any chance this is a typo?