HealthLawProf Blog

Editor: Katharine Van Tassel
Creighton University School of Law

Saturday, December 17, 2005

Intermediate Sanctions: Comment Period on Proposed Rule Closed

A short commentary  in HealthLeaders News ("The Intersection of Intermediate Sanctions and Loss of Tax-Exempt Status for Nonprofits," by J. Leigh Griffith and Donald B. Stewart) reminded me of a proposed rule from the IRS on the always timely issue of intermediate sanctions.  Published on Sept. 9, the NPRM identifies the five factors to be taken into account when the IRS is trying to decide whether to revoke the exempt entity's tax-exempt status in addition to imposing intermediate sanctions.  As the authors point out, the factors omit any mention of good faith on the part of the entity's managers and emphasize the importance of self-discovery and self-correction (i.e., rectification of the excess-benefit transaction before the IRS brings it to the entity's attention).  The transaction may still enjoy a rebuttable presumption of reasonableness if it satisfies the requirements of 26 CFR § 53.4958-6, but good-faith reliance on those factors (including valuations and opinion letters) won't save the entity from loss of its exemption.  On the other hand, as the authors point out, the proposed rule introduces the five factors with this clause: "the Commissioner will consider all relevant facts and circumstances, including, but not limited to, the following—," so the good faith of the managers won't necessarily be irrelevant.  The comment period for this NPRM closed on Dec. 8.  The IRS has indicated this rule is a priority, so we should see a final rule sometime early in 2006. [tm]

December 17, 2005 | Permalink | Comments (0) | TrackBack (0)

Top 10 SSRN Downloads

Of 74,306 downloads in the SSRN Health Law database, 10 articles account for 21,000 of 'em.  Here, in the first of what will be a weekly summary, is the straight dope on the top 10 downloads.  Later this weekend, look for a listing of the latest titles posted to the database.

  1. Safe Storage Gun Laws: Accidental Deaths, Suicides, and Crime
    John R. Lott Jr. and John E. Whitley
    American Enterprise Institute (AEI) and University of Adelaide - School of Economics
    Date Posted:May 22, 2000
    Last Revised:June 10, 2002
    Working Paper Series
  2. Abortion and Crime: Unwanted Children and Out-of-Wedlock Births
    John R. Lott Jr. and John E. Whitley
    American Enterprise Institute (AEI) and University of Adelaide - School of Economics
    Date Posted:May 16, 2001
    Last Revised:June 5, 2001
    Working Paper Series
  3. Stability, Not Crisis: Medical Malpractice Claim Outcomes in Texas, 1988-2002
    Journal of Empirical Legal Studies, Vol. 2, pp. 207-259, 2005

    Bernard S. Black , Charles Silver , David A. Hyman and William M. Sage
    University of Texas at Austin - School of Law , University of Texas Law School , University of Illinois College of Law and Columbia Law School
    Date Posted:October 25, 2005
    Last Revised:December 5, 2005
    Accepted Paper Series
  4. 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 - General
    Date Posted:March 9, 2000
    Last Revised:June 30, 2000
    Accepted Paper Series
  5. TRIPs, Pharmaceuticals, Developing Countries, and the Doha 'Solution'
    Alan O. Sykes
    University of Chicago Law School
    Date Posted:February 19, 2002
    Last Revised:March 7, 2002
    Working Paper Series
  6. Incentives in Nonprofit Organizations: Evidence from Hospitals
    James A. Brickley and R. Lawrence Van Horn
    Simon School, University of Rochester and Simon School, University of Rochester
    Date Posted:February 14, 2000
    Last Revised:April 2, 2002
    Working Paper Series
  7. 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
  8. 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
  9. Medical Problems and Bankruptcy Filings
    Norton's Bankruptcy Adviser, May 2000

    Elizabeth Warren , Teresa Sullivan and Melissa B. Jacoby
    Harvard Law School , University of Texas at Austin - Office of the Vice President and Dean of Graduate Studies and University of North Carolina at Chapel Hill - School of Law
    Date Posted:May 9, 2000
    Last Revised:July 29, 2000
    Accepted Paper Series
  10. The TRIPS Agreement, Access to Medicines and the WTO Doha Ministerial Conference
    Frederick M. Abbott
    Florida State University College of Law
    Date Posted:October 8, 2001
    Last Revised:October 15, 2001
    Working Paper Series


December 17, 2005 | Permalink | Comments (0) | TrackBack (0)

Friday, December 16, 2005

More on the Ethics of Face Transplant

The New York Times has been all over the bioethical implications this story, ever since its piece on Dec. 6, "Ethical Concerns on Face Transplant Grow," by Michael Mason & Lawrence K. Altman (blogged).  In the last couple of days, they've published these articles:

  • "As a Face Transplant Heals, Flurries of Questions Arise," by Craig S. Smith (Dec. 14)
    • in the rush to perform the first face transplant, were corners cut to avoid ethical issues?
    • is the carnival atmosphere compromising the patient's well-being?
    • "Among the most disturbing aspects of the debate are conflicting reports from doctors about whether the transplant was the result of two suicide attempts, one successful by the donor, and one failed by the recipient.

      "If Ms. Dinoire's disfigurement resulted from an attempted suicide, it would raise questions about her emotional stability and her ability to consent to such a risky operation.

      "Reports that the donor committed suicide also have implications for Ms. Dinoire's future, because if true, and if the transplant is successful, it would mean that for the rest of her life, she would see in the mirror the nose, mouth and chin of a woman who herself met a brutal end."

    • "Critics have already questioned the ethics of a commercial arrangements brokered by Dr. Dubernard ['the flamboyant French doctor and politician in charge of Ms. Dinoire's post-transplant treatment'] in which exclusive rights for photographs and video of the operation were given to Microsoft's Corbis photo agency under an agreement that allows Ms. Dinoire to share in the proceeds from the materials' sale."

  • "The Face of the Future," by Ruth La Ferla & Natasha Singer (Dec. 15)

    • What's next? Cosmetic face transplants? The authors sample lay opinion on the nettlesome issue.  Sound farfetched?  Check back in 20 years . . . .


December 16, 2005 | Permalink | Comments (0) | TrackBack (0)

Thursday, December 15, 2005

Breaking Into Law Teaching

Paul Caron at TaxProf Blog has posted some great resources for lawyers who want to teach but need advice on how to break into academe.  I'll save you the mouse-click:

Teaching Fellowships for Aspiring Law Professors

For practitioners and others contemplating joining the law professor ranks, many law schools offer wonderful opportunities to transition into the legal academy with one- or two-year fellowships which allow you to enter the AALS Faculty Recruitment Conference (the "meat market") armed with teaching experience and published scholarship under your belt:

A great discussion of many of these fellowship programs can be found in Patricia A. Cain (Iowa) & Faith Pincus (Iowa), Faculty Fellowship Programs That Lead to Law Teaching.

For more information on becoming a law professor, including a discussion of the advantages of these fellowship programs, see:


December 15, 2005 | Permalink | Comments (0) | TrackBack (0)

Tuesday, December 13, 2005

WSJ: Debate on the Future of Health Care

The Wall Street Journal ends its "Big Issues" debate series with "Consumer Choice: Can It Cure The Nation's Health-Care Ills?" (free feature).  Here's the intro:

Joining the debate are American Enterprise Institute scholar Joseph Antos, who was former assistant director for health and human resources at the Congressional Budget Office, John C. Goodman, founder and president of the National Center for Policy Analysis, and Robert Reischauer, president of the Urban Institute and vice chair of the Medicare Payment Advisory Commission. The debate is moderated by Laurie McGinley, assistant bureau chief at The Wall Street Journal's Washington bureau.

The policy journal Health Affairs covers much the same territory in its Nov./Dec. 2005 issue (series of articles on "Consumerism").  [tm]

December 13, 2005 | Permalink | Comments (0) | TrackBack (0)

Monday, December 12, 2005

Informed Consent, Medical Devices, and Financial Conflicts of Interest

As reported in today's Kaiser Daily Health Policy Report:

The Wall Street Journal on Monday examined how the Cleveland Clinic advocates and performs heart surgery with a medical device manufactured by AtriCure, despite undisclosed financial ties with the company. According to the Journal, Cleveland Clinic physicians "have been leading advocates of" the surgery, an operation for atrial fibrillation often called the "AtriCure procedure," but the hospital's "relationship with Atricure ... goes deeper." Cleveland Clinic helped found and invested in a venture capital partnership that owns about 4.1% of AtriCure stock, valued at about $7 million, and Clinic CEO Delos Cosgrove had served as a board member of the company until March. In addition, Cosgrove personally invested in the venture capital partnership and had served as a general managing partner of the fund until October. However, Cleveland Clinic did not disclose its financial ties to AtriCure to patients who underwent the AtriCure procedure. According to the Journal, Cleveland Clinic's conflict-of-interest committee raised concerns about the financial ties to AtriCure last spring (Armstrong, Wall Street Journal, 12/12[, page A1 (paid subscription required)].


December 12, 2005 | Permalink | Comments (0) | TrackBack (0)

More on the Ethics of Face Transplants

The American Journal of Bioethics devoted a substantial part of Vol. 3, No. 3 (Sept. 2004) to the ethics of face transplantation.  It ran an article ("On the Ethics of Facial Transplant Research," by by Osborne P. Wiggins, John H. Barker, Michael Cunningham, Cedric G. Francois, Frederico V. Grossi, Moshe Kon, Claudio Maldonado, Serge Martinez, Gustavo Perez-Abadia, Marieke Vossen, Joseph C. Banis), followed by a particularly rich "open peer commentary."  [tm]

December 12, 2005 | Permalink | Comments (0) | TrackBack (0)

Face Transplant in France Produces Ethical Concerns

On November 27, French surgeon Jean-Michel Dubernard and his team performed the world's first face transplant on a woman whose face had been half ripped away by her pet dog.  The ethical questions have been swirling ever since.  They were nicely summarized by Michael Mason and Lawrence Altman in the NY Times on Dec. 6 in "Ethical Concerns on Face Transplant Grow."  The basic concerns are these:

  • the use of stem cells from donor bone marrow to help stave off rejection of the transplanted tissue combined two experimental regimes; the surgeons have made it virtually impossible to know whether the success or failure will be due to some aspect of the surgery or the use of stem cells;
  • "the transplant was performed months after the woman's injury, and before any attempt at conventional reconstructive surgery"; radically experimental surgery is generally made available only after the patient has attempted to live with the alternatives, including traditional surgery;
  • British papers report that the woman was mauled by her Labrador retriever after she had overdosed on sleeping pills; this raises the question of the patient's emotional stability, which in turn raises questions of her ability to stick with the post-surgical medical regime required to avoid rejection of the graft, and the absence of longer-term psychological assessments leave open the question whether the patient will be able to withstand the emotional pressures that will follow.

Despite all this, the AP reported on Sunday that the patient reportedly stated that she has no regrets about undergoing the first face transplant:

"When I looked at my new face I knew straight away that it was me," Britain's Daily Mail quoted the 38-year-old patient as saying. "It was amazing to see a nose and mouth on my face again."

The newspaper did not explain how it obtained the woman's comments. The article was datelined from Valenciennes, northern France, where the woman lives, though she is convalescing 400 miles to the south at a hospital in Lyon.

The woman said she still had no feeling in her face, as the nerves were not yet working correctly, the Daily Mail reported. Doctors hoped feeling would return in six months to a year, she said.

The patient said she had taken a walk in the hospital, but was "very scared of leaving" and being recognized as the face transplant recipient, the paper said.

"I just want to live a normal life, without being stared at all the time," she said. "It's still too early to think about the future. But I regret nothing - if I was asked again, I would do it again."

The AP article also raises the possibility of a previous suicide attempt, which her surgeon continues to deny. [tm]

December 12, 2005 | Permalink | Comments (0) | TrackBack (0)

Sunday, December 11, 2005

WSJ: More on the NEJM/Merck Mess

Monday's Wall Street Journal will have an article (requires paid subscription) that suggests that one of Merck's chief defense witnesses in its Vioxx litigation -- Alice Reisin, a top Merck scientist -- may have been irreparably harmed by last week's NEJM editorial, in which the medical journal suggested scientific misconduct in the underreporting of known instances of myocardial infarctions among Vioxx users.  In Monday's print edition, look for "Top Merck Witness May Become Liability In New Vioxx Trials," by Heather Won Tesoriero & Barbara Martinez, Page B1.  [tm]

December 11, 2005 | Permalink | Comments (0) | TrackBack (0)

NEJM Weighs in on Merck, Vioxx

The New England Journal of Medicine this week released an editorial early by publishing on its web page a piece that will appear in print in the Dec. 29 issue: "Expression of Concern: Bombardier et al., 'Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis,' N Engl J Med 2000;343:1520-8," by Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D.  The crux of the editorial is this:

We have recently obtained information regarding inaccuracies in data in the report of the VIGOR (Vioxx Gastrointestinal Outcomes Research) study by Bombardier et al. that raise concern about certain conclusions in the article.

The VIGOR study was designed primarily to compare gastrointestinal events in patients with rheumatoid arthritis randomly assigned to treatment with rofecoxib (Vioxx) or naproxen (Naprosyn), but data on cardiovascular events were also monitored. Three myocardial infarctions, all in the rofecoxib group, were not included in the data submitted to the Journal. The editors first became aware of the additional myocardial infarctions in 2001 when updated data were made public by the Food and Drug Administration.

Until the end of November 2005, we believed that these were late events that were not known to the authors in time to be included in the article published in the Journal on November 23, 2000. It now appears, however, from a memorandum dated July 5, 2000, that was obtained by subpoena in the Vioxx litigation and made available to the Journal, that at least two of the authors knew about the three additional myocardial infarctions at least two weeks before the authors submitted the first of two revisions and 41∕2 months before publication of the article. Given this memorandum, it appears that there was ample time to include the data on these three additional infarctions in the article.

Conventional wisdom (as reported by the AP on Sunday): This can't help Merck in its defense of Vioxx suits pending around the country. [tm]

December 11, 2005 | Permalink | Comments (0) | TrackBack (0)