HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

A Member of the Law Professor Blogs Network

Friday, March 4, 2005

Schiavo Update

Jurist Associate Editor Phillip Hong-Barca posted a summary today of the most recent legal maneuverings in the increasingly convoluted medico-legal saga of Terri Schiavo.  The Department of Children and Families (DCF) is seeking a 60-day stay of the removal of Ms. Schiavo's feeding tube on top of the current stay that runs until March 18 (ordered last week by Judge Greer), in order to investigate 30 charges of "abuse, neglect, or exploitation" filed against her husband/guardian, Michael Schiavo.  Jurist links to an AP story (courtesy of Yahoo! News) with more details on the public release Friday of the DCF files.

Meanwhile, "a Florida congressman said he will introduce a bill next week that would require legal representation for incapacitated people who leave no advance directive. Supporters say such a law would give the Schindlers access to the federal courts to try to save their daughter. U.S. Rep. Dave Weldon, a Melbourne Republican, said he would introduce the bill Tuesday." (ABC Action News/TampaBay.Live

If you need a good chronology of events in this case, Abstract Appeal has it, though I like the chronology by Kathy Cerminara and Steven Haidar better (more links to primary source material).  [tm]

March 4, 2005 | Permalink

Measuring Maturity

In light of the Supreme Court's decision in Roper v. Simmons holding that the death penalty "is a disproportionate punishment for juveniles," and violates the Eigth Amendment, some of have been asking about ways that we determine maturity.  Slate has an interesting article on this issue and provides some helpful background links for those who want to learn more about the scientfic research that has been done in this area. [bm]

March 4, 2005 | Permalink

Flu Vaccine For Next Year

Som good News on the Flu Vaccine front.  The New York Times reported yesterday that the Chiron Corporation received permission to resume production of the flu vaccine, potentially in time to avoid a shortage next winter.  As was mentioned earlier in this blog, doctors had been having some difficulties placing orders for next winter.   Chiron still must receive permission from the Food and Drug Administriation before it can sell its vaccine here in the U.S.  The Times reports,

"This is extremely encouraging and kind of a milestone in the process," Dr. Jesse L. Goodman, the director of the drug agency's branch in charge of vaccines, said in an interview. But he added, "They do still have a number of things to do to convince the F.D.A. and make us comfortable that the vaccine they produce will be as safe and effective as we expect."

Dr. Goodman said that once manufacturing had resumed, probably in the spring, his agency would conduct a comprehensive inspection.

Dr. Jeanne M. Santoli, an immunization official at the Centers for Disease Control and Prevention, was cautious.

"We absolutely cannot count on Chiron being able to supply vaccine for the U.S. based on the news today, although it is good news," Dr. Santoli said in a telephone interview.

So, some hopeful news but still some concerns as well.  [bm]

March 4, 2005 | Permalink

Thursday, March 3, 2005

Constitutional Amendment Introduced by Stark, Jackson

From Modern Healthcare's "Daily Dose": "Reps. Pete Stark (D-Calif.) and Jesse Jackson Jr. (D-Ill.) proposed a constitutional amendment to establish healthcare as a basic right: 'All persons shall enjoy the right to healthcare of equal high quality.' . . . Twenty-seven other House members co-sponsored the amendment legislation, Stark said in a news release."

Rep. Jackson's news release indicates he "introduced legislation to transform what he called 'seven human rights and one rational right into constitutional amendments: [the] right sto vote, to a public education and health care of equal high quality, to affordable housing, to a clean, safe and sustainable environment, to employment, and equal rights for women."

[tm]

March 3, 2005 | Permalink

Terri Schiavo and Myths Surrounding Her Condition

Majikthise has a detailed overview of some of the myths surrounding Terri Schiavo and her condition that have been floating around in the news media recently.   She provides a great summary of disputed facts and issues, including medical issues.  I tend to agree with her analysis, although her characterization of those who side with Terri's parents is a little harsher than I would have stated it.  I do agree that, while the case is tragic, it doesn't seem to be as medically or legally difficult as some people have made it out to be. [bm]

March 3, 2005 | Permalink

Hospital Regulatory Issues

Yawningdogs Does this resemble your students when you try to examine hospital regulatory issues in class?  Well, you might want to check out Glenn Reynolds' (aka Instapundit) columns for some extra spice (see here, here and here).  His wife, fortunately now recovering nicely at home, was in the hospital.   He now relates some of the more interesting and frustrating aspects of her hospital visit - including his dislike for certain hospital regulations that he claims made his wife's stay less pleasant than it had to be.  Other medical bloggers have chimed in and given their responses to his concerns.  It makes for some interesting reading and could be used to stimulate some discussion in your class about the real-life consequences of hospital regulations.  [bm]

March 3, 2005 | Permalink

Upcoming Presentation by Rebecca Dresser

Dresser_rebecca05 Rebecca Dresser, Daniel Noyes Kirby Professor of Law and Professor of Ethics in Medicine at Washington University, and member of the President's Council on Bioethics, will be speaking at Seton Hall Law School on March 10, 2005 from 6-8pm.  Her presentation is entitled, "Stem Cell Research:  The Bigger Picture."  Because she serves on the President's Council on Bioethics, and because of her extensive knowledge in this area, Professor Dresser is in an unique position to provide insight into this controversial area of study. If you happen to be in Newark, New Jersey on the 10th of March, you should stop by to hear her.  For further information, please call (973) 642-8871 or e-mail HeLPP@shu.edu.[bm]

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March 3, 2005 | Permalink

Wednesday, March 2, 2005

Tenet, Sued. Again.

At some point, I guess you have to start to feel sorry for Tenet.  What the troubled hospital chain now probably needs more than anything else is some breathing space, a chance to put the past behind it, and an opportunity to chart a new future.  You know: like HCA after it settled all of the government claims against it.  But after the mistrial in the Alvarado (Calif.) case (followed by the docketing of a new trial date of March 29), now this:  Florida has sued Tenet in federal court in Miami, claiming that Tenet's much publicized outlier payment program deprived Florida's public hospitals of millions of dollars in reimbursements that would have flowed their way but for Tenet's alleged abuse of Medicare's outlier program.  The suit is described in Reuter's news alert.  Jones Day had a nice summary of outlier issues in this 2003 newsletter.

March 2, 2005 | Permalink

FDA Requests Greater Labeling Authority

Yesterday, the Food and Drug Administration (FDA) asked Congress for authority to require label changes for drugs to end disputes with pharmaceutical companies that occur when a health risk arises.  The Associated Press reports that Sandra L. Kweder, the FDA's deputy director for new drugs, testified that after the dangerous side effects of Vioxx became known, the FDA had to negotiate the wording of the new warning label with Merck & Co. (the manufacturer of Vioxx), which delayed information to the public about health concerns.  The Senate Committee on Health, Education, Labor and Pensions will hold a second day of testimony concerning potential changes to the FDA later this week.  [bm

Meanwhile, the Consumer's Union, an organization created to help improve the access and safety of prescription drugs, provides a different option for improving drug safety.   Click here.  Thanks to blog.bioethics.net for this website.

March 2, 2005 | Permalink

Tuesday, March 1, 2005

Law and Economics and Assisted Suicide

Professor Daniel Gilman of the University of Maryland School of Law has recently published an interesting article entitled, "Thou Shalt Not Kill as Defeasible Heuristic: Law and Economics and the Debate Over Physician-assisted Suicide."  He brings an interesting law and economics perspective to the PAS debate.  The abstract follows:

Although the literature addressing medical decisions at the end of life is vast, surprisingly little of it has come from the perspective of law and economics. This article begins with a critical account of one of the very few law and economics-based discussions of physician-assisted suicide (PAS), that developed by Judge Richard  Posner in his book, Aging and Old Age. Central to Judge Posner's account is a model of PAS as a sort of technological innovation. What this particular innovation is supposed to bring is a radical reduction in certain critical information costs attending end-of-life decision making. It is argued that Judge Posner's model - although innovative and instructive - is incomplete and, consequently, inadequate to the normative task of justifying a change in legal regime with regard to PAS. Certain cognitive issues are held to confound the already difficult task of securing bona fide  patient consent. That prompts interesting questions about how to value inevitable errors in consent, questions examined in light of the risk management literature regarding valuation of life methodologies. It is argued that the PAS debate makes telling certain difficulties in such methodologies. It is also argued that we ought to adopt conservative standards with regard to attempts to legislate revisions in certain fundamental moral norms. Finding that Judge Posner and others have failed to meet such standards is an argument on behalf of what is, under the laws of most states, the status quo.

The entire article can be found here and will be available later this Spring in the Oregon Law Review.  [bm]

March 1, 2005 | Permalink

Next Year's Flu Vaccine - Already Looking Shaky

Although not as alarming as the bird flu news that we keep hearing, according to AMNews, doctors are reporting difficulty in securing flu vaccine supply for next fall.   The AMNews reports,

At press time, neither sanofi pasteur, formerly Aventis Pasteur, which usually makes more than half the flu vaccine supply, or FFF Enterprises, a large distributor based in Temecula, Calif., was taking pre-bookings. And, although Henry Schein, another large distributor based in Melville, N.Y., was doing so, it offered no guarantee, noting that if a new round of problems were to occur, the company would use this information to direct supplies to those who need it the most.

Ultimately, the situation is the domino-effect result of the 2004-05 season, which began with an expected vaccine surplus of nearly 100 million doses that was transformed into a shortage when Chiron Corp. withdrew from the market amid contamination problems. The impact now is an unusually high level of marketplace uncertainty. . . . .    "We don't know if Chiron will come back. There are other companies that may be in the market," said Kit-Bacon Gressit, FFF spokeswoman. "We will be able to provide product. The question is, which product?"

The article seems to imply that all should be well as soon as this supplier issue is worked out.  I hope that they are correct.  [bm]

On a slightly related note, the New York Times reports today on a scientific protest to the current Administration's germ-research policy.  The article states,

More than 700 scientists sent a petition on Monday to the director of the National Institutes of Health protesting what they said was the shift of tens of millions of dollars in federal research money since 2001 away from pathogens that cause major public health problems to obscure germs the government fears might be used in a bioterrorist attack.

March 1, 2005 | Permalink

Monday, February 28, 2005

More on Avian Flu Risk

NPR's Diane Rehm show had a very good program this morning on the avian flu situation.  Guests included Dr. Nancy Cox, chief of the Centers for Disease Control and Prevention influenza branch, and director of the World Health Organization's Collaborative Center for Influenza Reference and Research; Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases/NIH; and Mei Fong, staff reporter of The Wall Street Journal.  They reiterated the major risk factors discussed in this week's New Yorker piece by Michael Specter -- i.e., that a "perfect storm" scenario for a world-wide pandemic requires three things: (1) a virus that is capable of crossing over from one animal species to man (this has already been established); (2) the virus must be one that is not simply benign in a human host (ditto: the human death rate for this virus appears to be 70-76%); and (3) the virus must mutate into a form that is capable of efficient transmission (i.e., by shaking hands, sneezing, coughing, etc.).  This third factor is the still an open question.  Dr. Fauci, in particular, provided a useful perspective on the array of possible public-health responses to the appearance of avian flu in this country, should that occur.

Meanwhile, for those of us who could benefit from a public-health law refresher, the CDC has a useful public health law site and has recently concluded a 27-week series on basic public health law readings that I can strongly recommend.  Here's the list:

  • Epilogue: "Redefining Public Health," a speech by William H. Foege, MD, MPH
  • Reading No. 26:  Revision of the World Health Organization's International Health Regulations, by David P. Fidler
  • Reading No. 25:  Illinois House Bill 5164 (2004)
  • Reading No. 24:  The Draft Model State Emergency Health Powers Act (December 21, 2001)
  • Reading No. 23:  Chapter 10:  "Legal Authorities for Interventions During Public Health Emergencies"
  • Reading No. 22:  Louisiana v. Gamberella  (1993)
  • Reading No. 21:  Food and Drug Administration v. Brown & Williamson Tobacco Corp.  (2000)
  • Reading No. 20:  Queenside Hills Realty Co., Inc. v. Saxl
  • Reading No. 19:  McCarthy v. Boozman  (2002)
  • Reading No. 18:  Brown v. Stone  (1979)
  • Reading No. 17:  New York v. New St. Mark's Baths  (1986)
  • Reading No. 16:  "The Path of the Law," by Oliver Wendell Holmes, Jr. (1897)
  • Reading No. 15:  Camara v. Municipal Court  (1967)
  • Reading No. 14:  Altman v. City of High Point  (2003)
  • Reading No. 13:  Jew Ho v. Williamson (1900)
  • Reading No. 12:  In re Halko (1966)
  • Reading No. 11:  People v. Strautz
  • Reading No. 10: Benning v. State of Vermont, 161 Vt. 472; 641 A.2d 757(1994)
  • Reading No. 9:  State of Iowa v. Hartog, 440 N.W.2d 852 (1989)
  • Reading No. 8:  Bill of Rights, New Hampshire Constitution
  • Reading No. 7:  Lorillard Tobacco Co. v. Reilly
  • Reading No. 6:  Wisconsin Statutes Chapter 250, Health: Administration and Supervision
  • Reading No. 5:  Pelman v. McDonald's Corp., No. 02 Civ. 7821 (S.D.N.Y. 2003)
  • Reading No. 4:  Chapter 1: "The Law and the Public's Health: The Foundations"
  • Reading No. 3:  Chapter One of " Public Health Law (3rd Edition) " (1947) by James A. Tobey
  • Reading No. 2:  Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905)
  • Reading No. 1:  The United States Constitution

[tm]

February 28, 2005 | Permalink

Drug Manufacturer Pulls A Drug

The CNN Health website, as well as many others, are reporting that the makers of a new multiple sclerosis drug have voluntarily pulled it from the market today after one patient died and another developed a serious disease.   According to CNN,

Experts said the announcement by Biogen Idec Inc. and Elan Corp. marks sad turn of events for MS sufferers who have endured a more than centurylong search for effective treatments for the incurable disease.

The news came three months after the government approved the drug, called Tysabri. Stocks of both Massachusetts-based Biogen Idec Inc. and Ireland-based Elan Corp. tumbled on the announcement.

The companies said they will investigate the effects of the medication further, and they are not giving up hope that the drug may eventually return to the market.

I don't know what to think of the drug manufacturer's vigilence here.  I don't have the data here but it seems to me that the quick reaction may be a little too quick. [bm]

February 28, 2005 | Permalink

Spector v. Norwegian Case Argued Today

The Supreme Court will hear arguments today in the Spector v. Norwegian Cruise Line Case.  The question presented to the Court concerns whether Title III of the Americans With Disabilities Act applies to cruise ships, and foreign-flagged cruise ships in particular. Title III forbids discrimination in public accommodations.  A brief overview of the case is available from SCOTUSblog, which also has a link to the briefs.   For a more in-depth review of the case and its issues, please see the National Council of Disability website. [bm]

February 28, 2005 | Permalink

Sunday, February 27, 2005

Kansas Prosecutor and Abortion Records

The New York Times reported earlier this week on a Kansas prosecutor's request for certain abortion records from two Kansas medical clinics.  The article states,

Attorney General Phill Kline, a Republican who has made fighting abortion a staple of his two years in the post, is demanding the complete medical files of scores of women and girls who had late-term abortions, saying on Thursday that he needs the information to prosecute criminal cases.

Mr. Kline emphasized statutory rape at a news conference here but also spoke obliquely of other crimes that court documents suggest could include doctors' providing illegal late-term abortions and health professionals' failing to heed a state law that requires the reporting of suspected child sexual abuse.

"When a 10-, 11- or 12-year-old child is pregnant, under Kansas law that child has been raped, and as the state's chief law enforcement official it is my obligation to investigate child rape in order to protect Kansas children," Mr. Kline said. "There are two things that child predators want, access to children and secrecy. As attorney general, I'm bound and determined not to give them either."

I agree with the individual in the story who states that they don't like seeing medical records used to determine whether crimes have been committed.  Surely, there are other law enforcement methods available.  For a further discussion of this case, and some of the politics involved, please see Ezra Klein's blog, February 26, post entitled, "What's the Matter with Kansas Now?"  [bm]

February 27, 2005 | Permalink

Drug Ads

If you are still recovering from the news that some of the drug advisors that voted to keep various cox-2 drugs on the market also had ties to the pharmaceutical industry, well, you should brace yourself for yet another pharma story . . . .

According to Science Daily, a UCLA study uncovered the fact that nearly 1/3 of drug ads in medical journals did not contain references supporting medical claims.   The researchers explained their reasons for conducting such a study in addition to their findings.  Science Daily reports,

"Previous studies have shown that physicians' drug prescribing is influenced by pharmaceutical ads. We wanted to see what documents were being used to substantiate the claims and how accessible these were to physicians who may want to verify the research findings," said lead author Dr. Richelle Cooper, assistant clinical professor, Division of Emergency Medicine, David Geffen School of Medicine at UCLA.

Two UCLA investigators independently reviewed 438 ads from 10 American medical journals from 1999 and also reviewed a random sample of 400 references in journal articles from the same publications for comparison.

Researchers found that out of 438 pharmaceutical ads, 126 (29 percent) offered no references in support of medical claims. The most commonly cited references in the ads included journal articles (55 percent) and data-on-file (19 percent), which is a reference to an unpublished company document. Other sources included books; prescribing information such as the Physician's Desk Reference, which annually provides information on drug usage, warnings and drug interactions; government documents; or an Internet site.

You can read the full study in Cooper RJ, Schriger DL. The availability of references and the sponsorship of original research cited in pharmaceutical advertisements. CMAJ. 2005;72: February 15. [Free full-text]

For further comments, see Majikthise, Caveat Medicus, from February 24, 2005.  She is a wonderful blogger and has some great insight into this story having worked previously as a medical writer. 

Thanks to Majikthise for this story and her illuminating comments.  [bm]

February 27, 2005 | Permalink

Bizarre Story of the Week

I apologize that I have not been blogging regularly this week.  I have pink eye and a rather nasty cold thanks to my beloved son, so I have been out of commission.   I am feeling a little better today and will try to catch up on some of the exciting news in health law.

This first piece is just a bit of fun (although not so much for the parties involved).  With an eye catching headline like:  "Court:  Man May Sue Over Surprise Pregnancy, But Sperm Were Hers to Keep" -  even someone with pink eye takes note.  The story as reported by AP continues

A man who says his former lover deceived him by getting pregnant using semen obtained through oral sex can sue for emotional distress but not theft, an appeals court has ruled.

Dr. Richard O. Phillips accuses Dr. Sharon Irons of a "calculated, profound personal betrayal" six years ago, but she says they had the baby through sexual intercourse.

[ok, how did these two get to be doctors?]

The Illinois Appeals Court said Wednesday that Phillips can press a claim for emotional distress after learning Irons had used his sperm to have a baby, but agreed that however the baby was conceived, Irons didn't steal the sperm.

"She asserts that when plaintiff 'delivered' his sperm, it was a gift," the decision said. "There was no agreement that the original deposit would be returned upon request."

Ok, I always thought the pre-embryo custody cases (Davis v. Davis, J.B. v. M.B. and A.Z. v. B.Z. just to name a few) were interesting because they involve difficult questions about life and when it begins,as well as whether reproduction should occur over someone's objection.  I usually have rather interesting class discussions about these topics.  This case also involves someone who has had their genetic material used for reproductive purposes without their permission, and how we can define  genetic reproductive material.   However, I will need to read this case to see if it adds anything further to the discussion. (I mean, who would have thought - sperm may be viewed as a gift that individuals receive during sex - and an irrevocable gift at that.  Once you get lawyers involved, even sex doesn't seem quite as exciting).   [bm]

February 27, 2005 | Permalink

More on Bird Flu

This week's New Yorker (Feb. 28 issue) has a longish piece by Michael Specter on avian flu and the chances that it might be the next global pandemic.  It's well worth reading but unfortunately is not available on-line.  An on-line companion piece, though, is available here.  It's a Q&A with Specter and provides a quick overview of Specter's article.  Caution: This piece is not going to help you sleep any better tonight.  [tm]

February 27, 2005 | Permalink

Save Medicare a Bundle by Dying Sooner?

Well, sure, at least in theory.  At least, that's the topic of an article in today's Business section of The New York Times.  The driving force behind the theory is the inexorable rise in the cost of Medicare, as projected by the Congressional Budget Office, which projects that annual Medicare expenditures will more than double over the next ten year and increase from 6+% of total federal outlays to nearly 20%.  Health care goods and services in the last year of life account for 28% of the Medicare budget, a share that has held steady for a number of years.

As the article points out, there are a couple of stumbling blocks between where we are now and the eradication of nonbeneficial end-of-life treatment. 

First, it is sometimes obvious only in hindsight that these were a patient's last months of life.  There are some clinical markers that are helpful in this regard, but a lot of research remains to be done before our prognostic ability gets markedly better.

Second, it is not yet clear that substituting palliative care for more invasive and intensive care will save a lot of money for the program.  Hospice care, for example, accounts for a tiny fraction (1.6%) of the Medicare program (and, if my memory serves, is typically provided in the last week or so of life, despite Medicare's six-month hospice benefit).  Again, the research to determine how much money, if any, will be saved by a transition to greater hospice use just isn't there.

Third, forgoing high tech interventions when confronted with a life-threatening condition runs contrary to human nature.  The best possible care is often equated with the most care obtainable at any price.  Unfortunately, this stance ignores the human cost of such decision making in terms of increased suffering.  The article quotes Arnold Relman: "Sometimes, you know that death is inevitable over the next few weeks or few months.  And then there are some doctors, and some families, who just don't want to confront that, and feel that they want to and should invest everything possible - the maximum amount of resources - in fighting the inevitable. That often results in prolonging the pain and discomfort of dying."

If there is an answer to any of this, it seems to turn on the availability of better research that translates into evidence-based medicine.  Without it, the culture shift that is needed before there will be progress on this issue just won't happen.  [tm]

February 27, 2005 | Permalink