The Laches Defense not Available in Medical Malpractice Actions

By Alex Stein

The DC Court of Appeals has ruled last week that the laches defense does not apply in actions for medical malpractice: Naccache v. Taylor, — A.3d —-, 2013 WL 3820942 (D.C. 2013). The Court reasoned that laches is only available in equity proceedings but not in actions at law. For actions at law, held the Court, the applicable time bars are set by the statute of limitations. This statute, the Court explained, accounts for all relevant tradeoffs between plaintiffs’ and defendants’ interests. Hence, “To import laches as a defense to actions at law would [improperly] pit the legislative value judgment embodied in a statute of limitations … against the equitable determinations of individual judges.” In making this ruling, the Court also took notice of the fact that forty-eight states bar laches as a defense for actions at law.

This ruling appears impeccable, but it has a wrinkle. Read More

Fox discussed in The Atlantic article on Brain Imaging and the Right to Silence

A new article in The Atlantic, “Could the Government Get a Search Warrant for Your Thoughts?: Why remain silent if they can just read your mind?“, cites Bill of Health blogger Dov Fox’s research on brain imaging.

Last year, a Maryland man on trial for murdering his roommate tried to introduce results from an fMRI-based lie detection test to bolster his claim that the death was a suicide. The court ruled the test results inadmissible, noting that the “fMRI lie detection method of testing is not yet accepted in the scientific community.” In a decision last year to exclude fMRI lie detection test results submitted by a defendant in a different case, the Sixth Circuit was even more skeptical, writing that “there are concerns with not only whether fMRI lie detection of ‘real lies’ has been tested but whether it can be tested.”

So far, concerns regarding reliability have kept thought-inferring brain measurements out of U.S. (but not foreign) courtrooms. But is technology the only barrier? Or, if more mature, reliable brain scanning methods for detecting truthfulness and reading thoughts are developed in the future, could they be employed not only by defendants hoping to demonstrate innocence but also by prosecutors attempting to establish guilt? Could prosecutors armed with a search warrant compel an unwilling suspect to submit to brain scans aimed at exploring his or her innermost thoughts?

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Rape and Abortion: Negating a Myth

Cross-post from bioethics.net.

Sabine Hildebrandt, MD
William Seidelman, MD
Arthur Caplan, PhD

A recurring assertion in the ongoing debate on abortion in the United States is the statement that pregnancy is an uncommon consequence of rape. Rep. Trent Franks, R-Ariz., has recently argued on the floor of the House of Representatives that an exception for rape wasn’t necessary in a proposed law banning abortions after 20 weeks because “the incidence of rape resulting in pregnancy are very low.”

Why do so many Americans believe this claim? Where does it come from?

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Importing unapproved drugs: lethal injections and shortages

By Nicholson Price

In a unanimous opinion (pdf) in Cook v. FDA, the DC Circuit just held that FDA must prohibit the importation of misbranded or unapproved new drugs, including those made by unapproved manufacturers abroad. In this case, a set of prisoners on death row sued FDA to require it to prohibit the importation of sodium thiopental, the first drug in the three-drug cocktail used in most states for lethal injection (and the only drug typically used in states with one-drug protocols).  Since 2009, no domestic company has made thiopental, and the foreign source used by most states is not registered with FDA, which makes it “misbranded” under 21 U.S.C. §§ 331(a), 352(o).  In 2011 FDA stated that it wouldn’t block importation of thiopental, using its enforcement discretion.  The DC Circuit rejected this approach, holding the statute compels FDA to inspect the drugs and prohibit their importation.  The opinion relates to both lethal injections and, less obviously, drug shortages – but though at first glance the implications look potentially significant, I have a hard time seeing how they’ll make much of a practical difference in either scenario. Read More

Anthony Weiner, Sexting, Medicalization, and Legal Moralism, Or (To Be Provocative) “What’s So Wrong About Sexting?”

Like most people, I am both amused and shocked by the latest Anthony Weiner sexting revelations and scandal. It is like a car crash where it is hard to look away even though you know you should.

Most germane to Bill of Health’s readership, I am fascinated by the “medicalization” of Weiner’s behavior by some sectors, this CNN clip with therapists is to me a good example. The words “sexual addiction,” “exhibitionism,” comparisons to alcoholism, “not in control of his actions” are bandied about. This to me has fascinating echoes of the medicalization of homosexuality in the 70s and also the medicalization of the choices made by the transgendered. There like here the strategy is fraught. The patient has to perform the “sick role” as a way of excusing himself from responsibility and/or earn governmental support.

The comparison, though, prompts the following question (and yes I am purposefully trying to be provocative so take it with the appropriate grain of salt): As with homosexuality, what is the underlying problem here that calls out for condemnation? Is this merely legal moralism rearing its head again? What’s so Wrong About Sexting?

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Petrie-Flom Intern’s Weekly Round-Up: 7/19 – 7/24

By Aleeza Hashmi

ART, lesbians and justice in the distribution of health care

In the wake of our seemingly everlasting economic crisis, the Spanish health authorities have decided to exclude single women to access ART treatments – mainly artificial insemination- in the public health care system. “The lack of a male partner is not a medical problem”, has said Ana Mato, our Secretary of Health. Coming from a devout Catholic and extremely conservative politician, her remark, and ultimately, her Department’s policy, have been widely interpreted as another vindication of the idea that only traditional, i. e. heterosexual, families are suitable for rearing children. The spokeswomen of various feminist and lesbian NGOs have entered the public arena to denounce her lesbophobia.

The fact of the matter is that women in Spain, whether married to another woman or single, will still be authorized to be artificially inseminated (in some European countries such as France, Austria or Sweden, for instance, single women are excluded from medically assisted reproduction). Even the fertile, married heterosexual woman might still get artificial insemination – maybe she just wants to do things differently, for a change- although they will all have to bear the costs. The public health care system has, therefore, reconfigured ART as a pure medical remedy for a medical condition: infertility. The days of IA as an “alternative means of reproduction” for “alternative life-styles” are over. But with this new policy the demand made by economically disadvantaged lesbian couples willing to procreate finds an answer along the following lines: “go find a male”. A crude response if there is one. Read More

Shifting the burden of proof regarding placebo controls

By Annette Rid

Placebo controls usually get special treatment. Almost all ethical guidelines for research specify how to use placebo controls, in particular when an established or proven effective treatment exists. To list just a few: guidance issued by the World Medical Association, CIOMS and the Council of Europe all have provisions dedicated to the use of placebo controls. But is there any reason to consider placebo controls a special case? I believe there isn’t, and I also think the burden of proof is on those who hold that placebos should be evaluated differently from other research interventions.

Using a placebo when an established effective treatment exists deprives the control group of the benefits of that treatment. This poses relative net risks to participants – that is, risks from delaying or foregoing a treatment that participants may have received outside the trial. Some placebo interventions also pose risks themselves, but these risks are typically so low – taking a “sugar pill” or receiving a saline injection through an existing i.v. line, for example – that we rightly focus on the risks of foregoing or delaying treatment. (There are other cases, though, such as certain forms of sham surgery. I won’t consider these cases here.)

So how should we evaluate the risks of using a placebo when an established effective treatment exists? We have general criteria for evaluating the risks of research interventions, in particular:

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Art Caplan on GlaxoSmithKline research conduct in China

An article in today’s New York Times explores allegations of improper research practices at GlaxoSmithKline’s research and development center in Shanghai, China. The article quotes Art Caplan in reference to evidence that researchers proceeded with drug trials in humans before animal studies were complete:

“If that’s true, it’s a mortal sin in research requirements,” said Arthur L. Caplan, the head of the division of medical ethics at NYU Langone Medical Center. He served as the chairman of an advisory committee on bioethics at Glaxo from 2005 to 2008. “No one could approve human trials without having that information available, scientifically or ethically. That’s kind of a Rock-of-Gibraltar-sized ethics violation.”

Read the full article here.

Whole Lot o’ Shakin’ Goin’ On

By Scott Burris

Over the weekend, my social science friends were all emailing about Nicholas Christakis’ op ed about how we should “shake up the social sciences.”  On one level, the piece is easy to mock. Christakis makes a big deal out of the contrast between the academic organization of the natural and social sciences: the former have hybridized: “Departments of anatomy, histology, biochemistry and physiology have disappeared, replaced by innovative departments of stem-cell biology, systems biology, neurobiology and molecular biophysics.” In contrast, sociology is still sociology, economics is still economics, etc.  So? As one friend notes, Chistakis’ own Yale Sociology Department sure seems to be keeping up with the interdisciplinary times:

Well, so, the sociology department in which Christakis now sits describes its scholarly endeavor as follows:  “Comparative and Historical Sociology; Culture/Knowledge; Economic Sociology and Organizations; Family/Gender/Sexuality; Global, Regional and Transnational Sociology; Health, Medicine, and Biosocial Interactions; Law and Criminology; Methods; Political Sociology and Social Movements; Race and Ethnicity; Religion; Social Networks; Social Stratification; Theory.”

Whatever that all amounts to, I think it’s slightly disingenuous to suggest that this enterprise is somehow fettered and hampered by calling it “sociology”, or by the fact that its practitioners (including Christakis) call themselves “sociologists,” or by having an academic department that’s indulgent and elastic enough to claim all these people and pay them for teaching and being public intellectuals that write op-eds in the New York Times.

Even more grin-worthy is his claim that we should declare knowledge victory and move on to new topics: “everyone knows that monopoly power is bad for markets, that people are racially biased and that illness is unequally distributed by social class.” Another friend sends that up like this:

This is wonderful news.  Somehow I missed it in all the papers, but it appears that we’ve agreed on the basic mechanics of macroeconomics and understand exactly how much government spending is needed to keep an economy out of recession.  Thank goodness that subject is ‘settled’.  Time to move on.   Next, we can put the basic economics of healthcare to rest.  For that to happen all we have to do is not change how we pay for healthcare, not give patients new rights, not allow any new diseases, and — most importantly — not develop new cures for existing diseases.

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