Capsule Endoscopy Instead of Colonoscopy? The FDA Approves the PillCam COLON

By Jonathan J. Darrow

In January, the Food and Drug Administration (FDA) approved the use of the PillCam COLON 2 as a minimally-invasive means of viewing the colon, a development that is sure to be welcomed by U.S. patients who currently undergo an estimated 14 million colonoscopies each year.  While the approval represents a major step forward, the PillCam is unlikely to supplant current procedures just yet.

The colon has traditionally been examined via optical colonoscopy, a procedure perceived by many to be uncomfortable and embarrassing that involves insertion through the rectum of a 5-6 foot long flexible tube as part of an examination that can take 30 to 60 minutes. Air must be pumped in through the rectum in a process called “insufflation.” Sedatives and pain medication are generally used to help relieve discomfort. In contrast, the PillCam COLON contains a power source, light source, and two tiny cameras encapsulated in an easy-to-swallow pill that produces no pain or even sensation as it moves through the colon. Reflecting the absence of discomfort, one report from a clinical researcher noted that a few patients have insisted on X-rays to confirm that the device had passed in their stool (FDA Consumer). The pill takes about 30,000 pictures before passing naturally from the body, which usually occurs before the end of its 10-hour battery life.

The safety record of capsule endoscopy, the category to which the PillCam COLON belongs, so far appears to compare favorably with the alternatives. Capsule endoscopy may be less likely to produce accidental colonic perforations or other serious complications, which occur in less than 1% of traditional colonoscopies despite the best efforts of the treating physician. Tears of the colon wall can in turn “rapidly progress to peritonitis and sepsis, carrying significant morbidity and mortality.” (Adam J. Hanson et al., Laparoscopic Repair of Colonoscopic Perforations: Indications and Guidelines, 11 J. Gastrointest. Surg. 655, 655 (2007)). Splenic injury or other serious complications also occur rarely with optical colonoscopies. Unlike “virtual colonoscopy,” which uses computed tomography (CT) to peer into the body, capsule endoscopy does not involve bombarding the body with radiation. A leading study published in the New England Journal of Medicine reported no serious adverse events among 320 subjects given the PillCam COLON, and concluded that use of the device was “a safe method of visualizing the colonic mucosa through colon fluids without the need for sedation or insufflation.” Read More

Anti-Abortion Practices at Catholic Hospitals as Medical Malpractice

By Alex Stein

The New York Times has recently reported about a suit filed by ACLU against the United States Conference of Catholic Bishops for requiring Catholic hospitals to avoid abortion “even when doing so places a woman’s health or life at risk.” The suit unfolds a disturbing story about an 18-week pregnant woman who rushed to the Mercy Health Partners in Muskegon, Michigan – the only one in her county – after breaking water. According to the suit, the plaintiff’s pregnancy was not viable but posed significant risks to her health. Instead of inducing labor or surgically removing the fetus to reduce the plaintiff’s chances of infection, the doctors at Mercy Health sent her home. The doctors also did not tell the plaintiff that her pregnancy is not viable and that it poses risk to her health. The plaintiff returned to the hospital next morning and was sent home again (!!) despite her bleeding and pain. On her third visit to the hospital – with severe pain and fever – the plaintiff miscarried and her fetus died shortly thereafter.

Described by the NYT as opening “a new front in the clash over religious rights and medical care,” the suit was filed in federal court in Michigan. Read More

Oregon’s Unfulfilled Tort Reform

By Alex Stein

Oregon has a statute capping noneconomic damages recoverable in medical malpractice suits at $500,000.

The Oregon Supreme Court decided that this cap is unconstitutional insofar as it clashes with a person’s right to recover full jury-assessed compensation for injuries recognized as actionable in 1857 when Oregon adopted its constitution. Specifically, it ruled that Article I, sections 10 and 17, of the Oregon Constitution entrench this right and deny the legislature the power to curtail it: see Smothers v. Gresham Transfer, Inc., 23 P.3d 333 (Or. 2001), and Hughes v. PeaceHealth, 178 P.3d 225 (Or. 2008). This ruling separated the constitutionally protected pre-1857 causes of action, which the statutory cap cannot curtail, from the constitutionally unprotected causes of action that came into existence after 1857 and that can consequently be capped.

Consequently, in order to reduce a jury’s award of noneconomic damages to $500,000, the defendant must show that the plaintiff’s complaint was not actionable before 1857. To adjudicate such claims, courts must carry out an historical investigation into Oregon’s medical malpractice law.

The Court’s most recent decision on that issue, Klutschkowski v. Oregon Medical Group, — P.3d —-, 2013 WL 5377913 (Or. 2013), made this task easy to perform. Read More

Daubert as a Problem for Psychiatrists

By Alex Stein

Most psychiatrists don’t know about it, but the switch from Frye to Daubert in the admission of expert testimony matters for them a lot. Psychiatrists treat patients with second-generation antipsychotics: Zyprexa, Risperdal, Clozaril, Seroquel, and similar drugs. A reputable, but still controversial, body of research links those drugs to tardive dyskinesia: a serious neurological disorder involving uncontrollable facial grimacing, repetitive tongue thrusting, and other untoward bodily movements. Under Frye, expert evidence can only be admitted upon showing that it received “standing and scientific recognition” from the relevant community of experts. Absence of a solid consensus disqualifies the evidence. Expert testimony linking tardive dyskinesia to antipsychotic drugs consequently would not be admissible under Frye. Under Daubert, however, it would go into evidence because its underlying research is grounded in scientific method and procedure that can be replicated, examined, and properly explained to the jury.

This is exactly what happened in a recent case decided by the United States District Court for the District of Columbia: Patteson v. Maloney— F.Supp.2d —-, 2013 WL 5133495 (D.D.C. 2013). Read More

Using Malpractice Laws to Sabotage Roe v. Wade

By Alex Stein

This method was pioneered by South Dakota and Indiana that set up special “informed consent” requirements for abortion procedures, SDCL § 34-23A-10.1 and IC 16-34-2-1.1. Under these requirements, physicians must tell the pregnant woman (inter alia) that “the abortion will terminate the life of a whole, separate, unique, living human being” with whom she has a relationship that enjoys constitutional protection; that “human physical life begins when a human ovum is fertilized by a human sperm”; that the abortion might lead to depression, suicide ideation, and suicide; and that she should “view the fetal ultrasound imaging and hear the auscultation of the fetal heart tone”; and also have the name, address, and telephone number of a nearby pregnancy help center.

The prize for innovation and ingenuity in this area, however, squarely belongs to Louisiana, whose special abortion-malpractice statute—Act 825, La. Rev. Stat. § 9:2800.12—was upheld this week in K.P. v. LeBlanc, — F.3d —-, 2013 WL 4746488 (5th Cir. 2013).  Act 825 complements Louisiana’s “Woman’s Right to Know Act,” La. Rev. Stat. § 40:1299.35.6, that established “informed consent” requirements for abortion similar to those of South Dakota and Indiana. Read More