New hospital safety scores were released this week, and around the country, those that scored well are crowing (see e.g., here and here). The data is provided by a nonprofit called Leapfrog Group, which compiles survey-responses and CMS data on a website called hospitalsafetyscore.org. Check out your own hospitals. The Leapfrog Group includes several leaders in the hospital safety movement, including Peter Pronovost (of checklist fame) and Lucian Leape (author of the seminal 1994 JAMA article on the topic). Is anyone aware of an empirical study that looks at the relationship between these scores and medical malpractice liability claims or payouts? Any attorneys that use this sort of data in the litigation of individual cases?
Penn State’s former president, Graham Spanier, is the latest person to be charged in the fallout involving Jerry Sandusky’s sexual abuse of boys on the Penn State campus. A year ago, I blogged about Spanier’s curiously timed defense of his former staff members following the horrific allegations involving the former, popular football coach.
Jerry Sandusky’s crimes are deplorable. He was convicted of molesting boys from a charity he helped to found (Second Mile) and will serve 30-60 years in prison; he will likely die there. Yet no less problematic were Spanier’s statements immediately following the release of the grand jury’s presentment. Last year, the statement released by Spanier could only be described as cavalier and irresponsible. Spanier claimed that the perjury charges against his former athletic director, Timothy Curley, and Gary Schultz, his senior vice president for finance and business, were “groundless,” and that he has “complete confidence in how they… handled the allegations” against Sandusky. Stunning.
Remember the grand jury report? Schultz said that the allegations were “not that serious” and that he and his colleague “had no indication that a crime had occurred.” What we know now from the Freeh Report is that there were emails between Spanier, Curley, and Schultz about allegations of Sandusky’s showers with boys in the Penn State football locker room. Spanier claims that there may have been emails that he received, but he can’t remember them. He told Jeffrey Toobin in a New Yorker article: “I was apparently copied on two emails…I didn’t reply to them.” A few years later, Michael McQuery (a former graduate student) reported witnessing Sandusky sexually abusing a child in the shower; he also testified before the grand jury.
It was an exciting time to attend the annual meeting of the American Society for Reproductive Medicine in San Diego this week. Just before the meeting, ASRM reclassified cryopreservation of oocytes for future use, removing the procedure’s “experimental” label. The possibility of increased uptake of this procedure raises many ethical issues (some of which I hope to discuss in a later post), but it also presents the potential to sidestep a number of legal liabilities and ethical issues associated with frozen embryos which are not implicated by frozen gametes. This begs the question: Is a move towards egg freezing in lieu of freezing embyos a safeguard against some types of liability for IVF clinics? I think this may be the case.
Perhaps most importantly, frozen oocytes will not implicate personhood laws. Advocates of personhood laws, such as vice presidential candidate Paul Ryan, have come under fire by pro-choice and feminist groups for their attempts to ascribe legal rights to embryos and fetuses. However, IVF clinics and clinicians should also be concerned. It is an unanswered legal question if an IVF clinician or embryologist could be found guilty of manslaughter if there was an accidental thaw of a cryotank full of embryos. There have been no such criminal proceedings brought against an IVF clinic — yet. Freezing eggs would guard IVF clinics in states with personhood laws from this kind of criminal liability. Another question implicated by personhood laws is whether there is a doctor-patient relationship between a newly-created or frozen embryo. If one exists, then negligence claims regarding proper storage of embryos could become medical malpractice claims; if frozen gametes are mishandled it is unlikely such a relationship could exist. Litigation against the Oschner Fertility Clinic (which has now closed) brings some of these issues to life.
Art Caplan has a new article out in the Journal of Law, Medicine, and Ethics – “Free to choose but liable for the consequences: should non-vaccinators be penalized for the harm they do?” (subscription required)
Here’s the abstract: Can parents who choose not to vaccinate their children be held legally liable for any harm that results? The state of laboratory and epidemiological understanding of a disease such as measles makes it likely that a persuasive causal link can be established between a decision to not vaccinate, a failure to take appropriate precautions to isolate a non-vaccinated child who may have been exposed to measles from highly vulnerable persons, and a death. This paper argues that, even if a parent chooses to not vaccinate a child under a state law permitting exemptions, that decision does not create complete protection against liability for the adverse consequences of that choice.
On October 3, 2012, the FDA’s Division of Professional Drug Promotion issued an untitled letter to Genentech in connection with its cancer drug Tarceva. Tarceva (erlotinib) was approved in 2004 for the treatment of non-small cell lung cancer, and has since been approved, in combination with Gemzar (gemcitabine), for the treatment of pancreatic cancer. Its approval letter reported a tumor response that was 9 times greater with Tarceva than with placebo (0.9% in placebo versus 8.9% in Tarceva), but relatively modest improvements in 1-year survival rates: approximately 8 of 10 patients on placebo did not survive 1 year, while about 7 of 10 patients on Tarceva did not survive (see page 6, line 102 of the approval letter). A 2005 New York Times article was less than enthusiastic about Tarceva’s efficacy, noting that it (along with several other cancer drugs that were new at the time) “help[s] most patients only marginally . . . .” Despite its modest efficacy, Tarceva was reported in the same New York Times article to cost almost $31,000 per year. A number of patents are listed in the FDA’s Orange Book as covering Tarceva until 2020.
The recent untitled letter accused Genentech’s promotional materials of misleadingly indicating that Tarceva in combination with gemcitabine extended overall survival by 3.7 months in comparison with gemcitabine alone, when the actual increase in survival was only about 12 days. The FDA characterized the discrepancy as “drastically overstat[ing] the efficacy of Tarceva.” (The figure of 3.7 months was derived, according to the FDA, “from a retrospective, exploratory subgroup analysis that does not provide substantial evidence to support the efficacy claims cited . . . .”). In addition, the front cover of one of the promotional materials in question contained an image of an hourglass positioned on its side, presented with the claim: “Extending survival for moments that matter.” Although the claim with its associated image may be literally true (“moments” is left undefined), the FDA characterized the image and claim as “drastically overstat[ing] the overall survival benefit for patients” because it “strongly suggests that time is standing still for the cancer patient because of Tarceva therapy.” The FDA noted a number of other instances of misleading overstatement of efficacy or minimization of risk.
The October 3 Tarceva letter brings to 23 the total number of Drug Marketing and Advertising Warning Letters (and untitled letters) listed by the FDA’s Office of Drug Promotion as having been sent this year.
In his latest MSNBC column, Art Caplan addresses a different angle of the fungal meningitis outbreak:
The quest for relief from pain has now resulted in the deaths of 19 people and a total of 247 confirmed infections of fungal meningitis from tainted steroid injections. Thousands more who got the injections, made by the New England Compounding Center in Massachusetts, are worried that they too may wind up sick or dead.
The horrific outbreak has resulted in the outrage about a lack of oversight of the compounding pharmacy.
But, this tragedy has another aspect that is not getting sufficient attention. Why are so many Americans getting spinal injections?
In May 2011, Jennie Linn McCormack was charged with violating an Idaho law making it a felony for any woman to undergo an abortion in a manner not authorized by statute. The 9th Circuit Court of Appeals has recently upheld the U.S. District Court for the District of Idaho’s grant of a preliminary injunction restraining enforcement of the statute under which McCormack was charged.
McCormack’s crime, according to prosecutor Mark Heideman, was that she used medication legally prescribed by a physician on the Internet to induce abortion. McCormack pursued this option because there were no abortion providers in the eight southeastern Idaho counties proximate to her home, and the cost of traveling 138 miles to a provider Salt Lake City, Utah was beyond her means.
Idaho’s abortion statute is unusual in that it expressly permits prosecution of pregnant women who pursue illegal abortions, rather than being limited to third-party abortion providers. Hiedeman contended that his prosecutorial authority under the statute was valid, arguing that the health and safety justifications for criminalizing illegal abortions are just as relevant when the responsible actor is the pregnant woman herself. The 9th Circuit disagreed. It noted that abortion laws have historically been aimed at protecting women from unqualified abortion providers, and that most statutory and common law precedents exempt women from liability for actions taken in connection with abortion. Judge Pregerson supported the validity of McCormack’s claim that prosecuting pregnant women for illegal abortion poses an undue burden on reproductive choice in that it requires women to police their providers’ compliance with abortion laws.