Category: Liability

IRBs Advise Physician Involvement in Informed Consent

Nadia Sawicki 1 Comment

By Nadia N. Sawicki

Much has been written about the Supreme Court of Pennsylvania’s recent decision in Shinal v. Toms, in which the court held that a physician’s duty to obtain informed consent, as codified in Pennsylvania’s MCARE Act, is non-delegable. According to the court, a physician faced with an informed consent suit cannot defend himself on the grounds that the patient was adequately informed of the risks and benefits of treatment by a physician assistant, nurse, or other intermediary acting under the physician’s direction. Pennsylvania is not the first state to adopt this view – courts in other jurisdictions (Connecticut, Louisiana, South Dakota, Texas, New Mexico) have similarly held that the duty to secure informed consent rests with the treating physician alone.

The MCARE (Medical Care Availability and Reduction of Error) Act was passed in 2002 to reform Pennsylvania’s medical malpractice laws, and refers to the duties and rights of “physicians” and “patients.” Shinal, likewise, addressed the issue of informed consent in the context of medical treatment. Thus, I was very surprised to learn that some commercial institutional review boards (IRBs), in reliance on the Pennsylvania Supreme Court’s decision, have been advising clinical trial investigators to revise their consent forms and processes to ensure that physician-investigators – and not recruitment coordinators, nurses, or other study staff – secure the consent of research participants.

Schulman, one of the most well-known commercial IRBs, recently posted about the Shinal case on its website; while noting that the case focused on medical malpractice “and does not address consent in the research context,” it advised investigators to “discuss with their legal counsel the impact of this decision on their consent process.” Sterling IRB had a similar post, advising investigators to “consider drafting consent form updates to clearly require that only physician members of the research team may obtain informed consent from a research subject.” In an e-mail that went directly to investigators and study staff, Sterling also suggested that they submit updated consent forms that “make clear that the only person who can obtain consent is the PI/physician.” A recent article in the Journal of Clinical Research Best Practice, titled “What Impact will the Shinal Case have on Informed Consent in Clinical Research?,” offered a more detailed analysis of the case, and concluded that “there is little to suggest that courts would not uniformly apply the same informed consent standards used in the medical practice to clinical research.” Read More

CAVEAT HOSPITIA: Suits Alleging Negligent Credentialing Against Hospitals Get Exemption from Tort Reform

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By Alex Stein

Policymakers and scholars interested in medical malpractice and torts generally should read Billeaudeau v. Opelousas General Hospital Authority, — So.3d —-, 2016 WL 6123862 (La. 2016). In this recent and important decision, the Louisiana Supreme Court ruled that suits alleging negligent credentialing against a hospital sound in regular negligence, rather than medical malpractice, and consequently fall outside the purview of the state’s Medical Malpractice Act (MMA) and its limitations on liability. The Court made this decision in connection with the state’s cap on damages recoverable in medical malpractice actions, La. Rev. Stat. § 40:1231.2(B)(1), which limits the total amount that courts can award the victim to $500,000, plus interest and cost, on top of the victim’s future expenditures on medical care and support. For many victims of medical malpractice and their families this cap amount is meager, but the Court nonetheless upheld its constitutionality back in 1992. See Butler v. Flint Goodrich Hosp., 607 So.2d 517 (La. 1992).

The Court has now decided that suits alleging negligent credentialing against hospitals are not subject to this cap and that successful plaintiffs consequently will recover full compensation for any proven damage. Read More

President Trump’s Tort Reform

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By Alex Stein

President Trump’s budget for Fiscal Year 2018 proposes a thoroughgoing reform of our medical malpractice system [Executive Office of the President of the United States, Major Savings and Reforms, Budget of the U.S. Government, Fiscal Year 2018, at 114 (2017) (hereinafter, the “Budget”)]. The reform’s stated goals are “[to] reduce defensive medicine … limit liability, reduce provider burden, promote evidence-based practices, and strengthen the physician-patient relationship.”

To achieve these goals, the reform will introduce the following measures:

  • a cap on non-economic damage awards of $250,000 (adjustable to inflation);
  • a three-year statute of limitations;
  • allowing courts to modify attorney’s fee arrangements;
  • abolition of the “collateral source” rule (to allow judges and jurors to hear evidence of the plaintiff’s income from other sources such as workers’ compensation and insurance);
  • creating a safe harbor for clinicians who follow evidence-based clinical-practice guidelines.

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The First Human Body Transplant – Ethical and Legal Considerations

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By Ana S. Iltis, PhD

brain_glowingprofileTo what lengths should we go to preserve human life? This is a question many are asking after hearing that three men plan to make medical history by conducting the first human head transplant. Or, rather, whole body transplant. Italian neurosurgeon Dr. Sergio Canavero and Chinese surgeon Dr. Xiaoping Ren plan to provide a Russian volunteer, Valery Spiridonov, a new body. During the procedure, Spiridonov’s body and head would be detached and, with the help of a crane, surgeons would move the head and attach it to the donor body.  But is this ethical? What role might law and regulation play in monitoring them or in assessing their conduct after the fact?

Critics call the plan crazy, unethical, and sure to fail. The likelihood of success is very low and the risk of Spiridinov dying is high. Spiridonov says that as soon as animal studies confirm the possibility of survival, the risks will be worth taking. He has Werdnig-Hoffmann Disease, a genetic disorder that destroys muscle and nerve cells. He is confined to a wheelchair and has lived longer than expected. Body transplantation offers him the best chance at a life worth living. Read More

Fetal Consequentialism and Maternal Mortality

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By Nadia N. Sawicki

It is well known that maternal mortality rates in the United States are higher than in other countries in the developed world, and that many of these deaths are preventable. But a report published by NPR last week, just a few days before Mother’s Day, drew a direct link between these poor maternal outcomes and health care providers’ focus on fetal health. The report quotes Barbara Levy, vice president for health policy and advocacy at the American Congress of Obstetricians and Gynecologists, who said, “We worry a lot about vulnerable little babies, [but] we don’t pay enough attention to those things that can be catastrophic for women.” According to the authors of the NPR report, “newborns in the slightest danger are whisked off to neonatal intensive care units … staffed by highly trained specialists prepared for the worst,” while new mothers are instead monitored by nurses and physicians “who expect things to be fine and are often unprepared when they aren’t.”

These patterns are consistent with what Prof. Jamie Abrams calls “fetal consequentialism” – the premise that the birth of a healthy child outweighs any harm to the birthing mother. The increase in U.S. maternal mortality rates highlighted in the NPR report is certainly a product of such fetal consequentialism. So is the practice of obstetric violence, described in my previous posts, where health care providers dismiss birthing mothers’ informed requests for minimal intervention during labor and delivery in an effort to reduce the risk of fetal harm, even when that risk is minimal. Fetal consequentialism is likely driven not only by providers’ judgments of the relative liability risks for harms to fetuses versus harms to mothers, but also by conservative societal trends (evidenced by increasing anti-abortion legislation) that preference fetal interests over maternal interests. Read More

Birth Plans as Advance Directives

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By Nadia N. Sawicki

There is growing public recognition that women’s autonomy rights during labor and delivery are being routinely violated. Though such violations rarely rise to the level of egregious obstetric violence I described in an earlier blog post, women recognize that hospital births, even for the most low-risk pregnancies, often involve cascades of medical interventions that lack evidence-based support and can have negative health consequences for both mother and child. Indeed, evidence suggests that an increasing number of women are pursuing options like midwife-assisted birth, delivery in free-standing birthing centers, and even home birth in an effort to avoid interventionist hospital practices. According to the 2013 Listening to Mothers Survey, nearly six in ten women agree that birth is a process that “should not be interfered with unless medically necessary.”

One tool that women frequently use to increase the likelihood that their autonomous choices will be respected during labor and delivery is the birth plan, a document that outlines a woman’s values and preferences with respect to the birthing process, and serves as a tool for facilitating communication with care providers. However, while most women view the creation of a birth plan as empowering, there is little evidence to suggest that the use of birth plans actually improves communication, increases women’s feelings of control, or affects the process or outcome of childbirth. In fact, there appears to be some resistance within the medical community to women’s reliance on birth plans, with one article describing “the two words ‘birth plan’ strik[ing] terror in the hearts of many perinatal nurses.”  Read More

Negligent Failure to Prevent Suicide in the Age of Facebook Live

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By Shailin Thomas

In 2016, Facebook unveiled a new tool that allows users to post live streams of video directly from their phones to the social media platform. This feature — known as “Facebook Live” — allows friends and followers to watch a user’s videos  as she films them. Originally conceptualized as a means of sharing experiences like concerts or vacations in real time, the platform was quickly adopted for uses Facebook likely didn’t see coming. In 2016, Lavish Reynolds used Facebook Live to document the killing of her boyfriend, Philando Castile, by the Minneapolis police, sparking a national debate surrounding police brutality and racial disparities in law enforcement. Recently, another use for Facebook Live has arisen — one that Facebook neither foresaw nor wants: people have been using Facebook Live as a means of broadcasting their suicides.

This tragic adaptation of the Facebook Live feature has put Facebook in a tough spot. It wants to prevent the suicides its platform is being used to document — and just a few weeks ago it rolled out real-time tools viewers of Live videos can use to identify and reach out to possible suicide victims while they’re filming — but it’s often too late by the time the video feed is live. Accordingly, Facebook is focusing its efforts at identifying those at risk of suicide before the situation becomes emergent. It currently has teams designing artificial intelligence algorithms for identifying users who may be at risk for suicide. These tools would scan Facebook users’ content, flagging individuals that have warning signs of self-harm or suicide in their posts.

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Reforming the approach to clinical negligence in the National Health Service (NHS)

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By John Tingle

The Department of Health in England  have just published a consultation paper on the Governments proposal to introduce a Rapid Resolution and Redress Scheme (RRR) – a voluntary administrative compensation scheme for families affected by severe avoidable birth injury. Action against Medical Accidents (AvMA) the UK charity for patient safety and justice cautiously welcomes the stated intentions of the scheme but state that more thought needs to be given to the proposals. There needs to be more detail of the scheme and  some serious concerns are expressed.

The case for change

There are central three policy objectives behind the (RRR) scheme:

  • Reducing the number of severe avoidable birth injuries by encouraging a learning culture.
  • Improving the experience of families and clinicians when harm has occurred; and
  • Making more effective use of NHS resources.

In the consultation paper, a leading policy justification for the (RRR) scheme is the success of a Swedish initiative called, ‘The Safe Delivery Care Project’ which shows evidence of a reduction of claims for severe neurological birth injury. Read More

Obstetric Battery

Nadia Sawicki 1 Comment

By Nadia N. Sawicki

In 2013, Kimberly Turbin came to Providence Tarzana Medical Center for a momentous occasion – the birth of her first child. In the delivery room, she was surrounded by supportive family members. Her mother stood by her side with a video recorder, hoping to capture the once-in-a-lifetime event for posterity.

And this is where Kimberly’s birth story veers off course. According to the complaint filed in Los Angeles County Superior Court against her OB/GYN, Dr. Alex Abbassi, Kimberly is a survivor of sexual assault who had confided in the medical staff that she had previously been raped. She requested that the staff ask permission before touching her, and asked them to “be gentle.” And when Dr. Abbassi told Kimberly during delivery that he would be performing an episiotomy – a surgical procedure in which the perineum and vaginal wall are cut to provide more room for the baby to pass through the vaginal canal – Kimberly objected. When she asked why the episiotomy was necessary, Dr. Abbassi provided no medical justification. He responded, “What do you mean, Why? I am the expert here! … You can go home and do it! You go to Kentucky!” Kimberly continued to object, loudly saying “No!” and “No, don’t cut me!” numerous times. Dr. Abbassi proceeded nevertheless, cutting her perineum twelve times. A video of this entire encounter, which is extremely graphic and difficult to watch, is viewable on YouTube.

These allegations, if true, present a textbook case of battery – the defendant intended to cause contact with the patient, the contact was harmful and offensive, and the contact was neither consented to nor justified by any emergency. And yet, when Kimberly filed suit for battery and intentional infliction of emotional distress, Dr. Abbassi moved to dismiss her suit – he argued that because Kimberly’s claim was grounded in the failure to obtain informed consent, it constituted negligence under California’s medical malpractice laws and therefore was barred by a shorter statute of limitations. In June of 2016, however, Judge Benny Osorio denied Dr. Abbassi’s motion to dismiss the battery claim, holding that the “alleged act of proceeding against the express wishes of Plaintiff … is premised on intentional misconduct and not professional negligence.”

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Artificial Intelligence and Medical Liability (Part II)

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By Shailin Thomas

Recently, I wrote about the rise of artificial intelligence in medical decision-making and its potential impacts on medical malpractice. I posited that, by decreasing the degree of discretion physicians exercise in diagnosis and treatment, medical algorithms could reduce the viability of negligence claims against health care providers.

It’s easy to see why artificial intelligence could impact the ways in which medical malpractice traditionally applies to physician decision-making, but it’s unclear who should be responsible when a patient is hurt by a medical decision made with an algorithm. Should the companies that create these algorithms be liable? They did, after all, produce the product that led to the patient’s injury. While intuitively appealing, traditional means of holding companies liable for their products may not fit the medical algorithm context very well.

Traditional products liability doctrine applies strict liability to most consumer products. If a can of soda explodes and injures someone, the company that produced it is liable, even if it didn’t do anything wrong in the manufacturing or distribution processes. Strict liability works well for most consumer products, but would likely prove too burdensome for medical algorithms. This is because medical algorithms are inherently imperfect. No matter how good the algorithm is — or how much better it is than a human physician — it will occasionally be wrong. Even the best algorithms will give rise to potentially substantial liability some percentage of the time under a strict liability regime.

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