Advancing the Global Patient Safety Agenda

By John Tingle and Jen Minford

All too often it seems that patient safety and health quality policy makers work in their own silos unaware of what is taking place in other countries, wasting valuable resources by trying to re-invent the wheel. There is a clear need to have a way of cascading the news down on what is happening in patient safety globally. Developing and transitioning countries do not always have the resources to build up patient safety infrastructures, tools and policies and letting them know about initiatives going on in other countries fulfils a very important global public health need.

There is also the concept of ‘reverse innovation’.  Developed countries’ patient safety practices and policies can be informed by the experiences of developing and transitioning countries who may be using them in a different and novel way. Patient safety learning can be a two-way street. Continue reading

The National Health Service (NHS) in England is standing on a burning platform?

By John Tingle

In the introduction to a new report on the state of acute hospitals in the NHS in England, the Chief Inspector of Hospitals, Professor Sir Mike Richards of the Care Quality Commission (CQC) controversially states:

“The NHS stands on a burning platform — the model of acute care that worked well when the NHS was established is no longer capable of delivering the care that today’s population needs. The need for change is clear, but finding the resources and energy to deliver change while simultaneously providing safe patient care can seem near impossible.” (p.4)

This statement raises the fundamental question of whether the current model of the NHS is,’ fit for purpose’? The NHS since its formation has always had both a good and bad press. Since its inception it always been short of resources. Changing times bring with them new demands which can make established health care delivery structures obsolete and no longer capable of delivering optimal performance. One important NHS developing health care trend is the need to keep pace with a growing elderly population with more complex health needs along with other trends. Continue reading

Undocumented Organ Transplants

By Brad Segal

Manuel—not his real name—was admitted to the hospital with decompensated heart failure. As a child he had scarlet fever which, left untreated, had caused the valves of his heart to calcify and stiffen. Over time, pumping against increased resistance, his heart’s contractions began to weaken until finally, they lost all synchrony and the normal function of his heart spiraled out of control. At this stage, his fate was tied to whether or not he would receive a new heart in time.

He was in his 30’s and had no other illnesses. From a medical perspective, Manuel was the ideal candidate for a cardiac transplant. But a decade ago Manuel crossed the United States border in pursuit of a better life. As an undocumented immigrant, he was ineligible for the insurance coverage necessary to pay for a heart transplant. After being thoroughly evaluated by the hospital’s transplant center, given his modest financial resources and inability to obtain new insurance coverage, Manuel was not placed on the waiting list for a new heart.

The average heart transplant costs about a million dollars to perform. Subsequent follow-up care adds another $30,000 annually. Health insurance will usually cover most, if not all, of these costs. But uninsured patients are kept off transplant lists on the grounds that the inability to pay for care allegedly jeopardizes an organ’s long-term success. Continue reading

Improving the safety of maternity care in the National Health Service (NHS) and other medico-legal matters

By John Tingle

There are some very interesting Government patient safety and access to justice policy development activities currently going on in England.

Maternity Services

In maternity services, there is a clear recognition by Government that safety is inconsistent and that there is significant scope for improvement. Our still birth rates are amongst the highest in Europe despite the National Health Service (NHS) making advances in patient safety in this area. In the National Maternity Review we are reminded that half of the Care Quality Commission (CQC) inspections of maternity services result in safety assessments that are either ‘inadequate’ (7%) or ‘requires improvement (41%) (page 22). The CQC is the independent regulator of health and social care in England.

In a speech to the Royal College of Obstetricians and Gynaecologists (RCOG) in London, the Secretary of State for Health, 17th October, 2016, Jeremy Hunt laid out plans to make giving birth safer, including maternity safety funding and other related matters. The Government’s ambition is to halve neonatal death, stillbirth, maternal death and brain injuries caused during or shortly after labour by 2030 and a series of measures were  launched. There will be a £250,000 maternity safety innovation fund and a new national Maternity and Neonatal Health Quality Improvement Programme. New maternity ratings will also be published to help improve transparency, raise standards and will give families better information about the quality of local maternity services.

A safe space Continue reading

Learning from adverse health care events in Scotland

By John Tingle

We can learn a lot from how other countries deal with patient safety issues and it can save us from reinventing the wheel at some financial cost.Healthcare improvement Scotland  (HIS) is the national healthcare improvement organization for Scotland and is part of NHS Scotland. The organization provides some excellent patient safety resources. The work of HIS involves supporting and empowering people to have an informed voice in managing their own care and shaping how services are designed and delivered. Delivering scrutiny activity, providing quality improvement support and providing clinical standards, guidelines and advice. HIS produce a rich range of programmes and publications that are relevant to all those concerned with patient safety and health quality in England, USA and elsewhere.

A recent report from HIS focuses on the adverse event lessons learned by health boards and the improvements they subsequently put into place after the events,Learning from adverse events – Learning and improvement summary: May 2016 There is some very good thinking in the report which should be essential reading for all staff involved in patient safety policy development.

Continue reading

Trap for the Unwary: Records compiled by a hospital’s risk-management specialist held discoverable

By Alex Stein

In a recent case, Frankfort Reg. Med. Ctr. v. Shepherd, 2016 WL 3376030 (Ky. 2016), the Kentucky Supreme Court held that the attorney-client privilege and its work-product extension do not protect records compiled by a hospital’s risk-management specialist. Records that the Court held to be discoverable contained information pertaining to a baby delivery that went badly. The risk-management specialist gathered that information with an eye on a possible medical malpractice suit, but her primary goal was risk management (which presumably precluded the applicability of the “subsequent remedial measures” privilege).

The Court’s decision relied on the familiar “dominant purpose” test, under which the attorney-client privilege only covers documents compiled primarily in preparation to litigation. Understandable as it may be from a purely doctrinal viewpoint, this decision makes no economic sense. All it does is create a trap for the unwary and an opportunity for hospitals familiar with the law to protect their risk-management information against disclosure. To obtain the needed protection, all that a hospital needs to do is ask its in-house counsel or outside attorney to control the risk-management procedures and decisions, so that risk management becomes part of the attorney’s work as a protector of the hospital’s legal interests. Doing so isn’t difficult but costlier than simply relying on a risk-management consultant.

Can Negligent Providers of Medical Care Use the Patient’s Self-Destructive Behavior to Fend Off Liability?

By Alex Stein

The Colorado Supreme Court recently delivered an important decision on medical malpractice, P.W. v. Children’s Hospital Colorado, — P.3d —- (Colo. 2016), 2016 WL 297287. This decision denied a hospital the comparative negligence and assumption of risk defenses that purported to shift to the patient the duty to eliminate or reduce the risk that the hospital was obligated to guard against.

The defendant hospital admitted a known suicidal patient to its secure mental health unit and placed him under high suicide-risk precautions. The hospital’s staff failed to follow those precautions by allowing the patient to be alone in a bathroom for twenty minutes. During these twenty minutes, the patient hanged himself with his scrub pants and suffered a devastating anoxic brain injury. Continue reading

Hospitals’ Exposure to Products Liability Suits

By Alex Stein

The United States District Court for the District of Connecticut has recently delivered an important decision that opens up new possibilities for suing hospitals and clinics. This decision allowed a patient alleging that hospital employees injected her with a contaminated medication to sue the hospital in products liability. Gallinari v. Kloth, — F.Supp.3d —- (U.S.D.C. D.Conn. 2015), 2015 WL 7758835. Continue reading

“Medical Malpractice or Ordinary Negligence?” in the Context of Psychiatric Treatment

By Alex Stein

“Medical Malpractice or Ordinary Negligence?” is an issue that will stay on the courts’ agenda for long. See hereherehereherehere, here, and here.

As I explained in these posts and in a foundational article on medical malpractice, categorizing a plaintiff’s action as “medical malpractice” rather than “ordinary negligence” determines whether it must satisfy rigid limitations and repose provisions, comply with special and costly requirements with regard to expert testimony, face the difficult burden of proving the defendant’s deviation from the medical profession’s customary practices and protocols, and suffice itself with the compensation amounts allowed by the statutory caps on damages.

A recent Florida court decision, Shands Teaching Hosp. & Clinics v. Estate of Lawson, — So.3d —- 2015 WL 5057325 (Fla. 5th DCA 2015), illustrates the centrality of this issue for suits complaining about a psychiatric hospital’s neglect. Continue reading

Uninsured Practice of Medicine as Actionable Tort

By Alex Stein

A week ago, the Supreme Court of New Jersey has delivered an important decision on whether uninsured practice of medicine is actionable in torts. Jarrell v. Kaul, — A.3d —- 2015 WL 5683722 (N.J. 2015). This decision involved an uninsured anesthesiologist who allegedly provided negligent pain management treatment to a patient. Under New Jersey statute, N.J.S.A. 45:9–19.17; N.J.A.C. 13:35–6.18(b), a physician’s license to practice medicine is only valid when she holds medical-malpractice liability insurance in the requisite amounts. Continue reading

“Medical Malpractice” vs. General Negligence: The Case of Falling Accidents

By Alex Stein

As I wrote previously – see here, here, here, here, here, here, here, here, and here – whether a tort action sounds in “medical malpractice” as opposed to general negligence, or vice versa, can be crucial. Suits sounding in “medical malpractice” must satisfy special requirements that include shortened limitations periods, statutes of repose, and expert affidavits (or certificates of merit) at filing. In many states, those suits are also subject to special damage caps. Suits sounding in general negligence are free from these constraints. Filing and prosecuting those suits is consequently not as onerous and expensive as filing and prosecuting medical malpractice actions. For that reason, we witness many disputes over this pivotal categorization issue. Continue reading

Do Medical-Malpractice Time Bars Apply to Hospitals’ Indemnification Suits Against Doctors?

By Alex Stein

The South Carolina Supreme Court has recently decided that a hospital’s indemnification suit against doctors whose malpractice made it pay compensation to the aggrieved patient is subject to the same time bars as patients’ actions against defaulting physicians. Columbia/CSA-HS Greater Columbia Healthcare System, LP v…., — S.E.2d —- (2015), 2015 WL 249536 (S.C. 2015).

Chief Justice Jean Hoefer Toal wrote a vehement dissent in which she was joined by Justice Kaye Hearn. In that dissent, she wrote that “The majority’s holding represents a fundamental misunderstanding of the nature of indemnification actions which I fear will have far-reaching effects on the ability to seek indemnification.”

The Chief Justice was absolutely right. Continue reading

Last Year Was A Wild One For Health Law — What’s On The Docket For 2015?

This new blog post by Greg Curfman, Holly Fernandez Lynch and I. Glenn Cohen appears on the Health Affairs Blog:

Everywhere we look, we see the tremendous impact of new legal developments—whether regulatory or statutory, federal or state—on health and health care. These topics range from insurance to intellectual property to religion to professionalism to civil rights. They remain among the most important questions facing Americans today.

This post is the first in a series that will stem from the Third Annual Health Law Year in P/Review event to be held at Harvard Law School on Friday, January 30, 2015. The conference, which is free and open to the public, brings together leading experts to review major developments in health law over the previous year, and preview what is to come.

Read the full post here, and register for the Third Annual Health Law Year in P/Review for free here.

Teamwork as Malpractice

By Alex Stein

A team of doctors employed by the same hospital had failed to properly monitor a patient after his heart surgery in order to rule out a well-known neurological complication. The patient subsequently developed an irreversible neurological disorder, and a suit ensued.

The patient’s expert identified the team’s omission as malpractice. However, he was unable to attribute the omission to any specific member of the doctors’ team. Under the common law doctrine of vicarious liability, because the omission could be attributed to the team as a whole, the patient could still win his suit against the hospital. This doctrine holds that a hospital employing a team of doctors assumes vicarious liability for the team’s malpractice even when there is no way to single out the defaulting team member.

Washington’s appellate court, however, has decided that this doctrine was inapplicable because medical malpractice is a statutory, rather than common law, tort under Washington law.  Grove v. Peace Health St. Joseph Hospital, — P.3d —-, 2013 WL 5786888 (Wash.App. Div. 1 2013). Continue reading

The Tylenol Debate: Can Hospitals be Sued for Excessive Markups on Medications and Devices?

By Alex Stein

Steven Brill’s TIME MAGAZINE blockbuster article, Bitter Pill: Why Medical Bills are Killing Us, uncovers the CHARGEMASTER: a publicly undisclosed pricelist accountable for what we see in hospital bills. What we see there doesn’t look good: it includes acetaminophen sold for $1.50 a tablet (you can buy 100 of those for the same price at Amazon); $77 for a box of sterile gauze pads (Amazon’s prices vary between $6 and $11); $18 for a single diabetes test strip (sold for 54 cents by Amazon); $108 for antibacterial Bacitracin ointment (Amazon’s prices vary between $2.50 and $6.50); and so forth. Charges for stay, scans, surgeries, canes, and wheelchairs skyrocket as well.

The American Hospitals Association (AHA) rejects Brill’s analysis. According to AHA, the chargemaster aggregates the hospital’s overall costs on delivering quality care to patients: “In order to take medications in a hospital, even over-the-counter medicines, they must be prescribed by a doctor (a little bit of cost for the doctor), that order gets transmitted to the pharmacy (a little more cost), the order gets filled by a pharmacist or pharmacy tech who retrieves just one Tylenol pill and individually packages that one pill (still more cost), the pill gets transported from the pharmacy to the nursing unit where the patient resides (a little more cost), then the pill is retrieved by a registered nurse who personally gives the pill to the patient and then must document the administration of that pill in the patient medication administration record (a little more cost). All of this process to give a patient a single dose of Tylenol in a hospital bed [must also be] in compliance with all pertaining regulations (a little more cost).”

This post will not try to resolve the Tylenol Debate. Nor will it say anything about the government as a plausible substitute for the eccentric chargemaster. Instead, I will raise a legal question: Can patients sue hospitals for excessive markups on medications and devices?

My answer to this question is a qualified YES. Entrepreneurial and business aspects of running a hospital fall under states’ consumer protection laws (Brookins v. Mote, 292 P.3d 347 (Mont. 2012)). Those aspects certainly include billing (Jaramillo v. Morris, 750 P.2d 1301, 1304 (Wash. App. 1988); Ambach v. French, 216 P.3d 405 (Wash. 2009)). The key question here is whether an excessive markup on medications and devices amounts to deceit or an unfair trade practice. If it does, the hospital would be in violation of the relevant state consumer protection law. This might happen to hospitals whose billing practices—to which patients gave no informed consent—are particularly aggressive. Those hospitals might face class action suits and the prospect of paying treble damages. They also may be stripped of the special protections given to defendants in medical malpractice suits (that include shortened limitations and repose periods for filing suits, caps on damages, and charitable immunities). For my account of the competition between medical malpractice and consumer protection rules, click here.

Brill and other participants in the Tylenol Debate call on the government to start regulating hospital prices. My short advice to hospitals: get rid of unconscionable markups forthwith.