Patient Safety at the Crossroads

By John Tingle, Associate Professor,Nottingham Law School,Nottingham Trent University, UK.

The NHS (National Health Service) in the UK is 70 next year, it was founded on 5th July 1948 and celebrations are being planned. Clearly a lot has changed since it was founded. Our concept of wellness has changed, we go to the doctor for reasons that would never have been considered appropriate in 1948. Health today is not just about the absence of physical diseases.

What is clear is that ever since 1948 the NHS has been short of resources in the face of a seemingly insatiable demand for its services. Balancing finite resources against infinite demands is no easy task. Seventy years on it is most concerning that a vast amount of money in the NHS is now being spent on clinical negligence claims. In their latest annual report and accounts, NHS Resolution estimates the total amount for clinical negligence claims it estimates it owes is £65 Billion. Damages paid to patients rose significantly from £950.4 million to £1,083.0 million, an increase of 14%. The high cost of clinical negligence is not sustainable and something must be urgently done to reduce the number of claims against the NHS.The issues were recently considered by the National Audit Office (NAO) who found:

-The cost of clinical negligence claims is rising at a faster rate year-on-year, than NHS funding.

-Even if successful, NHS Resolution and the Department’s current actions are unlikely to stop the growth in the cost of clinical negligence claims.

-The government lacks a coherent cross-government strategy, underpinned by policy, to support measures to tackle the rising cost of clinical negligence.

On the patient safety side, there is little more for the NHS to celebrate. There have been improvements but patient safety in hospitals  is still the main concern for the NHS health and social care regulator, the CQC (Care Quality Commission). They say in their latest report that they have seen a clear improvement overall in safety and across each of the sectors they regulate and rate since the introduction of their new system of regulation. However, there is still a large amount of variation in the quality of care of services across the NHS, within individual hospitals and between hospitals in the same NHS acute trust (hospital). At hospital level, 40% of acute hospitals were rated as good and 6% were rated as outstanding. Just under half of hospitals (49%) were rated as requires improvement with 5% rated as inadequate. Overall, they say this is a slightly improved picture compared with last year, although variation in the quality of care remains. Seven per cent of NHS acute hospitals were rated as inadequate for safety.

In a recent article on patient safety, the Secretary of State for Health, Jeremy Hunt has pondered as to whether the NHS has reached a patient safety crossroads. We must say that even after sustained efforts to improve patient, there is a lot still to do, we cannot rest on our laurels. He provides an excellent overview of the NHS patient safety agenda.

An Analysis of Five Years of Cerebral Palsy Claims in the UK

By John Tingle

NHS Resolution, an arm’s length body of the Department of Health that manages clinical negligence and other claims brought against the NHS in England, have just published a report on cerebral palsy legal claims. These claims are complex and result in large awards of compensation. In 2016-17, whilst the obstetrics specialty accounted for only 10% of the 10,686 claims received, they represented 50% of the £4,370 Million value of claims received.

Once case may cost £20 Million or more for one child. The report shows that the same errors are often being repeated and that key patient safety lessons go unlearned. The report analyses the data held by NHS Resolution on its claims management system on compensation claims for cerebral palsy that occurred between 2012-2016.There were 50 claims between this period that were suitable for review with a potential financial liability greater than £390 Million. This figure excludes the costs of defending the claim and the wider cost impact on the NHS as a whole. The results of the report are split into two parts. Part one looks at the quality of the serious incident (SI) investigation reports and part two looks at arising clinical themes. Continue reading

IRBs Advise Physician Involvement in Informed Consent

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.” Continue reading

Current trends in clinical negligence litigation in the National Health Service (NHS)

By John Tingle

NHS Resolution (the new operating name for the NHS LA, National Health Service Litigation Authority) occupies a central role in the NHS clinical negligence claims environment. They manage clinical negligence claims on behalf of NHS trusts (hospitals) and other bodies. They also provide indemnity cover and have an increasing role in assisting the NHS with risk management and patient safety.

NHS Resolution have recently published their Annual Report and Accounts which contains important data, trends, case studies and other information on clinical negligence and patient safety. This report also very clearly signals the new more inclusive, upstream, closer to the problem approach that NHS Resolution is now taking to its work.

Facts, figures and trends Continue reading

The Rising Cost of Clinical Negligence: Who Pays the Price?

By John Tingle

The Medical Protection Society (MPS) have recently published a report arguing that the rising costs of clinical negligence needs to be urgently controlled. They state that the NHS is struggling under the increasing burden of clinical negligence costs and suggest some reforms.The report is detailed and thorough and raises some good and interesting points but in reading it, it should be remembered that there is also a very good contrary position that can be advanced by those who act for patients in clinical negligence litigation. This report puts the issues to test.

The Report

The report begins by looking at the increasing costs of clinical negligence claims. Costs have increased over the years and the figures are stark. The report quotes figures from NHS Resolution, the new name for the NHS LA (National Health Service Litigation Authority) who estimates that the provision for future clinical negligence costs, relating to claims arising from incidents that have already occurred, stands at £56.1 billion:

“Expenditure on clinical claims by NHS Resolution increased by 72% (11.5% a year on average) over the five years to 2015/16. Should this trend continue it risks becoming wholly unsustainable for the NHS and wider society, which ultimately pays for these cost. Last year alone, nearly £1.5billion was spent and, put into context, this equates to the cost of training over 6,500 new doctors.(p4).” Continue reading

More on the ECJ Vaccine Liability Decision

By Alex Stein

My friend and mentor, the former Israeli Chief Justice Aharon Barak, used to say that when neither side likes the court’s decision, chances are that the court was right. This is likely to be the case with the European Court of Justice (ECJ) decision on vaccine manufacturers’ liability, N.W. et al. v. Sanofi Pasteur MSD, C‑621/15. Popular press reacted to this decision with sharp criticism that included unsubstantiated assertions about the European law of products liability, about what the Court did and did not say, and about the economics of vaccines. My short blog-post, which appeared here, offered a more positive (and hopefully more informative) assessment of this decision and its implications. I argued that the decision was balanced and well grounded in the principles of evidence and products liability. The follow-ups and subsequent analyses that appeared in Nature, Science and Hipertextual (in Spanish) have largely vindicated the decision (while citing some of its critics alongside the decision’s supporters such as myself).

To remove any remaining confusion about the implications of the ECJ decision, I thought I should clarify the Court’s statement that a vaccine liability suit can only succeed when the plaintiff proves that the vaccine complained against was “defective” within the meaning of Article 6(1) of the European Council Directive on products liability (85/374/EEC) (the Directive). Critics of the Court’s decision have uniformly missed this important proviso. Continue reading

WHO: Global Patient Safety Leadership

By John Tingle

The World Health Organisation (WHO) has just produced a very informative and helpful report on the need to view patient safety as a global concern and to highlight resources that they have made available to deal with the problem and those in development. Patient safety is a fundamental principle of health care and this is fully acknowledged in the report. The report begins by quoting several facts and figures which emphasize the fact that medical errors should be regarded as a matter of acute global concern:

“According to a new study, medical errors are the third leading cause of death in the United States. In the United Kingdom, recent estimations show that on average, one incident of patient harm is reported every 35 seconds. Similarly, in low- and middle income countries, a combination of numerous unfavourable factors such as understaffing, inadequate structures and overcrowding, lack of health care commodities and shortage of basic equipment, and poor hygiene and sanitation, contribute to unsafe patient care (p1).”

Approximately two-thirds of all adverse health events happen in low-and middle-income countries. Fifteen per cent of hospital expenditure in Europe can be attributed to treating patient safety accidents. Continue reading

Psychiatrists’ Liability for Patient’s Violence Against Other People: Washington Supreme Court Abolishes the Inpatient-Outpatient Distinction

By Alex Stein

In a recent decision, Volk v. DeMeerleer, 386 P.3d 254 (Wash. 2016), the Washington Supreme Court relaxed the “control” prerequisite for psychiatrists’ duty to protect third parties against violent patients.

The Court made this decision in a case involving a psychiatric patient who murdered his girlfriend and her nine-year old son and then committed suicide (after attempting to kill the girlfriend’s older son as well). For nine years leading up to that tragedy, the patient received outpatient care from the defendant psychiatrist, during which he expressed suicidal and homicidal ideations (without naming the potential victims).

The Court held that the psychiatrist had a “special relationship” with the victims because he was able to control the patient. Correspondingly, the psychiatrist had a duty to exercise “reasonable care to act consistent with the standards of the mental health profession, in order to protect the foreseeable victims of his or her patient.” The Court reasoned in this connection that some ability to control the patient’s conduct is sufficient for the “special relationship” and the consequent duty of care to exist. For that reason, psychiatrists should assume responsibility not only for an inpatient’s actions, but also in connection with an outpatient’s violence against third parties. Continue reading

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

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. Continue reading

President Trump’s Tort Reform

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.

Continue reading

Patient Safety in the NHS: The Culture Change Agents

By John Tingle and Jen Minford 

It is important to take a broad holistic approach when looking at patient safety policy development and practice in the NHS. There cannot be a one size fits all approach and a number of possibly quite disparate organisations and stakeholders in the NHS and beyond must be consulted and involved so that effective and positive culture change takes place.

The  CQC (Care Quality Commission) is a major patient safety culture change agent whose job is to ensure that health and social care services provide people with safe, effective, compassionate and high-quality care. The CQC encourages care service providers to be on an upward trajectory of improvement. They have recently produced a report to analyse what impact they have on quality and improvement in health and social care. The report provides evidence that the CQC is having a significantly positive impact  on regulating care and ensuring good standards.

A majority of new providers and registered managers responding to a CQC survey said that their guidance and standards are clear. The CQC approach to regulation and their standards have an influence on how some providers measure their own quality. CQC inspection reports were also said to be useful. Continue reading

Reflection and Review at The National Health Service Litigation Authority (NHS LA)

By John Tingle

The NHS LA is a pivotal organisations in the NHS whose work has a daily impact on the lives of patients and on all those who work in the health service. The NHS LA  have recently published its new five year strategy which reveals some very interesting and informative data, trends, insights into patient safety and regulation, governance and litigation.

NHS LA functions

If you work as a solicitor, lawyer handling  NHS clinical negligence claims, acting either for an injured patient or a hospital  then the NHS LA will be a daily feature of your professional life. They appoint solicitors to act for the hospital or other NHS organisation which is being sued from an approved panel of law firms and manage the claims process. Continue reading

The Economics of Patient Safety: Adopting a Value-based Approach

By John Tingle

The OECD (Organisation for Economic Co-operation and Development) have recently published a report on the economics of patient safety.The report is in two main sections, section 1, the cost of failure and section 2, reducing harm effectively and efficiently.

Section 1 focuses on a review of the literature in the area. The reports begins by making the point that health care has always been and continues to be, a risk-laden activity:

“While modern medical sciences can certainly do more, the risks of complication, error and harm are commensurately greater.” (p.9)

The report states that adverse health care events can happen at any point of the patient’s journey and can vary between care settings. Similar causative factors can be attributed to most types of harm.On the world patient safety stage, the report states that despite global efforts to reduce the burden of patient harm in developing countries, the situation does not appear to have changed over the past 15 years. WHO data is cited from 2000 which indicates that two –thirds of all adverse events occurred in low-and middle income countries. The risk of patient death as a result of an adverse event appears to be much higher in developing countries with some estimates suggesting that as many as one in three adverse events result in the patient’s death. The report does suggest some ways forward in avoiding adverse health care events in developing countries. Continue reading

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

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. 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

NHS patient care and treatment errors: developing a learning culture.

By John Tingle

PACAC, the House of Commons, (Public Administration and Constitutional Affairs Committee) has just published its analysis of the PHSO’s, (Parliamentary and Health Service Ombudsman ) second report into the tragic death of Sam Morrish, a three year old child whose death from sepsis was found to have been avoidable. PACAC  is composed of MP’s (Members of Parliament) and its remit includes considering matters relating to the quality and standards of administration provided by civil service departments which includes the Department of Health. PACAC also examines the reports of the PHSO.

The PACAC report is very thorough and detailed and really gets to grips with the issues surrounding NHS (National Health Service) health adverse incident investigation. It addresses very clearly the current challenges and opportunities in this area and puts forward some major concerns which need to be fully addressed by the NHS before it can be said to have a listening and learning culture. It is clear from reading the report that the NHS has a very long way to go before it can be said to be even close to reaching its listening and learning culture attainment goal.

The PACAC report also identifies what could be regarded as some muddled thinking by the Department of Health on the concept of the ‘safe space’ in NHS investigations and identifies some important patient safety policy gaps.

Continue reading

The High Cost of Clinical Negligence Claims

By John Tingle

In the UK, the Department of Health (DH) have just published a consultation paper on introducing fixed recoverable costs in lower value clinical negligence claims. The document contains some controversial proposals which many claimant, patient lawyers are very concerned about. They feel the proposals will make it much harder for patients with lower value claims to find a solicitor to fight their case .The publication of the consultation paper comes in the wake of criticism that some clinical negligence claimant lawyers, solicitor firms , make excessive and unreasonable costs demands. The NHS LA (The National Health Service Litigation Authority) which manages negligence and other claims against the NHS in England states:

“Claimant costs for lower value claims are disproportionate and excessive. For claims where compensation is less than £10,000, claimant lawyers recover almost three times more in costs on average.”(p.10)

The DH Consultation Paper begins by stating the annual cost of clinical negligence in the NHS. It has risen from £1.2bn in 2014/15 to £1.5bn in 2015/2016.Legal costs were 34% of the 2015/16 expenditure.The consultation paper states that the current system of claims resolution is often lengthy and adversarial. This creates what can be termed a dual problem. Delaying possible learning of lessons from incidents and also escalating the costs of litigation when claims are brought. Continue reading

Tort Law: Public and Private

By Alex Stein

Readers interested in medical malpractice might be interested in seeing—and commenting on—my new article, The Domain of Torts, forthcoming in 117 Colum. L. Rev. (2017).

This Article advances a novel positive theory of the law of torts that grows out of a careful and extensive reading of the case law. The Article’s core insight is that the benefit from the harm-causing activity determines the form and substance of tort liability. This finding is both surprising and innovative, since tort scholars universally believe that the operation of the doctrines that determine individuals’ liability for accidents—negligence, causation, and damage—is driven by harms, not benefits. The key role of benefits in the operation of our tort system has eluded the searching eye of scholars, even though it is fully consistent with the case law.

Specifically, this Article shows that our tort system operates in two parallel modes—private and public—rather than just one, as conventional accounts erroneously suggest. Furthermore, the system’s mode of operation and the rules allocating liability for accidental harm are dictated by the type of the benefit sought by the alleged tortfeasor. If the benefit sought by the tortfeasor is purely private, she will be held liable for the harm resulting from her actions whenever she exposes her victim to a nonreciprocal risk. The tort system never allows actors to inflict harm on others when the benefit they seek to derive from their activity is purely private, no matter how significant that private benefit is relative to the victim’s harm. The system consequently does not hesitate to discourage the production of private benefits even when they are economically more valuable than the victim’s safety. That is, in cases of private benefit, tort law excludes cost-benefit analysis in favor of the reciprocity and equality principles. When the benefit that accompanies the harm-causing activity is public, by contrast, tort law adopts a strictly utilitarian approach and focuses exclusively on minimizing the cost of accidents and the cost of avoiding accidents as a total sum. Liability in such cases is imposed based on the famous Learned Hand formula (and similar formulations). Accordingly, if the benefit from the harm-causing activity is greater than the expected harm and precautions are too costly, no liability will be imposed. The consequent reduction in the victim’s protection is counterweighted by society’s need not to chill the production of public benefits that the victim enjoys on equal terms with all other members of her community. Continue reading

Trap for the Unwary Works Again: Federal Healthcare and the Limitations Provision of the Federal Tort Claims Act

By Alex Stein

The same story involving a federally qualified health center (FQHC) repeats itself again, again, and now again: see Phillips v. Generations Family Health Center, — Fed.Appx. —- (2016), 2016 WL 5340278 (2d Cir. 2016).

A patient from Connecticut receives medical treatment from a physician who works at a Connecticut-based facility known as Generations Family Health Center. This center is an FQHC and the physician is consequently deemed a federal employee pursuant to 42 U.S.C. § 233(g)-(n) (as explained, inter alia, in Phillips v. Generations Family Health Center, 723 F.3d 144, 145 (2d Cir. 2013)). The patient is unaware of this fact even though she could easily find it on the center’s website and in this database that belongs to the Department of Health and Human Services (DHHS). Subsequently, when the patient suspects that her physician committed malpractice, she and her attorney sue him in a Connecticut court because they believe him to be just a regular doctor from Connecticut. Alas, they could only sue the physician according to the Federal Tort Claims Act (FTCA) after going through a mandatory administrative claim process at DHHS. 28 U.S. Code §§ 1346 (b)(1), 2675. When they realize it, the suit becomes time-barred pursuant to the FTCA, 28 U.S. Code § 2401 (b) (“A tort claim against the United States shall be forever barred unless it is presented in writing to the appropriate Federal agency within two years after such claim accrues or unless action is begun within six months after the date of mailing, by certified or registered mail, of notice of final denial of the claim by the agency to which it was presented.”). Continue reading

National Survey Suggests that Off-Label Status is Material to Informed Consent

By Christopher Robertson

As many readers of this blog know, the FDA requires that, prior to entering the market, companies prove safety and efficacy for each intended use of their products, but physicians are then free to prescribe the products for any other uses.  (Companies are not allowed to promote off-label uses however.)

A recent national survey by Consumer Reports includes two interesting findings:

  1. About two-thirds (63%) of Americans “would not take a doctor prescribed medication that has been approved by the FDA, but not for their specific condition.”
  2. Almost all Americans (94%) “say they have never been told by a physician that a medication they were taking was not approved by the FDA for their condition.”

Patients are right to be skeptical of off-label uses, though they may not appreciate just how common they are.  In fact, most off-label use is unsupported by scientific evidence as to safety and efficacy.  A new report by the FDA illustrates several off-label uses that were subjected to rigorous clinical trials and turned out to be ineffective or dangerous.   For example, Aliskiren is approved for treatment of hypertension and was used off-label for prevention of congestive heart failure (CHF) complications.  A large trial showed that, although it did not significantly improve CHF mortality, it did significantly increase rates of kidney failure for CHF patients.  We do not know how many other off-label uses would fail if similarly tested.   Continue reading