One thing that strikes the UK visitor to the USA is the vast array of large public and private hospitals that exist with many having trauma and emergency rooms. Private hospitals don’t exist on this scale in the UK. Our major hospitals are public, state run NHS (National Health Service) hospitals. Independent, private acute hospitals are generally small in size, have no emergency rooms and maintain a bespoke health care provision. The focus is on patients with a single condition and routine elective surgery. The myriad number of complex multiple conditions, dementia etc that the NHS regularly face as a norm are not covered in the independent sector here with such cases being screened out. This limited focus on the type of care provided does mean that staff within independent acute hospitals have a sheltered and more controlled work remit and environment. This is a significant patient safety issue.
The Independent Health and Social Care Regulator of England, the Care Quality Commission (CQC) have recently published their findings of independent acute hospital inspections. They inspected and rated 206 independent acute hospitals and the majority were assessed as providing high quality care. At 2nd January 2018, 62% were rated as good,16 (8%) as outstanding. The report contains some very positive findings on health care provision in these hospitals but also some major governance and patient safety failings were found which are very concerning.
The Independent Newspaper reported back in 2015 reported that private hospitals ‘lack facilities to deal with emergencies’, and quoted a study that found that between 2010 and 2014, 800 patients, including those referred by the NHS, died unexpectedly in private hospitals. Continue reading →
Failings in National Health Service (NHS) care for patients with mental health problems is a worryingly persistent story in the English media. Many reports show harrowing and dramatic failings in NHS care provision for the mentally ill some of which result in avoidable deaths.The Health Service Ombudsman (HSO) represents the final stage in the NHS complaints procedure and is an independent office reporting directly to Parliament.The HSO carry’s out investigations into complaints and makes the final decisions on those that have not been resolved by the NHS in England.In a recently published report the HSO reveals reveals unjust, shocking and tragic failings in NHS care provision for patients with mental health problems.Some mental health care complaints figures are given in the report.In 2016-2017 there were 14,106 complaints made to NHS mental health trusts (hospitals) with ,65% being upheld or partly upheld by the local organisation.Case work data between 2014-15 and 2017-18 was analysed and five key themes showing persistent failings that the HSO see in complaints being made emerged from this exercise:
Diagnosis and failure to treat.
Risk assessment and safety
Dignity and human rights.
Inappropriate discharge and provision of aftercare.
The HSO also points out in the report that the other common factor in the cases examined is too frequent substandard complaint handling by the NHS organisation. This adds insult to injury, compounding the impact of failings. Continue reading →
STEIN on Medical Malpractice has recently published a survey of noteworthy court decisions in the field for 2017. This survey includes an important decision, Weaver v. Myers, 229 So.3d 1118 (Fla. 2017), that voided Florida statute allowing defendants in medical malpractice suits to hold ex parte interviews with the aggrieved patient’s care providers.
The case at bar involved a medical malpractice suit filed in connection with the patient’s allegedly wrongful death. The defendants attempted to take advantage of Florida’s pre-suit discovery statute, Fla. Stat. Ann. §§ 766.106, 766.1065. This statute authorized defense attorneys to hold secret ex parte interviews with all doctors and organizations that have ever provided treatment to the deceased patient.
The Florida Supreme Court decided that this statute violates the broad constitutional right to privacy under Fla. Const. art. 1, § 23. The Court reasoned that “The ex parte secret interview provisions of sections 766.106 and 766.1065 fail to protect Florida citizens from even accidental disclosures of confidential medical information that falls outside the scope of the claim because there would be no one present on the claimant’s behalf to ensure that the potential defendant, his insurers, his attorneys, or his experts do not ask for disclosure of information from a former treating health care provider that is totally irrelevant to the claim.” The Court also clarified that “the right to privacy in the Florida Constitution attaches during the life of a citizen and is not retroactively destroyed by death. Here, the constitutional protection operates in the specific context of shielding irrelevant, protected medical history and other private information from the medical malpractice litigation process. Furthermore, in the wrongful death context, standing in the position of the decedent, the administrator of the decedent’s estate has standing to assert the decedent’s privacy rights. Finally, the Legislature unconstitutionally conditioned a plaintiff’s right of access to courts for redress of injuries caused by medical malpractice, whether in the wrongful death or personal injury context, on the claimant’s waiver of the constitutional right to privacy.”
STEIN on Medical Malpractice has published a survey of noteworthy court decisions in the field for 2017. This survey includes an important decision, North Broward Hospital District v. Kalitan, 219 So.3d 49 (Fla. 2017), that voided Florida’s cap on medical malpractice victims’ noneconomic damages, Fla. Stat. Ann. §§ 766.118(2), 766.118(3).
Section 766.118(2) provides that in a cause of action for personal injury arising from the medical negligence of practitioners, the noneconomic damages award shall not exceed $500,000 per claimant; however, if the negligence resulted in a permanent vegetative state or death, or if the negligence caused a catastrophic injury and a manifest injustice would occur unless increased damages are awarded, then damages may be awarded in an amount up to $1 million. Section 766.118(3) similarly limits damages to $750,000 and $1.5 million, respectively, when the injury results from the negligence of non-practitioners.
Based on the precedent laid down in McCall v. United States, 134 So.3d 894 (Fla. 2014), and discussed here, (holding Florida’s cap on wrongful-death noneconomic damages unconstitutional), the Florida Supreme Court held that Section 766.118 violates the Equal Protection Clause of the Florida Constitution. Art. I, § 2, Fla. Const. The Court reasoned that Section 766.118 arbitrarily reduces the damages that may be awarded to the most drastically injured victims and that this arbitrary reduction is “not rationally related to alleviating the purported medical malpractice crisis…”
STEIN on Medical Malpractice has published a survey of noteworthy court decisions in the field for 2017. This survey includes an important decision, King v. Bryant, 795 S.E.2d 340 (N.C. 2017), that examines the validity of a doctor-patient agreement to arbitrate disputes over medical malpractice.
A front desk employee at a surgeon’s practice provided the patient with several intake forms to complete and sign while he waited to meet the surgeon. The forms included an agreement to arbitrate medical malpractice disputes, which the patient signed without reading (together with other documents) because he believed it to be “just a formality.” After an unsuccessful surgical procedure, the patient sued the surgeon in court for medical malpractice. The surgeon filed a motion to stay the action and enforce the arbitration agreement. The trial court denied the motion after finding the arbitration agreement unconscionable. The Court of Appeals affirmed that decision and the surgeon appealed to the North Carolina Supreme Court. Continue reading →
The Guardian newspaper recently published it’s investigation into Coroners Prevention of Future Deaths Notices (PFDN’s) issued between 2012-2017 involving people receiving NHS care for mental health conditions. The findings from its investigation are shocking; many cases deaths could have been prevented had better care been given. Some errors identified are classic patient safety errors and these included:
Poor communication between agencies and/or staff, non-observation of protocols or policies (or lack of protocols or policies.
Lack of appropriate care or continuity of care.
Poor record keeping, poor communications with the patient or his or her family.
Insufficient risk assessment and delays.
The investigation revealed 45 cases reported by the coroner where patients were discharged too soon or without adequate support. Seventy-two instances of poor or inappropriate care, 41 cases where treatment was delayed.
Children and young people’s mental health The Care Quality Commission (CQC) is the the independent regulator of health and social care in England and they have recently reviewed children and young people’s mental health services and have found significant systems failures which could well put children and young people at risk of harm. Mental health problems are the report states, quite common in children and young people with estimates suggesting around 1 in 10 being affected.
STEIN on Medical Malpractice has published a survey of noteworthy court decisions in the field for 2017. This survey includes an important decision, Doherty v. Merck & Co., Inc., 154 A.3d 1202 (Me. 2017), featuring reproductive negligence.
The plaintiff, Kayla Doherty, visited a federally-supported health care center in Maine to inquire about birth control options. Her physician recommended an implantable drug manufactured by the defendant, the Merck company. The drug consisted of a single, four-centimeter-long rod inserted under the skin of the inner side of the patient’s upper arm with a syringe-like applicator. The drug works by inhibiting ovulation and is designed to be effective for at least three years unless the rod is removed sooner by a physician. The drug’s applicator, however, occasionally malfunctioned: it had a history of failed insertion attempts that occurred when the rod would remain stuck in the applicator following the procedure (unbeknownst to the treating physician and the patient).
The Care Quality Commission (CQC) is the independent regulator of health and social care in England and they have recently produced their annual report to Parliament on how health services are applying the Mental Health Act 1983 (MHA) .This report, shines a very strong light on failing health care practices in mental health care relating to the MHA. Shocking failures are revealed and the errors are compounded by the fact that the poor practices have been identified in previous reports and are long standing in nature.
The CQC state that national data from the last 25 years shows an increasing use of the MHA to treat people in hospitals. From 2005/06 to 2015/16, the reported number of uses of the MHA to detain people in hospital increased by 40%. There was a 9% increase from 2014/15 to 2015/16 rising to 63,622 uses of the MHA. The CQC can find no single cause for the increases in detention rates over the last 10 years.
The CQC once again draw attention to the persistent theme present in its previous reports of black and minority ethnic over representation figures in the use of the MHA.
The CQC found that there are still services that continue to fail in their legal duties to give patients information about their rights, verbally and in writing as soon as possible after their detention or community treatment order commences. They found no evidence that staff had discussed rights with the patient on admission in 11 % (378) of patient records that they checked. In a further inspection of 9%, (286) of records, no evidence could be found to say that patients received the information in an accessible format.
Consent to treatment
The CQC state that they have concerns about whether the patient consents, refuses consent or is incapable of consent. They expect to see capacity assessments to support views and possibly evidence that staff have considered ways in which they could help the patient gain or regain capacity. They have frequently raised concerns over whether clinicians have recorded evidence of their conversations with patients who are detained over their proposed treatment and their views. Continue reading →
A common theme found in patient safety reports in England going back as far as the year 2000 is that the NHS (National Health Service) is poor at learning lessons from previous adverse health incident reports and of changing practice. The seminal report on patient safety in England, Organisation with a memory in 2000 stated:
“There is no single focal point for NHS information on adverse events, and at present it is spread across nearly 1,000 different organisations. The NHS record in implementing the recommendations that emerge from these various systems is patchy. Too often lessons are identiﬁed but true ‘active’ learning does not take place because the necessary changes are not properly embedded in practice.” (x-xi).
In late 2003 our NRLS (National Reporting and Learning System) was established.This is our central database of patient safety incident reporting. Can we say today that the NHS is actively learning from the adverse patient safety incidents of the past and changing practice? That the NRLS has been a great success? Or is the jury still out on these questions? Unfortunately the jury is still out. Sadly, there is no shortage of contemporary reports saying that the NHS still needs to improve its lesson learning capacity from adverse events.
UK national and social media have been buzzing all last week about a letter sent on Monday 29th January 2018 by the NHS Confederation to the Justice Secretary and copying in the Secretary of State for Health.BBC news set the scene under the banner headline, ‘Curb rising NHS negligence pay-outs, health leaders urge’.
The NHS Confederation is a charity and membership body that brings together and speaks on behalf of all organisations that plan, commission and provide NHS services. Members are drawn from every part of the health and care system. The letter coordinated by them had several co-signatories in the medical establishment including the Chief Executives of the doctor’s defence organisations, the British Medical Association (BMA), The Academy of Medical Royal Colleges. The letter said that the current level of NHS compensation pay-outs is unsustainable and is diverting significant amounts of funding away from front line care services. Last year the NHS spent £1.7 billion on clinical negligence claims, representing 1.5 % of front line health services spending. This annual cost has almost doubled since 2010/11 with an average 11.5 % increase every year:
In tort law we have a very well-known Latin phrase, ‘Res Ipsa Loquitur’ (the thing speaks for itself). An inference of negligence can be raised by the events that occurred. In the National Health Service (NHS) in England there is a similar concept,‘the Never Event’. The Never Event concept is a USA import into the NHS and was introduced from April 2009. The list of what is to be regarded as a Never Event has been revised over the years in the NHS and is currently set out by NHS Improvement.
Never events include, wrong site surgery, wrong implant/prosthesis, retained foreign object post procedure, mis-selection of a strong potassium solution, administration of medication by the wrong route and so on. Never Events are defined in NHS policy documentation as:
“…patient safety incidents that are wholly preventable where guidance or safety recommendations that provide strong systemic protective barriers are available at a national level and have been implemented by healthcare providers. Each Never Event type has the potential to cause serious patient harm or death. However, serious harm or death does not need to have happened as a result of a specific incident for that incident to be categorised as a Never Event.” (p.6)Continue reading →
The House of Commons Committee of Public Accounts (Committee of Public Accounts) has recently considered the issue of managing the increasing clinical negligence costs in NHS (National Health Service) hospitals in a report. They make a number of important recommendations as well as putting into the spotlight a number of developing trends and themes. The report is linked to a report recently published by the National Audit Office on managing clinical negligence costs.This report is closely examined by the Committee with witnesses giving oral and written evidence.
The high cost of clinical negligence litigation
The report begins with a statement on the high and increasing cost of clinical negligence which sets the scene and tone for the rest of the report The Committee has raised concerns about the rising costs of clinical negligence on a number of previous occasions going back as far as 2002. The questions and answers of witnesses called by the Committee do reveal some very interesting and telling insights into the issues and the problems faced. Continue reading →
The Department of Health and the government in England have published a draft Bill for discussion which will create a Health Service Safety Investigations Body (HSSIB) with powers enshrined in law. The HSSIB replaces the current Healthcare Safety Investigation Branch (HSIB) which operates under the umbrella of NHS Improvement and came into operation in April 2017. Unlike the HSIB, the new HSSIB will be independent of the NHS, and have its own statutory power base. The HSSIB will not be responsible for investigating all serious patient safety incidents in the NHS and existing frameworks will remain.
Eight fact sheets have been published by the Department of Health to accompany the draft Bill which explain its purpose and rationale and how everything will work. It is expected that the HSSIB will investigate up to 30 serious patient safety issues a year and will have an annual budget of £3.8 Million.
It will be important for the HSSIB to manage public and NHS expectations of what it can actually achieve given its small budget, staffing and the number of investigations that it intends to carry out. There are around 24,000 serious patient safety incidents a year in the NHS. The small-scale operation of the HSSIB can be justified as it will act as an exemplar of good investigative practice and will cascade down standards into the NHS.
In terms of NHS health quality and patient safety regulation, the Care Quality Commission (CQC) occupies a pivotal role as the independent regulator of health and social care in England. How well it performs its function is fundamental to the health of the nation. The CQC functions and operations has been recently put under the microscope by the National Audit Office (NAO).The NAO scrutinises public spending for Parliament, making sure it is well spent. Both good and bad findings are made on the work of the CQC in the report and a number of recommendations are made.
On reading the report it’s fair to say that overall the CQC is doing a good job but there are deficiencies identified which need to be remedied. The report is divided into four parts: Continue reading →
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 shortage of resources in the face of a seemingly insatiable demand for its services. Balancing finite resources against near 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 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), which 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.
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 →
Muchhasbeenwritten 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 →
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.
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 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 →
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 →