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

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

Does an Arbitration Clause in a Nursing Home Agreement Preclude Tort Actions Relating to the Resident’s Wrongful Death?

By Alex Stein

Arbitration clauses in nursing home agreements are pretty much standard. Whether such a clause precludes tort actions complaining about the resident’s wrongful death is consequently an important issue.  The Pennsylvania Supreme Court has recently addressed this issue in Taylor v. Extendicare Health Facilities, Inc., 147 A.3d 490 (Pa. 2016). In that case, the resident’s family members sued the nursing home in their individual capacity as derivative victims of the alleged tort (the wrongful death action) and as representatives of the resident’s estate (the survival action). In the wrongful death action, the plaintiffs sought compensation for the emotional harm they sustained from losing their loved one prematurely and possibly for their economic losses as the resident’s dependents (the Court’s decision provides no details on that). The survival suit, on the other hand, focused on the resident’s entitlement to be compensated for pain and suffering and other harms she sustained from the alleged negligence. This entitlement belonged to the resident’s estate rather than her successors as individuals.

The agreement between the resident and the nursing home contained a standard compulsory arbitration provision that covered any resident’s suit against the nursing home. This provision consequently extended to the survival action, but not to the wrongful death suit filed by the nonparties to the agreement. However, under Pennsylvania Rule of Civil Procedure 213(e), wrongful death and survival actions cannot be bifurcated and must be tried together. Based on that rule, the trial court decided that the two actions must be consolidated, and because one of the actions fell outside the scope of the arbitration provision, both actions should go to trial.

The Pennsylvania Supreme Court overturned this decision for failure to account for the Federal Arbitration Act (FAA), as interpreted (inter alia) in Southland Corp. v. Keating, 465 U.S. 1, 3 (1984); Moses H. Cone Mem’l Hosp. v. Mercury Constr. Corp., 460 U.S. 1, 20 (1983); Dean Witter Reynolds, Inc. v. Byrd, 470 U.S. 213, 218 (1985); AT & T Mobility LLC v. Concepcion, 563 U.S. 333, 346 (2011); and KPMG LLP v. Cocchi, 132 S.Ct. 23, 26 (2011).  Continue reading

The Ill-Designed “Continuous Treatment” Rule for the Health Law of Massachusetts

By Alex Stein

Under Massachusetts law, suits alleging medical malpractice in a treatment of a minor patient must be filed “within three years from the date the cause of action accrues.” G.L.c. 231, § 60D. In a recent case, Parr v. Rosenthal, 57 N.E.3d 947 (Mass. 2016), the Supreme Judicial Court of Massachusetts decided that a patient’s continuous treatment by the same physician can toll this period under certain restrictive conditions. One of those conditions requires the plaintiff to show that the physician continued to treat the patient “for the same or related condition” after committing the alleged malpractice, and that “treatment” in that context includes supervision of, as well as consultation and advice to, other treating physicians. Another condition makes continuous treatment part of the discovery rule that moves the onset of the limitations period to the day on which the patient knew or could have reasonably suspected that her physician treated her negligently. According to the Court, continuous treatment instills in the patient “innocent reliance” that the physician treats her properly, which makes the physician’s malpractice not reasonably discoverable. Moreover, innocent reliance can even be present when the patient realizes that she sustained harm from the physician’s treatment. As the Court explained, “A patient who continues under the care of the same physician will still have the same challenges in learning whether the harm [she] suffered from the physician’s treatment arose from the physician’s negligence.” Based on these observations, the Court decided that the “continuous treatment” rule will not benefit patients who affirmatively suspected that they received negligent treatment from their physician. Such patients, the Court held, cannot show “innocent reliance.” Continue reading

Missed opportunities to learn from patient deaths in the NHS

By John Tingle

The National Health Service (NHS) in England’s quality regulator, the Care Quality Commission (CQC) has recently published a highly critical report on the way patient deaths are investigated in the NHS. The investigation follows events at the Southern Health NHS Foundation Trust where a number of failings were identified in the way patient deaths were identified and investigated. Certain groups of patients including people with a learning disability and older people receiving mental health care were far less likely to have their deaths investigated by this Trust. The Secretary of State for Health called for a CQC investigation into how acute, community and mental health NHS facilities across the country investigate and learn from deaths. The findings of the report are not good and major improvements in this area are needed across the NHS.

There are failings in openness, transparency and missed opportunities to learn important patient safety lessons. Families of patients and carers told the CQC reviewers that they often have a poor experience of investigations and are not always treated with kindness, respect, honesty and sensitivity. The CQC states that across their review they were unable to identify any NHS healthcare facility that could demonstrate good practice across all aspects of identifying, reviewing and investigating deaths and ensuring that learning from the events is implemented. Continue reading

Outpatient Psychiatric Treatment: The Duty to Prevent Patient Suicide

By Alex Stein

In Chirillo v. Granicz, — So.3d —- (Fla. 2016), 2016 WL 4493536, the Florida Supreme Court formulated an important rule for psychiatric malpractice cases. Back in 2001, the First District Court of Appeal decided that psychiatrists assume no liability for an outpatient’s suicide because it is generally unforeseeable. Tort liability, it held, can properly be imposed on a psychiatrist only for a custodial psychiatric malpractice. According to the First District, an inpatient’s suicide is foreseeable and psychiatrists can effectively prevent it by restraining the patient. Lawlor v. Orlando, 795 So.2d 147 (Fla. 1st DCA 2001).

The Florida Supreme Court has now overruled Lawlor. 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

Undiagnosed Cancer under Alabama’s Statute of Repose

By Alex Stein

Alabama Code Section 6–5–482(a) that extends to “all actions against physicians, surgeons, dentists, medical institutions, or other health care providers for liability, error, mistake, or failure to cure, whether based on contract or tort” prescribes, (inter alia) that –

“in no event may the action be commenced more than four years after such act.”

The Alabama Supreme Court interprets this provision as beginning the four-year repose period when the plaintiff suffers “legal injury” from the defendant’s malpractice. See Crosslin v. Health Care Auth. of Huntsville, 5 So.3d 1193, 1196 (Ala. 2008) (“‘[w]hen the wrongful act or omission and the resulting legal injury do not occur simultaneously, the cause of action accrues and the limitations period of § 6–5–482 commences when the legal injury occurs’” (quoting Mobile Infirmary v. Delchamps, 642 So.2d 954, 958 (Ala. 1994)). This interpretation is far more generous to plaintiffs than the conventional doctrine of repose, under which the countdown of the statutory repose period begins on the day of the physician’s malpractice even when the patient develops the resulting illness or injury later on. For my analysis of the conventional doctrine of repose, see here and here.

This plaintiff-friendly interpretation did not help the plaintiff in Cutler v. U. Ala. Health Services Foundation, — So.3d —- 2016 WL 3654760 (Ala. 2016). Continue reading

Medical Malpractice Under a National Health System and the ACA

By Matthew H. H. Young

What will happen to the current medical malpractice system under a single-payer system?

To answer this question, I started by looking at the information provided by Physicians for a National Health Program, whose mission is to replace the ACA (Affordable Care Act) with single-payer. On their website under Single-Payer FAQs, it says:

What will happen to malpractice costs under national health insurance?

They will fall dramatically, for several reasons. First, about one-fourth of all malpractice awards go to pay present and future medical costs (e.g. for infants born with serious disabilities). Single payer national health insurance will eliminate the need for these awards. Second, many claims arise from a lack of communication between doctor and patient (e.g. in the Emergency Department). Miscommunication/mistakes are heightened under the present system because physicians don’t have continuity with their patients (to know their prior medical history, establish therapeutic trust, etc) and patients aren’t allowed to choose and keep the doctors and other caregivers they know and trust (due to insurance arrangements). Single payer improves quality in many ways, but in particular by facilitating long-term, continuous relationships with caregivers. For details on how single payer can improve the quality of health care, see “A Better Quality Alternative: Single Payer National Health Insurance.” For these and other reasons, malpractice costs in three nations with single payer are much lower than in the United States, and we would expect them to fall dramatically here. For details, see “Medical Liability in Three Single-Payer Countries” paper by Clara Felice and Litsa Lambkros.

Let me address the most salient part of the above argument, which states that the significant burden of malpractice recoveries composed of future medical costs will be alleviated because all individuals will be insured. 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.

Sovereign Immunity Protects State-Owned Hospitals and Medical Personnel Against Malpractice Suits

By Alex Stein

Pike v. Hagaman, — S.E.2d —- 2016 WL 3097727 (Va. 2016), is a must-read for anyone interested in medical malpractice and health law. This new decision of the Virginia Supreme Court grants state-owned hospitals and their personnel categorical sovereign-immunity protection against medical malpractice suits. Continue reading

Medical Malpractice vs. General Negligence under California Law

By Alex Stein

In its recent decision, Flores v. Presbyterian Intercommunity Hosp., 369 P.3d 229 (Ca. 2016), the California Supreme Court has sharpened the critical distinction between “medical malpractice” and general negligence.

Under California statute, a plaintiff’s ability to file a medical malpractice suit expires in one year after the accrual of the cause of action. The statute tolls this period for two additional years, provided that the plaintiff files the suit within one year after he discovers the injury or could reasonably have discovered it. Cal. Code Civ. Proc. § 340.5 (providing that suits for medical malpractice must be filed “three years after the date of injury or one year after the plaintiff discovers, or through the use of reasonable diligence should have discovered, the injury, whichever occurs first.”). For other personal injury suits, the limitations period is “two years of the date on which the challenged act or omission occurred.” Cal. Code Civ. Proc. § 335.1.

In the case at bar, the plaintiff was injured when one of the rails on her hospital bed collapsed. Continue reading

Malpractice, Terminal Patients, and Cause in Fact

By Alex Stein

Any person interested in medical malpractice or torts in general must read the Missouri Supreme Court’s recent decision, Mickels v. Danrad, 486 S.W.3d 327 (Mo. 2016). This decision involved a physician who negligently failed to diagnose the presence of a malignant brain tumor, from which the patient was doomed to die. The patient first saw the physician when he experienced numbness, blurred vision, and headaches. The physician sent the patient to an MRI scan, which he subsequently reviewed but made no diagnosis. Eleven weeks later, the patient arrived at a hospital in an altered mental state and underwent a CT scan of his brain, which showed a malignant and incurable tumor. Four months later, the patient died of that tumor. According to patient’s oncologist – who testified as a witness in a subsequent malpractice trial – the tumor was incurable when the patient first saw the physician. The plaintiffs offered no evidence controverting that testimony. Continue reading

Tort Reform in Oregon: Constitutional, After All?

By Alex Stein

Three years ago, Oregon’s Supreme Court voided the state’s $500,000 cap on noneconomic damages for medical malpractice for violating the constitutional guarantee that “In all civil cases the right of Trial by Jury shall remain inviolate” (Or. Const., Art. I, § 17, as interpreted in Lakin v. Senco Products, Inc., 987 P.2d 463, modified, 987 P.2d 476 (Or. 1999)). Klutschkowski v. Oregon Medical Group, 311 P.3d 461 (Or. 2013). This cap also clashed with “every man’s” right to “remedy by due course of law for injury done him in his person, property, or reputation” (Or. Const., Art. I, § 10, as interpreted in Smothers v. Gresham Transfer, Inc., 23 P.3d 333 (Or. 2001), and in Hughes v. PeaceHealth, 178 P.3d 225 (Or. 2008)). The Court reasoned that a person’s right to recover full jury-assessed compensation for injuries recognized as actionable in 1857, when Oregon adopted its constitution, cannot be abolished or abridged by statute or common law. For my discussion of the Klutschowski decision, see here. For my discussion of a similar entrenchment principle adopted by the Utah Supreme Court in Smith v. United States, 356 P.3d 1249 (Utah 2015), see here.

The Oregon Supreme Court has now changed this course in a long precedential decision, Horton v. Oregon Health and Science University, — P.3d —- 359 Or. 168 (Or. 2016). Continue reading

The Reproductive Rights Case the Supreme Court Decided *Not* to Decide

By Dov Fox

The landmark abortion decision in Whole Woman’s Health v. Hellerstedt eclipsed quieter reproductive rights news out of the Supreme Court at the end of its term. It involves a couple’s claim that the Tennessee Supreme Court violated their equal protection rights by refusing to recognize “disruption of family planning as either an independent cause of action or element of damages.” You won’t have heard about this case. It wasn’t a merits judgment, but a decision not to decide. The Court’s denial of certiorari in Rye v. Women’s Care Center of Memphis has gone all but unremarked. It shouldn’t. This post lays out the arguments and why the Court (most likely) declined to hear it on appeal (without explaining its decision, as standard for cert denials). My updated article out in next year’s Columbia Law Review elaborates on the significance of professional wrongdoing that imposes, deprives, and confounds procreation in the face of people’s best efforts to plan a family.

The dispute arose during Michelle Rye’s third pregnancy. Rye has Rh negative blood, meaning that she produces antibodies that attack the blood cells of a Rh-positive fetus, potentially leading to serious harm in a born child. Doctors nowadays easily prevent this Rh-sensitization by injecting the pregnant woman with a compound called RhoGAM. But Rye’s doctor didn’t give her that injection. Now the couple couldn’t have more children of their own without risking serious health problems. Their Catholic faith took fetal testing and abortion off the table. They couldn’t even use birth control to prevent a risky pregnancy. Rye and her husband sued the doctor (who admitted negligence) for disrupting their family plans. Tennessee courts, all the way up to the state’s Supreme Court, rejected their claim. The courts held that the couple had not suffered the kind of injury that would support a legal cause of action. The Ryes’ petition to the U.S Supreme Court argued that the state Court’s refusal to recognize their claim denied them equal protection under the law. Continue reading