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

Housing Equity Week in Review

Here’s the latest news in housing law and equity, for the week of August 15-21, 2017:

  • The Urban Institute has released a new tool about using fair housing data. The report contains details on data sources related to demographics and segregation, housing, land use, disability, education, employment, environment, health, and public safety.
  • The Washington Post reports that California lawmakers are planning on putting housing as a top priority after the summer.
  • Richard Rothstein, author of the critically acclaimed book The Color of Law, writes an op-ed for the LA Times about the role law plays in maintaining racial segregation in Los Angeles.
  • From the Brookings Cafeteria Podcast: How past racial segregation predicts modern-day economic (im)mobility.
  • Durham County, the county with the highest eviction rate in North Carolina, is taking on the eviction crisis by launching an eviction diversion program. Story via IndyWeek.
  • Bill de Blasio signed the first law in the nation to establish a right to counsel for the poor in housing cases. Story via CityLab.
  • New York Magazine and ProPublica collaborate on an in-depth look into Ben Carson’s HUD.

Biobanks as Konwledge Institutions – Seminar 11/3 at the University of Copenhagen

Biobanks as Knowledge Institutions

“Global Genes –Local Concerns” Seminar with Prof. Michael Madison (University of Pittsburgh, U.S.)

Join us at the University of Copenhagen on November 3rd, 2017 to discuss the legal implications of “Biobanks as Knowledge Institutions” with Professor Michael Madison. 

Abstract

The presentation characterizes the material and immaterial attributes of biobanks as knowledge resources, and it characterizes the broader questions that they pose as resource governance questions rather than as questions solely of law or of public policy. Biobanks are knowledge institutions. Professor Madison argues that despite the varied and diverse nature of biobanks today (indeed, precisely because of their diversity), their social and scientific importance dictates the need for a robust program of research of a comparative nature to identify shared features that contribute to their success (where they succeed) and features that likely contribute to problems or even failure. Both their importance and the associated governance challenges have only grown larger and more complex as biobanks meet the era of data science. In that regard Professor Madison points to emerging scholarly literature that focuses on governance challenges of material and data in biobank contexts, which builds on a knowledge commons governance framework. He concludes by suggesting directions for future work. 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

Housing Equity Week in Review

Our latest round-up of the biggest stories in housing law and equity, for the week of June 12-18, 2017:

  • The Joint Center for Housing Studies of Harvard University released the yearly State of the Nation Housing report. The report encourages a renewed national commitment to expand the range of housing options available.
  • A NY State Appellate Court struck down a chronic nuisance ordinance in Groton, NY, because of provisions that led to the eviction of those who seek emergency services. Story via Ithaca.com
  • The Out of Reach report and tool that was published a couple of weeks ago by the National Low Income Housing Coalition is getting press around the country for showing the gap between current wages and rents in most US cities. This article, from CNBC highlights the lack of affordable housing for minimum wage workers.
  • An opinion piece in The Hill makes, again, the case for investment in housing as an investment in childhood development and health.
  • 79 people are presumed dead in the fire at Grenfell Tower in London. Some argue that the tragedy should be a red light for distressed public housing in the US.
  • The Philadelphia Inquirer posted its second article in its Toxic City series. This most recent article investigates lead-poisoned soil in the city’s River Wards neighborhoods. While lead paint is often considered the biggest danger to children, in these areas and others, the soil may be a great danger.

Housing Equity Week in Review

Affordable housing was the biggest topic of conversation last week, May 29-June 4. Here’s the week in review for housing equity and the law:

  • Vox published an interactive tool with “Everything you need to know about the affordable housing debate.” It covers issues from “What is affordable housing?” to gentrification, section 8, and zoning.
  • California’s State Senate and Assembly passed multiple laws to tackle the affordability crisis in California cities. Laws include more funding and relaxed regulation to build affordable housing units. Coverage via KQED.
  • Last week, HUD secretary Ben Carson said that, to a large extent, “poverty is a state of mind.” Today, Carson clarified that “state of mind” is just one component. Affordable housing advocates like Diane Yentel, of the National Coalition of Low Income Housing, responded that housing poverty is due in large to HUDs budget, not state of mind. Coverage via NPR.
  • The mortgage interest tax deduction is a controversial program that many critique as being beneficial mainly to the rich. Eliminating the mortgage interest tax deduction could make houses much more affordable. CityLab offers a way to make homes 10 percent more afforable.
  • Five hundred people lined up to try to get an apartment in a 88 unit development in Philadelphia, shedding light on the city’s affordability and homelessness crisis. Coverage via Philly.com.

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

Housing Equity Week in Review

Lots of news from the past week in housing equity and law. Check out the latest in the field from the week of April 10-17, 2017:

  • In his first television interview as Secretary of Housing and Urban Development, Ben Carson talked about the rich’s obligation to help the poor and the importance of private sector involvement in planning of housing policy. Coverage from NY Times.
  • Ben Carson’s listening tour arrived in Miami, where he then got stuck in an elevator at a public housing complex. Some advocates hope that this will be a live example of the need for more funds to maintain these facilities, via CBSNews.com
  • Chronic nuisance ordinances continue to be a driver for eviction, but do they have a disparate impact against victims of domestic abuse? Via the NY Times.
  • Baltimore is taking a new approach to neighborhood revitalization. Can it be done without gentrification? Via the Nation.
  • The Atlantic’s CityLab published a New Urban Crisis Index map!

Housing Equity Week in Review

The HUD budget was the big story the last week of March in housing law and equity. Here’s the week in review for March 27-April 2:

  • The largest story in housing is still the looming HUD budget cuts. The New York Times ran a story of a couple in Ohio, living well below the poverty line, who used the HOME Investment Partnership Program to renovate their home to make it habitable. The next year they voted for Trump. Now, Trump’s proposed budget is considering eliminating the HOME Program.
  • Secretary Ben Carson is currently on his listening tour. The first stop of the tour was Carson’s home town, Detroit (story via the Detroit Free Press). None of the Assistant Secretary positions have been filled so far.
  • Seattle’s stable, livable but expensive, housing market is undergoing a crisis and a dramatic spike in homelessness. The mayor started challenging the powers that be, seeking more input from renters and low income residents and not exclusively from affluent homeowners. Would this shakeup of traditional power lead to solutions to the crisis? Story via NextCity.

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

Global Genes, Local Concerns: A Symposium on Legal, Ethical and Scientific Challenges in International Biobanking

I am happy to announce our “Global Genes, Local Concerns Symposium on Legal, Ethical and Scientific Challenges in International Biobanking” to be held at the University of Copenhagen (DK) on 16 March 2017, 08:00-18:30. Among the many prominent experts speaking at this conference  we find the PFC’s very own Glenn Cohen and several speakers with a PFC “history” or close PFC links, such as Bartha Knoppers, Tim Caulfield, Nicholson Price and Jeff Skopek.

A detailed program and further information is available here and here.

This Symposium marks the final phase of the Global Genes-Local Concerns project. In accordance with the goals of this large cross-faculty project, the Symposium deals with legal, ethical and scientific challenges in cross-national biobanking and translational exploitation. Leading international experts and invited speakers will discuss how national biobanks contribute to translational research, what opportunities and challenges regulations present for translational use of biobanks, how inter-biobank coordination and collaboration occurs on various levels, and how academic and industrial exploitation, ownership and IPR issues could be addressed and facilitated. Special emphasis will be laid on challenges and opportunities in addressing regulatory barriers to biobank research and the translation of research results, while at the same time securing ethical legitimacy and societal interests.

These issues will be dealt with in 4 main sessions covering (1) BIG DATA AND MODES OF COLLABORATION; (2) PATIENT INVOLVEMENT; (3) TRANSLATIONAL MEDICINE & TECH TRANSFER, as well as (4) GUIDELINES & GOOD GOVERNANCE.

Speakers:

  • Bartha Knoppers, Mc Gill University (Canada)
  • Glenn Cohen, Harvard University (US)
  • Timo Minssen, University of Copenhagen (DK)
  • Tim Caulfield, University of Alberta (Can)
  • Michael Madison, University of Pittsburgh (US)
  • Jeff Skopek, University of Cambridge (UK)
  • Brian Clark, Director, Human Biosample Governance, Novo Nordisk A/S (DK)
  • Jane Kaye, University of Oxford (UK)
  • Anne Cambon-Thomsen, INSERM, Toulouse / CNRS Director (Fr)
  • Klaus Høyer, University of Copenhagen (DK)
  • Aaro M. Tupasela, University of Copenhagen (DK)
  • M. B. Rasmussen, University of Copenhagen (DK)
  • Åsa Hellstadius, Stockholm University (Sweden)
  • Peter Yu, A&M Texas University (US)
  • Esther van Zimmeren, University of Antwerp/Leuven (Belgium)
  • Nicholson Price, University of Michigan Law School (US)
  • Karine Sargsyan,  BBMRI/Head of Biobanking-Graz (Austria)
  • Eva Ortega-Paino,  BBMRI, Lund University (Sweden)
  • Nana Kongsholm, University of Copenhagen (DK)
  • Klemens Kappel, University of Copenhagen (DK)
  • Helen Yu, University of Copenhagen (DK).

For participation in the event please use this registration form no later than Friday, 10 March 2017, 12:00 at the latest.

We are looking very much forward to welcoming you in wonderful Copenhagen on 16 March 2017.

Best wishes/

Timo Minssen

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

Call for Papers – European Pharmaceutical Law Review (EPLR)

Dear Colleagues,

I am happy to announce that I have just joined the Board of Editors of the new journal “European Pharmaceutical Law Review” (EPLR). One of my first tasks is to spread the news about our “Call for Papers”. Further information is available here.

The European Pharmaceutical Law Review (EPLR) reports on key legislative developments in the EU and the Member States, and identifies and analyses important judgments that shape the interpretation and application of EU pharmaceutical law, in particular those by the European Courts, international courts and tribunals such as the WTO’s Dispute Settlement Body, and higher national courts.

In order to establish itself as a forum for dialogue between different stakeholders in pharmaceutical regulation and governance, it will invite contributions from academics, practitioners, regulators and civil society representatives. Topics covered by EPLR include:

  • Pharmaceutical law and policy in all jurisdictions (regional, national, international);
  • Commission decisions (EMA opinions) and regulatory guidelines;
  • National EU, and International Jurisprudence;
  • Medical devices;
  • Borderline cases: pharmaceuticals/food/cosmetics/chemicals
  • Patents /Trademarks;
  • Health Technology Assessment and pricing/reimbursement;
  • Digital health/Big data;

All contributions will be subject to double blind peer-review before acceptance for publication and are required to conform to the author guidelines.

We are looking forward to receive and review the first submissions!

Best wishes/ Timo

Housing Equity Week in Review

Last week, January 23-29, 2017, saw a mix of national and local-level housing news. Here’s our round-up for the past week:

  • Surprising some on the “Warren-wing” of the Democratic Party, Elizabeth Warren came out in support of Dr. Ben Carson as the 17th Secretary of Housing and Urban Development. In the confirmation hearing, Warren asked Carson if he can promise that no taxpayer dollar will go from HUD to developments’ of Donald Trump, then pointing out that it was a trick question since there was no financial disclosure,  no one knows exactly what how or what President Trump benefits from financially. However, due to promises to abate lead in housing and to protect from LGBTQ discrimination in housing markets, Warren decided not to stand in Carson’s way. Coverage via The Hill.
  • President Trump’s pick for Secretary Treasury, Steve Mnuchin, lied during his confirmation hearing about foreclosure practices of One West Bank while he was the chairmen and CEO, according to the Columbus Dispatch.
  • As the population ages, housing needs change. Are we keeping up with the new demand? New York Times opinion piece on the housing needs of the elderly.
  • Bay Area housing prices are going down due to building boom, via the Business Journal.
  • The National Low Income Housing Coalition released a statement in opposition of the Local Zoning Decisions Protection Act of 2017.

Did we miss anything? Let us know!

Housing Equity Week in Review

Here’s the latest in housing equity and law for the week of January 16-22, 2017:

Did we miss anything? Let us know.

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

Violations of federal antifraud provisions alleged against two hepatitis B treatment producers

By Wendy S. Salkin

Two investor class-action suits have been filed within days of one another against two different California-based pharmaceutical companies both of which produce hepatitis B treatments, Dynavax Technologies and Arrowhead Pharmaceuticals. The named plaintiffs in both shareholder class-action suits, David Soontjens and Yaki J. Meller, are represented by counsel at Pomerantz, LLP.[1]

Meller v. Arrowhead Pharmaceuticals, Inc., et al., complaint filed (C. D. Cal. Nov. 15, 2016)

On November 15th, named plaintiff Yaki J. Meller filed a Class Action Complaint in the United States District Court for the Central District of California against Pasadena-based Arrowhead Pharmaceuticals, Inc., its President and CEO (Christopher Anzalone), and its CFO (Kenneth Myszkowski). Arrowhead is a biopharmaceutical company that, according to its website, “develops medicines that treat intractable diseases by silencing the genes that cause them.”

Among its clinical stage drugs are ARC-520 and ARC-521, which “are designed to treat chronic hepatitis B virus infection by reducing the expression and release of new viral particles and key viral proteins with the goal of achieving a functional cure.” ARC-520 is the drug at issue. According to the Complaint, Arrowhead knew but failed to disclose that ARC-520 “could be fatal at its higher doses and that the FDA was unlikely to approve the treatment as a result.”[2] In particular, the Complaint alleges that Arrowhead:

made false and/or misleading statements and/or failed to disclose that: (i) the Company’s ARC-520 was unsafe at certain doses and caused deaths in an ongoing primate toxicology study; and (ii) as a result, Arrowhead’s public statements were materially false and misleading at all relevant times.

According to Meller’s Complaint, in so doing, Arrowhead violated Sections 10(b) (“Position Limits and Position Accountability for Security-Based Swaps and Large Trader Reporting.”) and 20(a) (“Liability to contemporaneous traders for insider trading.”) of the Securities Exchange Act of 1934, “Position Limits and Position Accountability for Security-Based Swaps and Large Trader Reporting” and “Liability to contemporaneous traders for insider trading,” respectively, and Securities and Exchange Commission Rule 10b-5, “Employment of manipulative and deceptive devices.”

Continue reading

New dimensions in patient consent to treatment

By John Tingle

In the patient care equation doctors  and nurses will always be in a more dominant and powerful position. They have the professional  knowledge the patient needs, they are in their usual environment. The patient is ill, not in their usual environment and is often thinking the worst about their condition. The law recognises the need to correct this power imbalance and cases have gone to court over matters such as patient informed consent to treatment. Modern cases emphasise the importance of patient autonomy against that of medical paternalism. In the House of Lords case of Chester v Afshar [2004] UKHL 41 involving consent to treatment failures, Lord Steyn stated:

“In modern law medical paternalism no longer rules and a patient has a prima facie right to be informed by a surgeon of a small, but well established, risk of serious injury as a result of surgery.” (Para 16).

The focus of the modern day law and that of many professional health organisations policy development is on patient rights, trying to balance the unequal care equation. Continue reading

“That I Don’t Know”: The Uncertain Futures of Our Bodies in America

By Wendy S. Salkin

I. Our Bodies, Our Body Politic

On March 30, at a town hall meeting in Green Bay, Wisconsin, an audience member asked then-presidential-hopeful Donald J. Trump: “[W]hat is your stance on women’s rights and their right to choose in their own reproductive health?” What followed was a lengthy back-and-forth with Chris Matthews. Here is an excerpt from that event:

MATTHEWS: Do you believe in punishment for abortion, yes or no as a principle?
TRUMP: The answer is that there has to be some form of punishment.
MATTHEWS: For the woman.
TRUMP: Yeah, there has to be some form.
MATTHEWS: Ten cents? Ten years? What?
TRUMP: I don’t know. That I don’t know. That I don’t know.

Much has been made of the fact that President-Elect Trump claimed that women who undergo abortion procedures should face “some sort of punishment.” Considerably less has been made of the fact that our President-Elect, in a moment of epistemic humility, expressed that he did not know what he would do, though he believed something had to be done. (He later revised his position, suggesting that the performer of the abortion rather than the woman undergoing the abortion would “be held legally responsible.”)

I am worried about the futures of our bodies, as, I think, are many. That a Trump Presidency makes many feel fear is not a novel contribution. Nor will I be able to speak to the very many, and varied, ways our bodies may be compromised in and by The New America—be it through removal from the country (see especially the proposed “End Illegal Immigration Act”), removal from society (see especially the proposed “Restoring Community Safety Act”), or some other means (see especially the proposed “Repeal and Replace Obamacare Act”).

But, I am like President-Elect Trump in this way: Like him, “I don’t know.” I don’t know what to say about what will happen to our bodies or to our body politic. So instead, today, I will take this opportunity to point to one aspect of the changing face of access to reproductive technologies that has already become a battleground in the fight over women’s bodies and will, I suspect, take center stage in the debate over the right and the ability to choose in coming years. Continue reading

Biosimilars – In The Pipeline or Still a Pipe Dream?

By Jonathan Larsen, JD, MPP and Adrienne R. Ghorashi, Esq.

The US Food and Drug Administration (FDA) approved the first biosimilar for use in the United States in March 2015. The approval came after several years of regulatory process development authorized by the Biologics Price Competition and Innovation (BPCI) Act of 2009, a component of the Affordable Care Act.

Biosimilars are highly similar, but not identical, copies of FDA-approved biologics, known as “reference” products. Biologics are used to treat a variety of diseases and medical conditions, including cancer. For many years, biosimilar development was thought to be too complex and too costly to advance, and exclusivity patents for reference biologics prohibited developers from marketing competing biosimilars. Now that those patents have started to expire, biosimilar development can finally begin, at a potentially huge benefit to patients.

Continue reading