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

Advancing the Global Patient Safety Agenda

By John Tingle and Jen Minford

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

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

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.

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

By John Tingle

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

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

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

Undocumented Organ Transplants

By Brad Segal

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

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

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

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.

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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

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.

Housing Equity Week in Review

We’ve rounded up the latest news from the past week, January 9-15, 2017, for housing law and equity. The HUD confirmation hearing was, of course, the biggest news, but a few other items of note:

Did we miss anything? Let us know!

“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

Health Equity in Housing Book Club: “Knocking on the Door”

Q&A with Christopher Bonastia, PhD

This is the first in a series of posts we will share during our research for our housing equity project. Have a suggestion for what we should read next? Let us know.

In his 2006 book, Knocking on the Door: The Federal Government’s Attempt to Desegregate the Suburbs, Christopher Bonastia, PhD, reviews the federal government’s role in perpetuating residential segregation in the United States, and its fleeting attempts to desegregate the nation’s neighborhoods.

Dr. Bonastia discusses the active role federal agencies and courts have played in creating and perpetuating residential segregation. He points to the Home Owners’ Loan Corporation, the Federal Housing Administration, the Veterans Administration, and the US Department of Housing and Urban Development as significant players in segregation and desegregation.

Understanding the roots of segregation and policy attempts to desegregate is key to understanding housing as a social determinant of health. Empirical research has shown associations between black-white segregation and an increased black infant mortality rate, elevated rates of black mortality, black homicide rates, and other negative individual and public health outcomes. Addressing racial residential segregation is imperative when attempting to improve any of those health outcomes.

Christopher Bonastia is professor of sociology at Lehman College and the City University of New York Graduate Center, as well as associate director of the Lehman Scholars Program and Macaulay Honors College at Lehman. He is the author of Southern Stalemate: Five Years without Public Education in Prince Edward County, Virginia as well as Knocking on the Door: The Federal Government’s Attempt to Desegregate the Suburbs.

Our team read Knocking on the Door during our initial research period on housing, health equity and legal levers. Continue reading below for our interview with Dr. Bonastia about this book and ongoing research in this area.

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CMS Prohibits Arbitration Clauses in Long-Term Care Facility Contracts

By Wendy S. Salkin

On Wednesday, the Centers for Medicare and Medicaid (CMS)—an agency within the Department of Health and Human Services (HHS)—released a final rule that “will revise the requirements that Long-Term Care facilities [LTCs] must meet to participate in the Medicare and Medicaid programs” (1). (Almost all LTCs receive funds from Medicare or Medicaid.) This is the first time that these requirements have been “comprehensively reviewed and updated since 1991” (6)—that is, in the past 25 years. One of the most striking changes to the regulation is found in §483.65, where CMS “require[es] that facilities must not enter into an agreement for binding arbitration with a resident or their representative until after a dispute arises between the parties” (12) which means that CMS is “prohibiting the use of pre-dispute binding arbitration agreements” (12). Among the reasons provided by CMS for this change is a recognition of the notable power differential between LTCs and their residents:

There is a significant differential in bargaining power between LTC facility residents and LTC facilities. LTC agreements are often made when the would-be resident is physically and possibly mentally impaired, and is encountering such a facility for the first time. In many cases, geographic and financial restrictions severely limit the choices available to a LTC resident and his/her family. LTC facilities are also, in many cases, the resident’s residence. These facilities not only provide skilled nursing care, but also everything else a resident needs. Many of these residents may reside there for a prolonged period of time, some for the rest of their lives. Because of the wide array of services provided and the length of time the resident and his/her family may have interactions with the LTC facility, disputes over medical treatment, personal safety, treatment of residents, and quality of services provided are likely to occur. Given the unique circumstances of LTC facilities, we have concluded that it is unconscionable for LTC facilities to demand, as a condition of admission, that residents or their representatives sign a pre-dispute agreement for binding arbitration that covers any type of disputes between the parties for the duration of the resident’s entire stay, which could be for many years. (402-403)

As The New York Times reported, when the rule was first proposed in July 2015, it was “aimed at improving disclosure.” But, this final version of the rule “went a step further than the draft, cutting off funding to facilities that require arbitration clauses as a condition of admission.”

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Child safeguarding: the National Health Service (NHS) can do much better

By John Tingle

Our children are our future and we need to look after them well. There is however a lot of evidence to suggest that we are failing our children in a number of key health areas. UNICEF in a report put the UK in 16th position – below Slovenia, the Czech Republic and Portugal – in a league table of child well-being in the world’s richest countries. The report considers five dimensions of children’s lives – material well-being, health and safety, education, behaviours and risks, and housing and environment – as well as children’s subjective well-being.

There are a number of health and other child well-being challenges for the UK to meet. The UNICEF report provides some useful context from which to view the recently published Care Quality Commission (CQC) report on the arrangements for child safeguarding and healthcare for looked after children in England.The CQC is the independent regulator of health and social care in England.Whilst the report does contain some positive findings, when read as a whole, these seem subsumed by the large number of negative findings, some of which are very worrying. 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

Amicus brief in Sequenom v. Ariosa: Why the U.S. Supreme Court should grant the petition for a writ of certiorari

I am happy to announce that on April 20th the New York attorney Robert M. Schwartz and I have filed an amicus brief at the US Supreme Court with Berkeley-based Andrew J. Dhuey as Counsel of Record. The brief, which was signed by 10 prominent  European and Australian Law Professors as amici curiae, adds a European perspective to the many amicus briefs that have been submitted in support of Sequenom’s petition for certiorari to the United States Supreme Court. Sequenom’s petition in Case No. 15-1182 was filed on March 21, 2016 and seeks review of the Federal Circuit’s controversial decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, reh’g denied, 809 F.3d 1282 (Fed. Cir. 2015). The case concerns the revocation of Sequenom’s patent claims directed to inventive methods of genetic testing by detecting and amplifying paternally inherited fetal cell-free DNA (cffDNA) from maternal blood and plasma. Before the development of this highly beneficial, non-invasive prenatal diagnostic test, patients were placed at higher risk and maternal plasma was routinely discarded as waste. Distinguishing this case from previous Supreme Court decisions and highlighting the mitigating effects of other patentability requirements, we are concerned that the Federal Circuit’s overly rigid approach to claims eligibility decision might jeopardize the development of new therapies in an increasingly important area of modern medicine.

As most Bill of Health readers know, the US Supreme Court has in a recent series of cases (i.e. the combined effect of Bilski, Prometheus, Myriad and Alice) barred the patent eligibility for many genetic inventions as “products and processes of nature”. In Sequenom the CAFC interpreted these to mean – in essence- that “laws of nature” had to be entirely eliminated from the test of patent eligibility under §101 of the Patent laws. Should this interpretation be institutionalized it will contravene the tests for exclusions and exceptions under the EPC, arguably contradict longstanding US treaty policy and disrupt international patent harmonization. More importantly, we fear that the broader impact of such an restrictive interpretation may have grave consequences for a sustainable global drug delivery system, which should involve both public and private actors.

Although we believe that patents will remain the backbone of the industry, we acknowledge in our brief that  there are certain areas of biomedical innovations, such as antibiotics and orphan drugs, where the patent system does not work particularly well. We further recognize that both in Europe and in the US concerns have been raised about overly pre-emptive patents scope, but these are addressed at different levels. In contrast to Europe, the CAFC has interpreted the uncodified exception as part of a “threshold test” for patent-eligibility applied before other patentability requirements can be assessed. A strict and coherent application of these requirements, however, would invalidate overly-broad patent claims (including some of Sequenom’s arguably too broad and badly drafted claims), while also permitting, well-defined, narrower claims on diagnostic technology. In our view, the current approach conflates the patent eligibility test with issues that can be more sensibly addressed within a strict and coherent assessment of novelty, non-obviousness and sufficient disclosure criteria or at the post-grant level. We believe that, the Federal Circuit’s threshold test has not sufficiently considered the manner in which today’s statutory requirements have developed in both the U.S. and Europe to address policy rationales for patentability exceptions. To entirely transplant those issues into the patent eligibility assessment would categorically close the patentability door on many well-defined and beneficial inventions that deserve patent protection. In absence of sufficient public involvement and appropriate alternative incentives we risk that the wells driving technological progress run dry and that companies engage in business strategies, such as increased reliance on trade secrecy, that are not necessarily beneficial for our innovation system.

Accordingly, we urge the Supreme Court to clarify a patent eligibility test in line with its longstanding jurisprudence and in harmony with international and European law.

If the CAFC’s restrictive interpretation should prevail, however, I believe that it will be crucial to swiftly optimize the framework for PPPs and alternative innovation incentives, such as prizes and regulatory exclusivities. This would have to be done on an international level to allow for greater flexibilities and encompass further technological areas, such as biomedical diagnostics. Regarding regulatory exclusivities, Article 39 of the TRIPS agreement should provide sufficient leeway for such changes. The pros and cons of the different alternative approaches would of course have to be carefully considered.

The Amici curiae have no stake in the parties or in the outcome of the case. A full list of the Amici is appended at the end of the brief.

 

What do doctors know about FDA drug approval standards and the breakthrough therapy designation? Less than we’d hope.

By Dalia Deak

A study published this week in JAMA examined how much physicians know about FDA approval standards for new drugs and the breakthrough therapy designation. The investigators found major gaps in understanding with regard to both issues, despite intuitive beliefs to the contrary.

For the study, Kesselheim et al. conducted a national survey of board-certified internists and specialists. They selected a random sample of 300 clinically active internists and 900 specialists in endocrinology, hematology, and infectious diseases from the American Board of Internal Medicine’s diplomate list. Of the 1,148 physicians contacted, 692 physicians, or 60%, responded.

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Regulating genetically modified mosquitoes

By Dalia Deak

Fears of spreading zika virus have renewed interest in the use of genetically modified mosquitoes to suppress disease, with recent attention focused on the UK firm Oxitec. Last week, the developing public health crisis around zika prompted the federal government to tentatively clear a small-scale field test for the first time in the United States, pending a public comment process on a draft environmental assessment submitted by Oxitec. It should be noted that a final approval for the trial will not be made until the FDA completes the public comment process.

The genetically modified insects, which are male Aedes aegypti mosquitoes, are designed to breed with the female Aedes aegypti mosquito (primarily responsible for transmitting zika, dengue fever, and other diseases) and contain a gene lethal to their offspring. The female mosquitoes lay eggs but the larvae die well before adulthood. Oxitec claims that recent tests have shown up to a 90% decrease in the population of the Aedes aegypti mosquito, with a recent test in Piracicaba (~100 miles from Sao Paulo in Brazil) showing an 82% decline. Tests have also been conducted in the Cayman Islands and Malaysia.

In the United States, Oxitec is in the process of waiting for FDA approval to conduct trials in the Florida Keys. However, this is relatively unclear and uncharted territory for the federal government in terms of what group should be responsible for the review, and the decision for the CVM jurisdiction in this case remains hotly debated. Jurisdictional debate exists between the U.S. Department of Agriculture and the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Veterinary Medicine (CVM).

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In Flint, Echoes of DC Lead Crisis

By Dalia Deak

The public health crisis in Flint, MI is a long way from resolved. The short-term public health effects have been staggering, a state of emergency has been declared in the city, uncertainty looms in the long-term, and the city, state, and federal government have a serious trust issue on their hands.

Last April, the city of Flint changed its water source from Lake Huron to the Flint River in an effort to reduce mounting financial pressure on the city. However, the new water source corroded the city’s old pipes, leaching lead into the water. Adding insult to injury,
when residents complained about the taste, smell, and appearance, or attributed rashes and other medical conditions to the water source, city officials told residents that they were continually monitoring the levels to ensure that they were safe (a claim which has been called into question). Despite concern over the quality of the water dating back almost immediately after the switch, a state of emergency was declared when parents started bringing children in to the pediatrician for concerns about delayed development. When researchers at Hurley Medical Center looked into the issue, they found that the proportion of infants and children with above-average lead levels close to doubled after the switch. Residents filed a class-action lawsuit against the Governor, the state, the city, and 13 public officials in November for damages from the high levels of lead in the water, claiming that their 14th amendment right was violated when the city took away their safe drinking water and replaced it with a cheaper, more dangerous alternative.

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