Caps on medical malpractice verdicts raise real issues of due process, right to trial and fundamental fairness. Therefore, it seems appropriate to occasionally publicize med mal cases that illustrate the incredible human burdens created by medical errors that could be remedied with better systems that actually require follow-up. Accordingly, here’s the full text of  a July 24, 2018 story from the Chicago Daily Law Bulletin.

 

“By Jordyn Reiland 
Law Bulletin staff writer

Cook County jurors awarded $12 million to the family of a woman who died from lung cancer three years after a chest X-ray revealed an abnormality doctors never told her about.

Renee Chiero sued several of the doctors who treated her mother, Doris Newberry, contending they failed to diagnose and treat the cancer she had leading up to her death in September 2013.

The verdict is higher than any previously reported cancer-related wrongful-death verdict or settlement, according to John L. Kirkton editor of the Jury Verdict Reporter, a product of Law Bulletin Media.

The last similar case with a large award was a $5.25 million verdict from 2003 involving a delayed cervical cancer diagnosis, Kirkton said.

Chiero’s suit named Alexian Brothers Medical Group, St. Alexius Medical Center, her mother’s primary care physicians Wanda Iza and Jeffrey Lindahl of Alexian Brothers, radiologist Jeffrey Chung of Radiological Consultants of Woodstock LLC and St. Alexius emergency room physician Michael Frumkin.

On July 24, 2010, Newberry went to St. Alexius Medical Center emergency room in Hoffman Estates because she was experiencing shortness of breath.

Frumkin ordered a chest X-ray, initially read it as “normal,” decided to prescribe Newberry with antibiotics and sent her home.

Chung also read the X-ray, but he found an abnormality in her lung. He put a note in Newberry’s chart recommending a follow-up X-ray in three months but Newberry was never told to do so, according to Chiero’s attorney John J. Perconti of Levin & Perconti.

Three weeks later, Newberry followed up with Iza on her own. Although Iza had the chart with Chung’s note, neither she Lindahl, whom Newberry saw after Iza left the practice, told Newberry about the abnormality or to seek a follow-up X-ray, Perconti said.

Newberry was diagnosed with lung cancer in December 2012 by another physician and she died from Stage Four lung cancer on Sept. 9, 2013.

The verdict was reached Thursday after a Daley Center trial before Circuit Judge Thomas V. Lyons II.

Iza, Chung, and Lindahl were found liable but Frumkin was not.

A series of deals brokered before the verdict will affect how the defendants split up the damages.

Chiero’s attorneys entered into a high-low agreement with Frumkin. The high was $700,000 and the low was $250,000, Perconti said. As a result of the verdict in his favor, Frumkin will owe $250,000 of the $12 million.

Frumkin’s attorney, Robert L. Nora of Nora & Partners LLP, said his client’s care was not what was at issue, rather the jury had to determine whether he had an obligation to follow-up on Chung’s recommendation and radiological analysis of the patient’s X-ray.

“The jury correctly found that the obligation did not exist,” he said.

Frumkin was also represented by Taylor V. Nora of Nora & Partners LLP.

Perconti also entered into a high-low agreement with Chung — the high was $2 million and the low was $500,000. He’ll owe $2 million of the $12 million in damages.

Iza and Lindahl’s attorneys offered a $100,000 low and $1 million high agreement, which was rejected, Perconti said. They’ll be left to cover the amount not paid through the settlements.

Chiero is also represented by Michael F. Bonamarte IV and Cari F. Silverman of Levin & Perconti.

“We trust doctors to figure out what’s wrong and to begin treatment right away, to give patients the best possible chance at survival, or, at the very least, the best possible quality of life in the time they have. When doctors don’t live up to the trust we put in them, they have to face consequences,” Bonamarte said in a press release.

Chung is represented by Amy L. Anderson of Brenner Monroe Scott & Anderson Ltd. She could not be reached for comment.

Iza and Lindahl are represented by Michael E. Prangle and Elizabeth M. Neidig of Hall Prangle & Schoonveld LLC. They could not be reached for comment.

The case is Renee Chiero v. Wanda Iza, M.D., et al., 14 L 7734.”

We continue to see increases in the the scale and pace of the development of molecular and genetic knowledge. A recent example arises from the announcement of serious plans for detailed analysis of 500,000 blood samples for 200 biomarkers. That’s impressive by itself.

Then, note the related factors. The new data will be related back to and added to the UK Biobank, which already has genetic information about many of the people. And, the data will be made public for research after 9 months of  exclusive use of the data for Nightingale.

The complete text of Nightingale’s June 21, 2018 press release provides more specifics on the project:

“Nightingale Health, the Finnish innovator of an internationally recognized blood biomarker technology for studying chronic diseases, will analyse the biomarker profiles of 500,000 blood samples from UK Biobank. The ground-breaking research initiative was announced today at the UK Biobank Scientific Conference 2018 in London.

Nightingale’s biomarker profiling technology will be used to analyse UK Biobank blood samples by measuring metabolic biomarkers that recent studies have found are predictive of future risk for heart disease, type 2 diabetes and many other common chronic diseases. Until recently, technological constraints and prohibitive costs have prevented the analysis of comprehensive metabolic data from large-scale biobank collections, but this process has been made viable by Nightingale’s technology, which measures over 200 metabolic biomarkers in a single blood test.

This initiative will further enrich the world’s most detailed public health database provided by the UK Biobank.

Professor Sir Rory Collins, UK Biobank’s Principal Investigator, said the commitment by Nightingale to perform these assays would allow researchers around the world to advance health research more quickly. He expects the combination of these biomarker data with the detailed health information that participants have already provided to generate many new insights. “We are delighted to see these novel blood sample analyses being done in UK Biobank,” said Professor Collins. “We already have an enormous amount of information about the lifestyles and genetic make-up of the participants in UK Biobank, as well as about their health, and are currently conducting imaging studies of their brains, hearts and bodies. Providing the medical research community with these additional high quality metabolic biomarker data on such a large scale will enhance discovery science and population science, providing opportunities to benefit patient care and public health.”

“Analysing 500,000 blood samples from a single study with Nightingale’s comprehensive biomarker profiling technology allows us to uncover metabolic signatures that reflect a risk for future disease onset, as well as their underlying risk factors. We anticipate this detailed molecular readout of the health state, combining both lifestyle and genetic makeup, will result in a wealth of scientific applications from the research community. This will be relevant not only to the British population but also yield ground-breaking science and enhanced drug development opportunities with a global public health impact,” said Dr. Peter Würtz, Scientific Director and Founder, Nightingale Health.

Nightingale Health’s technology has been previously used to analyse more than 500,000 blood samples from over 200 cohort studies and clinical trials around the globe, with more than 150 peer-reviewed publications showcasing how the detailed metabolic biomarker data provide novel insights into health and disease.

“Nightingale’s mission is strongly linked to scientific evidence generation. This means working with world-leading institutions and biosample collections to continuously improve the understanding of health and disease. Our aim is to translate this understanding into improved early prediction of diabetes and cardiovascular diseases, achieving better healthcare for everyone. Our initiative with the UK Biobank demonstrates Nightingale’s unwavering commitment towards supporting innovative medical science carried out by researchers from across the world,” said Teemu Suna, CEO and Founder, Nightingale Health.

The initiative corresponds to over 10 million EUR investment in UK Biobank and will be funded by Nightingale Health, with analyses of UK Biobank samples being performed at Nightingale’s laboratory in Finland. In line with the founding principles of the UK Biobank, this metabolomic data will be incorporated back into the UK Biobank’s resource following a 9 months exclusivity period for Nightingale Health and made openly available to the scientific community.

###

Media contact:

Teemu Suna, CEO & Founder 
Nightingale Health 
teemu.suna@nightingalehealth.com 
+358 40 196 1669

Nightingale Health:

Nightingale Health Ltd. is the innovator of an internationally recognized NMR (Nuclear Magnetic Resonance) metabolomics technology, supplying biomarker analysis services for human serum, plasma, urine, CSF and umbilical cord blood samples. By measuring biomarkers from multiple pathways in a single experiment, Nightingale equips biomedical researchers with comprehensive insights into the effects of lifestyle factors and future disease risk, accelerating breakthroughs in precision medicine. The company is investing and working towards integrating its technology into clinical practice to bring about precision medicine, helping to empower patients to follow their own well-being and take proactive steps to stay healthy.

For more information, please visit https://www.nightingalehealth.com

UK Biobank:

Andrew Trehearne, Head of Communications 
UK Biobank 
Andrew.Trehearne@ukbiobank.ac.uk 
+44 1865 743960

About UK Biobank

UK Biobank is the most comprehensive resource of its kind in the world. Its 500,000 participants have provided information about their health, well-being and lifestyle, as well as blood and other biological samples for long-term storage and analysis. In addition, they have agreed to have their health followed through medical records for many years. Scientists from around the world are able to use the resource for research intended to improve the prevention and treatment of a wide range of common disorders. UK Biobank is funded by the Medical Research Council, Wellcome Trust, Department of Health, Welsh Government, Scottish Government, British Heart Foundation, Cancer Research U.K. and Diabetes U.K.

Yesterday’s punitive damages verdict against J&J arrived after interesting questions from the jury to the court. One wonders how J&J will account for the questions on a going forward basis. As reported by LAW360, the questions were as set out below:

“Law360, Los Angeles (May 24, 2018, 1:09 PM EDT) — A California jury found Thursday that Johnson & Johnson should pay $4 million in punitive damages a day after finding that asbestos in its talc baby powder was responsible for a woman’s mesothelioma and awarding the woman $21.7 million in compensatory damages.
***
The jury began deliberations on Thursday morning posing questions to the court, asking if any punitive damages would go to Anderson and whether they could circumvent monetary punitive damages and instead punish the defendants by requiring them to place a warning label on their products.

The court responded that yes, any punitive damages would go to Anderson, and no, the jury could not order a warning label.”

Therapy with CAR-T cells (artificially modified t-cells) is a “hot” idea these days in cancer therapy.  Last week, the Mesothelioma Applied Research Foundation highlighted some early days, limited success in researchers at MMSK using CAR T cells in a clinical trial setting involving treatment of persons suffering from mesotheliomas; see this May 18, 2018 article.  The article highlights a first report titled: Phase I Clinical Trial of Malignant Pleural Disease Treated with Regionally Delivered Autologous Mesothelin-Targeted CAR T Cells: Safety and Efficacy – A Preliminary Report.   The full article abstract is online here. For optimists, the key sentence is one that reports a “remission,” as follows:

“One patient with MPM had complete metabolic response on PET scan (3E5 CAR T cells/kg and 10 cycles of anti-PD1 therapy to date); this patient remains clinically well 8 months after CAR T-cell infusion, with evidence of CAR T-cell persistence in peripheral blood and tissue at 31 weeks.”

For lawyers, on either side of the aisle, one might think about the implications of increased survival time and/or perhaps even better. One might also think about the expenses/damages.  When procedures of this sort are provided as part of a clinical trial, the patient does not pay. But, the hospital and drug company do incur expenses and pay fees. And, the sponsors of the trials hope to create working therapies that will cost notable dollars if approved by the FDA.

Jock McCulloch (and colleagues) wrote multiple books attacking companies that manufactured and/or sold asbestos-containing products in Australia or South Africa.  They include Asbestos – Its Human Cost (1986),  Asbestos Blues: Labour, Capital, Physicians & The State in South Africa (2002), and Defending the Indefensible (2008).   As fate would have it, he died of mesothelioma on January 18, 2018 in Melbourne. A tribute to Mr. McCulloch is online here at IBAS, written by Laurie Kazan-Allen. According to Ms. Kazan-Allen’s article, Mr. McCulloch had preferred to “contain” news of the cancer that would kill him.

Agent Orange. Two words that drove massive litigation and helped to drive increased scientific research, including the Human Genome Project.  Some say Agent Orange has caused tens of thousand of injuries in US soldiers. Others focus on multiple generations of profoundly deformed people who live in Vietnam.

Agent Orange is back in the news at a science and law intersection point. The news arises because of yet more delay by the VA in making additional decisions on compensation for veterans.  Further specifics are provided in a November 2, 2017 article by Pro Publica.  No matter what the decision, expect controversy.

A recent article explains that mesotheliomas in South Korea are projected to increase over the years ahead, mainly because of demographics, according to these authors. The article is  “Estimated future incidence of malignant mesothelioma in South Korea: Projection from 2014 to 2033.”

The abstract explains:

“Malignant mesothelioma is a malignant tumor on the pleura or the peritoneum caused mostly by asbestos. Although asbestos is not currently used in South Korea, the incidence of mesothelioma is increasing due to its long latent period. This study predicted the incidence of malignant mesothelioma in South Korea over the next 20 years using an age-period-cohort (APC) model. Data regarding mesothelioma incidence from 1994-2013 were acquired from the Korea Central Cancer Registry (KCCR). Demographic data, including prospective resident data, were acquired from the Korean Statistical Information Service (KOSIS) for 1994-2033.

An APC model with Møller’s power-link function was utilized to predict the incidence of mesothelioma. It was predicted that 2,380 and 1,199 new cases of mesothelioma in men and women, respectively, would occur over the next 20 years. For both sexes, the mesothelioma incidence rate was predicted to be greater in 2029-2033 compared to that in 2009-2013 (men, 0.282 vs 0.563; women, 0.155 vs 0.217). For men, the age-standardized incidence rate was predicted to be slightly greater in 2029-2033 relative to the rate in 2009-2013 (0.228 vs 0.235), while the age-standardized incidence rate in women decreased within the same timeframe (0.113 vs 0.109).

The changes in mesothelioma incidence were mostly caused by changes in the population structure due to aging and not by changes in the mesothelioma risk ratio. The results of this study project a continuous increase in mesothelioma incidence in South Korea over the next 20 years. Although the projected increase in mesothelioma incidence was not related to an increase in the mesothelioma risk ratio, continuous preventive efforts are necessary to reduce the exposure to asbestos and prevent the trend from worsening.”

The article is online and open access:  Kwak KM, Paek D, Hwang SS, Ju YS. Estimated future incidence of malignant
mesothelioma in South Korea: Projection from 2014 to 2033. PLoS One. 2017 Aug
17;12(8):e0183404. doi: 10.1371/journal.pone.0183404.

The molecular revolution continues, with continuing implications for improving our understanding of how external events effect our cells.  As part of that journey, a group of researchers recently used CRISPR to embed a video into DNA and then retrieve it from the DNA, as described in a July 12, 2017 article at Stat News.  Why? One goal of this work is to learn how to get cells to record what happens to them. A key quote: “With this work, Shipman said they eventually want to create “molecular recorders,” which are living cells that could sense things in the environment, like toxins or heavy metals, and record and store that information within their DNA.”