Hypoxia, Brain

A C-section was not performed for over two hours after being ordered, leading to the child's asphyxiation and severe, lifelong disability, the plaintiffs said. The nonprofit health system intends to appeal the decision. A Michigan jury has found Detroit-based Henry Ford Health and some of its practitioners to be negligent in a case involving a delayed caesarean section and resulting severe disability. Jurors handed down the verdict March 28 and awarded $120 million in damages to a mother, Kristen Drake, and her 13-year-old son, K’Jon Drake, according to court documents. The minor has severe disabilities, plaintiffs said, and jurors agreed, which are the result of a Henry Ford obstetrician and hospital nurses’ failure to perform a C-section procedure for more than two hours. In a statement, the nonprofit health system told Fierce Healthcare it intends to appeal the decision. The case was filed in Michigan’s Wayne County Circuit Court in 2020. Plaintiffs were joined by the Michigan Department of Health and Human Services, which sought to recover money paid to support K’Jon Drake’s medical care. Kristen Drake had presented to Henry Ford Hospital in 2010, where fetal monitoring “began to show decelerations due to cord compression and decreased variability” after arrival, according to a court filing from the plaintiffs. The attending obstetrician called for a C-section that was “unnecessarily delayed” for two hours and 19 minutes, they wrote. “Obviously time is of the essence in delivering a baby who is showing non reassuring fetal heart tones. There is simply nothing to be gained by waiting,” plaintiffs wrote in a filing. “On the other hand delay can result in a baby becoming progressively more hypoxic to the point where he develops metabolic acidosis and can suffer hypoxic ischemic brain damage and other sequelae of intrapartum asphyxia. Tragically … that is exactly what happened in this case.” K’Jon Drake, who is now 13, lives with cerebral palsy, blindness and permanent brain damage due to that asphyxiation, plaintiffs said. He requires lifelong care, which until now was largely delivered by his mother and grandmother. The four-week medical malpractice trial culminated in the jury awarding about $120 million in damages for the family, part of which will be paid to the state’s health department. It represents a combination of past and future economic damages for needed care, future loss of wage earning capacity, and past and future noneconomic damages broadly related to pain and suffering. Henry Ford Health is an integrated care provider with more than 250 locations and five acute hospitals in Michigan. In an emailed statement, the nonprofit said it’s been “deeply saddened for the Drake family since the birth of their son more than a decade ago. “At the same time, we do not believe the verdict is consistent with the facts of this case and plan to vigorously appeal the jury’s verdict. Given the ongoing nature of the case, we are not able to provide any additional comment at this time,” the system wrote.

NORFOLK, Va.--(BUSINESS WIRE)-- ReAlta Life Sciences, Inc. (“ReAlta” or the “Company”), a mid-stage clinical biotech company dedicated to saving lives by rebalancing the inflammatory response to address life-threatening diseases, today announces that the company will be utilizing the preclinical services program offered by the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate RLS-0071 as a medical countermeasure for Acute Radiation Syndrome (ARS). Under a research collaboration, scientists at the Armed Forces Radiobiology Research Institute (AFRRI), working with support from the Radiation and Nuclear Countermeasures Program (RNCP) at NIAID, will evaluate the ability RLS-0071 to mitigate the gastrointestinal effects of ARS (GI-ARS) in a preclinical mouse model. “We are very pleased to partner with NIAID and AFRRI to evaluate ReAlta’s lead drug candidate, RLS-0071, as a radiation countermeasure for GI-ARS,” says Dr. Ulrich Thienel, Chief Executive Officer of ReAlta. “Our collaboration may provide a much-needed therapy for radiation-induced tissue damage that is associated with high mortality.” Dr. Neel Krishna, Chief Scientific Officer at ReAlta adds that, “the anti-inflammatory, dual mechanism-of-action of RLS-0071 enables the rapid inhibition of both complement activation and neutrophil effectors that are key initiators of deadly inflammation in ARS.” About the National Institutes of Health (NIH) As one of the 27 institutes and centers of the U.S. NIH, NIAID conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 60 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the U.S. and around the world. About AFRRI AFRRI was established in 1961 and operated by the U.S. Defense Atomic Support Agency and the Defense Nuclear Agency until 1993, when it was realigned with the Uniformed Services University of the Health Sciences (USUHS). AFRRI is unique and powerful radiobiological research institute, with six decades of active, robust, and outstanding support to the U.S. Department of Defense through research, reach-back, and education. It is the only U. S. Department of Defense medical R&D facility dedicated solely to nuclear and radiological defense. About Acute Radiation Syndrome ARS, also known as radiation sickness or radiation poisoning, is a collection of health effects that are caused by exposure to high amounts of ionizing radiation in a short period of time. Symptoms can start within minutes of exposure and can last for several months. Early symptoms are usually nausea and vomiting. In the following hours or weeks, initial symptoms may appear to improve, before the development of additional complications, after which either recovery or death follows. Exposure to radiation can occur accidentally or intentionally, and may involve nuclear power reactor accidents or attacks, certain devices used in cancer therapy, dirty bombs, or nuclear or radiological weapons. About ReAlta Life Sciences ReAlta Life Sciences, Inc. is a mid-stage clinical biotech company dedicated to saving lives by rebalancing the inflammatory response to address life threatening acute inflammatory and rare diseases. The Company’s EPICC peptides are based on research into the human astrovirus, HAstV-1, which causes a non-inflammatory, self-limiting gastroenteritis unique among viruses by inhibiting components of the innate immune system. ReAlta’s therapeutic peptides leverage these virus-derived mechanisms to rebalance complement and inflammatory processes in the body. The company’s pipeline is led by RLS-0071, which has received IND clearance by the U.S. Food and Drug Administration (FDA) for the treatment of acute exacerbations of chronic obstructive pulmonary disease and acute graft-versus-host disease, and IND clearance, Orphan Drug Designation, and Fast Track Designation by the FDA, and Orphan Drug Designation by the European Medicines Agency, for the treatment of hypoxic-ischemic encephalopathy (HIE). The company launched in 2018 and is located in Norfolk, Virginia and Aguadilla, Puerto Rico. For more information, please visit .

Acute radiation syndrome occurs when a person is exposed to high levels of ionising radiation, usually within a short period. Credit: Crystal Eye Studio via Shutterstock. US-based pharma company ReAlta Life Sciences has teamed up with the US National Institute of Allergy and Infectious Diseases (NIAID) to evaluate its acute radiation syndrome (ARS) drug RLS-0071 (PIC1-01). Scientists at the Armed Forces Radiobiology Research Institute (AFRRI), with support from the Radiation and Nuclear Countermeasures Program (RNCP) at NIAID, will assess RLS-0071’s effectiveness in reducing gastrointestinal damage from ARS using a mouse model in preclinical research collaboration. ARS is a severe condition that occurs when a person is exposed to high levels of ionising radiation, usually within a short period. Symptoms can vary depending on the dose and duration of exposure but typically include nausea, vomiting, diarrhoea, and in severe cases, damage to the gastrointestinal tract. Symptoms worsen as the radiation exposure increases. RLS-0071, ReAlta’s leading candidate, is a 15 amino acid peptide conjugated with polyethylene glycol (PEG) and acts by targeting the complement C1q. The drug has received investigational new drug (IND) clearance by the US Food and Drug Administration (FDA) for treating acute exacerbations of chronic obstructive pulmonary disease and acute graft-versus-host disease, and also holds IND clearance, orphan drug designation, and fast track designation for hypoxic-ischemic encephalopathy (HIE), as well as an orphan drug designation from the European Medicines Agency. In the announcement accompanying the collaboration, ReAlta’s chief scientific officer Neel Krishna said: “The anti-inflammatory, dual mechanism-of-action of RLS-0071 enables the rapid inhibition of both complement activation and neutrophil effectors that are key initiators of deadly inflammation in ARS.” See Also: Sorrento Therapeutics gets grant for transdermal drug delivery device with microneedle assembly and reservoir Eli Lilly and Co gets grant for patent granted for nasal drug delivery device In July 2023, Pluri signed a three-year contract worth $4.2m with the NIAID and the US Department of Defense (DoD) to develop its cell therapy avoplacel (PLX-R18) to treat haematopoietic ARS or radiation poisoning. The same month, RedHill Biopharma received additional funds worth $1.7m from the US Government to advance the development of Yeliva (opaganib) as a medical countermeasure for gastrointestinal ARS. Other drugs currently under development for acute radiation sickness include South Korea-based Enzychem Lifesciences’ Phase II mosedipimod (EC-18), and New Amsterdam Sciences’ Phase I small molecule NAS-150 (AEOL-10150).