Monday, October 16, 2023

U.S. Government Reaches Settlement in Class Action Family Separation Case Seeking Injunctive Relief

U.S. Government Reaches Settlement in Class Action Family Separation Case Seeking Injunctive Relief

U.S. Government Reaches Settlement in Class Action Family Separation Case Seeking Injunctive Relief

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On Oct. 16, the United States reached a settlement in Ms. L., et al. v. ICE, et al., a class action litigation filed in 2018 seeking injunctive relief relating to the separation of parents and children at the southwest border. The proposed settlement agreement is subject to final approval by the district court after notice to the class and an opportunity to object.

“The practice of separating families at the southwest border was shameful,” said Attorney General Merrick B. Garland. “This agreement will facilitate the reunification of separated families and provide them with critical services to aid in their recovery. I am grateful to Associate Attorney General Vanita Gupta and the Department’s Civil Division for their work on this matter.” 

Under the proposed settlement, new standards will be established to limit family separations in the future. The settlement provides for continued family reunifications, immigration relief, and certain support services for separated families, including behavioral health services, targeted legal support related to immigration claims, limited housing assistance, and certain medical coverage. The settlement does not involve the payment of monetary damages. Those who believe they are class members may submit claims of class membership to the Family Reunification Task Force through the Together.gov website.

“The separation of families at our southern border was a betrayal of our nation’s values,” said Associate Attorney General Vanita Gupta. “By providing services to these families and implementing polices to prevent future separations, today’s agreement addresses the impacts of those separations and helps ensure that nothing like this happens again.”

On Feb. 26, 2018, a plaintiff identified as “Ms. L” filed a complaint in the Southern District of California alleging she had been unlawfully separated from her child. The American Civil Liberties Union (ACLU) later filed an amended complaint to add class action claims contending that the separation of putative class member parents from their children violated procedural and substantive due process, as well as the asylum statute. On June 26, 2018, the district court certified a class of separated parents and issued a preliminary injunction prohibiting future separations except in certain specified circumstances. The court also required the reunification of families previously separated.

Since that time, the Justice Department, the Department of Homeland Security (DHS), and the Department of Health and Human Services (HHS) have worked with plaintiffs to identify class members and their children, developed plans for reunification, and reunified class members with their children. On Jan. 26, 2021, the Justice Department rescinded the Department’s 2018 zero-tolerance policy for offenses under 8 U.S.C. § 1325(a). In Feb. 2021, President Biden issued an Executive Order establishing the Interagency Task Force on the Reunification of Families, comprised of representatives from various federal agencies, including the Justice Department, DHS, and HHS. The parties have worked extensively to reunify families in accordance with the Executive Order and subsequent orders from the district court. The task force has searched through thousands of government records to identify separated families and has thus far reunited more than 750 children with their families and has identified 85 additional children who are currently in the process of being reunited with their families. The task force has also identified more than 290 U.S. citizen children who were separated from their parents during the relevant time frame, is working to confirm that they have been reunified with their families, and will offer them services to support their reunification.

Director William C. Peachey, Assistant Director William C. Silvis, Senior Litigation Counsel Sarah B. Fabian, and Trial Attorney Fizza Batool, all of the Civil Division’s Office of Immigration Litigation, are handling the case.

Saturday, October 14, 2023

Former CEO Pleads Guilty to Causing the Distribution of Adulterated and Misbranded Medical Devices Intended to Treat Migraine Headaches

Former CEO Pleads Guilty to Causing the Distribution of Adulterated and Misbranded Medical Devices Intended to Treat Migraine Headaches: Former CEO Pleads Guilty to Causing the Distribution of Adulterated and Misbranded Medical Devices Intended to Treat Migraine Headaches Mark Wright, 67, pleaded guilty on Oct. 11 in federal court to misdemeanor charges of causing the introduction of misbranded and adulterated devices into interstate commerce. According to documents filed with the court, from July 2013 to July 2017, Wright served as the chief executive officer of Dolor Technologies Inc., a Utah-based medical device company. Dolor sold a device known as the SphenoCath, which was intended to treat migraine headaches by administering nerve blocks to the sphenopalatine ganglion (SPG), a collection of nerves located in the midface of the skull. As part of his guilty plea, Wright admitted that Dolor did not seek approval or clearance from the Food and Drug Administration (FDA) to distribute the SphenoCath for this intended use, rendering the SphenoCath devices adulterated and misbranded under the Federal Food, Drug and Cosmetic Act. Wright also admitted that, while FDA had recommended in April 2014 that Dolor proceed with investigational studies regarding the SphenoCath’s safety and effectiveness, Dolor never conducted any such study. Instead, Wright and Dolor continued to market the SphenoCath with the intention that it be used to treat migraine headaches by administering SPG nerve blocks. Among other things, Wright provided healthcare providers with marketing materials and unsolicited directions for unapproved use of the SphenoCath. U.S. Magistrate Judge Cecilia M. Romero presided at the plea hearing and set sentencing for Nov. 8. “Patients must be able to trust that they are being treated with medical devices that have been shown to be safe and effective,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Department of Justice will continue to take action against companies and individuals that put public health at risk by not complying with the law.” “The United States will continue to prosecute those who flout the Food, Drug, and Cosmetic Act by marketing unapproved, adulterated, and misbranded drugs and devices to the public,” said U.S. Attorney Trina A. Higgins for the District of Utah. “These individuals pose a danger to the community and put the public’s health and safety at risk.” “U.S. consumers rely on the FDA to ensure that their medical devices are safe and effective for their intended uses,” said Special Agent in Charge George M. Scavdis of the FDA’s Office of Criminal Investigations Metro Washington Field Office. “We will continue to investigate and bring to justice those who threaten the health of consumers by evading FDA requirements.” The FDA’s Office of Criminal Investigations investigated the case. Trial Attorneys David Hixson and Emily C. Powers of the Justice Department’s Consumer Protection Branch and Assistant U.S. Attorney Jacob Strain for the District of Utah prosecuted the case. Additional information about the Consumer Protection Branch and its enforcement efforts may be found at www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the District of Utah, visit its website at www.justice.gov/usao-ut. October 13, 2023 Souce: https://www.justice.gov/opa/pr/former-ceo-pleads-guilty-causing-distribution-adulterated-and-misbranded-medical-devices – Midtown Tribune News – Big New York news BigNY.com

Monday, October 2, 2023

Мэр Нью-Йорка Адамс объявляет о рекордных расходах в 6 миллиардов долларов на коммерческие предприятия Нью-Йорка, принадлежащие меньшинствам/женщинам, за первый финансовый год правления

Мэр Нью-Йорка Адамс объявляет о рекордных расходах в 6 миллиардов долларов на коммерческие предприятия Нью-Йорка, принадлежащие меньшинствам/женщинам, за первый финансовый год правления

 Мэр Нью-Йорка Эрик Адамс сегодня объявил, что город установил новый рекорд по расходам на сертифицированные городом предприятия, принадлежащие меньшинствам и женщинам (M/WBE), в 2023 финансовом году (23 финансовом году), первом полном финансовом году. администрации Адамса. В 23 финансовом году через OneNYC городские агентства и аффилированные организации выделили фирмам M/WBE в общей сложности более 6 миллиардов долларов США, заключив контракты с рекордными 1903 сертифицированными фирмами-поставщиками. 

\Новые городские цифры M/WBE включают контракты на сумму более 1,4 миллиарда долларов, заключенные с M/WBE в соответствии с  местным законодательством 1. программа, установившая рекорд по количеству контрактов M/WBE с момента ее создания в 2013 году, и установила самый высокий за всю историю города уровень использования M/WBE в 28 процентов за один финансовый год. Мэр Адамс сделал это заявление на открытии 15-й ежегодной общегородской ярмарки закупок.

Ранее в этом году мэр Адамс ввел расширенные дискреционные полномочия в рамках метода неконкурентной покупки, что позволило M/WBE получить миллионы долларов в виде дополнительных контрактов. Используя этот метод, город также заключил контракты на рекордную сумму в 175 миллионов долларов с M/WBE — на 60 процентов больше, чем в 22 финансовом году, и более чем вдвое превышает стоимость контракта в предыдущие финансовые годы.

https://brightonbeachnews.com/rus/mer-nyu-jorka-adams-minority-money/