Yvonne Puig (US)

Yvonne Puig (US)

US Head of Life Sciences and Healthcare Yvonne Puig has a substantial commercial litigation practice in both state and federal courts. She represents hospitals, HMOs, managed care organizations, medical schools and other institutional health care providers and educational services companies. A partner in Norton Rose Fulbright’s Austin office, Yvonne’s practice involves commercial and health care litigation, antitrust, regulatory and compliance advice, crisis management, staff privileges, exclusive contracting and administrative law.

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COVID-19 Update: Trump Issues ‘Buy American’ Executive Order Related to Drugs

On August 6, 2020 President Trump signed an Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States.  The Executive Order states that “the domestic supply chains must be capable of meeting national security requirements for responding to threats arising from CBRN (chemical, biological, radiological, and nuclear) threats … Continue reading

COVID-19 Update: Senators Release Liability Protection Draft Legislation

On July 27, 2020, Senators Mitch McConnell (R-KY) and John Cornyn (R-TX) released the SAFE TO WORK Act (“the Act”).   The Act was released as part of the Senate Republicans draft coronavirus legislation, the HEALS Act, which stands for Health; Economic Assistance; Liability protection; and Schools.  The Act seeks to limit liability for healthcare providers … Continue reading

COVID-19 Update: FDA Inspections Signal Resumption of Government Enforcement Efforts

On July 10, 2020, the U.S. Food and Drug Administration (FDA) announced it would resume domestic on-site inspections beginning the week of July 20.  Due to the COVID-19 pandemic, the FDA suspended inspections of facilities in March “to help slow the spread of the virus and help flatten the curve of the COVID-19 pandemic.”   To … Continue reading

COVID-19 Update: The Joint Commission Resumes Laboratory Survey Activities

In a special LabFocus The Joint Commission revealed they have resumed some laboratory survey activities.  TJC stated that “[a]ccount executives are contacting organizations due for a survey to assess the impact that the coronavirus pandemic had on their operations and their current state.”   To determine which organizations will be surveyed, TJC is looking at “a … Continue reading

COVID-19 Update: World Health Organization Warns of Dangerous Phase

During a press conference on June 19, 2020, World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus stated that “[t]he pandemic is accelerating” and that we are now in a “dangerous phase” where the virus is “spreading fast.”   June 22, 2020 saw the largest single day spike in cases, with 183,020 new cases worldwide.   In the … Continue reading

COVID-19 Update: FDA revokes EUA for malaria drugs used as COVID-19 treatment

On June 15, 2020, the U.S. Food and Drug Administration (FDA) revoked emergency use authorization (EUA) for chloroquine (CQ) and hydroxychloroquine (HCQ).  The FDA found that the criteria for issuance of the EUA are no longer met and “in light of ongoing reports of serious cardiac adverse events and several newly reported cases of methemoglobinemia … Continue reading

COVID-19 Update: CDC Issues Guidelines for Events and Gatherings

On Friday June 12 the U.S. Centers for Disease Control and Prevention (CDC) published guidelines for events and gatherings ranging from lowest risk (virtual-only) to highest risk (large, in-person, where difficult to space at least six feet apart and attendees come from other areas).  The guidelines arrive at a time when cities and states have … Continue reading

COVID-19 Update: The Joint Commission to Resume Hospital Surveys

The Joint Commission (TJC) is resuming regular surveys and reviews after suspending them at the outset of the COVID-19 pandemic.  Safety will be “the first and foremost priority” as surveys and reviews are resumed and the survey’s will “assess the impact that the coronavirus pandemic had on their operations and their current state.”   The surveys … Continue reading

COVID-19 Update: CDC Releases Interim Guidelines on Antibody Testing

On May 24, 2020 the U.S. Centers for Disease Control (“CDC”) issued interim guidelines for COVID-19 antibody tests.  The CDC states that data on serologic testing is “rapidly evolving” and “will have an important public health and clinical uses to monitor and respond to the COVID-19 pandemic.”  The interim guidelines specifically address: Development of Antibodies … Continue reading

COVID-19 Update: CDC Publishes Additional Guidance on Reopening

The U.S. Centers for Disease Control and Prevention (“CDC”) has quietly released more expansive guidance regarding the reopening of different types of organizations.  The document, entitled  CDC Activities and Initiatives Supporting the COVID-19 Response and the President’s Plan for Opening America Up Again,  builds upon the decision tools issued by the CDC last week.  The … Continue reading

COVID-19 Update: CDC Releases Guidance for Reopening

On May 14, 2020, the U.S. Centers for Disease Control (“CDC”) published voluntary guidance that provides checklists for reopening certain workplaces and activities.  The decision tools state that “[i]t is important to check with state and local health officials and other partners to determine the most appropriate actions while adjusting to meet the unique needs … Continue reading

COVID-19 Update: FBI Warns of Hackers Targeting COVID-19 Research

In a Public Service Announcement issued May 13, 2020, the U.S. Federal Bureau of Investigation (“FBI”) and Cybersecurity and Infrastructure and Security Agency (“CISA”) warned of the targeting and compromise of U.S. organizations conducting COVID-19 research.   More specifically, the announcement warns that “actors have been observed attempting to identify and illicitly obtain valuable intellectual property … Continue reading

COVID-19 Update: U.S. and U.K. Issue Joint Alert Regarding COVID-19 Research Cyber Threat

The U.S. Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency and the U.K.’s National Cyber Security Centre issued a joint alert on Tuesday that advanced persistent threat groups “are actively targeting organizations involved in both national and international COVID-19 responses.”   This warning should be heeded by hospitals, health systems, pharmaceutical companies, and academic medical … Continue reading

COVID-19 update: WHO urges cautions on immunity passports

As countries around the world seek creative policy solutions to permit the opening of their economies, the World Health Organization (“WHO”) released a Scientific Brief on April 24, 2020 finding that “[t]here is currently no evidence that people who have recovered from COVID-19 and have antibodies are protected from a second infection.”  The WHO is … Continue reading

COVID-19 Update: HHS Issues Omnibus Advisory Opinion Regarding PREP Immunity

The HHS Office of the General Counsel has released an important Advisory Opinion that provides insight regarding the interpretation and application of the Secretary’s March 17, 2020 Declaration, which is retroactively effective beginning February 4, 2020. (HL Pulse discussion here).  The Declaration provides immunity to certain individuals and entities for liability against “all claims for … Continue reading

COVID-19 Update: Texas Medical Board Adopts Emergency Rule Regarding Elective Surgeries

The Texas Medical Board (“TMB”) has adopted an emergency rule based on Governor Greg Abbott’s April 17, 2020 Executive Order, which permits certain elective procedures beginning at 11:59 p.m. on April 21, 2020.  The emergency rule incorporates a violation of the Executive Order to the definition of “Unprofessional and Dishonorable Conduct” under 22 Texas Administrative … Continue reading

COVID-19 Update: CMS Issues Recommendations for Re-Opening Facilities for Non-Emergent Care

On Sunday April 19, 2020, CMS issued guidance for permitting non-emergent, non-COVID-19 healthcare in states that have passed the Gating Criteria provided in the Guidelines for Opening Up America Again.  CMS reiterated support for telehealth, stating that “[m]aximum use of all telehealth modalities is strongly recommended.” Decisions should be” consistent with public health information and … Continue reading

COVID-19 Update: American Medical Association and Other Physician Organizations Request Liability Protections

In an April 15, 2020 letter to Congress, the American Medical Association and other physician organizations requested additional protection from “increased liability risk facing physicians and other clinicians” responding to the COVID-19 pandemic.   The organizations request liability protections broader than the protections provided to health care volunteers in section 3215 of the CARES Act.  The … Continue reading

COVID-19 Update: New CDC Guidance on Critical Workforce

On April 8, 2020, the U.S. Centers for Disease Control (“CDC”) issued updated guidance for critical infrastructure workers returning to work.  Previously, the CDC had provided that an individual exposed to the coronavirus should self-quarantine for fourteen days.  The CDC now recommends that critical infrastructure workers “may be permitted to continue to work following a … Continue reading

COVID-19 Update: FEMA Issues Interim Final Rule Allocating Scarce or Threatened Materials

On April 7, 2020, the Federal Emergency Management Administration (“FEMA”) released a final rule pursuant to the Defense Production Act (“DPA”) and Executive Orders issued by President Trump prohibiting the export of the scarce or threatened materials identified by President Trump on April 3, 2020.  HL Pulse summary is available here.  Specifically, the Executive Order … Continue reading

COVID-19 Update: CDC Recommends Use of Cloth Face Coverings and President Issues Executive Order on PPE

On Friday April 3, the U.S. Centers for Disease Control (“CDC”) recommended “the wearing of cloth face coverings in public settings where other social distancing measures are difficult to maintain (e.g., grocery stores and pharmacies) especially in areas of significant community-based transmission.”   The CDC provides citations for several studies finding that individuals with coronavirus may … Continue reading

COVID-19 Update: CDC Issues Guidance on Decontamination of FFR and President Trump Issues Executive Orders for Medical Equipment

Earlier this week the U.S. Centers for Disease Control (CDC) provided recommendations for the decontamination and reuse of filtering facepiece respirators (FFR).  The guidance states that a study found the coronavirus is able to survive for up to 72 hours on plastic, stainless steel, and cardboard.  The CDC provides that “decontamination and subsequent reuse of … Continue reading

COVID-19 Update: HHS Letter Permits Hospital Sharing of Ventilators

On March 30, 2020, a letter to hospitals from U.S. Surgeon General Jerome Adams and U.S. Department of Health and Human Services Assistant Secretary for Health Adm. Brett Giroir released Guidelines to Optimize the Use of Mechanical Ventilators permitting the use of a single mechanical ventilator for two patients.  However, this “strategy should only be … Continue reading
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