New York’s Gov. Cuomo Continues to Defend Claims of Cover-up Regarding COVID-19 Nursing Home Deaths

On January 28, 2021, New York’s Attorney General Letitia James released a report on her office’s investigation into nursing home responses to the COVID-19 pandemic. The investigation found that more nursing home residents died from COVID than the New York State Department of Health (DOH) had made public. It found nursing home deaths from COVID may be undercounted by New York’s DOH by as much as 50 percent and found the DOH misstated in-facility deaths at many nursing homes as well. A complete copy of…
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New Judge for New Jersey’s Multicounty Litigation Program

This week saw a major snowstorm for parts of New Jersey, bringing more than two feet of snow in some areas of the state (including my driveway). This week also saw the assignment of a new judicial face to New Jersey’s Multicounty Litigation cases. Many of you are likely aware of the federal Judicial Panel on Multidistrict Litigation, or JPML, which can decide to consolidate and transfer cases pending in the federal district courts for consolidated pre-trial management by a single District Judge. There have…
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New Year, New Administration, New Issues?

Much of the nation is watching the transfer of power from the outgoing Trump administration to the incoming Biden administration. Each new administration brings many things, but one constant is change. Obviously, COVID-19 has been the dominant issue for nearly all of 2020, impacting everything, from the drug and medical device industries to our legal system. We expect that while the new Biden administration will continue some of the policies and programs from the Trump administration relating to COVID-19, others will change or be modified,…
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A Farewell to 2020 and a Look Ahead at Life Sciences in 2021

What a year 2020 has been. The COVID-19 pandemic has been spewing death and economic destruction, and as scientists predicted, is now resurrecting itself in a second wave―just as it seemed there was light at the end of the tunnel. Now, we have news from the United Kingdom and elsewhere that the virus is mutating in a way that makes it more contagious. Yet, for the life sciences field, 2020 was a year of breathtaking achievement and innovation (e.g., ventilators, changes in standards of medical…
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New Jersey Appellate Panel Reverses Trial Court’s Detailed Exclusion of Unreliable Expert Testimony

Although COVID-19 remains a dominant topic in America, there are still some non-related COVID-19 developments worthy of note over the past few months. Don’t worry, this is not a comment on the recent presidential election or the post-election legal battles to overturn the results. We’re providing a brief discussion of something near-and-dear to most, if not all, of those who litigate in the life sciences arena―especially in the product liability realm: expert admissibility. In 2016, Judge Nelson Johnson, the New Jersey Superior Court judge then…
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New York Nursing Home Residents May Receive COVID-19 Vaccine Before End of Year

On December 6, 2020, the Trump administration provided a timetable for the rollout of the COVID-19 vaccine. Dr. Moncef Slaoui, chief science adviser of Operation Warp Speed, announced the administration’s program for distribution and deployment of the COVID-19 vaccine and advised that residents of long-term-care facilities will receive the first round of vaccinations by mid-January, perhaps even by the end of December. Speaking on ABC’s “This Week” on Sunday, Health and Human Services Secretary Alex Azar said: “If things are on track the advisory committee…
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OIG Issues Rare Special Fraud Alert Targeting Pharmaceutical and Medical Device Speaker Programs

The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a Special Fraud Alert on fraud and abuse risks “associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies.” The OIG generally defines speaker programs as company-sponsored events at which a physician or other health care professional (HCP) “makes a speech or presentation to other HCPs about a drug or device product or a disease state” on behalf of a manufacturer.…
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Best Wishes for a Happy Thanksgiving

It would be an understatement to say that 2020 has been a difficult year for most, if not all, of us in the United States. Since March, most of our posts have tried to relate to at least one of the myriad issues raised by the ongoing COVID-19 pandemic. We are by no means alone in that effort, but we hope that we have been able to provide some helpful information and/or promote some useful thinking for many of you. (If we did, feel free…
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HHS Issues Guidance on Vaccine-related COVID-19 Countermeasures

The Department of Health and Human Services (HHS) recently issued Advisory Opinion 20-03 addressing vaccination-related issues and the Public Readiness and Emergency Preparedness (PREP) Act. The opinion is significant because we are moving toward approval of COVID-19 vaccines over the upcoming months. In its opinion, HSS believes that the PREP Act preempts state law in three specified circumstances to the extent that state law may be more stringent than activities authorized by the HHS secretary under the PREP Act. “Covered countermeasures” under the PREP Act…
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Potential Supreme Court Review of Another Punitive Damages Case

Much of the nation is understandably focused on the presidential election results, as well as the troubling rise in COVID-19 cases across the country. While questions of punitive damages are likely far from the minds of most everyone at the present, the Missouri Supreme Court rejected a bid from Johnson & Johnson (J&J) to review the $2.1 billion damages award rendered against it in favor of a group of women suing over alleged ovarian cancer risks. As readers may recall, the initial verdict against J&J…
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