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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New York Bans Visitation at Nursing Homes, Hospitals, and Other Facilities in COVID-19 Hot Spots

On October 23, 2020, New York State issued a health advisory banning visits at nursing homes, hospitals, adult-care facilities, residential treatment centers, facilities for individuals with developmental disabilities, and other facilities seeing clusters of COVID-19 positive results. In July, NYS Health Commissioner Howard Zucker announced that nursing homes and long-term-care facilities in New York would be allowed to resume limited visitations subject to guidelines issued by the NYS Department of Health effective July 15, 2020. The new advisory reinstates the ban on visitation at these…
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FDA Approves First COVID-19 Drug: Veklury

The Food and Drug Administration (FDA) approved the first drug for the treatment of COVID-19. The antiviral drug Veklury (remdesivir), manufactured by Gilead Sciences Inc., is approved for use in hospitalized adult and pediatric patients 12 years of age and older. Veklury was previously issued as an emergency use authorization (EUA) in May 2020 following the National Institutes of Health’s clinical trial, which showed promising results in battling COVID-19. Under the Federal Food, Drug, and Cosmetic Act, approval of a new drug product requires substantial…
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FDA Issues Warning Letter for Off-Label Promotion of Drug to Treat COVID-19

The Food and Drug Administration (FDA) recently issued a warning letter to the manufacturer of an approved prescription drug for an off-label use to treat COVID-19 symptoms. Off-label use is defined as an approved prescription drug for unapproved conditions, patient groups, or dosages. While the FDA has previously pursued hundreds of fraudulent COVID-19 products, this appears to be the first warning letter addressing the unapproved use of an FDA-approved drug to treat patients with COVID-19. Currently, there are no FDA-approved COVID-19 products on the…
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Take-home Exposure Claims May Lead to COVID-19 Litigation

Anyone familiar with asbestos litigation over the past several decades is well-aware of the so-called “take-home exposure” claim, in which the injured plaintiff claims to have been exposed to and injured by asbestos that another household member brought home on their person or clothing. This type of claim often arises out of an alleged workplace exposure to asbestos. In that scenario, the injured plaintiff does not claim to have been personally exposed to asbestos at the workplace, but instead asserts that a family member was…
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Safe Assumption About EPA’S Safer Choice Labels

The U.S. Environmental Protection Agency (EPA) Safer Choice labeling program “helps consumers, businesses, and purchasers find products that perform and contain ingredients that are safer for human health and the environment.” The EPA offers lists of Safer Choice-Certified Products for different industries including all-purpose cleaners, car care products, dish soaps, floor cleaners, laundry products, and tub and tile cleaners. The Safer Choice Standard includes criteria for chemical ingredients and requirements for performance, packaging, pH, and VOCs (i.e., volatile organic compounds. Manufacturers, importers, and distributors of…
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New York DOH Fines Long-Term Care Facilities for COVID-19-Related Failures Raising Concerns Regarding Limitations of Immunity Statute

Recently, New York’s Department of Health (DOH) issued fines to multiple nursing homes in New York for infection control issues, including for providing COVID-19 care without gloves and adequate personal protective equipment (PPE) for their staff. Reports state that 77 nursing homes in the state were fined for similar infection control issues. The largest fine of $50,000 was to a facility in Buffalo, NY, where DOH inspectors found COVID-19-positive patients on the same floors with residents not known to have the virus. As discussed in…
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