On Dec. 22, 2021, Ohio Governor Mike DeWine signed “Esther’s Law,” allowing long-term care residents to install and use video cameras and recording devices in their rooms. The law is named for Esther “Mitzi” Piskor, who was a victim of elder abuse at a nursing home in Cleveland. Esther’s Law is intended to combat elder abuse and neglect and will likely lead to increased enforcement actions against Ohio nursing homes and long-term care facilities ...
European-based and operating digital asset investors and entrepreneurs are on notice: The European Union (EU) is considering hobbling the blockchain and crypto ecosystem ...
As you likely know, Brexit negotiations are underway, with the UK scheduled to withdraw from the EU on March 29, 2019. As a result of the withdrawal, all EU laws will cease to apply to the UK as of March 30, 2019 unless additional agreements or transitional processes are put into place before the scheduled exit ...
On Thursday, July 16, 2020, the European Union's top court issued a landmark ruling that will immediately transform how companies can lawfully transfer EU personal data to the United States. The court invalidated the EU-U.S. Privacy Shield, one of the most common mechanisms used by U.S. companies in connection with cross-border data transfers ...
The Securities and Exchange Commission (SEC) recently adopted a new amendment that adds additional categories of persons eligible to meet the accredited investor definition, expanding the pool of capital available to the private capital markets. Background Under the Securities Act of 1933 (Act”), offerings for the sale of securities must be registered with the SEC ...
After filing Form CRS ahead of the June 30 2020 deadline, many investment advisers breathed a sigh of relief. However, advisers must remain vigilant as the June 30 deadline was the beginning of a new set of compliance efforts which firms must meet on a going-forward basis. In an effort to keep firms on track, we have summarized these ongoing obligations. 1) Initial Delivery ...
The “good faith” requirement of a light-duty offer was just examined by the 10th District Court of Appeals and the Ohio Supreme Court with a somewhat surprising result. Light-duty job offers can be a good way for employers to minimize the payment of temporary total disability compensation and bring injured workers back to the workforce. However, these job offers must conform to very specific requirements under the Ohio Administrative Code ...
The International Trade Commission (ITC) sits in a nondescript office building about a block farther south of the National Mall than tourists usually care to venture. Patent owners come from around the country to this tree-lined street in Washington, D.C., to seek a powerful remedy to protect their patented products: an exclusion order. An exclusion order directs U.S. Customs and Border Protection to block infringing imports at the United States border ...
On December 22, 2017, President Trump signed into law the Tax Cuts and Jobs Act, which amended certain provisions of the Internal Revenue Code of 1986. Bank boards and management teams should take time to familiarize themselves with these changes, as several amendments to the Code relate to the payment of executive compensation. For corporate executives and compensation committees, the change to the Code that has garnered the most attention concerns an amendment to Code Section 162(m) ...
Effective June 24, 2020, a new executive order from President Donald Trump will go into effect, limiting the entry of certain categories of foreign nationals to the U.S. through December 31, 2020 ostensibly to protect the U.S. labor market as it recovers from COVID-19. The order focuses on suspending and limiting entry of foreign nationals who are currently outside of the U.S ...
Often, board of education members believe what happens in executive session, stays in executive session. However, you and your board’s members, both new and old, are well-served to remember that many issues, including those involving personnel, discussed in executive session are communications that may be subject to discovery in a deposition or other legal proceeding by an affected employee ...
Months into the United States’ trade dispute with China, and there is no end in sight to the dispute. There are three significant deadlines for U.S. importers to consider involving the tariffs the U.S ...
The Ohio Department of Commerce (Department) recently announced licensed medical marijuana cultivators who are maxing out their grow area capacity will be permitted to apply for an expansion. Presently, there are 20 Level I cultivators capable of growing up to 25,000 square feet of medicinal marijuana, and 15 Level II cultivator licensees that are smaller in scale and permitted up to 3,000 square feet of grow capacity ...
The Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”)[1] was enacted on October 24, 2018. Among other things, the SUPPORT Act amended the Physician Payments Sunshine Act (“Sunshine Act”)[2] to expand the definition of “covered recipients”[3] for payment tracking and reporting purposes ...
Guided by the materiality standard from Escobar, a key safeguard for FCA defendants, the Western District of Pennsylvania found the Zaldonis relator failed to show the alleged fraud “would have any effect on the government’s decision to pay a claim.” Five years after the Supreme Court decided it, Escobar thus continues to set a high hurdle for plaintiffs ...
It is rare that FCA defendants have their legal defenses paid for, and rarer still that DOJ must bear the expense. In United States ex rel. Wall v. Circle C Construction, the Sixth Circuit held that the government must pay roughly $500,000 in legal fees and expenses the defendant incurred as a result of the government’s unreasonable litigating position ...
Significant False Claims Act (FCA) developments in the courts during the latter part of 2022 have included the Supreme Court’s declining to take up one issue involving FCA qui tam actions (what level of pleading particularity Rule 9(b) requires) while holding argument on another (the scope of the government’s dismissal power following declination), and the D.C. Circuit’s adoption of the pro tanto rule in computing settlement offsets in multiple-defendant cases ...
On April 30, 2021, the U.S. Food and Drug Administration (FDA) announced it was revoking a policy related to new drug applications (NDAs) and abbreviated new drug applications (ANDAs). The FDA stated that the previous policy announced by the Department of Health and Human Services (HHS) on Jan. 15, 2021, was being rescinded because the new policy would have required the FDA to publish redundant information about new applications of NDAs and ANDAs ...
Those in the CBD sector should be mindful of their marketing tactics, as the FDA continues to police the industry. Manufacturers of CBD products must also evaluate their quality-control procedures to ensure safe products are hitting the marketplace. As we forecasted this past December in a previous legal alert, the U.S. Food and Drug Administration continues to referee the emerging cannabidiol (CBD) product market ...
Last week, the U.S. Food and Drug Administration (FDA) issued guidance for the health care industry, titled “Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency ...
On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule, which, if finalized, will allow an institutional review board (IRB) to waive or alter certain informed consent requirements if a clinical trial poses minimal risk to human subjects and includes appropriate safeguards to protect the rights, safety, and welfare of those human subjects ...
On December 7, 2018, the Food and Drug Administration (FDA) released a Proposed Rule that clarifies procedures and criteria for the de novo medical device clearance pathway. In a statement accompanying the Proposed Rule, FDA Commissioner Scott Gottlieb stated FDA believes the Proposed Rule will help facilitate classification of innovative low- to moderate-risk novel medical devices by providing more structure, clarity, and transparency to the de novo pathway ...
FDA announced it will open a public docket and hold an Immunology Devices Panel meeting to deliberate the potential for patients who receive medical device implants that contain select metal or metal alloys to develop immune and inflammatory reactions. The panel may provide input on scientific information the FDA should consider as part of premarket review and postmarket surveillance of metal-containing implants and dental amalgams ...
Acting Food and Drug Administration (FDA) Commissioner Norman Sharpless has issued a statement warning Americans to stop using vaping products that emit THC until further testing can be done. Federal and state public health agencies, including the FDA, have been investigating an unprecedented wave of 1,000-plus cases of severe lung injuries and deaths among consumers who claimed they used vaping products containing THC, nicotine, or both ...
The U.S. Food and Drug Administration (FDA) recently issued a burst of COVID-19-related guidance documents to facilitate expanded availability of medical products during the current public health emergency created by COVID-19. FDA-regulated products under these temporary policies include: PPE, diagnostic tests, hand sanitizers, disinfectant devices, remote monitoring devices, ventilators, and electronic thermometers for clinical use ...
