The manufacturer of a product generally has a duty to warn the end-consumer of any serious risks associated with that product. In the context of prescription drugs and medical devices, however, the “learned intermediary” doctrine holds that the manufacturer need not warn the end-consumer (i.e., patient). Instead, the manufacturer discharges its obligations by warning the prescribing physician ...
In Texas, tenants who are obligated to reimburse property owners for property taxes have a right to protest the appraised value of the property if the property owner does not file a protest relating to the property. To facilitate this right, the Texas legislature enacted a law (Section 41.413 of the Tax Code) that requires the property owner to give all such tenants a copy of the notice of appraised value received by the property owner within 10 days of receiving the notice ...
On January 3, 2018, San Francisco’s State Senator Scott Wiener introduced a bill (SB 827) that would all but abolish the city’s famously strict land use controls—and those of virtually all California’s urban neighborhoods. It is considered the most radical of all the pro-housing legislation introduced during the last year in California ...
The Finance (No 2) Act 2017(“FA”) received royal assent on 27 December 2017 and was introduced to amend theIncome Tax Act 1967, the Real Property Gains Tax Act 1976 (“RPGTA”), the Goods and Services Tax Act 2014and the Finance Act 2013. This article will discuss the amendments to the RPGTA as provided in sections 16, 17 and 18 of the FA. The amendments to the RPGTA came into operation on 1 January 2018 ...
The 2018 West Virginia legislative session was a busy one regarding consumer finance law. Legislators focused on the West Virginia Consumer Credit and Protection Act and the West Virginia Safe Mortgage Licensing Act. The West Virginia Legislature passed at least three bills this past session that affect consumers or financial transactions ...
More than two and a half years after the U.S. Food and Drug Administration (FDA) announced that it was re-evaluating its regulatory framework for homeopathic products, the FDA released its Draft Guidance on Drug Products Labeled as Homeopathic. The Draft Guidance summarizes the FDA’s current enforcement perspective on homeopathic products and provides a list of the FDA’s enforcement priorities ...
New rules will apply to disability benefit claims and appeals under certain plans that are subject to the Employee Retirement Income Security Act of 1974 (ERISA), effective for claims made after April 1, 2018. According to the Department of Labor (DOL), the new rules are intended to provide greater protection to claimants, and are modeled on the enhanced claims and appeals procedures that apply to health benefit claims under the Affordable Care Act (ACA) ...
As described in our earlier client alerts, since 1993, a central tenet in the structure of senior real estate lending documentation is the prevention of what is commonly referred to as “cram down ...
Last week, United States Attorney General Sessions announced the creation of the Department of Justice Prescription Interdiction & Litigation (PIL) Task Force to combat the prescription opioid crisis. According to the Department of Justice (Justice), the PIL Task Force will rely on “all available criminal and civil enforcement tools” to hold those at “at every level of the [opioid] distribution system” accountable for unlawful conduct ...
With collective sales on the rise again, it is timely to examine factors that challenge such deals in the current cycle. It was a saga worthy of a soap opera. In 2007, Horizon Towers was on the verge of breaking the then en bloc price record when, over a period of more than two years and several flip-flopping court and Strata Titles Board (STB) decisions, minority owners eventually blocked the transaction ...
Given the housing crisis, the city has enacted regulations that attempt to force a property owner to legalize an illegal unit, unless the owner can prove certain things to the satisfaction of San Francisco Planning Staff or the San Francisco Planning Commission. Long gone are the days in which an unhappy tenant or neighbor will report an illegal unit to the city and the city will fine the owner unless the illegal unit is removed ...
Earlier this year the enhanced Nurse Licensure Compact (eNLC) was implemented in all 29 participating states including Colorado, West Virginia and Kentucky. Illinois[1] and Michigan[2] are among the states with current legislation pending to adopt the eNLC, while Indiana, Ohio, Pennsylvania, California and a handful of other states do not yet have pending legislation ...
The State Medical Board of Ohio (Medical Board) recently released proposed rules that will create a non-disciplinary, confidential monitoring program for licensees with mental or physical illnesses. Historically, licensees with a mental or physical illness could not only be subject to formal disciplinary action pursuant to the Medical Board’s rules, but the licensee’s mental or physical illness became public information as a result of the disciplinary process ...
As the new year started, two Department of Justice memoranda began circulating that may bring a change in the way the United States focuses its efforts in the FCA arena. The first, entitled, “Factors for Evaluating Dismissal Pursuant to 31 U.S.C ...
As we described in our client alert dated September 14, 2016, in the aftermath of the real estate downturn from 1989 to 1993, when real estate mortgage lenders began to contemplate making new mortgage loans, they sought to create new legal structures to prevent their prospective borrowers from filing for Chapter 11, and to ameliorate the adverse consequences, if such a filing were to occur. One such structure is a device commonly referred to as the “Golden Share ...
Fresenius Medical Care North America (FMCNA), a provider of products and services for people with chronic kidney failure, has agreed to pay $3.5 million to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and adopt a comprehensive corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules ...
The recent end of the value-added tax (“VAT”) relief period for property developers in South Africa, who temporarily let their residential units, may have a significant impact on their cash flow. BackgroundOrdinarily, property developers acquire or develop fixed property (including residential properties) for the purpose of resale ...
After Atlanta-based developer, Carter USA, pulled out as the master developer of the Banks Project along Cincinnati’s riverfront, the project effectively stalled. However, the Joint Banks Steering Committee (JBSC), charged with offering recommendations with respect to this project, reconvened January 23, 2018 to take two actions ...
The State Medical Board of Ohio recently proposed amendments to the existing regulations governing light-based medical devices (lasers), which will significantly impact the provision of laser services in Ohio. While the proposal adds a new category to existing delegation authority, it also imposes new regulatory requirements to existing delegation authority which will impact Ohio physicians providing laser services ...
With the aim of breathing a bit of fresh air into the Slovenian construction legislation, three new laws have been adopted recently and will be applied with effect from 1 July 2018. The current Construction Act will be replaced with both the new Building Act and the Architectural and Civil Engineering Activities Act, while the current Spatial Management Act will also be subject to certain amendments ...
Under the Affordable Care Act (“ACA”), large employers (generally those with 50 or more full-time employees or full-time equivalents) must report annually to the IRS information about the health coverage offered to their full-time employees during the prior year using IRS Form 1095-C. The IRS uses the forms to assess whether an employer "shared responsibility" penalty applies. Employers also must provide copies of the forms to their full-time employees ...
In recent months the Serbian Parliament passed amendments to Serbian tax laws, including the Law on Personal Income Tax (PIT Law), the Law on Contributions on Mandatory Social Insurance (CMSI Law), the Law on Corporate Income Tax (CIT Law), and the Law on Value Added Tax (VAT Law). These amendments introduce tax relief for salaries paid to employees in newly incorporated legal entities ...
Last week, the U.S. Department of Labor (DOL) issued proposed rules to expand access to “Association Health Plans” for small businesses that are unaffiliated, but are in the same line of business or geographic area. An “Association Health Plan” or “AHP” is a group health plan adopted by members of an employer association to provide health coverage for their employees ...
The Construction Industry Arbitration Commission of the Philippines (“CIAC”) has original and exclusive jurisdiction over disputes arising from, or connected with, contracts entered into by parties involved in construction in the Philippines. Construction disputes may range from contractual money claims to disputes over the execution of the construction work. Construction disputes may involve government or private contracts ...
Originally filed in October 2014, the long-running and high-stakes battle between two powerhouse companies, Amgen and Sandoz, continues to lay out the ground rules for a growing biosimilar industry. The Federal Circuit’s first decision under the Biologics Price Competition and Innovation Act (BPCIA) involved Zarxio, Sandoz’s Neupogen biosimilar product. Amgen v. Sandoz, 794 F.3d 1347 (Fed Cir. 2015) ...
