It was this time last year that U.S. Environmental Protection Agency Administrator Scott Pruitt created a Superfund Task Force to “provide recommendations . . ...
With Administrator Scott Pruitt at its helm, cooperative federalism is the frequently recited principle underlying recent EPA enforcement efforts. As the Environmental Protection Agency’s regulatory oversight in areas like the Clean Water Act is delegated to the states, the agency is relying more upon state and local authorities to enforce the laws. There are shortcomings associated with this approach, which were raised in the recent U.S ...
Healthcare Hazards Involving Medical Records During Bankruptcy Companies in the healthcare industry face many unique challenges when undergoing a bankruptcy, including challenges arising due to the federal and state law framework governing the use and disclosure of medical information. In February 2018, the U.S. Department of Health and Human Services (HHS) announced that it had reached a settlement with the receiver appointed to liquidate the assets of Filefax, Inc ...
The Administrative provisions that set forth the guidelines for comprehensive management of waste requiring special management in the hydrocarbons sector (the “Guidelines”) were published in Mexico’s Federal Official Gazette on May 2, 2018 and became effective the following day ...
EPA Administrator Pruitt recently issued another policy to help streamline the New Source Review (NSR) Program. After receiving comments from many industry sources that the NSR Program should be reformed given its heavy time and cost burden, the Trump EPA has made reforming the NSR Program a priority ...
On April 12, 2018, President Trump issued a memorandum to Administrator Pruitt to promote domestic manufacturing and job creation through policies intended to streamline implementation of national ambient air quality standards (NAAQS) ...
Earlier this year, revisions to the requirements for new and existing indirect heat exchangers contained in 401 KAR 59:015 and 401 KAR 61:015 became effective. Indirect heat exchangers with a heat input capacity greater than one million Btu/hour (MMBtu/hour) are subject to either 401 KAR 59:015 (new sources) or 401 KAR 61:015 (existing sources). The classification as new or existing depends upon when the indirect heat exchanger was installed ...
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 ...
When a half-mile from the nearest body of water, must you obtain a federal permit when discharging treated wastewater to groundwater? According to a recent Ninth Circuit decision, the answer may be yes.[1] This alarmed many because the Clean Water Act regulates discharges to navigable waters from "point sources" like pipes or ditches ...
Biosimilar developers have been aggressive in filing petitions for inter partesreviews of biologics patents before the Patent Trial and Appeal Board, many ofthem preceding the filing of a marketing application. Such early IPRs are attractiveto biosimilar makers, because they provide a chance to challenge innovator patentsyears before the biosimilar maker files a marketing application with the U.S. Foodand Drug Administration ...
Population growth has become the be-all and end-all for economic prosperity, but how on Earth can we cope with the extra billions of people? While “leafing” – or should I instead say “scrolling” in today’s need to sound tech savvy – through the news websites, the two subjects seemed to have captured the media’s attention: immigration and plastic ...
Activists are recasting risk in a way that can only damage industry Last August, a California jury awarded plaintiff Eva Echeverria a total of $417m in compensatory and punitive damages in a lawsuit against Johnson & Johnson (J&J). Her case was that the company should have warned consumers that studies had found an inconclusive correlation between ovarian cancer and talcum powder ...
More than two and a half years after the U.S. Food and Drug Administration (FDA) announced that it was reevaluating 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.The bills reawakened a debate about the pros and cons of POHs ...
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 ...
On February 12, 2018 the Mexican Secretariat of Communications and Transportation (“SCT”) published the draft of Mexican Environmental Standard PROY-NOM-036-SCT3-2017 in the Official Daily Gazette, which sets forth the maximum allowable limits of noise generated by aircraft. Within the next 60 calendar days, any interested party may provide comments to the National Consultation Committee of Air Transportation Standardization ...
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) ...
On February 22, 2018, the Center for Biological Diversity (CBD) sent the Environmental Protection Agency (EPA) a notice of intent to sue letter for failure to approve Kentucky’s air quality plan for limiting fine particulate (PM2.5) emissions in the Louisville, Kentucky area. Kentucky’s Energy and Environment Cabinet submitted a revision to the Jefferson County portion of the Kentucky State Implementation Plan (SIP) to EPA December 21, 2016 ...
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 ...
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 ...
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 ...
On January 31, 2017, the First Appellate District Court in the case Santa Barbara Channelkeeper v. City of San Buenaventura found that an allegation of excessive water diversion to protect endangered fish species under the rule of reasonableness and the public trust doctrine, could not be resolved without consideration of all competing water users in the system ...
