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 ...
An increased number of corporate transactions and mergers have been observed in the oil and gas sector on the Norwegian Continental Shelf (NCS) in recent years. Several oil majors and traditional utilities and downstream companies have reduced their presence and, to some extent, been replaced by smaller companies, including start-ups backed by private equity ...
Guatemalan respected Judge Erika Aifan issues a historical ruling in a criminal case brought against construction companies. A plea bargain was reached under an abreviated process allowed under Guatemala´s Criminal Law where senior executives for the companies accepted making facilitation payments to the ex-Minister of Construction in order to accelerate backed payments owed for previous construction deals ...
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 ...
Increase in merger and acquisition deals notified in Ireland In recent months there has been 27 merger deals notified to Ireland's Competition and Consumer Protection Commission ("CCPC") which is up 42% from the 19 notifications as of the same date last year.This increase is following a pattern of sustained increases, for example, there had been 72 notifications across the whole of 2017 which was an increase on 2016's total of 67 ...
As with every year, the 2018 legislative session will impact education in West Virginia in a variety of ways. Today, we want to bring to your attention two bills that will make minor – but important – changes in the way schools operate, both of which were signed by the governor last week. The first is Senate Bill 244, related to possession of deadly weapons on school grounds or at school activities ...
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 ...
As of recently, state aid control is a part of theMontenegrin Competition Agency's (the "Agency") scope of authority ...
This article provides a brief review of MSHA enforcement data and a look at MSHA’s regulatory agenda. MSHA Enforcement Data (data from January 1, 2017 to December 31, 2017) MSHA issued 104,412 enforcement actions to mine operators in 2017, an increase of approximately 11,793 or 11.3 percent from 2016. Of these, 58,083 (or 55.63 percent) were issued to metal/nonmetal operators while 46,329 (or 44.37 percent) were issued to coal operators ...
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 ...
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 March 1, 2018, at the American Bar Association’s National Institute on White Collar Crime, top Department of Justice (DOJ) officials signaled expansion of DOJ’s self-disclosure policy to non-Foreign Corrupt Practices Act (FCPA) cases ...
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 ...
In West Virginia, we are approaching another Personnel Season (for Personnel Season deadlines for the 2017-2018 school year, click here). We are often asked about the listing of individual employee names on county board of education agendas ...
Earlier this year the European Commission published a draft Withdrawal Brexit Agreement. It is a draft treaty to embody the key principles from the Joint Report of the Commission and the UK on the first three elements of the Brexit negotiations (i.e., People, Ireland and Money - the "PIM" Phase). The draft Agreement sets out a roadmap for the EU's vision of the withdrawal process.This is a negotiating move by the EU - it is not an agreed draft. It is a move by the EU in the Brexit chess match ...
Yesterday, the U.S. Supreme Court significantly narrowed the scope of the Dodd-Frank Act's anti-retaliation measures. The decision resolved a split in authority by excluding from Dodd-Frank's whistleblower protections those persons reporting suspected violations only within their companies. In reversing the Ninth Circuit, the Court held that "Dodd-Frank's anti-retaliation provision does not extend to an individual who has not reported a violation of the securities laws to the SEC ...
READ: SEC Enforcement Division Announcement On February 12, 2018, the SEC Division of Enforcement announced the Share Class Selection Disclosure Initiative self-reporting initiative (the SCSD Initiative) ...
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 ...
The Securities and Exchange Commission’s Office of Compliance Inspections and Examinations (“OCIE”) has announced its 2018 examination priorities. The 2018 priorities provide insight into what activities OCIE believes present the highest risks to investors and, as such, what the examiners will be highlighting during their examinations of registered entities this year ...
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 ...
On February 7, 2018 the SEC Office of Compliance Inspections and Examinations (OCIE) issued the 2018 National Exam Program Examination Priorities. In introducing the examination priorities for 2018, OCIE describes the four pillars upon which the work of OCIE is based: promoting compliance; preventing fraud; identifying and monitoring risk; and informing policy. OCIE includes in the examination priorities factual data relating to the increase in examinations of investment advisers ...
IN THIS ISSUE: SEC Releases Update to 2018 Agenda of Regulatory Priorities The SEC Enforcement Division’s Initiatives Regarding Retail Investor Protection and Cybersecurity ENFORCEMENT ACTIONS: F-Squared Investment, Inc ...
Municipal Advisor Exam Results On November 7, the SEC’s National Examination Program issued a Risk Alert providing the SEC staff’s observations after conducting over 110 examinations of municipal advisors during the Municipal Advisor Examination Initiative ...
