MDR postponement On 17 April 2020 the European Parliament decided to postpone the transition timeline to implement the EU Medical Device Regulation (MDR), which was set to expire on 26 May 2020, until 26 May 2021. The EU MDR postponement was published in the Official Journal of the European Union and entered into force on 24 April 2020 ...
This 11th edition of Unprecedented, our weekly update on COVID-19-related litigation, identifies news reports placing the number of COVID-19 filings at around 2,700, with insurance coverage disputes former the single largest category. And so unsurprisingly, one of the matters we report this week is the dispute over whether those insurance coverage disputes should be consolidated into multi-district litigation ...
1. Introduction Pursuant to Law no. 40 of 5 June 2020, published in the Official Gazzette no. 143 of 6 June 2020 (the “Conversion Law”), Law Decree no. 23 of 8 April 2020 (the “Liquidity Decree”) was converted into law with amendments. Below is a summary of the key amendments made to Chapter II (Urgent Provisions to Ensure Going Concern) by the Conversion Law. 2 ...
In a highly anticipated decision, the U.S. Supreme Court held Title VII of the federal Civil Rights Act protects LGBTQ employees from being fired because of their sexual orientation or gender identity. The opinion, released on June 15, 2020, was a consolidation of three federal appellate court decisions—Bostock v. Clayton County; Altitude Express v. Zarda; and R.G. & G.R. Harris Funeral Homes v. Equal Employment Opportunity Commission ...
This time we address solutions from the front lines: devices for remote diagnostics which can improve effective detection of the coronavirus and also unburden the health service in other areas. These solutions can also serve as aproving ground for the regulatory approach to oversight of algorithms. The immediate inspiration for writing this text was asolution from the company StethoMe presented at the DemoDay organised by the MIT Enterprise Forum CEE ...
Preparation of financial statements and corporate income tax, recommencement of time periods, remote trials, gradual return to workplaces, insolvency proceedings and compliance with criminal law In a new edition of our COVID-19 Special Newsletter, we examine the key new legislation approved over the past two weeks in all areas of business law ...
This tenth edition of Unprecedented, our weekly update on COVID-19-related litigation, finds us reporting fewer shutdown-related cases than in previous weeks, suggesting that these cases are winding down as the country opens back up. By contrast, our prediction that workers' compensation and personal injury cases would begin to pick up with reopening appears to have borne out, with this week bringing the first reported “household exposure” claim ...
As clients and counsel wrestle with the changing dynamics within litigation and trial work, Bradley has assembled trial lawyers with experience from hundreds of trials and a jury consultant of national standing to present on what is happening in courts across the country and how it is impacting the judicial system as we know it ...
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 ...
Key Points As the State begins to open back up, COVID-19 employment related litigation also begins. Several trends have emerged. On an individual and class-wide basis, Plaintiffs cite disability discrimination, emotional distress, retaliation, reimbursement, public nuisance and WARN Act claims, among others ...
Following the World Health Organization’s announcement of a public health emergency caused by COVID-19 and its declaration ofan international pandemic, the President of the Republic declared a state of emergency on 18 March and this lasted until 2 May. On 30April, theGovernment declared a situation of calamity and this was renewed on 15May and 29 May ...
This ninth edition of Unprecedented, our weekly update on COVID-19-related litigation, continues to be dominated by shutdown challenges and workplace injury and wrongful death claims. But as governments discuss contact tracing as a way to control COVID-19’s spread, a data breach lawsuit against Deloitte illustrates the risks associated with creating the systems and collecting the necessary information ...
Natural products play an important role in pharmaceutical innovation. They are active components in many medicines. For example, nearly half of the small molecules used to treat cancer are natural products or directly derived from natural products.1 They are also components of vaccines. The pharmaceutical industry is constantly seeking access to natural products and the traditional knowledge associated with them ...
States’ responses to the global pandemic may, however well-intended, harm the interests of inward investors. Under international public law, those investors have rights and so a spate of investor-State arbitral claims may well be a legacy of the pandemic. Across the world, governments have responded to Covid-19 by introducing emergency measures, which have inhibited social interaction and hampered economic activity ...
As corporate policyholders continue to submit claims to their insurers for business interruption and related losses sustained from the COVID-19 pandemic, insurers appear to be denying such claims routinely where the policies at issue contain exclusionary language specific to viruses — whether in stand-alone virus exclusions or other types of exclusions ...
In times of the ongoing crisis, associated with the spread of the novel coronavirus infection (COVID-19), and the introduction of epidemiological requirements and restrictions, many businesses have faced difficulties with contractual performance, including the failure in supply, cancellation of scheduled events and often cutbacks in profits and the impossibility to perform monetary obligations ...
Business interruption insurance claims related to the COVID-19 pandemic have raised numerous questions for practitioners, businesses, and insurers ...
In Silbersher v. Valeant Pharmaceuticals International, Inc., the U.S. District Court for the Northern District of California dismissed a False Claims Act (FCA) qui tam lawsuit the court found was based largely on a Patent Trial and Appeal Board (PTAB) decision and thus violated the public disclosure bar. No. 3:18-cv-01496-JD, 2020 U.S. Dist. LEXIS 82548, at *22–27 (N.D. Cal. May 11, 2020) ...
In the context of COVID-19 pandemic, the field (on-site) tax audits in Russia are currently postponed, but once all restrictions are lifted, the tax authorities can start auditing Russian companies and replenishing the National Budget by redoubling their efforts. The pharmaceutical industry could be in the focus of the tax authorities and, above all, they could start with auditing of the contractual structures used for organizing clinical trials and promotion of pharmaceutical products ...
In the latest in a series of amendments to Federal Law No. 11 of 1992 (the UAE Civil Procedure Law) the recently issued Cabinet Resolution No. 33 of 2020 (the Resolution) brings about some important changes to how matters will be litigated in the UAE courts. The Resolution amends certain provisions of the regulations to the UAE Civil Procedure Code introduced by Cabinet Resolution No ...
On May 7, 2020, the amendment to Decree No. 466 was published in the Official Gazette, which approves the Regulation of Pharmacies, Drugstores and other pharmaceutical establishments, regarding the sale of medicines through electronic means. Particularly, article 8 of said Decree is modified, in order to allow the electronic sale of medicines in pharmacies, incorporating the following sentence: "Pharmacies may dispense medicines through electronic means ...
Key Points City council and planning commission recusals can have a significant impact on the outcome of hearings involving land use and environmental issues. Recusals can lead to tie votes or the loss of a quorum, which may make it impossible for local governments to approve development projects. In some circumstances, an elected or appointed official’s failure to recuse can be grounds for reversing local government decisions ...
Key Points City council and planning commission recusals can have a significant impact on the outcome of hearings involving land use and environmental issues. Recusals can lead to tie votes or the loss of a quorum, which may make it impossible for local governments to approve development projects. Failing to disclose conflicts of interests can be grounds for reversing local government approvals ...
As more workers begin to return to the workplace, it is expected that there will be an increase in the number of lawsuits related to employee contraction of the virus in the workplace. While the general rule in most states is that the workers’ compensation system provides the exclusive remedy for work-related injuries and illnesses, claimants and their attorneys are eyeing exceptions to the workers’ compensation system in order to maximize their potential recovery ...
Section 29 of the Bankruptcy Ordinance (Cap. 6) (BO) allows a trustee in bankruptcy to apply to the Courts for orders compelling disclosure of material documents and/or information of the bankrupt in order for the trustee to carry out his/her duties under the bankruptcy. For the authors’ previous article on Section 29, please see here ...
