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Practice Industry: Dispute Resolution, Healthcare & Pharmaceuticals

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The CDC’s New Definition of “Close Contact”: What You Need To Know
Dykema, November 2020

                The Centers for Disease Control and Prevention has expanded the definition of close contact to now evaluate exposure cumulatively over a 24-hour period such that “15 cumulative minutes of exposure at a distance of 6 feet or less can be used as an operational definition for contact investigation,”[1] Because the newly expanded definition is not limited, it impacts many different industries (inclu

Invoking Copyright to Block the Submission of Evidence? Nice Try, But No Cigar!
ALTIUS/Tiberghien, November 2020

The Court of Justice of the European Union delivers judgments regarding the concept of “communication to the public” faster than legal scholars can read and dissect them. While we are eagerly awaiting the Court’s analysis of different types of hyperlinking, it has taken less than two months to follow Advocate General Hogan’s opinion regarding the emailing of evidence containing copyrighted works to a court in legal proceedings...

“If I've Told You Once, I've Told You Eight Times…” HHS OIG Issues Another Audit Report on Hospitals’ Failure to Report Credits for Explanted Cardiac Devices and Lays the Groundwork Collection of Over
Verrill, November 2020

Each year, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issues dozens of audit reports. While each is important in its own way, some stand out with language that appears to reflect OIG’s fraying patience and may lay the groundwork for possible future enforcement action. A report issued on November 16, 2020, falls into this category...

OIG Takes Aim at Speaker Programs in Special Fraud Alert
Bradley Arant Boult Cummings LLP, November 2020

On November 16, 2020, the Office of Inspector General of the Department of Health and Human Services (OIG) issued a Special Fraud Alert addressing the fraud and abuse risks of speaker programs that are commonplace in the pharmaceutical and medical device industries...

FTC Sues to Block Methodist Le Bonheur-St. Francis Transaction
Bradley Arant Boult Cummings LLP, November 2020

On November 12, 2020, the Federal Trade Commission (FTC) sued to block the acquisition of two Memphis-area hospitals by Methodist Le Bonheur Healthcare. Eleven months earlier, on December 12, 2019, Methodist entered into an agreement with Dallas-based Tenet Healthcare Corporation to purchase Saint Francis-Memphis and St. Francis-Bartlett (along with their associated physician practices, urgent care centers, and other ancillary care providers) for $350 million...

For the First Time Since TC Heartland, the Federal Circuit Addresses Venue in an ANDA Case – the Holding May Also Impact BPCIA Litigation
Patterson Belknap Webb & Tyler LLP, November 2020

On November 5, 2020, in Valeant Pharms. N. Am. LLC  v. Mylan Pharms. Inc., No. 2019-2402, the Federal Circuit held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where actions related to the submission of an Abbreviated New Drug Application (‘ANDA’) occur, not in all locations where future distribution of the generic products specified in the ANDA is contemplated.”  Slip op. at 3...

Healthcare & Life Sciences Department Report
Beccar Varela, November 2020

In this report, you will find a summary of two important decrees published yesterday in the Official Gazette. Regulatory Decree of Law No. 27,350 of medical and scientific research on the medicinal use of the cannabis plant and its derivatives By means of Executive Branch’s Decree No...

Joint Resolution No. 1/2020: Health Emergency - Maximum Prices for Certain Drugs
Beccar Varela, November 2020

The Joint Resolution No...

Exceptional Rules for Products to Prevent Spread of COVID-19
PLMJ, November 2020

Introduction The rapid spread of COVID-19 pandemic has led to a significant increase in demand for medical devices (MDs) and personal protective equipment (PPE), masks for social use (textile articles) and other products destined to prevent the spread of the disease. As a result, it became clear that there was insufficient supply to meet existing needs during the state of emergency and the subsequent period...

The Separability of an Arbitration Clause - The Sharjah Court of Appeal Sets Liimits
Afridi & Angell, November 2020

The Sharjah Court of Appeal recently declined to apply the principle of separability of an arbitration clause, on the basis that the underlying agreement (i.e. in which the arbitration clause was contained) was not defective or argued to be invalid by the appellant. This judgment has potentially significant implications for parties who intend to rely on an agreement which contains an arbitration clause to assert claims in court...

Battling COVID-19: Mechanisms for Access to Antiviral Products and Diagnostics
ENSafrica, November 2020

IP landscape While the world is in the grip of the deadly COVID-19 pandemic, the patenting of pharmaceutical and biological compositions and the launch of generic products is even more hotly debated than before, particularly in the world's developing and least-developed countries...

Know Your Contract: Case Law Highlights
MinterEllisonRuddWatts, November 2020

New Zealand’s construction industry and projects have weathered a turbulent year with a consistent flow of seminal judicial decisions addressing issues arising in the life cycle of a project...

Hospital Price Transparency Rule: Full Steam Ahead
Verrill, November 2020

Neither COVID-19 nor continued legal challenges appear likely to derail the Centers for Medicare & Medicaid Services (CMS) Hospital Price Transparency Rule from going into effect on January 1, 2021. Hospitals therefore should continue to comply with the requirements by the deadline...

Washington Supreme Court Alters State's Agricultural Exemption in the Minimum Wage Statute
Schwabe, Williamson & Wyatt, November 2020

On November 5, 2020, the Washington Supreme Court altered a 60-year provision of Washington’s Minimum Wage Statute when it issued its decision in Martinez-Cuevas v. DeRuyter Brothers Dairy. The court held that the agricultural overtime exemption at RCW 49.46.130(2)(g), which exempted agricultural employers from paying overtime at a rate of 1.5 times the regularly hourly rate, violated article I, section 12 of the Washington State Constitution as applied to dairy workers...

Can Parallel Importers Rebrand Generic Medicines?
ALTIUS/Tiberghien, November 2020

If a branded medicine and its generic version are put on the EEA market by economically linked undertakings, is a parallel importer then allowed to rebrand and repackage the imported generic version as the branded reference medicine? This has been a hotly debated issue in recent years and recently led the Brussels Court of Appeal (CoA) to refer three questions to the European Court of Justice (ECJ) (Cases C-253/20 and C-254/20)...

In Morehouse, Eleventh Circuit Underscores Threshold Test for FCA Retaliation Claims
Dinsmore & Shohl LLP, November 2020

In Brown v. Morehouse College, a False Claims Act (FCA) retaliation action, the U.S. Court of Appeals for the Eleventh Circuit affirmed the case’s dismissal, agreeing with the district court that while the plaintiff’s ethics complaints may have led to retaliation against him by the College, the complaints did not allege FCA fraud and therefore were not protected by the statute. No. 19-13773, 2020 U.S. App. LEXIS 33444 (11th Cir. Oct. 23, 2020)...

Do Not Forget to Provide Any of Your Employees Who Must be Present in Your Workplace with a Document to Certify this Fact
ALTIUS/Tiberghien, November 2020

Belgium is, for the second time, in lockdown. The new Ministerial Decree of 1 November 2020 stipulates that, as from today until 13 December 2020, all workers are obliged to telework. However, an exception applies when either the employee’s role or the continuity of business operations, activities and services does not allow for teleworking...

Top tips on comparative advertising
MinterEllisonRuddWatts, November 2020

Comparative advertising is a risky method of advertising. But if care is taken to address those risks, comparative advertising can be an incredibly effective tool for your business. It also has an important part to play in regulating competition and educating consumers. Comparative advertising compares a product produced or service provided by the advertiser to an equivalent product or service produced or provided by a competitor (or competitors)...

Environmental Claim ‘Flushable' Not False or Misleading
MinterEllisonRuddWatts, November 2020

The Full Australian Federal Court recently upheld the decision that Kimberly-Clark’s Kleenex Cottonelle Flushable Cleansing Cloths (Kleenex Wipes) did not make false or misleading claims in using the word ‘flushable'. The guidance on the evidence required and weight given to complaints is instructive for New Zealand entities making environmental claims...

How to Avoid False or Misleading Pricing Representations
MinterEllisonRuddWatts, November 2020

Pricing representations receive ongoing scrutiny from the Commerce Commission. The Commission frequently brings enforcement action in this area and in recent years the Commission has signalled that it receives a significant number of complaints from consumers who have been misled by or are concerned about pricing practices...

Buchalter COVID-19 Client Alert: San Francisco Moves to Lowest COVID Tier in California, Begins Process of Reopening Non-Essential Offices; Other Bay Area Counties Slower to Follow
Buchalter, November 2020

On October 20, 2020, San Francisco County was upgraded to the “minimal” tier within the California COVID-19 tracking system, meaning it has the fewest restrictions on reopening all businesses as promulgated by the State of California. In order to qualify for the “minimal” tier, a county must have an infection rate of less than one daily new positive COVID case per 100,000 residents and have a positive test rate of less than 2% for two consecutive weeks...

Information Blocking Rule Compliance Date Extended Due to Pandemic
Bradley Arant Boult Cummings LLP, October 2020

The U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) released an interim final rule on October 29, 2020, delaying the implementation of the information blocking rule under the 21st Century Cures Act (Information Blocking Rule)...

DOJ Announces First Life Sciences Settlement Involving the Open Payments Program
Dinsmore & Shohl LLP, October 2020

The U.S. Department of Justice (DOJ) announced on October 29, 2020 it reached a more than $9.2 million settlement with Medtronic USA Inc. to resolve allegations it violated the False Claims Act (FCA) and Open Payment Program.[1] Specifically, Medtronic agreed to pay $8.1 million to resolve FCA allegations it paid kickbacks to induce a South Dakota neurosurgeon to use its SynchroMed II intrathecal infusion pumps...

US-India Partnership in the Defence Sector Under the Atmanirbhar Bharat (Self-Reliant and a Resilient India)
Kochhar & Co. Advocates & Legal Consultants, October 2020

Background and about Atmanirbhar Bharat The idea of Atmanirbhar Bharat,or self-reliance, was at the heart of the Hon’ble Prime Ministerof India, Shri Narendra Modi’s address to the nation on 12May 2020 when he announced an economic package towards building aAtmanirbhar Bharat, or a self-reliant, resilient India...

COVID-19 – A Force Majeure Event or Simply a Pandemic?
Kochhar & Co. Advocates & Legal Consultants, October 2020

Introduction What is known to exist but is not visible is surrounded by mystery. It excites the imagination and people spin yarns about it. Though that is not true when it comes to novel coronavirus (“COVID-19”), the outbreak of which has been globally reported, COVID-19 has caused worldwide unprecedented disruptions to business operations; and the commercial turmoil continues...

 

 

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