In recent years, the Department of Justice, the FDA and the FBI have stepped up enforcement of the Food Drug and Cosmetic Act’s (FDCA) drug importation, distribution and misbranding requirements particularly with respect to high-priced and difficult-to-obtain drugs used in cancer treatment. Recently, these efforts suffered an unexpected setback in the Sixth Circuit following the United States’ decision to abandon its prosecution against an East Tennessee Oncologist and his wife ...
The top level domain .УКР was delegated to Ukraine by the Internet Corporation for Assigned Names and Numbers (ICANN) on 28 February 2013. The Ukrainian Network Information Center (UANIC) became administrator and manager of .УКР domain. Registration in the .УКР domain opened on 22 August 2013. Thus, this domain became the fourth Cyrillic domain of top level after the Russian .P$, the Serbian .CPS and the Kazakh .КАЗ ...
On December 1, 2014, the Department of Health and Human Services Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule that included numerous changes for accountable care organizations (“ACOs”) participating in the Medicare Shared Savings Program (“MSSP”) in light of the experience CMS gained during the first two years of the program ...
In an opinion published on November 11, 2014, Connecticut joined a growing number of jurisdictions that have found that state law causes of action based on a health care provider’s unauthorized disclosure of a patient’s medical records are not preempted by the Health Insurance Portability and Accountability Act (“HIPAA”) ...
On January 1, 2015, the jurisdictional threshold of the Small Claims Court will be raised from $7,000 to $15,000. This constitutes a first step toward the modernization of civil procedure, explained the Minister of Justice, which will be followed by the coming into force of the new Code of Civil Procedure in January 2016.On February 28, 2014, the National Assembly passed Bill no ...
Last week, Waller launched an Ebola legal resource website. Since then, we have received positive feedback from our clients, follow-up questions and suggestions for additional topics we should cover. As the needs of our clients continue to evolve, we are updating the site regularly ...
How do we discipline employees that refuse to work due to the Ebola virus? What patient information is protected during an outbreak? How should we communicate with our employees about Ebola? Has OSHA issued new guidelines on Ebola for healthcare providers? These are just a few of the questions we are hearing from our clients ...
With the recent announcement to extend the waivers of certain fraud and abuse laws for accountable care organizations (ACOs) participating in the Medicare Shared Savings Program (MSSP), ACOs can continue using the waivers in their current form - at least for now ...
On October 3, 2014 the Department of Health and Human Services, Office of Inspector General (“OIG”), released a proposed rule to add new safe harbors to the Anti-Kickback Statute (“AKS”) and to amend the definition of “remuneration” in the Civil Monetary Penalties (“CMP”) regulations. The OIG additionally solicited comments on same which must be submitted no later than 5 pm EST on December 2, 2014 ...
On October 3, 2014, the Supreme Court of Canada, by a majority decision of 5 to 4,1 confirmed that a disposition ordering the treatment of an accused who is found unfit to stand trial requires the prior consent of the designated hospital to all the terms of the disposition order, inclusive of the date on which the treatment is to begin ...
Motivated by the desire to optimize all matters concerning arbitration and to adapt our previous legislation to the principles set by the United Nations Commission of International Trade Law (UNCITRAL), the Panamanian National Assembly enacted the Law No. 131 of 31st December 2013 on National and International Commercial Arbitration (the “Arbitration Act”). A summary thereof follows. Scope This Act applies to arbitrations, both national and international, with seat within Panamanian territory ...
The starting point for mediation in commercial disputes is that the parties themselves are in the best position to resolve the dispute, instead of entrusting it to an arbitrator or a judge. In this way, the parties retain control over their conflict, thus increasing the opportunities to reach a flexible solution. In this article we will briefly review the alternatives offered by the public courts in Sweden when a dispute already has emerged ...
The quality of one’s life is determined by the quality of the questions one asks oneself every day, and the realization that this truth applies equally to lawyering. Our theory, borne of experience, is that a lawyer conditioned to ask an empowering question when adversity strikes, such as: “How can I use this?” is a better and more effective advocate. You might one day owe your life to an accident. Literally ...
In an unanimous decision dated September 4, 20141 , the Court of Appeal confirmed that the 45-day time limit under the Act Respecting Health Services and Social Services2 (ARHSSS) to allow the medical examiner and the local service quality and complaints commissioner to process a user complaint is not mandatory but rather serves to indicate that the Legislator intends the complaint to be diligently processed ...
The draft regulations for OTC derivatives have been released, which means that change is in the air. The government is stepping forward into unchartered territory and is set to regulate an area which has never been regulated before. Following our recent breaking news on the draft regulations, ENSafrica will, over the coming weeks and months, unpack the regulations for you, highlighting all the essentials. What follows is a sneak peak at affected areas and a snapshot of the bigger picture ...
Loose lips sink ships. They also can sink the protections of the attorney-client privilege. A case in point is a recent decision from the Southern District of Florida. Guarantee Insurance Co. v. Heffernan Insurance Brokers, Inc., Case No. 13-23881-CIV (S.D. Fla. June 13, 2014). In that case, Guarantee Insurance had been sued for the alleged bad faith handling of a worker’s compensation insurance claim ...
On July 16, 2014, the Sixth Circuit Court of Appeals confirmed that a “health care provider can bring the Medicare Secondary Payer Act’s (“MSP’s”) private cause of action against a non-group health plan that denies coverage for a reason besides Medicare eligibility.” In Michigan Spine & Brain Surgeons, PLLC v. State Farm Mutual Automobile Insurance Co., the Court clarified a key holding in its prior decision in Bio-Medical Applications of Tennessee, Inc. v ...
The U.S. Supreme Court during its 2013-2014 term decided on six patent cases, the last on June 19, 2014. These cases will have significant consequences for companies as they work to advance their strategy for protecting their intellectual property. The following summary provides highlights of each case. Medtronic Inc. v. Mirowski Family Ventures LLC Question: First some background: The Supreme Court in MedImmune, Inc. v. Genentech Inc., 549 U.S ...
In March 2013, the Florida Supreme Court issued a seminal decision for businesses and commercial litigators, Tiara Condominium Association Inc. v. Marsh & McLennan Companies, 110 So. 3d 399 (Fla. 2013), in which it expressly limited the applicability of the economic loss rule to products liability cases. For decades, Florida courts had applied the economic loss rule to prohibit a party in contractual privity from seeking to recover economic damages arising from the contract ...
This year marks the 30th anniversary of the passage of the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act). Considered to be one of the most successful pieces of legislation ever enacted, the Hatch-Waxman Amendments created the modern generic drug industry, which is responsible for dramatically increasing the availabilty of low-cost generic drugs and saving the U.S. healthcare system billions of dollars ...
The numbers have been crunched and we have a winner! The United States District Court for the Eastern District of Virginia — known nationally as the “Rocket Docket” — had the fastest trial docket in the country in 2013. Once again. For the sixth year in a row. The median time interval to trial for the 12-month time period ending March 31, 2013, (the most recently released data) is 11.1 months. That’s 11 ...
