After the Netherlands, Slovakia, and the UK, it is now France’s turn to impose Sunshine-like obligations on the pharmaceutical industry. Soon, similar obligations will apply to all EU countries, after EFPIA, the European trade association for the pharmaceutical industry, adopts a code of conduct on disclosure of transfers of value between pharmaceutical companies and health care professionals or institutions ...
In a recent decision by the Court of Appeal of Québec, the Honourable Jacques Chamberland, J.C.A. reviewed the application of exclusion clauses contained in a home insurance policy in the context of criminal activities1. THE FACTSThe Appellant, Union canadienne compagnie d’assurance insured the building of respondent, Mrs. Lise Houle and her spouse, Christian Alexandre. The latter was growing cannabis in the insured building ...
Last week, a federal jury in South Carolina found that Tuomey Healthcare System, Inc. violated the Stark Law and the False Claims Act by submitting false claims for reimbursement to the United States, resulting in $39 million in damages to the government. United States ex rel. Drakeford v. Tuomey Healthcare Sys., Inc., No. 3:05-2858-MBS (D.S.C. May 8, 2013) ...
In recent months, high profile M&A warranty claims1 and falling premiums have dramatically increased the utilization of "representations and warranty insurance" (RWI), also known as "warranty and indemnity insurance," in mergers, acquisitions and related transactions. By one account, demand for transactional risk insurance policy limits in North America grew by eighty-six percent (86%) in 2012 ...
1 The regulator The Insurance Commission is the insurance regulator. It is a government agency under the Department of Finance. The Commission supervises and regulates the operations of insurance and reinsurance corporations, which need to be authorised ...
On April 17, 2013, the Health and Human Services Office of Inspector General (OIG) released an Updated Provider Self-Disclosure Protocol (SDP), which replaces the original SDP published in 1998. The SDP is used by providers and suppliers to voluntarily disclose violations of the fraud and abuse laws. According to the OIG, it has received more than 800 disclosures since the SDP’s inception, resulting in more than $280 million in recoveries ...
The decision of the Indian Supreme Court to deny Novartis’s application for patent protection for an improved version of its patented Glivec drug – the culmination of a seven-year battle - has certainly made the headlines. There are a number of reasons for this. First, Glivec is a well-known drug – described by some as a ‘wonder drug’ – that’s used to combat cancer, including leukaemia and gastro-intestinal cancer ...
The decision of the Court of Appeal in the La Capitale Case has been expected since February 2012 when the Superior Court dismissed the Class Action taken against an insurer who, with the consent of the policyholder, had unilaterally modified the waiver of premiums clause in a group insurance contract2. To better understand the context, please refer to our NEWSLETTER IN JUNE 2012 following the Superior Court judgment ...
A March 7, 2013 piece on Morning Edition, the morning news program from National Public Radio, raised a lot of questions. “In A Grain Of Golden Rice, A World Of Controversy Over GMO Foods” told the story of golden rice, a beautiful yellow rice enhanced with beta-carotene, or Vitamin A. This rice was ostensibly developed to be grown in developing countries, where foods high in Vitamin A either are uncommon or are expensive ...
On March 1, 2013, the Court of Appeal rendered a judgment on the insurer's duty to defend and indemnify the insured in the area of commercial general liability insurance.1 It confirmed the decision of the trial judge which had held that the insurer has the duty to defend and indemnify,2 and ordered it to reimburse its insured for the amounts paid to settle the claim of a third party and the amounts incurred by the insured in defending itself against the action ...
Only the terms of the insurance policy itself - and not the provisions of an underlying indemnity contract - determine the scope of coverage afforded to an additional insured, provided that the insurance and indemnity provisions in the underlying indemnity contract are separate and independent from one another. For additional insured and indemnity provisions to be deemed “separate and independent,” “Texas law only requires the additional insured provision to be a discrete requirement ...
A federal court jury in Illinois found that nursing home operator Momence Meadows fraudulently billed Medicare and Medicaid for “worthless services” and falsely certified compliance with health care laws and regulations, resulting in $28 million in damages to the government. United States ex rel. Absher v. Momence Meadows Nursing Ctr., Inc., No. 2:04-cv-02289 (C.D. Ill. Feb. 8, 2013) ...
It took thirteen years, four months, and five days of heated debates and passionate protests before the country’s first reproductive health law was passed. Four days shy of Christmas last year, President Aquino finally signed the 24-page bill into law. It is now Republic Act No. 10354 or The Responsible Parenthood and Reproductive Health Act of 2012 (RH Law). The passing of the RH Law, however, does by no means close this chapter of Philippine history ...
On Tuesday, February 19, 2013, information security firm Mandiant issued a report documenting computer security breaches at hundreds of organizations, allegedly resulting from a cyber-espionage campaign undertaken by elements of the Chinese government. The Mandiant report is only the latest in a series of much-publicized incidents of “hacking” performed by what is believed to be a variety of public and private actors ...
Sixteen years since the enactment of Law No. 7 of 1996 regarding Food (“the 1996 Food Law”), the Government issued the new Food Law (ie Law No. 18 of 2012) (“Food Law”) on 18 October 2012, two days after World Food Day. The Food Law replaces The 1996 Food Law. The Food Law covers three significant areas which were not governed by the 1996 Food Law, ie imports of food; the halal requirement; and the establishment of a new non-ministerial agency in-charge of food matters ...
Sometimes, litigants are forced to reevaluate their strategy mid-course. Occasionally, a plaintiff in a pending trademark infringement action faces a cancellation counterclaim that poses a real threat to the plaintiff’s trademark. In that situation, to avoid the risk of cancellation or a declaration of invalidity, the plaintiff may want to voluntarily dismiss its claim and grant a covenant not to sue to the alleged infringer ...
Under the Patient Protection and Affordable Care Act (“PPACA”), an employer that employs an average of at least 50 full-time and full-time equivalent employees (a “Large Employer”) during 2013 may be subject to a penalty in 2014 if the Large Employer fails to offer “minimum essential coverage” to all but 5 percent (or, if greater, five) of its full-time employees (“No Coverage Penalty”) ...
The long awaited Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Regulation amendments (the “Changes”) to incorporate the changes made by Health Information Technologyfor Economic and Clinical Health (HITECH) in 2009 as part of the American Recovery and Reinvestment Act and by the Genetic Information Nondiscrimination Act (“GINA”) were recently released ...
The wait is over. On January 17, 2013, the Department of Health and Human Services’ ("HHS’") Office for Civil Rights ("OCR") released its long-anticipated megarule ("Omnibus Rule") amending the HIPAA Privacy, Security, Breach Notification and Enforcement Rules. These amendments implement and expand on the requirements of the Health Information Technology for Economic and Clinical Health ("HITECH") Act and the Genetic Information Nondiscrimination Act of 2008 ...
The access to records clause, sometimes called the inspection or audit clause, is a common fixture in reinsurance agreements and serves an important function. It enables the reinsurer to track the performance of the agreement and maintain an accurate view of the business ceded. More specifically, it allows the reinsurer to ensure the cedent is complying with the terms and conditions of the agreement, including timely reporting of losses and calculation of premiums ...
The U.S. District Court for the Eastern District of Virginia recently overturned the United States Patent & Trademark Office ("USPTO") interpretation of the patent term adjustment ("PTA") statute in Exelixis, Inc. v. Kappos. Similar to Wyeth v. Kappos, where a previous USPTO interpretation of the PTA statute was overturned, the Exelixis decision promises to add months and even years to the patent term of many patents ...
The U.S. Court of Appeals for the Second Circuit, in VAM Check Cashing Corp. v. Federal Insurance Company, No. 11-2644-cv, (2d Cir. Nov. 7, 2012), found the "overt felonious act" requirement in a crime insurance policy to be ambiguous. The court held, therefore, that the insured would be entitled to coverage for a theft at the insured’s store, even though it occurred as a result of a covert scheme to defraud ...
Narrow Construction of Food & Drug Act Undermines FDA Regulation, Class Actions A divided panel of the Second Circuit Court of Appeals in New York overturned on First Amendment grounds the conviction of a pharmaceutical sales representative for conspiracy to introduce a misbranded drug into interstate commerce, an offense more commonly referred to as off-label marketing. The decision, United States v. Caronia, No. 09-5006-cr (2d Cir. Dec ...
