This paper will address the varying requirements for fair market value in transactions involving physicians and hospitals and other health care providers. The paper will first examine the Stark law and how and when transactions may satisfy Stark’s requirements for fair market value. Second, the use of fair market value for compliance with the federal Anti-Kickback statute will be addressed ...
The Federal Circuit, in an opinion written by Judge Rader and joined by Judges Lourie and Prost, has determined that a termination of a contract for the government’s convenience does not terminate obligations to perform warranty and software upgrade services under the contract. The Court of Federal Claims, in a well-reasoned opinion by Judge Miller, had determined otherwise ...
The Arbitration Institute of the Stockholm Chamber of Commerce upholds a strong position as one of the most important centres of international arbitration. The steady growth in the number of cases involving foreign parties that are administered by the Arbitration Institute convincingly demonstrates its worldwide popularity and reputation ...
In the past few years China has introduced significant regulatory changes in an effort to modernize its pharmaceutical industry and bring it in line with international standards. These include reorganizing the former State Drug Administration into the State Food and Drug Administration (SFDA), thoroughly amending drug regulation and good manufacturing practice (GMP), enhancing intellectual property protection and changing drug import licensing ...
The purposes of this Health Care Alert are to: 1) summarize recently proposed federal regulations which will require physician disclosure of ownership interests in hospitals to patients; 2) remind health care providers of existing Texas laws requiring disclosure of ownership interests and 3) suggest best practices for disclosure of ownership interests ...
On Capitol Hill, U.S. lawmakers are considering legislation that would authorize the U.S. Food and Drug Administration (FDA) to approve generic versions of biological products. Representative Henry Waxman (D, CA), of “Hatch-Waxman” fame, has introduced the “Access to Life Saving Medicine Act” (H.R. 1038) to advance this change to U.S. law. In introducing the legislation, Rep ...
An Illinois federal district court held, in Massachusetts Bay Ins. Co. v. Faber Bros., Inc., No. 04 C 5160, 2007 WL 1029366 (N.D. Ill. March 30, 2007), that a distributor of firearms is not covered under general liability insurance contracts for claims alleging that its sales of firearms created a public nuisance that led to bodily injuries. Factual BackgroundThe insured, Faber Bros., Inc., is a distributor and wholesaler of firearms ...
Can the cost of remedying a manufacturing defect be considered as damage resulting from an “accident” covered under a liability insurance policy? This is the question the Quebec Court of Appeal considered in CGU, Compagnie d’Assurance du Canada v. Soprema Inc., [2007] QCCA 113 ...
The U.S. Department of Justice’s revised corporate charging policy, which was named after deputy attorney general Paul McNulty, was unveiled in December 2006. In the wake of its predecessor document, the 2003 Thompson Memo, we have seen a steady increase in the resolution of corporate criminal investigations without indictments or trials ...
A reputation for counterfeiting, poor quality control, ever-changing and inconsistent application of regulations and the challenges of ensuring that development does not unduly prejudice the welfare of the general population - this description of China’s pharmaceutical industry is representative of much that is good, bad and challenging in China’s recent regulatory and economic development ...
Advocate General Sharpston has recently expressed her opinion in the Commission v Republic of Finland case that ensuring a sufficient degree of transparency for the award of sub-threshold procurements should be determined by national law, rather than Community law. If these views were to be followed by the ECJ, it would provide renewed impetus to create national rules on low value awards and represent a meaningful evolution of the ECJ's past case law ...
We are pleased to advise you of recent Quebec Superior Court judgments rendered in favour of our clients. Two motions for authorization to institute a class action were recently denied by the Court, which should be a matter of interest to decision-makers and lawyers dealing with issues involving competition, environment and natural resources as well as class actions generally ...
In our July 2006 legal update, we reported on a ground-breaking agreement (Agreement) signed by the Hong Kong and Mainland China Governments, under which they agreed to recognise and enforce judgments made in each others courts. Legislative changes are now underway in Hong Kong in order to implement the Agreement ...
It is known that an insurer has a considerable duty to inform in group insurance. The Superior Court, in a decision by Justice Hélène Langlois, specified the extent of this duty in Tanguay et al v. L’Ordre des ingénieurs du Québec and The Manufacturers Life Insurance Company of North York, doing business under the name Manulife Financial(1) ...
The Court of Appeal rendered an important decision on October 31, 2006, which dealt with the liability of manufacturers and professional sellers, as well as several other related issues, in the case of The Boiler Inspection and Insurance Company of Canada and Prima Viande Ltd v. Manac inc./Nortex (manufacturer of the Arcoplast product) and Systèmes intérieurs Atlas inc ...
On October 18th, 2006, the Quebec Court of Appeal rendered a much-awaited decision regarding class actions. In Bouchard v. Agropur Coopérative et al,(1) the province’s highest court was called upon to rule on the issue of whether, when there is a multiplicity of defendants, it is necessary that a legal relationship exist between the petitioner applying for authorization to bring a class action and each defendant ...
Assuming that a foreign court exercises the power to issue letters rogatory or to appoint a commission to examine a witness in Quebec and to ask him to produce some documents, how can that be carried out in Quebec and is there a «blocking statute» protecting some of the documents?The Special Procedure Act (R.S.Q. c. P-27)The Special Procedure Act, Division VI (the «S.P.A.») governs rogatory commissions within Quebec for the purposes of a foreign lawsuit ...
A spectacular smash-up always draws a crowd. In the outsourcing world, where the wreckage is nearly always kept under wraps, that’s even more true. When a problem deal does break into view, it’s always worth watching for lessons in how to manage – or how not to manage – these complex transactions ...
The cause of an action in defamation exists to provide some recourse and remedy to victims of falsehoods which can and do cause injury to reputation. In a classic formulation, recently adopted and approved by Geopel J ...
Pursuant to the Act on Drugs, the Ministry of Health of the Slovak Republic has specified in annexes to this Decree details on forms to be used for prescriptions of drugs and medical aids. By this Decree, the Ministry also has set the sample forms of medical prescription, special medical prescription, medical reference, and extract from medical prescription, order and special order ...
The federal Pipeline and Hazardous Material Safety Administration (PHMSA) has proposed new regulations for rural onshore low stress pipelines and rural onshore gathering lines. Although PHMSA has been anticipating further regulation of these types of lines for the past few years, the Agency acknowledges that the proposed rule is a direct response to legislative and media scrutiny of recent incidents that occurred in the Alaska Prudhoe Bay field ...
As the poultry farming crisis looms and countries are on the lookout for outbreaks of infection, scientists are closely following the evolution of the virus, which is moving to new sources of infection.Before a crisis is on our doorstep, businesses should prepare themselves for the consequences of a high rate of absenteeism. Without exaggerating the risks, they should adopt preventive strategies and become aware of the legal ins and outs of their actions ...
On July 17, 2006, the Court of Appeal rendered a judgement concerning the duty of financial institutions making loans to inform and advise their clients.(1) This decision, written by Judge Jacques Chamberland, sheds further light on the obligations of group loan insurance policyholders. The facts In early June 1994, the Respondent, 9000-7048 Québec inc ...