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Lavery Lawyers | July 2011

After more than three years of delays, studies and public consultations, the Canada Consumer Product Safety Act (the “Act”) came into force on June 20, 2011. The Act imposes new obligations on manufacturers, importers and sellers of consumer products and grants significant powers to Health Canada. It will impact this critical sector of our economy ...

Haynes and Boone, LLP | July 2011

During the 2011 legislative session that just ended, Texas Governor Rick Perry signed into law a bill that allows rural hospitals to employ physicians, known as the “corporate practice of medicine,” despite the state’s long-standing ban on such practices. This legislation, along with similar recent legislation, signals that Texas might eventually do away with its ban on corporate employment of physicians altogether ...

Carey | July 2011

On May 5th, 2011 Chile joined the Budapest Treaty on the International Recognition of the Deposit of microorganisms for the Purposes of Patent Procedure. In Chile, this treaty will enter into force on August 5th, 2011 ...

Lavery Lawyers | June 2011

FIRE SAFETY ACTThe Fire Safety Act (the “Act”) came into force on September 1, 2000. Its purpose is to implement organizational arrangements pertaining to fire safety within the regional county municipalities (“RCMs”) and major urban centres in Quebec. Section 8 of the Act requires them to establish a fire safety cover plan (a “Plan”) which must then be approved by the Minister of Public Security ...

Haynes and Boone, LLP | June 2011

On June 16, 2011, the Supreme Court issued an opinion in Smith v. Bayer allowing a plaintiff to pursue class certification in a state court action after a federal court had denied certification in a substantially similar case. The Court held that it was improper for the federal court to enjoin the state proceeding under the “relitigation exception” of the Anti-Injunction Act because the issues were not identical and the state court plaintiff was not a party to the federal lawsuit ...

Haynes and Boone, LLP | June 2011

A bipartisan U.S. Senate committee has asked both the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services to study the proliferation of physician owned distributorships (PODs), citing a lack of regulatory guidance on how these arrangements square with existing federal law ...

On May 25, 2011, the en banc Federal Circuit announced its decision in Therasense, Inc. v. Becton, Dickinson & Company regarding the appropriate standards for succeeding with an inequitable conduct defense ...

The Office for Civil Rights (OCR) of the Department of Health and Human Services today proposed an expansion of the rights of individuals to obtain reports from health providers and insurers about how their protected health information (PHI) is used.1 The draft regulations will require health providers and insurers (called “Covered Entities”) to provide more data faster and in a variety of formats as requested by individuals ...

The Centers for Medicare and Medicaid Services (CMS) announced the creation of so-called “Pioneer ACOs” on May 17 in an attempt to blunt heavy criticism over the draft regulations on Accountable Care Organizations (ACOs) issued on March 31, 2011 (the “Draft Regulations”).1 The Draft Regulations have been criticized due to their burdensome data collection requirements, large start-up costs, uncertain savings, possible losses and troublesome governance mandates ...

Southwest Health Alliance (“Southwest”), an independent practice association with approximately 900 member-physicians, has agreed to a proposed order recently entered by the Federal Trade Commission (“FTC”) settling charges that it engaged in anticompetitive conduct in its dealings with insurers and other payors for the provision of physician services (collectively, “insurers” or “payors”) ...

A former GlaxoSmithKline attorney, Lauren Stevens, was acquitted on May 10 of all criminal charges stemming from her response to an FDA investigation. The acquittal, ordered by U.S. District Judge Roger W. Titus, is a stunning defeat for the government’s anti-fraud enforcement measures. The judge also severely rebuked the government’s efforts in the matter, stating the case should never have been prosecuted. Had she been convicted, Stevens would have faced a prison term of up to 60 years ...

Haynes and Boone, LLP | April 2011

On April 18, 2011, the Centers for Medicare and Medicaid Services (CMS) began the attestation phase under its $27 billion Medicare EHR Incentive Program. Incentive payments for the meaningful use of electronic health records (EHR) will begin in May 2011 and will continue over the next several years. Eligible professionals (i.e ...

Haynes and Boone, LLP | April 2011

Accountable Care Organizations (ACOs) will face large start-up costs under proposed rules issued on March 31, 2011 by the Centers for Medicare and Medicaid Services (CMS), with an uncertain outlook for savings and even possible losses. An ACO is an organization of health care providers that agrees to be accountable for cost, quality and the overall care of Medicare beneficiaries who are assigned to it ...

How is health care in your jurisdiction organised? The basic principles of the organisation of the health-care system are governed by Act CLIV of 1997 (the Health-care System Act), more specifically by sections 141 et seq. Pursuant to section 141, the state is ultimately responsible for the state of health of the population, and for the creation of a system that protects, promotes and – if necessary – restores it ...

Haynes and Boone, LLP | March 2011

The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services has recently announced two significant enforcement actions against health care providers for violating the HIPAA Privacy Rule. In the first matter, Cignet Health Care of Prince George’s County, MD was fined $4.3 million for failure to provide patients with access to their health records and for failing to cooperate with the ensuing OCR investigation ...

Lavery Lawyers | February 2011

HARMONIZATION OF CLINICAL RESEARCH CONTRACTS IN QUEBEC OLGA FARMAN and MARIE-ÈVE CLAVET [email protected] [email protected] Over the past few decades, a high-quality system of research and innovation has been built in the Province of Quebec. The contractual research conducted by university-affiliated health-care institutions in Quebec has become a fundamental scientific, economic and social activity ...

Delphi | December 2010

In Sweden, the directive has been implemented through amendments to the Medical Devices Act (1993:584), and through the regulation which the Medical Products Agency has issued in connection with this Act and the directive. The revised directive contains some clarifications but also some news ...

Lavery Lawyers | December 2010

THE FACTS OF THE CASEThe case has as its backdrop a family tragedy. On the morning of April 22, 2002, Martin Brossard went to the residence of his former spouse, Liliane de Montigny. Following a sequence of events, the order of which could not be determined from the evidence, he strangled his spouse and drowned their two children, Claudia and Béatrice, in the bathtub of the residence ...

Haynes and Boone, LLP | November 2010

Late on Friday, November 19, 2010, the Wall Street Journal reported that federal prosecutors, the FBI and the SEC are in the final stages of an unprecedented three-year investigation into insider trading by consultants, investment bankers, hedge fund and mutual fund traders, and analysts.1 The SEC has already subpoenaed more than thirty hedge funds and investors, and some civil or criminal charges may be brought before the end of the year ...

Lavery Lawyers | October 2010

ON SEPTEMBER 23, 2010, THE SUPREME COURT OF CANADA ISSUED AN UNANIMOUS JUDGMENT IN THE CASE OF PROGRESSIVE HOMES LTD. V. LOMBARD GENERAL INSURANCE CO. OF CANADA(1) , REVERSING TWO LOWER COURT JUDGMENTS OF BRITISH COLUMBIA WHICH HAD CONCLUDED THAT THE INSURER, LOMBARD, HAD NO DUTY TO DEFEND THE GENERAL CONTRACTOR PROGRESSIVE HOMES, AGAINST A CLAIM FOR DEFECTS AND DAMAGES CAUSED BY WATER INFILTRATION IN FOUR BUILDINGS BUILT BY IT ...

Lavery Lawyers | October 2010

On August 25th, the Court of Appeal, for the reasons of Justice Nicholas Kasirer(1), rendered a significant decision(2) with regard to the duty of care required from ski instructors and the assessment of damages awarded to a victim who developed a serious neurological disorder resulting from a ski accident.In their capacity as tutors of their child (referred to as “X” in the judgment), as well as in their personal capacity, Plaintiffs claimed damages for approximately $3 ...

Hunton Andrews Kurth LLP | October 2010

  Hunton & Williams announced today the launch of its new website — the Hunton & Williams Health Care Reform Center,  huntonhealthcarereform.com ...

Van Doorne | September 2010

The hospital has lost lengthy legal proceedings about the uninsured patients from the governments of the Netherlands Antilles and Curaçao. The governments are not obligated to write a “blank check”, as it were, for the costs Sehos had to incur for uninsured persons that cannot be recovered, according to judge Van Schendel yesterday ...

Lavery Lawyers | September 2010

Damage Insurance - Lavery, de Billy, L.L.P. - Canada Hidden Defect, Reduction in the Purchase Price and Liability Insurance Coverage On June 2, 2010, the Quebec Court of Appeal confirmed the Superior Court’s decision (per Justice Gill es Hébert), which dismissed the insured’s action in warranty against his liability insurer under his home owner’s policy ...

Lavery Lawyers | September 2010

The Quebec Court of Appeal confirmed the Superior Court’s decision, which dismissed the insured’s action in warranty against his liability insurer under his home owner’s policy. The insured alleged that the purchasers’ claim for reducing the purchase price due to a hidden defect was covered under the liability insurance policy. The Facts   In April 2005, Plaintiffs, Bérubé and Marcil, purchased Johnston’s residence ...

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