Don't bank just yet on putting your marketing muscle behind the safe and effective off-label uses of your FDA-approved drugs, or defending your next mass consumer class action on First Amendment grounds. But you can start giving those multi-billion dollar prospects some serious thought, because constitutional winds are blowing through the Code of Federal Regulations ...
Batas Kasambahay Implementing Rules The Implementing Rules and Regulations (IRR) of Republic Act No. 10361, otherwise known as the “Domestic Workers Act” or “Batas Kasambahay” dated 09 May 2013 was published in full in the 19 May 2013 issue of the Philippine Star at pages B-14 to B-16 ...
Myriad Genetics is known as a leader in the market for diagnostic testing of BRCA1 and BRCA2 gene mutations that have been linked to breast and ovarian cancer. These same diagnostic tests were recently in the celebrity press, as Angelina Jolie announced she had been tested positive for the mutations, resulting in her electing to have a preventative double mastectomy ...
Governor Perry recently signed four bills into law designed to combat Medicaid fraud, waste, and abuse. The bills are a mixed bag of enhanced enforcement capabilities for the state and a few new protections for healthcare providers. Most notably, the legislature made several changes to the Texas Medicaid Fraud Prevention Act (TMFPA), bringing the statute more in line with the federal False Claims Act. Changes to the Medicaid Fraud Laws On the enforcement side, S.B ...
On July 3, 2013, the Department of Labor issued its Semiannual Agenda of Regulations. Executive Order 12866 requires the semiannual publication of the listing of all regulations the Department of Labor expects to have under active consideration for promulgation, proposal or review during the coming one-year period. Here are some of the highlights regarding OSHA’s agenda. A ...
The Occupational Safety and Health Administration (“OSHA”) has announced a new National Emphasis Program (“NEP”) to protect workers from the health effects from occupational exposure to isocyanates. With the addition of this program, OSHA has thirteen (13) currently active NEPs, including programs on PSM Covered Chemical Facilities, Lead, Nursing and Residential Care Facilities, and Primary Metals Industries ...
In 2012, more than 99,000 charges of discrimination were filed with the U.S. Equal Employment Opportunity Commission. Of these charges, 31,208 of them alleged retaliation under Title VII of the Civil Rights Act of 1964 (“Title VII”). On June 24, 2013, the United States Supreme Court issued two much-anticipated employment law rulings, both of which are beneficial to employers confronted with these charges ...
In Vance, the Supreme Court announced a narrow standard for determining which employees constitute "supervisors" for purposes of establishing vicarious liability under Title VII. In a 5-4 decision, the Court decided that a supervisor is a person authorized to take "tangible employment actions," such as hiring, firing, promoting, demoting or reassigning employees to significantly different responsibilities ...
In Wyeth and Cordis Corp. v. Abbott Laboratories, 2012-1223, -1224 (Fed. Cir. June 26, 2013), the Court of Appeals for the Federal Circuit affirmed the district court’s grant of summary judgment in favor of the defendants, holding method of treatment claims invalid under 35 U.S.C. § 112(a) (2012) as not being enabled for their full scope. (Slip op. at 3) ...
Many employers are wary of hiring applicants with criminal records because they fear exposing themselves to potential negligent hiring or negligent supervision claims, but they also have concerns imposed by the EEOC’s aggressive interpretation of Title VII that a blanket rule against hiring persons with criminal convictions is a violation of the law ...
On June 13, 2013, in the highly anticipated decision for Ass’n for Molecular Pathology v. Myriad Genetics, Inc., the Supreme Court shed some light on the future of genetic patenting to companies and scientists working in the personalized medicine and genetics industry. The personalized medicine industry seeks to revolutionize patient care by using genetic sequencing and testing to predict disease likelihood, severity, progression, and/or treatment response ...
In a decision that will likely have a significant impact on the pharmaceutical industry (and possibly broader implications for patent, antitrust, and high technology), the Supreme Court yesterday refused to exempt so-called reverse payment (or "pay for delay") patent settlements from antitrust scrutiny. Prior to yesterday’s ruling in FTC v. Actavis, Inc., 570 U.S. ___ (2013), most of the circuit courts to have considered the issue (i.e ...
On Friday June 14, 2013, the Supreme Court of Canada released its eagerly-awaited decision, Communications, Energy and Paperworkers Union of Canada, Local 30 v. Irving Pulp & Paper, Ltd., 2013 SCC 34, a case concerning random alcohol testing at a paper mill operation in Saint John, New Brunswick ...
The Supreme Court has unanimously upheld an arbitrator’s ruling that a contract that required arbitration of "any dispute" constituted an agreement to class-wide arbitration. The Court’s narrow ruling turns on the parties’ express agreement to allow the arbitrator to decide whether their contract, which contained an arbitration provision but did not mention class proceedings, authorized class arbitration ...
As discussed in our previous Alert, the French government has imposed Sunshine-like obligations on the pharmaceutical industry. Article 2 of Law No 2011-2012 of 29 December 2011 on the Strengthening of Health Protection for Medicinal and Health Products ("loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé" or "Loi Bertrand") inserted Articles L. 1453-1 in the French Code of Public Health ("Code de la santé publique" or "CSP"). Article L ...
On May 28, 2013, the US Food and Drug Administration (FDA) published a draft guidance entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements."1 The draft guidance describes FDA’s views on defining, establishing and documenting the responsibilities of parties that are involved in the contract manufacturing of drugs that are subject to current good manufacturing practice (cGMP) requirements ...
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 2012, the National Labor Relations Board (NLRB) set the business community atwitter when an administrative law judge in American Red Cross decided that an at-will disclaimer in an employee handbook violated the National Labor Relations Act (NLRA) by being overly broad ...
America’s high school and college students will soon be finishing another school year, and employers across the country are gearing up to welcome many of these young adults as interns for the summer. Interns are staples in many organizations and often provide valuable benefit to a business. As employers strive to keep costs down, including that of labor, many use unpaid summer help where possible ...
On February 25, 2013, the Department of Health and Human Services (HHS) released its final rule (the Final Rule) setting forth standards for health insurance issuers under the Patient Protection and Affordable Care Act (the Affordable Care Act). Specifically, the Final Rule outlines exchange and issuer standards related to coverage of essential health benefits, minimum value and actuarial value ...
Last month, the United States Supreme Court (Supreme Court) provided an unexpected gift to entities facing collective actions under the Fair Labor Standards Act (FLSA) by holding that defendants may moot such a case by making an offer of judgment pursuant to Rule 68 of the Federal Rules of Civil Procedure. This ruling could have application to the more common vehicle for multiple plaintiff claims, class actions under Rule 23, but that has yet to be tested ...
Because of recently-enacted changes to the West Virginia Wage Payment and Collection Act, West Virginia employers will have more time to pay final wages to discharged employees. Prior to this change, the Wage Payment and Collection Act required that employers pay discharged employees within 72 hours of termination ...
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) ...
