In recent months, in a unanimous decision authored by Justice Thomas, the Supreme Court issued its much-awaited decision in Sandoz Inc. v. Amgen Inc. et al., No 15-1039, considering two critical questions in the biosimilar approval mechanisms adopted in the Biologics Price Competition and Innovation Act of 2009 (“BPCIA” or “Biosimilars Act”) ...
Long-term care (LTC) facilities received a boost last week when the Centers for Medicare and Medicaid Services (CMS) reversed its position regarding the use of arbitration agreements in this setting. On June 8, 2017, CMS published a proposed rule amending LTC facilities’ conditions of participation in the Medicare and Medicaid programs to remove prohibitions on binding pre-dispute arbitration agreements ...
“It is a treasured value in humanity … that no parent would want her child to grow up thinking that she (the child was) a mistake." - Justice Choo Han Teck In 2010, a Chinese woman, trying to conceive a child with her Caucasian husband, underwent an in vitro fertilisation (“IVF”) procedure at a clinic. Like the previous time she bore a child through IVF at that clinic in 2006, no third party’s gametes were meant to be used ...
In a recent decision concerning off-site drilling, the Texas Supreme Court affirmed the San Antonio Court of Appeals1 and held that an oil and gas operator could drill through the mineral estate underlying an adjacent tract of land without the adjacent mineral lessee’s permission. Lightning Oil Co. v. Anadarko E&P Onshore LLC, No. 15-0910, 2017 Tex. LEXIS 463, --- S.W.3d --- (Tex. May 19, 2017) ...
On Wednesday, April 26, 2017, the Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. et al., a landmark case that many hope will provide clarity and guidance for consumers and the pharmaceutical industry on the regulatory approval pathway for biosimilar drugs under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA” or “Biosimilars Act”) ...
As part of the implementation of the Mexican Energy Reform of 2013, several new regulations and administrative guidelines affecting the hydrocarbons and power industries were issued. These are of particular importance to oil and gas producers, power generators and others looking to invest or expand operations in Mexico’s dynamic energy sector. I. Hydrocarbons March 6, 2017.Ayín-Batsil Farmout ...
On March 23, 2017, the California Air Resources Board (CARB) approved new regulations on greenhouse gas emissions from oil and natural gas production and storage facilities. The regulations, which focus on methane emissions, represent the most aggressive effort by any U.S. jurisdiction to regulate greenhouse gas emissions from oil and natural gas production ...
Upon reconsideration in Gerard v. Orange Coast Memorial Medical Center, Case No. G048039 (March 21, 2017) (Gerard II), the Fourth Appellate District decided that IWC Wage Order 5 is valid and that healthcare employees may waive one of their two required meal periods on shifts longer than 8 hours ...
In the most recent ruling arising from the now infamous Sabine case (In re Sabine Oil & Gas Corp., 547 BR 66 (Bankr. SDNY 2016)), in which New York bankruptcy Judge Shelley Chapman held in favor of Sabine Oil & Gas Corp ...
The Treasury Department has announced further extensions for medium-sized and large-sized employers for compliance with the “employer mandate” of the Affordable Care Act (“ACA”). The employer mandate requires employers with a threshold level of employees to provide affordable health insurance to 95% of their full-time employees. Under the ACA, a full-time employee is defined as any employee who works on average 30 or more hours per week ...
With the recent proliferation of horizontal drilling for natural gas in the Marcellus region, there continues to be significant scrutiny on potential water quality impacts, including impacts to sources of water supply ...
Under legislation passed in December 2011, which established a comprehensive program for the regulation of oil and gas operations utilizing horizontal drilling methods and related activities, the West Virginia Legislature directed the Department of Environmental Protection to conduct certain studies to inform future decisions regarding the need, or lack thereof, for further legislation or regulations in this area ...
The U.S. General Services Administration recently added Green Globes as an additional third-party green building certification system for federal government construction projects. With this addition, many are now asking about the difference between Green Globes and LEED. Green Globes has emerged, in some parts of the U.S., as a rival building option to the more well-known Leadership in Energy and Environmental Design (“LEED”) system ...
Few areas of law have proven more dynamic over the last few years than the interplay between state tort laws and the federal regulation of pharmaceutical drugs and medical devices. During its last two terms, the United States Supreme Court has issued three separate opinions addressing federal preemption of state law claims under the Federal Food, Drug, and Cosmetic Act ...
Everyone likes pie of some sort, especially around the holidays. For those working in the construction industry, the rapidly developing energy sector appears to be an ever-expanding “Job Pie” for contractors designing, managing, supplying, engineering, clearing and erecting projects for participants in the energy sector. For clues on how to follow the pie crumbs to real construction jobs, I turned to Melvin Stroble of Black & Veatch. Here is a slice of the information Mr ...
The Patient Protection and Affordable Care Act ("ACA") has significantly changed the healthcare industry in the United States. Among the many changes is the new requirement that healthcare providers must provide all "Food and Drug Administration approved contraceptive methods, sterilization procedures, and patient education counseling for all women with reproductive capacity."77 Fed. Reg. 8725 (Feb. 15, 2012); see 42 U.S.C. 300gg-13(a)(4), 45 C.F.R. § 147.130(a)(1)(iv) ...
The September 23, 2013 deadline for covered entities, business associates and their subcontractors to implement the new HIPAA rules is approaching quickly. In case you missed it, on January 25, 2013, the U.S. Department of Health and Human Services issued an omnibus final rule modifying the Health Insurance Portability and Accountability Act of 1996 ...
INTRODUCTION: Recently, Spilman's Director of Energy & Transportation Services, Scott Rotruck, interviewed David Spigelmyer, president of the Marcellus Shale Coalition (MSC) ...
With 125 days left in 2014, we find ourselves looking at What’s Next for the oil & gas industry in the Marcellus and Utica Shale Plays for the remainder of 2014. It has been an eventful year and with just four months until 2015, we look forward and identify key events and issues that are top of mind. 2014 Events There are a wide range of upcoming events with programs and topics relevant to E&P, midstream, field services and downstream markets ...
Before ultimately answering the questions posed in the title above on a National Energy Plan, in full disclosure it should be noted that I have been employed by and/or have been an investor in oil, natural gas, coal and solar. The same applies for two railroads, CSX and NS, which hauled a lot of the aforementioned products or their supply chain components to market ...
by Allyn G. Turner, as seen in the December 2008 issue of IOGA Newsletter As we head toward 2009, West Virginians will be governed by second-term Governor Joe Manchin and the new administration of President-Elect Barack Obama. In the environmental regulation arena, this means change. West Virginia’s Executive Branch, including the Department of Environmental Protection (“DEP”), may not be headed for immediate changes ...
by Eric E. Kinder President Bush signed the ADA Amendments Act into law. The ADAAA significantly increases the scope of the Americans with Disabilities Act of 1990 as it has been interpreted by federal courts by overturning several United States Supreme Court decisions regarding the Act. According to the Congressional Committees that oversaw the passage of the ADAAA, these amendments will restore the original Congressional intent behind the ADA ...
The Law that “Amends the Gas Service Law and other legal provisions” (hereinafter, the “New Law” ) entered into force on February 9, 2017. The purpose of the New Law is to fill in the legal gaps existing in a market that, according to the parliamentary discussion, needs to improve the level of competition among their different actors ...
