Manufacturers

News & Analysis as of

Brexit – Major Upheaval and Change

As the UK leaves the EU, in light of the seismic result of the United Kingdom referendum on June 23, 2016, there will be an immense amount to do, for the UK and the remaining EU, and for companies that are either based in, or...more

Industry, NGOs, Republicans, and Democrats Bond over Chemistry

The Frank R. Lautenberg Chemical Safety for the 21st Century Act was passed in the House by an overwhelming vote of 403 – 12. After passing the Senate, it was signed into law by President Obama on June 22, 2016. The...more

Tokyo Dispute Resolution and Crisis Management Newsletter - June 2016

Dispute-Management - Best Practices in Construction Projects - Introduction - What do you do when an unforeseen event threatens to increase the costs or time necessary to complete a major construction project?...more

Senators Introduce the CREATES Act

In furtherance of the government’s efforts to bring down healthcare costs, Senators Patrick Leahy (D-VT.), Chuck Grassley (R-IA), Amy Klobuchar (D-MN), and Mike Lee (R-UT) have introduced the Creating and Restoring Equal...more

Texas Supreme Court Narrows the Ability of General Contractors to Seek Chapter 82 Indemnity for Product Claims

On June 17, the Texas Supreme Court further clarified the definition of the word "seller" in Chapter 82 of the Texas Civil Practice and Remedies Code (known as the Texas Products Liability Act), which was intended to provide...more

CPSC Recall Snapshot: June 2016

Please see full CPSC Recall Snapshot below for more information....more

President Obama Signs Frank R. Lautenberg Chemical Safety For The 21st Century Act Reforming The Toxic Substances Control Act...

On June 22, 2016, President Obama signed H.R. 2576, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) during a signing ceremony. Lautenberg represents years of negotiation and is a towering...more

California May Collect Certain Information from Businesses to Support Its New Proposition 65 Website

California’s Office of Environmental Health Hazard Assessment (OEHHA) has launched a website, www.P65Warnings.ca.gov, intended to provide both businesses and consumers with information regarding the requirements for...more

The Toxic Substances Control Act Overhaul: What You Need to Know

On June 22, 2016, President Obama signed the “Frank R. Lautenberg Chemical Safety for the 21st Century Act” into law, making comprehensive changes to the Toxic Substances Control Act (TSCA). This step comes after years of...more

New Weapon For Manufacturers: Defend Trade Secrets Act of 2016

On May 11, 2016, President Barack Obama signed the Defend Trade Secrets Act of 2016 (the “DTSA”), which provides a federal civil cause of action to manufacturers for the misappropriation of trade secrets under the Economic...more

Toxic Substances Control Act Overhauled Chemical Risk Regulation in the U.S. Joins the 21st Century

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the Act). Passed with significant bipartisan support, the Act is the first major update to a federal...more

President Signs TSCA Legislation Modernizing Nation’s Chemical Safety Program

On June 22, 2016, the President signed the “Frank R. Lautenberg Chemical Safety for the 21st Century Act,” a landmark law containing major reforms to the Toxic Substances Control Act (“TSCA”). As noted in Balch &...more

Online Sales Restrictions Remain a Hot Topic: UK CMA Issues Statement of Objections

On 9 June 2016, the UK’s Competition and Markets Authority (CMA) issued a statement of objections (SO) to Ping Europe Limited (Ping), a golf equipment manufacturer, alleging that Ping had breached EU and UK competition law by...more

Implications of New Lautenberg Act’s Sweeping Changes to Toxic Substances Control Act

President Obama signed HR 2576, the Frank Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), into law on June 22, 2016. The Lautenberg Act makes significant changes to the Toxic Substances Control Act...more

The UK has voted to leave the EU: What now?

The British public have voted that the UK should leave the EU. The EU Referendum vote (the Leave Vote) does not by itself result in an automatic UK exit from the EU. The EU Treaty provides for a framework for a...more

Picture of Health: FDA Rule Allows Symbols to Replace Text on Device Labels

In June 2016, the U.S. Food and Drug Administration (FDA) issued its final rule explicitly allowing the use of approved symbols, without accompanying text, on medical device and certain biological product labeling. The FDA...more

FAA’s New Rules for Small Unmanned Aircraft

Since the Federal Aviation Administration issued its proposed rules for small Unmanned Aircraft Systems (UAS) in February of 2015, the industry has been eagerly waiting to learn what the final rules will be. On Tuesday, June...more

Like Dominoes: Vermont Follows New Hampshire’s Lead and Makes Drastic Changes to Its Equipment Dealer Statute

In a dealer-friendly move that is growing increasingly common, see here, Vermont recently made substantial changes to the law that governs the relationship between equipment manufacturers and dealers within the state. Much...more

President Obama Signs Major Overhaul of TSCA Changing the Way The EPA Regulates Toxic Substances In Commerce

President Obama just signed a bill amending the Toxic Substances Control Act (“TSCA”), changing the way the EPA regulates chemicals. For the last 25 years, the EPA has regarded TSCA’s principal control provision as unworkable...more

Understanding the Re-Vamped TSCA: Federal Preemption Gives Uniform Standards

The reformed Toxic Substances Control Act (TSCA) is the first major environmental law passed since 1990. President Barack Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (H.R. 2576) into law on...more

Full Federal Circuit Denies En Banc Review of Jurisdictional Decision with Important Implications for BPCIA Litigation

On June 20, 2016, the full Federal Circuit denied Mylan’s petitions for rehearing en banc in Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 817 F.3d 755 (Fed. Cir. 2016), leaving intact the panel’s decision affirming two...more

Federal Toxics Law Grows Up: Congress Strengthens the Toxic Substances Control Act

OVERVIEW - President Obama has signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amends the Toxic Substances Control Act (TSCA) for the first time since it was enacted in 1976. The compromise...more

Impact of Brexit for Intellectual Property Rights

A British vote to leave the European Union (EU)—the Brexit referendum issue scheduled for a vote June 23, 2016 — would have a significant effect on intellectual property right-holders, such as manufacturers doing business in...more

Fair Competition Review System

On June 14, 2016, the State Council issued Opinions on Establishing the Fair Competition Review System in the Development of Market System (hereinafter “Opinions”), which finally uncovers the veil of this system....more

Connecticut's New "Right to Try" Law Provides Hope for Patients and Providers, but FDA Remains in the Driver's Seat

Connecticut has recently joined the wave of states enacting a so-called “Right to Try” law, which ostensibly permits terminally ill patients access to investigational drugs (including biologics) and medical devices as a...more

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