Manufacturers

News & Analysis as of

Industry Dodges A Superfund Liability Expanding Bullet

The warm summer breeze you felt on July 27th may have been caused by the collective sigh of relief from the nation’s manufacturers and mining companies over the Ninth Circuit’s holding that Teck Cominco (a mining company)...more

Comments on 2011 Proposed SNURs Prompt Proposal Regarding Hierarchy of Controls

On July 28, 2016, the U.S. Environmental Protection Agency (EPA) proposed changes to the existing regulations governing significant new uses of chemical substances under the Toxic Substances Control Act (TSCA) to align these...more

EPA Issues Final Rule to Protect the Public from Exposure to Formaldehyde

Today the EPA issued its final rule related to formaldehyde emissions standards. This rule will affect manufacturers, importers, distributors, and retailers of furniture manufactured with composite woods (hardwood plywood...more

The “Most Contentious Issue” — Federal Preemption in the Amended Toxic Substances Control Act

This client alert is the third in a series that discusses the significant changes instituted by the passage of a new federal Toxic Substances Control Act. The first alert addressed broadly the law’s myriad of changes. The...more

Product Safety and Liability Prevention

When companies make products that are not safe, they automatically increase their liabilities. This is not in anyone’s interest. Costs increase. Bad PR increases. Good will is lost. Insurance rates go up. And, most...more

Regulatory and Legislative Changes: No Summer Holiday Break

While you may have thought that the major party conventions and Olympic Games in Rio would have resulted in a break from significant legislative and regulatory changes, that simply does not seem to be the case. ...more

Court Grounds the Use of Unbargained-for Warranty Disclaimers

The Pennsylvania Superior Court’s decision in Allen-Myland, Inc. will likely increase liability exposure for manufacturers. In a case of first impression, the Pennsylvania Superior Court recently rejected the...more

Liquor Control Board Weighs in on Alcohol Law Changes in Pennsylvania

Of particular interest to Pennsylvania residents and those doing business in the Commonwealth is the focus on expanding the location and availability of alcohol beyond traditional licensees. A month after Act 39 of 2016...more

How The Failure To Comply With The Conflict Minerals Law Can Expose Manufacturers To Criminal Penalties

Last year, we provided an overview regarding the requirement that U.S. publicly traded companies disclose their use of “conflict minerals.”  As of 2014, the Government Accounting Office reported that 1,321 companies filed the...more

Japan Amends Industrial Safety and Health Law

The Ministry of Health, Labor, and Welfare has issued 2016 Cabinet Order No. 50 to amend the Industrial Safety and Health Law (ISHL), and 2016 Health, Labor, and Welfare Order No. 24 to amend the Occupational Safety and...more

Competition News July-August 2016

The French Competition Authority severely punished the exclusivity practices put in place by company in a dominant position - On June 23, 2016, the French Competition Authority punished the Belgian group Umicore for...more

En Banc CAFC Requires UCC Sale For On Sale Bar

In an en banc decision issued in The Medicines Company v. Hospira, Inc., the Federal Circuit determined that in order for a commercial transaction to trigger the on-sale bar of § 35 USC 102(b), it must “bear the general...more

A One-Two Punch Case With An Off-Label Twist

When we were young(er), we had a pretty good memory. It is not bad now, as far as we recall, particularly when it comes to pulling up bits of esoteric nonsense. For more important stuff, we find qualifiers like “vague” and...more

AGG Food and Drug Newsletter - July 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

BioPharma Patents Quick Tips & News – July 2016

U.S. FDA Orange Book Refresher Edition - What types of patents can be listed on the FDA’s Orange Book? Listable = Pharmaceutical-related patents are allowed in the FDA’s Orange Book only if they’re “composition” or...more

Federal Circuit Patent Updates - July 2016 #2

WBIP, LLC v. Kohler Co. (No. 2015-1038, -1044, 7/19/16) (Moore, O'Malley, Chen) - Moore, J. Affirming denial of JMOL that patent was invalid as obvious and lacked an adequate written description, affirming finding of...more

2016 Chemical Data Reporting – New TSCA Requirements Apply for Confidential Business Information Claims

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

Congress Finds the Formula to Reform Chemical Regulation

The Toxic Substance Control Act (TSCA) is the primary federal law by which the manufacture, import and use of chemical substances are regulated in the United States. Since its inception in 1976, TSCA has not been updated...more

Landmark Overhaul of the Toxic Substances Control Act

EPA Issues First Year Implementation Plan - On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act was signed into law. This law amends the Toxic Substance Control Act (TSCA) and is the first...more

Environmental Notes - July 2016

CONGRESS FINDS THE FORMULA TO REFORM CHEMICAL REGULATION - The Toxic Substance Control Act (TSCA) is the primary federal law by which the manufacture, import and use of chemical substances are regulated in the United...more

CMS Guidance Addresses Impact of Value-Based Purchasing on Medicaid Drug Rebates

CMS has received questions from manufacturers regarding whether price concessions and services offered to payers within Value-Based Purchasing (VBP) arrangements in the pharmaceutical marketplace could impact their drug’s...more

Something Went Right In Brazil

Zika virus, Olympic unpreparedness, economic collapse, presidential impeachment - a lot of things have gone wrong in Brazil lately. But we’re not here to talk about any of that. Here’s something that went right: Brazil v....more

Sale of Manufacturing Services Does Not Trigger On Sale Bar Under Pre-AIA §102

In The Medicines Company v. Hospira, Inc., [2014-1469, 2014,1504] (July 11, 2016), the en banc Federal Circuit reversed a panel decision finding that U.S. Patent Nos. 7,582,727 and 7,598,343 were invalid under the on-sale bar...more

INTERPOL can expect more politically motivated requests from Venezuela – this time with sights on Kimberly-Clark representatives

Venezuela’s president, Nicolas Maduro, has threatened to at least attempt to continue Venezuela’s abuse of INTERPOL’s Red Notice system. The paper product supplier Kimberly-Clark stopped production in Venezuela several weeks...more

Products Liability: Appellate Victory of Children's Products Manufacturer Shows the Importance of Understanding State Products...

On July 5, 2016, the United States Court of Appeals for the Eighth Circuit affirmed a jury verdict in favor of Dorel Juvenile Group, Inc. ("Dorel") in a case involving claims that a defective doorknob cover manufactured by...more

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