News & Analysis as of

Keeping it Legal: Managing FDA Compliance for Consumer-Generated Content

Social technology platforms allow manufacturers to leverage consumer-generated content about their products (“CGC”) more easily than ever before. Such CGC generally takes the form of written testimonials and product reviews...more

Post-Approval Quality Control Testing of Pharmaceutical Products: What Constitutes 35 U.S.C. § 271(g) Infringement or Falls Under...

The Federal Circuit recently affirmed that a generic pharmaceutical company’s use of post-approval quality control testing was not “making” under 35 U.S.C. § 271(g). See Momenta Pharmaceuticals, Inc. et al. v. Teva...more

Why The Recent Indictments of Nutritional Supplement Executives Matter To All Manufacturers/Distributors

Our firm has substantial experience in representing nutritional supplement manufacturers.  For that reason, the news that the Justice Department and federal agencies (such as the FTC) is engaged in a nationwide sweep of such...more

OSHA Targets More Manufacturing Industries For Amputation Inspections

In August, OSHA issued a revised version of its 2006 Directive on the Agency’s National Emphasis Program on Amputations that includes an updated list of 80 industries, primarily in manufacturing, that are targeted for...more

U.K. Implements Global Supply Chain Disclosure Requirements

On October 29, 2015, Part 6 of the U.K. Modern Slavery Act 2015 (“MSA 2015”) came into force. The MSA 2015 has been described as a “historic milestone” by the U.K. Home Secretary and is representative of the increased focus...more

South Korea: Building for the future

Rising to the challenge - South Korea is one of Asia’s powerhouses, and its strong exports sector and willingness to adapt its economy make it highly attractive to investors. South Korea’s economic development has...more

The FDA Gets Pulled Into the "Natural" Labeling Fray: Surprise Move May Change the Food Fight

In a surprising change of tack, the U.S. Food and Drug Administration (FDA) announced Tuesday that it will accept public comments on the use of "natural" claims on food labels. The move, which may signal FDA's intention to...more

EPA Issues Final MACT for Brick and Structural Clay Products and Clay Ceramics Manufacturing

Section 112(d) of the Clean Air Act requires EPA to set emission standards for hazardous air pollutants emitted by sources in certain specified source categories and subcategories. EPA recently published final maximum...more

Manufacturing a Troubling Future Part Two:  Recent Decision

This is the second of two posts regarding the “troubling” state of multi-employer pension plans. My October post provided an overview of the recently published Teamsters’ Central States Pension “Rescue Plan” and discussed...more

Regulatory Concerns for the Sale of Extended Warranties to Commercial Purchasers

Products sold to commercial purchasers typically include a standard manufacturer’s warranty. Should the manufacturer’s distributor sell an extended warranty at the time of purchase, is that extended warranty considered...more

South Korean companies: progress with risk in the United States - South Korea: Building for the future

South Korean companies have made great strides in the US consumer product market, yet they must be more proactive in preventing US class action lawsuits. South Korean companies have progressively exposed themselves to...more

Update on Health Canada's Modernization Makeover: Proposed Changes to Labelling Standards for Products Containing Acetaminophen

Health Canada is in the midst of a “modernization makeover.” The Agency is undertaking a multi-year, comprehensive review of its regulatory frameworks for health products and food. Among other things, modernization efforts...more

Corporate E-Note - October 2015

By now, everyone has heard of the Department of Labor’s ("DOL's") proposed rule requiring a weekly salary of at least $970.00, or $50,440.00 annually, for employees to be exempt from the Fair Labor Standards Act's ("FLSA's")...more

OECD Tour de Table Documents Cover Developments in 2014 and 2015

The Organization for Economic Cooperation and Development (OECD) has posted two Tour de Table documents. The documents, dated October 26, 2015, cover activities from January to July 2014 and before September 2015...more

CERCLA Update: Court Reverses Divisibility Ruling

Earlier this year, we reported on a case that seemed to breathe new life into the divisibility defense under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA).  Under CERCLA, a party that...more

Massachusetts Court: Loss of Drink Product Caused By Faulty Workmanship And Design of Bottle Caps Not a Covered Ensuing Loss

Monday saw a unanimous panel of Massachusetts’ intermediate level appellate court reject a policyholder’s ensuing loss arguments. In H.P. Hood LLC v. Allianz Global Risks U.S. Ins. Co., 2015 Mass. App. LEXIS 175, 2015 WL...more

Common FCPA Issues

As our previous posts illustrate, violations of the Foreign Corrupt Practices Act (“FCPA”) can carry a hefty cost. Two issues are commonly the impetus for FCPA violations and, practically speaking, pose significant FCPA...more

Suppliers of Inherently Dangerous Raw Materials Remain Excluded from the Protections of the Component Parts Doctrine

In Brady v. Calsol, Inc. 2015 No. B262028, the California Court of Appeal, Second District, reversed summary judgment for a raw materials supplier where there was a triable issue of fact as to whether the benzene levels...more

California Enacts Craft Distilleries Act

Craft distilleries are on the rise in the United States, growing at a rapid rate in recent years as tastes have trended towards cocktails and spirits. Recognizing the opportunity for further growth in this $10.3 billion...more

Court Of Chancery Calculates The Length Of An Injunction Against Unfair Competition

How long should competition in violation of an agreement be enjoined? Normally, that would depend on what the agreement says. But when that is not set out by the parties’ contract, this decision explains how to determine the...more

Do New Anti-Trafficking Requirements Apply To Your Company?

As human trafficking and other forms of exploitation of labor continue to be a focus of public attention, requirements on some employers to prevent trafficking and related abuses have recently increased. ...more

Florida Supreme Court Protecting the Rights of Citizens

In another victory for the injured victims of our State, yesterday the Florida Supreme Court issued an opinion in a products liability case, Aubin v. Union Carbide, which reversed an appellate court’s adoption of more...more

Made in the USA? Or not?

When can a company tout its products as "Made in the USA"? Different (sometimes conflicting) standards under federal and state law can make it difficult for shoppers to know what they’re buying and manufacturers and retailers...more

Click it to Stick it: Guide to Creating Binding Online Agreements

Contract terms and purchaser assent to those terms, conditions, intended use and warning information provided with a purchased product are known fertile ground for defending product claims. In today’s virtual age,...more

Three Issues That Manufacturers/Distributors Should Consider When Drafting Terms and Conditions (T&Cs)

Over the last few years, our team has worked with several manufacturers and distributors on their terms and conditions of sale and/or purchase.  We have even developed a questionaire that we typically use when we speak to a...more

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