Manufacturers

News & Analysis as of

The Future of “Single Use Restrictions” in Jeopardy

In 1992, the United States Court of Appeals for the Federal Circuit held that manufacturers of patented medical devices can use the patent laws to enforce single-use restrictions on medical devices. Mallinckrodt, Inc. v....more

[Webinar] Does Your Company's Distribution Strategy Create Legal Risk? – April 27th, 12:30pm EST

What does in-house counsel need to consider when reviewing pricing and marketing decisions in a dual-distribution system? The internet can extend the geographic reach of your product, but what issues must in-house counsel...more

Medicinal Products: the EU and the US Mutually Recognize Manufacturing Standards

The European Union (“EU”) and the United States (“US”) have reached a sectoral agreement (the “Agreement”) that will greatly ease the administrative burden when proving compliance with Pharmaceutical Good Manufacturing...more

Amid Uncertain Trade Climate, a Look at Top Imports, Exports With Mexico

Auto companies, computer manufacturers and oil producers are closely watching how the trade relationship evolves between the U.S. and Mexico under President Donald Trump. Their products are among the top U.S. exports to...more

New York District Court Flushes Nationwide Class, Permits New York Classes to Go Forward

In three related actions before the Eastern District of New York, consumer plaintiffs who purchased moist toilet wipes manufactured and produced by Kimberly-Clark and sold by Costco alleged that defendants mislabeled the...more

Trade & Manufacturing - News of Note - March 2017

President Trump’s Trade-Related Nominees Confirmed - Several nominees selected by President Trump for key positions that will participate in the development of U.S. trade policy during his administration have been...more

CPSC Recall Snapshot: March 2017

Welcome to the March edition of the Alston & Bird CPSC Recall Snapshot. This past month, Republican Commissioner Ann Marie Buerkle was named acting chairman of the CPSC. Buerkle was confirmed as a...more

EU - US mutual recognition of GMP inspections: agreement published

On 4 March 2017, the agreement between the EU and the US governing the reciprocal recognition of GMP inspections of manufacturing sites for medicinal products for human use was published in the Official Journal of the EU:...more

Man(ufacturing) vs. Machine

Many of the conveniences that we have grown to take for granted in our daily lives we owe to remarkable advances in technology, including the development of artificial intelligence (AI). Over the past decade, we have...more

U.S. Ammonium Sulfate Manufacturers Win Relief from Unfair Imports from China

On February 8, 2017, the U.S. International Trade Commission (ITC) determined that domestic producers of ammonium sulfate are materially injured or threatened with material injury by reason of imports from China. As a result,...more

Important New Business Tax Proposals for U.S. Tax System

During the past few months, there has been considerable speculation over potential changes to the U.S. tax system that could have an impact on international businesses. At this stage, the discussions are preliminary and the...more

Court Finds Manufacturer/Distributor Relationship Does Not Create An Informal Fiduciary Relationship

In Samsung Electronics America v. Chung, Samsung Electronics America, Inc. (“Samsung”) filed suit against All Pro Distributing, Inc. (“All Pro”) and certain former employees alleging claims for breach of fiduciary duty and...more

FDA Is Cold As Ice As It Steps Up Foreign Inspection Enforcement

So far, in 2017, the Food and Drug Administration’s Office of Manufacturing Quality in the Center for Drug Evaluation and Research has released fourteen Warning Letters. Of these, 100% involved manufacturing facilities...more

FDA to Exempt Over 1,000 Types of Medical Devices from Premarket Notification Requirements

On March 13, 2017, the U.S. Food and Drug Administration (FDA or the Agency) identified a list of 1,003 types of Class II medical devices that, when finalized, will be exempt from the Agency’s premarket notification (i.e.,...more

“Made in the USA” Claims

Although every product imported into the United States must be marked with its country of origin pursuant to Section 304 of the Tariff Act of 1930, most products manufactured domestically are not required to list the United...more

Court Rejects Recent Interpretation of Oregon Overtime Laws That Would Have Required Certain Employers to Double-Count Daily and...

On March 9, 2017, the Multnomah County Circuit Court rejected the recent move by the Oregon Bureau of Labor and Industries (BOLI) to require Oregon’s “manufacturing establishments” to double-count daily and weekly overtime...more

Connected Cars and Data Privacy: Thinking Through the Federal Automated Vehicles Policy

One of the biggest challenges in implementing the seven privacy principles noted in the FAVP is closely coordinating all members of the connected cars ecosystem – from the original equipment manufacturers (OEMs) to the...more

Oregon Court Rejects BOLI’s New Guidance on Calculating Daily and Weekly Overtime for Mills, Factories, and Manufacturing...

After the Oregon Bureau of Labor and Industries (BOLI) made a surprising change to its interpretation of how daily and weekly overtime should be calculated for employees who work in mills, factories, and manufacturing...more

Breaking: Court Rules Against Double Overtime for Oregon Manufacturing Employers

Oregon manufacturing employers have been following the ongoing turmoil surrounding the Oregon Bureau of Labor and Industries’ (“BOLI”) recent interpretation of Oregon’s requirement that manufacturing employees receive...more

[Webinar] Keeping Up with the Consumer Product Safety Commission: Update on Recent CPSC Developments - March 29th, 12:00pm EST

With the complexity of today’s product safety regulatory environment and the civil penalty amounts for failure to report safety hazards, it is more important than ever for manufacturers and retailers to identify and resolve...more

DOC Solicits Industry Feedback for Regulatory Reform Plan

Spurring growth in domestic manufacturing through regulatory reform is a key objective of the Trump Administration. The Department of Commerce is tasked with developing the Regulatory Reform Plan. In order to achieve...more

Blockchain Walks the Runway As The New FashTech Fashion Tool

The World Customs Organization and International Chamber of Commerce estimate that seven to eight percent of all world trade each year involves counterfeit goods, resulting in lost sales of $512 billion globally and $200-250...more

Top 10 OSHA Violations of 2016

Every year, OSHA releases a list of the 10 most frequently cited violations, which, for 2016, were accumulated by reviewing the nearly 32,000 workplace inspections conducted by OSHA staff. The list for 2016 looks a whole lot...more

Washington: Product Manufacturers Must Warn Hospitals; May Be Strictly Liable for Failure to Warn

In Washington, manufacturers of medical devices now have a duty to warn hospitals that purchase their devices. Additionally, product manufacturers of “unavoidably unsafe products” face strict liability for failure to warn...more

The Impact of US Export Controls on the Sale of a Manufacturing Business

An owner of a US business that manufactures export-controlled items (“Export Business”) nears retirement. The owner decides to sell the Export Business. In a win for the owner, the sale of the Export Business interests both...more

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