Manufacturers

News & Analysis as of

European Court of Justice to Rule on Legality of Online Sales Bans

An appeal court in Frankfurt has asked the European Court of Justice to clarify the application of the competition rules to online sales. The Frankfurt court made its request in the context of a dispute between a leader in...more

Watch Out: Ontario Ministry of Labour Inspection Blitzes/Initiatives Are Coming

The Ontario Ministry of Labour recently announced its 2016 and 2017 enforcement blitz and initiative schedule. In an effort to emphasize the importance of protecting workers’ rights and ensuring employer compliance with both...more

Your daily dose of financial news The Brief – 5.2.16

Nearly a year-and-a-half after announcing their plans to join forces, Halliburton and Baker Hughes have reportedly called off their $35 billion merger. Serious DOJ reservations about the deal and a wildly changed energy...more

Mark Your Calendars: BPA Prop 65 Warnings Required as of May 11, 2016; Styrene Also Added to the Prop 65 List

Earlier this month, California’s Office of Environmental Health Hazard Assessment (“OEHHA”) issued a Notice of Emergency Action to allow temporary use of a standard point-of-sale warning message for bisphenol A (“BPA”)...more

Follow the Data: FDA Addresses cGMPs for Data Integrity Issues in Draft Guidance

The draft guidance provides insight into FDA’s expectations regarding data controls and compliance for pharmaceutical companies. In recent years, issues involving the integrity of and controls around manufacturing data...more

Preemption: Oregon Has Not Gone Bananas

Can you get sued over a picture of a banana? It seems the answer might depend on where you live and probably not in Oregon. That is one takeaway from a good preemption case that came out of the District of Oregon last week,...more

The New “Persuader Rule” and Its Impact on Manufacturers

The federal Office of Labor-Management Standards (“OLMS”) in the Department of Labor issued a Final Rule, on March 24, 2016, that significantly reinterprets the so-called Persuader Activities Rule. This rule represents the...more

[Webinar] New GHS Hazard Communication Standard: Roll-out Issues - May 11th, 1:00 pm EDT

Perhaps the most significant safety related regulatory reform during the Obama Administration has been the amended Hazard Communication Standard, bringing OSHA’s chemical Right-to-Know regulation more in line with the United...more

Lawsuits Involving Fluoroquinolones Piling Up Against Manufacturers

Google “fluoroquinolones,” and page after page of search results come up about the dangers, risks and side effects of the antibiotic. Articles appear citing arrhythmia, nerve damage and type 2 diabetes all being associated...more

Veterans Affairs to Permit Acquisition of Non-TAA-Compliant Drugs

In a significant policy reversal, the Department of Veterans Affairs (VA) has announced that it will require all covered drugs under the Veterans Health Care Act (VHCA) to be offered on Federal Supply Schedule (FSS)...more

FTC Cracking Down on Body Care Products . . . Naturally

The Federal Trade Commission (FTC) has commanded the attention of consumer products companies that claim their goods are completely natural, as it has now levied significant charges against five sellers of skin-care and...more

Turmoil for Food Brands: New Prop 65 Warning Requirement for BPA in Packaging

Just three weeks before new Proposition 65 warning requirements for BPA kick in, OEHHA has adopted emergency regulations that specify responsibilities for food manufacturers, retailers and others offering canned and bottled...more

Innovator Drug/510k Medical Device Impossibility Preemption and the Meaning of “A Fortiori”

According to Black’s Law Dictionary, “a fortiori” is legal Latin meaning: - By even greater force of logic; even more so it follows. We’ve been arguing for some time – since PLIVA v. Mensing, 131 S. Ct. 2567...more

U.S. Manufacturing Continues as World Leader

The latest Research Briefing from Oxford Economics claims that the U.S. manufacturing sector is “the most competitive worldwide.” Pretty strong statement there. Reading the news, one would find it hard to believe, so let’s...more

FDA Still Seeking Manufacturer Views on Medical Device ISO Regulation

On March 4, 2016, the FDA issued notice in the Federal Register that it had opened a docket to accept comments on the agency’s proposed plan to address the refurbishing, remarketing, rebuilding, remanufacturing, and servicing...more

Sophisticated User Defense Does Not Extend to Salesman

Richard Moran III v. Foster Wheeler Energy Corporation - Court of Appeal, Second Appellate District (April 13, 2016) - In 2008, the California Supreme Court unanimously held that the “sophisticated user” defense...more

TPPs Fail to Put Their Money Where Their (Litigation) Mouth Is and Lose

In third party payor litigation over prescription medical products, we have often marveled at the causation arguments that plaintiffs have offered and the willingness of some courts to accept collective proof over what really...more

CPSC Recall Snapshot: April 2016

Welcome to the April edition of the Alston & Bird CPSC Recall Snapshot. Last month, Administrative Law Judge Dean C. Metry issued a ruling against the CPSC in litigation with Zen Magnets over its small-diameter magnetic...more

OEHHA Proposes New Prop. 65 Warning Regulations

California’s Office of Environmental Health Hazard Assessment (OEHHA) has released another draft of its proposed amendments to the Proposition 65 warning regulations. This is the third draft OEHHA has released for public...more

New Regulations on the Horizon for Commercial Drones

Currently, the use of drones or unmanned aircraft systems (UAS) for commercial purposes in general is not permitted in the United States, although there is one exception. The Federal Aviation Administration (FAA) allows...more

The District of Columbia and Washington State Pass Back-to-Back Bans on Flame Retardants

The District of Columbia and the state of Washington recently enacted laws banning the use of listed flame retardants in certain products, ranging from children’s products and residential upholstered furniture in Washington...more

Losing Strength: US Steel Industry Analysis

The United States steel industry faces severe headwinds as steel prices continue to fall. Even as recently imposed protectionist measures on certain imported steel products take effect, tariffs alone may be insufficient in...more

U.S. OSHA’s “severe injury” statistics broken out by industry

The U.S. Occupational Safety and Health Administration has produced a “year one” impact-evaluation report on its Severe Injury Reporting Program. Effective January 1, 2015, U.S. employers have been required to report to...more

Big Pharma Should Take Reporting Adverse Events to FDA More Seriously

The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are...more

Having The “Are You Operating an (Illegal) Franchise System Without Knowing It?” Conversation

Franchising laws are very broad in scope and may inadvertently encroach upon standard licensing or distribution agreements. The repercussions for operating an illegal (or more likely inadvertent) franchise system can be very...more

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