Manufacturers

News & Analysis as of

Major New Wave of California Proposition 65 Lawsuits About to B(PA)reak

May 11, 2016. A day that may live in California Proposition 65 infamy. The date marks the one –year anniversary of the listing of Bisphenol A (BPA) as a reproductive toxicant under Proposition 65, and the expiration of the...more

Are Drug Prices Really Too High?

Those working in the pharmaceutical space are used to hearing complaints about the high costs of drugs, and patents often are blamed for allowing pharmaceutical companies to charge “too much” for their products. But are drug...more

Changes in Requirements of Magnuson-Moss Warranty Act: Option to Provide Warranty Terms Online Pursuant to E-Warranty Act of 2015

Manufacturers of consumer products sold in the United States should be aware that recent changes in the federal statute governing consumer product warranties allow for more flexibility in how manufacturers can satisfy their...more

Update: Transfer Pricing and Customs Valuation Case Study Published on WCO Website

On 29 April 2016 the World Customs Organization (WCO) published the full text of a case study where Customs takes into account a company's transfer pricing study based on the transactional net margin method (TNMM) in...more

Texas Federal Court Says Device Manufacturer is Not a Health Care Provider, but Also Not a Seller

Sometimes it takes us a while to catch on to things. This is more than a little embarrassing for a Jersey guy to admit, but while many of our high school classmates were devout Springsteen fans after his first two albums,...more

Bellwether Trials: What Manufacturers Can Learn from the GM Ignition Claim MDL

As product liability multidistrict litigation becomes more prevalent, it is important for manufacturers to understand how the bellwether trial process works and how to use it to their advantage. The ongoing bellwether trials...more

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

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