Manufacturers

News & Analysis as of

FDA Draft Guidance Aims to Clarify Appropriate Character-Space-Limited Social Media Use by Drug and Device Firms: Part One of Two

As technology continues to evolve, so do the ways in which patients and healthcare providers obtain information pertaining to medical products regulated by the Food and Drug Administration (FDA). Thomas Abrams, Director of...more

Prohibited Country Sanctions and Embargoes: Make Sure You Know the Difference When Drafting Contract Language and Evaluating...

Casually, the words ‘embargo’ and ‘sanction’ are often used interchangeably. But when it comes to drafting a contract or assessing the viability of an export opportunity, failing to use the correct word can have serious...more

Medical Device Update: FDA Medical Device Guidances Issued in 2014’s Second Quarter

In recent months, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued draft and final guidance documents at a relatively fast pace. To assist interested parties, we have...more

Eleventh Circuit Dials Back The Specificity Required In An Insurer’s Reservation of Rights—Will Georgia Courts Agree?

The U.S. Court of Appeals for the Eleventh Circuit recently held under Georgia law that an insurance company does not waive a coverage defense by defending the policyholder in an underlying case without reserving its rights...more

Rooting Out Conflict Minerals

If your company manufactures consumer electronics, avionics, or any product incorporating even trace amounts of gold, coltan, cassiterite, or wolframite— including their derivatives, tantalum, tin, and tungsten—you may need...more

Puerto Rico: A Haven for Manufacturers?

Perhaps not surprisingly to those familiar with the tropical island, manufacturing remains a key driver of economic activity in Puerto Rico. Indeed, manufacturing accounts for 45% of Puerto Rico’s GDP (compared to 11% in the...more

EU Court Says Loyalty Discounts Betray Competition: Ruling Underlines U.S. Differences

Intel's use of loyalty discounts and rebates to computer manufacturers and other actions directed at competitor Advanced Micro Devices violated EU competition law, according to the European Union's (EU) General Court. The...more

The Inversion Craze: Will Today's Routine Tax Planning Be Retroactively Outlawed?

Alongside the more typical summer fare, such as coverage of the best beach reading and the latest action movie blockbuster, this summer the media have been abuzz with seemingly daily reports on the latest so-called...more

Understanding Triple Net Leases

There is a thriving niche in commercial real estate for what are commonly called “triple net leased properties.” These transactions most commonly involve fast food restaurants, convenience stores or some other franchise-type...more

Food Safety Whistleblower Regulations on the Way

Otto von Bismarck once said, “Laws are like sausages, it is better not to see them being made.” Fortunately, the government that makes the laws does want to see the sausage being made and, as such, has instituted new...more

Proposed "Buy American" Regulations Complicate Doing Business with the State of Maryland

On July 11, 2014, the Maryland Board of Public Works issued a Notice of Proposed Action that proposed new regulations concerning the preference for American-manufactured goods on most public contracts. The regulations, as...more

Statements at industry conferences can violate competition law

U.S. steelmakers have recently found themselves paying huge sums totalling over USD 160 million to steel purchasers in order to ward off even larger damages claims. These come in the wake of a vast class action lawsuit...more

California Supreme Court Considers Component Parts Doctrine

Last week, the California Supreme Court granted review of Ramos v. Brenntag Specialties, Inc. to resolve a split in the Second Appellate District regarding the application of California’s component parts doctrine. The...more

The Shortened Shanghai Free Trade Zone Negative List: One Small Step for Reform…

Amidst high hopes in the foreign investment community for a streamlined framework regulating inbound investment to the PRC, China’s State Council launched the China (Shanghai) Pilot Free Trade Zone (the “SFTZ” or “Zone”) in...more

Federal Court Holds Manufacturer of Investigational Drug and Medical Device Responsible for Clinical Trial Investigator’s...

In a recent decision subject to multiple flaws, the United States District Court for the District of Massachusetts refused to dismiss a suit against the manufacturer of an investigational drug and medical device used in a...more

Teaching Hospitals and Physicians Must Take Action Now to Correct Erroneous Reports about them Submitted Under the Sunshine Act

On September 1, 2014, the Centers for Medicare and Medicaid Services (CMS) will make public the reports submitted by pharmaceutical and medical device manufacturers under the Sunshine Act. These reports will disclose...more

You Are Now on the Clock — Sunshine Act Dispute Window Now Open

Beginning Monday, July 14, 2014, the review, dispute and correction process outlined the National Physician Payment Transparency Program (also known as the "Sunshine Act") opens on CMS's Open Payments website. Physicians and...more

CBP Updates Informed Compliance Publication Providing Further Guidance on “First Sale” Requirements

On July 9, 2014, U.S. Customs and Border Protection (CBP) circulated a draft revised Informed Compliance Publication entitled “Bona Fide Sales & Sales for Exportation to the United States,” which identifies additional...more

Repetitive Water Heater Failure Claims – New Theories of Recovery

It can be frustrating when pursuit of a products liability case is not economically feasible due to the small dollar value of the claim. This is especially true with repetitive failure claims – when the same type of product...more

Week in Review

According to an article in The New York Times this week, high level executives make up the majority of tablet users in the workplace. That may change, though, as in the workplace tablet usage increases. It was predicted this...more

Facilities Siting: The Right Considerations Lead to the Right Choice

According to the research, manufacturers are on the move. The questions and considerations listed below are a great starting point for any company opening or relocating a manufacturing facility....more

CMS Wants To Shine Light On CME Payments To Physicians

It’s a question CMS has been wrestling with since the enactment of the Sunshine Act (sometimes called the Open Payments Program) as part of the Affordable Care Act. The Sunshine Act generally requires a manufacturer to...more

Settlement Over Deceptive Implant Marketing

Johnson & Johnson (“J&J”) has reached a four million settlement with the state of Oregon to resolve allegations that J&J improperly marketed its DePuy ASR metal-on-metal hip implants. J&J has recalled 93,000 ASR hip...more

Canada Endorses OECD Recommendation on Nanomaterials

The Summer 2014 issue of Canada’s Chemicals Management Plan Progress Report includes an item concerning nanomaterials. According to the article entitled “Canada Working on Nanomaterials at Home and Abroad,” Canada has...more

Trade & Manufacturing - News of Note - July 2014

Yemen Becomes the 160th Member of the WTO - Yemen became the 160th and newest member of the World Trade Organization (WTO) on June 26 – 30 days after depositing its "Instrument of Acceptance." WTO Members approved...more

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