Manufacturers

News & Analysis as of

Learned Intermediary: Arizona Supreme Court Restores Order in the Desert

We recently brought you the breaking news that the Arizona Supreme Court has adopted the learned intermediary doctrine in prescription drug cases. The case is Watts v. Medicis Pharmaceutical Corp., No. cv-15-0065-PR, 2016 WL...more

President Obama Highlights TPP, Cuba Embargo in Final State of the Union Address

On January 12, President Obama delivered his seventh and final State of the Union Address to Congress and the American people. Among the many topics that he raised in this annual speech were two trade-related priorities that...more

Legal Issues for Manufacturers To Consider When Selling Into New Markets

Manufacturers continue to look for ways to increase sales revenue without a massive infusion of capital. Many companies have been successful in adapting current products for new uses and markets. For instance, a company...more

Leaders Discuss Issues Facing Florida Manufacturers

As part of its ongoing 2016 State of Manufacturing Tour, the National Association of Manufacturers (“NAM”), including CEO Jay Timmons and others, stopped in Tampa, Florida on January 28 and 29, 2016. The visit included tours...more

China's “RoHS 2” Regulation: What Manufacturers Must Know

After years of deliberation and industry anticipation, China’s Ministry of Industry and Information Technology (“MIIT”) promulgated the “RoHS 2” regulation on January 21, 2016, with the formal (translated) title “Management...more

Postmarket Cybersecurity Recommendations for Medical Devices Issued by the FDA

We’ve blogged about medical device cybersecurity topics. The topic is in the news yet again with the FDA issuing a draft guidance outlining postmarket recommendations for medical device manufacturers to address cybersecurity...more

FDA Issues New Draft Guidance on Postmarket Cybersecurity for Medical Devices

The new Draft Guidance is one of a string of recent actions taken by FDA to address overall medical device cybersecurity. Recognizing the growing importance of cybersecurity for medical devices and the potential public...more

FDA Issues Postmarket Cybersecurity Recommendations for Medical Devices

On January 22, 2016, the federal Food and Drug Administration (“FDA”) issued a draft guidance outlining postmarket recommendations for medical device manufacturers to address cybersecurity risks. The draft guidance details...more

Workplace Safety in the U.K. - Multi-Million Dollar Fines for Workplace Safety Offences by Companies - New U.K. Sentencing...

Accidents do sometimes happen, even in well-run factories and construction sites. Where there has been an accident in the U.K., companies face prosecution by the Health & Safety Executive (“HSE”) in the criminal courts...more

The CMS Final Covered Outpatient Drug Rule Addresses Many Industry Concerns

The rule implementing the Medicaid Drug Rebate Program is less burdensome and costly than what was originally proposed. In 2010, the Affordable Care Act (ACA) directed the US Centers for Medicare and Medicaid Services...more

Product Liability Update: January 2016

Supreme Court Holds Defendant Cannot Moot Putative Class Action by Making Unaccepted Offer of Judgment for Complete Relief to Representative Plaintiff - In Campbell-Ewald Co. v. Gomez, No. 14-857, 2016 U.S. LEXIS 846 (S....more

Food And Drug Administration Issues Draft Guidance On Cybersecurity In Medical Devices

On January 22, 2016, the Food and Drug Administration (“FDA”) released draft guidance regarding postmarket management of cybersecurity risks in medial devices. This guidance comes over a year after the FDA issued similar...more

FDA applies postmarketing requirements to evolving medical device cyber-risks – key messages to manufacturers

With incursions on cybersecurity occurring daily across a variety of platforms, cybersecurity risks are top of mind for FDA and for the device industry....more

Weekly Update Newsletter - January 2016 #3

SMALL BUSINESS ADMINISTRATION - Employee Based Size Standards in Wholesale Trade and Retail Trade - The U.S. Small Business Administration (SBA or Agency) increased 47 small business size standards based on the...more

Spear-phishing campaigns continue to infiltrate critical infrastructure

The Department of Homeland Security’s Industrial Control Systems Cybersecurity Emergency Response Team (ICS-CERT) has reported that critical infrastructure systems in the U.S. experienced a 20% increase in cybersecurity...more

Environmental, Health & Safety – What to Watch in 2016

To round out our series on industry and legal outlooks for 2016, I have compiled some of the many things for manufacturers to be aware of in the Environmental Health & Safety world for 2016....more

Children's Products: A Discussion of the Regulations Governing Lead Content

Lead poisoning in children has been found to cause adverse health effects ranging from hyperactivity to developmental delays, blindness and even death. See 16 C.F.R. § 1303.5. Even minimally elevated blood lead levels in...more

Children's Products: An Overview of Advertising Laws and Regulations

Like all businesses, manufacturers and retailers of children's products must comply with advertising laws and regulations. Advertising laws protect consumers by requiring advertisers to be truthful about their products....more

Children's Product Recalls: Identifying Reportable Defects

The U.S. Consumer Product Safety Commission ("CPSC" or the "Commission") is the regulatory agency responsible for protecting the public from unreasonable risks of injury and death associated with consumer products. Pursuant...more

Mississippi Gives Teeth to the Safer Alternative Requirement

Maybe you’ve noticed that many of our recent posts have reported good decisions out of Mississippi. It’s as if there has been an outburst of judicial common sense in that fair state. But it has not really been such a sudden...more

Top Trends to Watch for in 2016

Cybersecurity - Manufacturers continued to face challenges and find opportunities related to cybersecurity in 2015, and those trends can only be expected to intensify in 2016. New laws and new threats have either...more

Legislative Compromise in Georgia

The Georgia Brewer’s Guild was prepared to introduce a significant piece of legislation this year that would have opened up a number of opportunities for craft breweries in Georgia. As of yesterday, that legislation will not...more

Maryland Expands the Potential for Manufacturer Liability in Failure to Warn Cases by Adopting an Exception to the Bare Metal...

Product manufacturers in Maryland have successfully argued for at least the last 16 years that, in terms of warnings, they are only responsible for products that they themselves have placed in the stream of commerce. In other...more

The Internet of Things: Evaluating the Interplay of Interoperability, Industry Standards and Related IP Licensing Approaches

The financial impact of the Internet of Things on the global economy will be significantly affected by interoperability. A 2015 McKinsey Global Institute report indicated that, “[on] average, interoperability is necessary to...more

Resource for Doing Business in the U.S. – Installment #5 – Products Liability

Many people have heard about the lawsuit in which a consumer won a substantial verdict against McDonalds over a burn from a cup of hot coffee. Last year, General Motors faced claims due to a faulty ignition switch that shut...more

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