Manufacturers

News & Analysis as of

Cell Phone Manufacturer and Firmware Provider Hit with Consumer Class Action Over Extracting and Transmitting User Information...

A recent class action lawsuit is alleging that cell phone manufacturer Blu Products, Inc. (“Blu”) and firmware providers Shanghai Adups Technology Co., Ltd. and Adups USA LLC (“Adups”) violated several federal privacy laws by...more

Anything Worthwhile For Product Liability Defendants In The 21st Century Cures Act?

We blogged about possibly interesting nuggets in the 21st Century Cures Act (“21CCA”) back in February, 2015 – when it was only 400 pages long. In true congressional fashion, it’s now twice as long and loaded up with enough...more

District of New Hampshire Denies Remand Under CAFA’s Local Controversy Exception

On November 30th, in Brown v. Saint-Gobain Performance Plastics Corp., United States District Judge Joseph Laplante of the District of New Hampshire denied plaintiffs’ motion to remand two related class action lawsuits based...more

Toxic Substances and Control Act Overhaul

Under the recently amended Toxic Substances and Control Act (TSCA), EPA is bound by new requirements and enforceable timetables to complete risk assessments for chemicals manufactured, distributed and imported to the United...more

Palm Oil Supply Chain Abuses Reported by Amnesty International: Steps to Mitigate Legal Risk

Amnesty International recently released a report alleging that supply chains for production of palm oil—a common ingredient in many consumer products—are tainted by forced and child labor. In the nearly 150-page report titled...more

Bennett Jones Fall 2016 Economic Outlook

This Fall Outlook has four sections. The first section describes the main aspects of the "new normal" of low growth that has prevailed for advanced economies in the last six years of economic recovery. The second section...more

FDA Regulatory and Compliance Monthly Recap — November 2016

OPDP issues fifth untitled letter of the year to Supernus for misrepresenting Oxtellar XR in KOL video - In its fifth untitled letter in 2016, the OPDP raised concerns about a Spanish KOL video suggesting Supernus’...more

Business Litigation Report - November 2016

Second Circuit: International Comity Precludes Antitrust Liability of Chinese Manufacturers for Conduct Mandated by Chinese Law - On September 30, 2016, the U.S. Court of Appeals for the Second Circuit issued its...more

Second Circuit: International Comity Precludes Antitrust Liability of Chinese Manufacturers for Conduct Mandated by Chinese Law

On September 30, 2016, the U.S. Court of Appeals for the Second Circuit issued its decision in In re Vitamin C Antitrust Litigation, No. 13-4791-cv, reversing a $147 million judgment against Chinese vitamin C manufacturers on...more

FDA Holds Hearing on Off-Label Communications

After several high-profile defeats in both district and circuit courts involving the off-label promotion of regulated products and the First Amendment, the U.S. Food and Drug Administration (FDA) is now engaged in a...more

DTSC Calls for Input on Next Potential Priority Products

On November 15, 2016, the California Department of Toxic Substances Control (DTSC) held a webinar to provide an update on its progress and seek input from stakeholders regarding the selection of the next set of Priority...more

Don’t Let Forced Labor and Bribery in Your Supply Chain Spoil the Holidays

The holiday retail season is an ideal time to check that forced labor and bribery—two top and interconnected supply-chain threats—do not undermine the success of your critical sales period. Not long ago, many in the...more

OSHA Updates General Industry Personal Fall Protection and Walking-Working Surfaces Standards

Recently, OSHA issued its long-awaited final rule on walking-working surfaces and personal fall protection systems for general industry. The new rule is intended to update the standards to align with general industry...more

Expansion of Liability in Product Labeling Cases

An unprecedented surge in consumer fraud lawsuits over the last several years has consumers and lawyers closely scrutinizing product labels and advertisements. While many of these claims challenge the veracity of “Organic,”...more

Five Important Themes to Watch in the Reform of FDA’s Off-Label Communications Policy

As we’ve previously reported, FDA has recently been forced to reexamine its legal position and enforcement policies related to drug and device manufacturers’ off-label communications. Although the Agency has for years...more

Rubber Ducks, Teethers and More: A Guide to Current and Proposed Regulations of Phthalates in Children's Products

Phthalates are chemicals that provide flexibility and durability to a variety of products. They have historically been used in children's toys, particularly those made of flexible plastics. Phthalates soften plastics,...more

FDA Hosts Public Meeting on Off-Label Communications

The US Food and Drug Administration (FDA) recently held a two-day public meeting on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (off-label communications), which offered...more

OSHA Issues Recommended Practices for Safety and Health Programs

In October, OSHA released its new Recommended Practices for Safety and Health Programs, which were issued to incorporate the experience and advances gained since the previous set of recommendations was released in 1989. ...more

NIOSH Sets Recommended Exposure Limits for Diacetyl

After years of study, earlier this month the National Institute for Occupational Safety and Health (NIOSH) released recommendations for employee exposure to diacetyl and a related chemical. Diacetyl is a naturally occurring...more

Guest Post – The FDA’s Two-Day Meeting on Manufacturer Off-Label Communications

Today’s guest post is by Liz Minerd, a Reed Smith associate, who closely followed the online feed of the recent FDA meeting that the Agency called to discuss what changes would be appropriate in its off-label promotion...more

MDR Reporting Final Guidance

FDA issued a final guidance on November 8, 2016, “Medical Device Reporting for Manufacturers”. As with all such guidance documents, it is nonbinding: “It does not establish any rights for any person and is not binding on...more

Trade & Manufacturing - News of Note - November 2016

Anniversary of Softwood Lumber Agreement Expiration Could Bring New Trade Case - October 12 marked the one-year anniversary of the expiration of the 2006 Softwood Lumber Agreement between the United States and Canada and...more

Analysis of sugar industry documents may impact litigation

Litigation targeting products that contain added sugar is on the rise, and plaintiffs’ attorneys are expanding their playbook. In a recent class action against cereal producer General Mills, Inc., in the Northern District of...more

NCCoE Releases Guidance For Securing Manufacturing Industrial Control Systems

The National Cybersecurity Center of Excellence (NCCoE) has released a draft Project Description for the manufacturing sector entitled: Capabilities Assessment for Securing Manufacturing Industrial Control...more

Election 2016:  WOW, Just WOW

I had a blog piece almost done. It was going to give an overview of another NLRB case which threatened to overturn settled law and expand the rights of unions to organize. I was going to use it as another “Year of Change”...more

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