Manufacturers

News & Analysis as of

Director of Manufacturing Policy Initiative Sought

Indiana University’s Manufacturing Policy Initiative (Initiative) has announced a candidate search for the first full-time Director of the Initiative. The Manufacturing Policy Initiative seeks to analyze how public policies...more

What a Trump Administration Could Mean for the 340B Drug Program

A Republican White House and a Republican-run Congress could bring significant changes to the 340B Drug Pricing Program (“the 340B program”). Many in Washington believe that the new administration and Republicans in Congress...more

EPA Proposes Ban on Common Degreasing Chemical TCE

Yesterday, EPA announced its first proposed ban of a new chemical under the amended TSCA (Frank R. Lautenberg Act, Pub. L. No. 114-182 (2016)), which, among other changes, mandated EPA risk assessments of all high-priority...more

EPA Identifies First Ten Chemical Substances For Evaluation Under New TSCA

As we outlined earlier this year, the Toxic Substances Control Act (“TSCA”) was recently updated to provide EPA with much broader authority to regulate “existing” chemical substances (i.e., those that are already in use in...more

The New “Swissness” Legislation

Swiss goods and services are valued by consumers who are ready to pay a premium for goods that are Swiss made. The current rules regulating the Swiss brand are often ignored by the market and enforcement is difficult and...more

EPA Selects First 10 Chemicals for TSCA Risk Evaluations

A Set of "Blueprints" for Future Reviews? - In satisfaction of a mid-December deadline under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA has issued the required initial list of ten “high...more

Litigation Alert: A Unanimous Supreme Court Reverses Federal Circuit Ruling on Damages in Samsung Electronics Co. v. Apple Inc.

On December 6, 2016, in a unanimous opinion written by Justice Sotomayor, the Supreme Court reversed the Federal Circuit’s affirmance of the damages award in Samsung Electronics Co. v. Apple Inc. The question before the...more

U.S. Supreme Court Overturns Apple's $400M Award Against Samsung

A Unanimous U.S. Supreme Court Pulls Back the Reach of Damages Awards for Design Patents Summary The U.S. Supreme Court on Tuesday, December 6, 2016, unanimously held that damages awards for design patent infringement need...more

Supreme Court Dismantles $400M Apple Design Patent Award Against Samsung

In Samsung Electronics Co. v. Apple Inc., the Supreme Court of the United States today reversed the Federal Circuit’s decision upholding Apple Inc.’s nearly $400 million design patent award against Samsung Electronics Co.,...more

Supreme Court Complicates Design Patent Damage Calculation – Apple v. Samsung

On December 6, 2016, the Supreme Court issued a rare unanimous decision on the issue of damages for design patent infringement that continues the Apple v. Samsung smartphone legal odyssey. It also marks only the second time...more

U.S. Supreme Court Reverses Damage Award In Samsung v Apple

The Supreme Court on December 6, 2016 ruled that when considering the basis for awarding damages based on the infringer’s profits from infringing a design patent, it is not necessary to base these damages on the profit made...more

Live! From the ACI Drug and Medical Device Litigation Conference

I’m blogging from the American Conference Institute’s Drug and Medical Device session on International Mass Tort Litigation: Strategies for Handling the Increasing Interplay Between Domestic and Global Products Liability...more

OSHA Reports Continuing Decrease in Workplace Injuries

Over the past decade, the Occupational Safety and Health Administration (OSHA) has reported a steady decline in the number of reported workplace injuries and illnesses in the U.S. Initially, the agency attributed this drop to...more

The Sixth Circuit Confirms What We Already Should Know — It Can Be Challenging to Enforce an Arbitration Provision in an Expired...

A unanimous panel of the Sixth Circuit recently rejected a manufacturer’s attempt to compel arbitration under an expired contract in Linglong Americas, Inc. v. Horizon Tire, Inc. The manufacturer and its distributor entered...more

TPP and Other Trade and Manufacturing Issues Front and Center After Election

Donald Trump’s opposition to trade deals, including the pending Trans-Pacific Partnership (TPP), were key components of his stump speeches and talking points throughout the campaign. His position on trade and manufacturing...more

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

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