Manufacturers

News & Analysis as of

EPA Proposes Rules to Implement TSCA Reform

The Frank R. Lautenberg Chemical Safety for the 21st Century Act was signed into law on June 22, 2016. We previously summarized that bill's key changes to the Toxic Substances Control Act ("TSCA"). This Commentary highlights...more

Applying Product Liability Theory, Washington State Sues for PCB Damages

In an effort to use product liability theories to hold manufacturers culpable for environmental releases, the Attorney General of Washington State sued PCB manufacturer Monsanto in state court in December. See Complaint,...more

CIT rules on Made in USA claim

A recent ruling by the U.S. Court of International Trade (CIT) has important implications for importers and manufacturers making “Made in USA” claims for products assembled from imported components. While the case concerned...more

U.S. Supreme Court Decision Limits Extraterritorial Reach of U.S. Patents: What Manufacturers and Exporters Need to Know

The U.S. Supreme Court's decision on February 22, in Life Technologies Corp. v. Promega Corp. limits the ability of a U.S. patent to cover infringing activity abroad. In particular, the Court held that a single component of a...more

Sixth Circuit Affirms Branded Drug Preemption and Trial Win

In the aftermath of Levine, with its generous interpretation of the CBE regulation and its novel “clear evidence” standard, we wondered how long it would be until we saw a court holding that a failure to warn claim with a...more

On-Sale Bar for Contractor and Supplier Activities

The Federal Circuit addressed the potential for contract manufacturing to create an “on sale” bar to patentability, in a decision that could affect how supplier relationships are managed. Whether a sale or offer for sale of...more

TSCA Reform Implementation Update

Eight months have now passed since President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA), Pub. Law 114-182, on June 22, 2016. This historic legislation overhauled the Toxic...more

Who Will Bear the Brunt of a NAFTA Renegotiation?

President Trump's plans to renegotiate the North American Free Trade Agreement (NAFTA) give rise to a number of questions about the future of trade between the United States, Mexico and Canada. While such a move might...more

Spoiler Alert: Florida Appellate Court Upholds PMA Preemption and Rejects Parallel Claim

Over the years, comedian Adam Carolla has played the “Germany or Florida” game on his various radio and tv programs and podcasts. The game is based on the observation that many of the most bizarre stories of human ineptitude...more

TechConnect Conference Will Include Panel on Safety and Innovation as Partners for Success in Advanced Manufacturing

The TechConnect World Innovation Conference and Expo, which will be held May 14-17, 2017, in Washington, D.C., will include a panel discussion on May 16, 2017, on “Safety and Innovation as Partners for Success in Advanced...more

Third Circuit Upholds Dismissal of Indirect Purchaser Class in Auto Transmission Case, Revives Individual Claims

On February 9, the US Court of Appeals for the Third Circuit upheld a ruling by the US District Court for the District of Delaware that indirect purchasers of Class 8 transmissions did not meet the requirements for class...more

The ReSET – Why Maryland’s Maker Movement Matters to Manufacturing

Finally Maryland has something to celebrate about its manufacturing sector – a growth spurt that it hasn’t seen for years. But it’s deceptive if we don’t recognize and support a more important underlying trend – the Maker...more

Expanding Duties and Eroding Protections for Medical Device Manufacturers

Earlier this month, the Washington Supreme Court saddled medical device manufacturers with a new duty to warn under Washington law—the duty to warn hospitals about potential risks their products may pose—and eroded exemptions...more

Non-Physician Learned Intermediaries

One of us was asked a question the other day that we couldn’t answer immediately. “Does the learned intermediary rule apply to a physician’s assistant?” We didn’t remember any cases actually deciding that issue. So we did...more

Vermont Vapor Up in Smoke for Allegedly Deceptive E-Cig Marketing Practices

Last week, Vermont Vapor, Inc. (“Vermont Vapor”) announced that the Vermont Attorney General’s Office is seeking $50,000 in penalties in connection with Vermont Vapor’s e-cig marketing practices. How can e-cig...more

EPA’s Proposed “Reset” of TSCA Chemical Inventory Requires Identification of “Active” and “Inactive” Chemicals and Confirmation of...

If you manufacture or import a chemical subject to the Toxic Substances Control Act (“TSCA”) Chemical Substance Inventory, the U.S. Environmental Protection Agency (“EPA”) has proposed to require you to confirm each such...more

China moves to implement security review of network products and services: but leaves foreign investor and manufacturer concerns...

On 4 February 2017, the Cyberspace Administration of China issued a draft of the Network Products and Services Security Review Measures (“Draft Measures”) for public comment: the Draft Measures remain open for comments until...more

Food for Thought: A Review of 2016 Litigation

Food for Thought is a review of significant court decisions affecting the food, beverage, dietary supplements and personal care products industry. Although many cases in this edition focus on class certification, others...more

What Is “Product Liability”?

We’re serious – we’re not planning to give a flip answer like “an extortion racket.” No, it’s more like law school, where a first-year contracts professor began with the question “What is Chicken?” (Hint – that’s discussed...more

Form Drug Distribution Services Agreements May Not Be Formulaic

Vanilla-looking form agreements may contain or omit terms that are important to one or both parties. We were recently reminded of the danger of entering into form pharmaceutical distribution services agreements. Although...more

Judge Orders Status Report in Conflict Minerals Case

The conflict minerals case was remanded to the United Stated District Court for the District of Columbia for further proceedings. Judge Jackson has ordered the parties to file a joint status report, on or before March 10,...more

Surpassing Even My Expectations, Predictions Come True

Last month, in my “Manufacturing Law Predictions for 2017: Labor and Employment” posting, I wrote: “Expect at least some high-profile workplace ‘raids’ to round up undocumented workers and substantial fines on the employers...more

International Product Liability Review - Issue 65

The International Product Liability Review provides quality updates and comment from around the world on legal developments in the field of product liability and product safety. Please see full Publication below for more...more

CFDA Amends Medical Device Recall Rules

Recently China’s Food and Drug Administration (“CFDA”) released the Provisions for Medical Device Recall (“New Recall Rules”). The New Recall Rules, becoming effective on May 1, 2017, will replace the existing Interim...more

FDA Devices Center Issues Multiple Guidances in the Obama Administration’s Final Months

A flurry of regulatory activity preceded the transition in administration on January 20. Anticipating that the new administration would impose a regulatory slowdown, the Food and Drug Administration’s (FDA’s or the...more

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