News & Analysis as of

Manufacturers

Michigan Strikes Back . . . In Pennsylvania

by Reed Smith on

A (relatively) long time ago in a state not so far away, the Michigan Legislature enacted the Michigan Product Liability Act. It contained a provision providing the manufacturers of FDA-approved drugs with immunity from...more

Toxic Substances Control Act:/Environmental Council of the States Comments: Chemical Data Reporting/Requirements for Inorganic...

The Environmental Council of the States (“ECOS”) submitted December 11th comments to the United States Environmental Protection Agency (“EPA”) on: Chemical Data Reporting: Requirements for Inorganic Byproduct Chemical...more

EDNY Rejects Successor Liability in Hip Implant Case

by Reed Smith on

Happy birthday, Christopher Plummer. The great Canadian actor turns 88 today, and seems as vibrant as ever. What a marvelous career Plummer has had. He is a preeminent Shakespearean actor. We saw him play Iago to James...more

New Source Review/Clean Air Act: December 7th U.S. Environmental Protection Agency Memorandum Addressing...

The United States Environmental Protection Agency (“EPA”) Administrator E. Scott Pruitt issued a December 7th guidance memorandum titled: New Source Review Preconstruction Permitting Requirements: Enforceability and Use of...more

WHO Publishes Guidelines on Protecting Workers from Potential Risks of Manufactured Nanomaterials

by Bergeson & Campbell, P.C. on

In December 2017, the World Health Organization (WHO) published WHO Guidelines on Protecting Workers from Potential Risks of Manufactured Nanomaterials. WHO developed the Guidelines, which provide recommendations on how best...more

Jury Gives Auto Parts Manufacturer a Pass on DOJ Conspiracy Claims

by McDermott Will & Emery on

On November 29, 2017, a Japanese auto parts manufacturer and its US subsidiary defeated the US Department of Justice’s claims that the companies conspired with others to fix prices and rig bids for automotive body sealing...more

New Amendments to Proposition 65 Provide Clarity and Guidance to Clear and Reasonable Warning Requirements

by Reed Smith on

The California Office of Environmental Health Hazard Assessment (“OEHHA”) announced the approval of new amendments to regulations implementing the Safe Drinking Water and Toxic Enforcement Act of 1986, more commonly known as...more

ISO Publishes Standard on Aquatic Toxicity Assessment of Manufactured Nanomaterials in Saltwater Lakes

by Bergeson & Campbell, P.C. on

In November 2017, the International Organization for Standardization (ISO) published standard ISO/TS 20787:2017, “Nanotechnologies — Aquatic toxicity assessment of manufactured nanomaterials in saltwater lakes using Artemia...more

2018 NDAA Analysis: Intellectual Property Provisions

by Holland & Knight LLP on

This is the seventh blog post in a series analyzing the current draft of the 2018 National Defense Authorization Act (NDAA) as agreed to by House and Senate negotiators on November 8, 2017. Stay tuned for more blog posts...more

FDA Provides Guidance on 3D-Printed Medical Device Products

by Knobbe Martens on

The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices. The guidance document, which issued on December 5, 2017, is based on the FDA’s review of more than 100 devices...more

Innovator Liability – A Word to the Wise

by Reed Smith on

A lot of us attended the annual ACI Drug & Medical Device Litigation Conference in New York City last week. One of the messages sent loud and clear from the initial client round table panel is that our clients don’t like...more

Prop. 65 Point-of-Sale Warnings Expiring for BPA in Food and Beverage Products

by Bryan Cave on

The California Proposition 65 regulation allowing a point-of-sale warning for bisphenol-A (BPA) in food and beverage products expires on December 30, 2017. After that date, retailers and manufacturers likely cannot rely on...more

INRS 2016/2017 Brochure Includes Studies in Progress Concerning Manufactured Nanomaterials

by Bergeson & Campbell, P.C. on

On November 23, 2017, the French National Research and Safety Institute for the Prevention of Occupational Accidents and Diseases (INRS) published a report summarizing studies and research completed in 2016 and in progress in...more

Regulations on block exemptions in vertical concerted actions come into force

by DLA Piper on

On 5 December 2017, a new regulation by the Antimonopoly Committee of Ukraine (hereinafter – the “AMCU”) on typical requirements for vertical concerted actions of undertakings has entered into force (hereinafter – the...more

OSHA: Disclosure of Workplace Injuries and Illnesses Due Next Week

As we outlined last year, OSHA recently revised its recording and reporting regulation to require certain employers to submit injury and illness data to OSHA on an annual basis for posting on OSHA’s website. The deadline for...more

Antitrust, distribuzione selettiva e piattaforme online: finalmente i chiarimenti della Corte di Giustizia

by Allen & Overy LLP on

Consultazione - È possibile nell’ambito di un sistema di distribuzione selettiva vietare ai rivenditori autorizzati l’utilizzo delle piattaforme online? A questa domanda nel recente passato hanno risposto in modo...more

Third Circuit Splits with the Seventh Over Standing To Sue For Alleged Inefficient Design of Eye Drop Dispenser

In a surprising decision and split with the Seventh Circuit, the Third Circuit recently held that plaintiffs have standing to sue for unfair trade practices under the theory that a manufacturer is obligated to optimize the...more

Local Government Contracts and Buying American

by Bilzin Sumberg on

In April 2018, President Trump issued an Executive Order calling for stricter enforcement of the federal government’s “Buy American” laws. These laws have been on the books for several decades and generally require that the...more

Trendy Building Material May Cause Future Problems

We all remember the litigation nightmare surrounding synthetic stucco or EIFS (exterior insulation finish systems) in the recent past. Now, commentators worry that Adhered Concrete Masonry Veneer, also known as manufactured...more

Guest post – Observations on FDA 3D Printing Guidance

by Reed Smith on

A lot has happened over the past 19 months, some good, some bad, and some just unbelievable. To name a few, and without sounding like a remake of We Didn’t’ Start the Fire, a total solar eclipse, a new human organ was...more

Rising Environmental Enforcement in the Food and Drug Sector: How to Stem the Tide for Your Facility

by Kelley Drye & Warren LLP on

Food and drug manufacturing facilities are an increasing target for federal and state environmental enforcement actions. Recent enforcement actions have highlighted the extent to which these facilities are subject to a host...more

FDA Guidance Offers Initial Thoughts on Technical Considerations Specific to Medical Devices Using 3D Printing

by Reed Smith on

The U.S. Food and Drug Administration (FDA) announced the availability of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration...more

Public Hearing Set for Amended Overtime Statutes

Manufacturers who will be affected by the new changes to the overtime rules may be interested in attending a public hearing and/or providing public comment on the development of the Oregon Administrative Rules that BOLI will...more

Toxic Chemicals in Consumer Products: Clean Water Action Retailer Report (Including Walmart)

The organization Clean Water Action announced the release of its second annual “report card” on toxic chemicals in consumer products titled: Who’s Minding the Store? – A Report Card on Retailer Actions to Eliminate Toxic...more

CBP Takes Measures to Enforce Ban on Imports Made With Forced Labor and Sanctions for Forced North Korean Labor in Supply Chains

On November 22, 2017, Apple, Inc. (“Apple”) released a statement confirming reports that its major supplier in China, Foxconn Technology Group (“Foxconn”) has used illegal student labor to assemble the latest version of the...more

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