News & Analysis as of

DC High Court Adopts Daubert Approach to Expert Testimony in Win for Wireless Industry

In an immediate victory for mobile phone manufacturers and service providers, and with implications for any other case involving expert testimony in the District of Columbia, the District of Columbia’s highest court abandoned...more

Vehicle Manufacturer Wins Summary Judgment on Keyless Entry System Claims

The U.S. District Court for the Central District of California recently granted Maserati, North America, summary judgment in a proposed class action concerning the manufacturer’s Ghibli model remote keyless entry system. See...more

FDA lets medical device-makers report safety woes in lax, secretive ways

Instead of acting as a tough federal watchdog that protects and informs patients about problems with medical devices-from heart valves to drug pumps-the federal Food and Drug Administration all too often has served as an...more

Medical Device Updates: U.S. Food and Drug Administration (FDA) Releases Numerous and Important Draft Guidance Documents

The summer of 2016 saw a flood of new medical device-related guidance documents coming out of FDA’s Center for Devices and Radiological Health (CDRH). Some of these draft guidance documents, such as those addressing device...more

Manufacturer Settles FTC “Made in USA” Lawsuit

Last week, the Federal Trade Commission (the “FTC” or “Commission”) announced that Georgia-based glue manufacturer Chemence, Inc. (“Chemence”) has agreed to pay $220,000 to settle a lawsuit filed in connection with Chemence’s...more

Upcoming FDA Public Meeting on Speech and Medical Products

As a reminder, the Food and Drug Administration (FDA) is holding a two-day public meeting on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” ...more

OSHA Proposes to Apply Its Lockout Standard to Expected Startups

The Occupational Safety and Health Administration’s (OSHA) Lockout Standard (29 C.F.R. 1910.147) applies today only to “unexpected” startups of machinery. For example, the standard does not apply if alarms give employees such...more

Coming Soon to a Lawbook Near You – New Cosmetic Requirements

Back in April 2015, Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) introduced the Personal Care Products Safety Act (S.1014). More recently, on September 22, 2016, the Senate Health, Education, Labor, and Pensions...more

3D Printing Quarterly Report: Q3 - 2016

Study offers plan to make Northeast Ohio region the Silicon Valley of 3D printing - A report from the Youngstown Business Incubator and America Makes in Youngstown and Team NEO and Magnet in Cleveland offers a plan to...more

CPSC Recall Snapshot: October 2016

Welcome to the October edition of the Alston & Bird CPSC Recall Snapshot. Earlier this month, CPSC Chairman Elliot Kaye took the uncommon step of threatening furniture makers with mandatory federal rules to address...more

Navigating the Maze of E-Cig Marketing Regulations

Federal regulators, and states, counties and cities throughout the country, are enacting new laws, rules and regulations in the e-cigarette marketing space. How can e-cig manufacturers and related marketing affiliates...more

Homeopathic Teething Products Linked to Child Deaths, FDA Says

Belladonna is blamed for the deaths of 10 babies. The parents treated their teething phase with homeopathic teething products (gels and tablets) containing the natural substance. Another name for belladona is deadly...more

Three Dozen States Sue Makers of Opioid Addiction Treatment Medications for Antitrust

With opioid abuse continuing to dominate national headlines, manufacturers of opioid overdose medications are facing intense scrutiny over pricing practices that threaten (or those perceived as threatening) public...more

2016 SNO Conference Will Focus on Sustainable Nanotechnology Systems

The 2016 Sustainable Nanotechnology Organization (SNO) conference will be held November 10-12, 2016. The conference sessions will be organized around selected “systems,” and sessions will be populated with talks on...more

Landmark Reform of Federal Chemicals Law Will Significantly Impact Chemical Manufacturers and Users

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety Act for the 21st Century Act (“Lautenberg Act”), a sweeping and historic overhaul of our nation’s primary chemical management law, the...more

Washington Healthcare Update

1. Congress - Senate - FDA Supports Expanded Authority Over Cosmetics - In an Oct. 5 letter to Senator Dianne Feinstein (D-CA), the Food and Drug Administration (FDA) says its current legal authority over...more

The Future of Technology for Manufacturers

I had the pleasure of moderating a panel at the Connecticut Business & Industry Association (CBIA)’s Annual Manufacturing Summit. The title of the Panel was “The Future of Manufacturing in Connecticut” and included three...more

EPA Taking First Actions to Restrict Existing Chemical Uses

On October 11, 2016, EPA announced the start of expedited rulemaking to restrict the existing uses of five widely used chemicals that have been identified as being toxic, persistent and/or bioaccumulative in the environment...more

Miscellaneous Tariff Bill Petition Process Goes Live - Potential for up to $500,000 in duty relief per product

The U.S. International Trade Commission (“ITC”) has begun accepting petitions seeking temporary duty suspensions and reductions pursuant to the American Manufacturing Competitiveness Act of 2016 (“the Act”). The Act...more

EPA Accepting Applications For 2017 Safer Choice Partner Of The Year Awards

On October 11, 2016, EPA published a notice in the Federal Register seeking applications for the 2017 Safer Choice Partner of the Year Awards. The Partner of the Year Awards were developed in 2015 to recognize Safer Choice...more

Trade & Manufacturing - October 2016

What the Next President Should Do About U.S. Manufacturing - Top industry executives, political leaders, small business and trade union leaders, researchers and policymakers are offering a blueprint for maintaining the...more

New TSCA Requirements for Chemical Importers

Companies planning to ship chemical-based products to the United States should have a basic understanding of the Toxic Substances Control Act (TSCA), the key U.S. chemicals law. That law was substantially amended in June...more

WARNING: Prop 65 Can Expose Product Manufacturers to Increased Litigation in California

California's Proposition 65 ("Prop 65") requires product manufacturers and sellers to provide a "clear and reasonable" warning before knowingly and intentionally exposing anyone in California to a chemical listed by the...more

Proposition 65: New regulations for "clear and reasonable" warnings

Remember when the warning above was “clear and reasonable” for purposes of Proposition 65? Soon that will no longer be true. Following a two-year rulemaking, the California Office of Environmental Health Hazard Assessment...more

California Prop 65: More Unintended Consequences

Last month, the California Office of Environmental Health Hazard Assessment (“OEHHA”) adopted new Proposition 65 warning regulations. Much of the discussions regarding these new regulations have centered on the warning...more

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