FAA Announces Drone Registration, but Legal Challenges Loom
- Note: In light of the FAA’s announcement of the drone registry, we’ve revisited our recent analysis of its authority to require registration.] On December 14, 2015, the FAA issued the much-anticipated “Registration and Marking Requirements for Small Unmanned Aircraft Interim Final Rule” (the “Interim... ›
New Settlement Highlights FDA’s Diminishing Power Over Off-Label Promotion
By: Erin M. Bosman, Julie Y. Park and Brittany Scheinok
In a surprising turn of events, Pacira Pharmaceuticals, Inc. and the Food and Drug Administration (FDA) announced that they have settled their dispute regarding the off-label promotion of Exparel, one of Pacira’s anesthetic drugs. This settlement represents the latest marker of the FDA’s diminishing... ›Sixth Circuit Sweeps State-Law Design Defect Claims Under the Rug of Impossibility Preemption
By: Erin M. Bosman and Julie Y. Park
Last week, the Sixth Circuit Court of Appeals issued a groundbreaking opinion in Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc. that could change the liability landscape for brand-name drug manufacturers. No. 15-3104 (6th Cir. Dec. 11, 2015). Yates is the first federal appellate authority to recognize... ›Consumer Products “Either/Or”: California Issues Guidance on Alternatives Analysis for Safer Products
By: William F. Tarantino
California’s Green Chemistry Initiative has taken another step forward with the issuance of guidance on the heart of the law, the analysis of safer substitutes for chemicals in consumer products. On September 24, 2015, the California Department of Toxic Substances Control (DTSC) released its... ›Pay Attention to the Man Behind the Curtain: DOJ Memorandum Adds Further Weight to CPSC Enforcement Efforts Against Corporate Officers
By: Erin M. Bosman and Julie Y. Park
The United States Department of Justice (DOJ) recently issued a memorandum to various enforcement agencies. The memorandum, available here , focuses on holding individuals accountable for corporate fraud and misconduct. [1] The DOJ has already shown it means business. Just days after the memorandum... ›CPSC Will Launch Electronic Filing System Pilot Program for Imported Products
By: Erin M. Bosman and Julie Y. Park
Last week, the Consumer Product Safety Commission (CPSC) approved a pilot program to test an electronic filing system that will require importers to submit data electronically for imported consumer products. The filing system will aid CPSC and other regulators in their surveillance of imported... ›Recall, Enforce, Repeat! CPSC and DOJ Team Up for Another Enforcement Action
By: Erin M. Bosman and Julie Y. Park
The United States Consumer Product Safety Commission (CPSC) continues to escalate its enforcement efforts. Last week, the United States Department of Justice, on behalf of CPSC, filed suit against Spectrum Brands, Inc. (“Spectrum”). United States v. Spectrum Brands, Inc. , No. 3:15-cv-00371 (W.D. Wisc.).... ›California Greenhouse Gas Mandates Keep Coming— Governor Orders 40 Percent Reductions Below 1990 Levels by 2030
On April 29, 2015, California’s Governor Jerry Brown issued an executive order to set a new interim target for reducing the state’s emissions of greenhouse gases (GHGs) to 40 percent below 1990 levels by 2030. In March 2015 , we wrote about the current... ›Alabama Legislature Says No to Innovator Liability
By: Erin M. Bosman and Julie Y. Park
On April 29, 2015, the Alabama Senate passed a bill, SB80, “to provide that a manufacturer is not liable. .. for damages resulting from a product it did not design, manufacture, sell, or lease.” Sponsored by Senator Cam Ward, the bill supersedes the Alabama... ›California’s Green Chemistry Agency Issues New Guidance to Identify Future Consumer Products for Regulation
By: William F. Tarantino
California’s Green Chemistry Initiative continues to build momentum. On April 16, 2015, the California Department of Toxic Substances Control (DTSC) released its final April 2015 Priority Product Work Plan for 2015–2017 (“Work Plan”). The Work Plan is the first step in identifying the next... ›