Class Dismissed

December 17, 2015 - FDA, Drug & Medical Device, Product Liability, Government Actions
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
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December 15, 2015 - ADA, Drug & Medical Device, Product Liability
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
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October 05, 2015 - Environmental Law, Product Liability, Consumer Products, Government Actions
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
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October 01, 2015 - Product Liability, Consumer Products, Government Actions, CPSC
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
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August 19, 2015 - Product Liability, Consumer Products, CPSC
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
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June 22, 2015 - Product Liability, Consumer Products, CPSC
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.).
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April 30, 2015 - Environmental Law, Product Liability, Consumer Products, Government Actions
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
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April 30, 2015 - Drug & Medical Device, Product Liability
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
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April 22, 2015 - Environmental Law, Product Liability, Consumer Products, Government Actions
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
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February 18, 2015 - FDA, Drug & Medical Device, Product Liability
FDA Proposed Rule in Flux?
By: Erin M. Bosman and Julie Y. Park
On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and discuss alternatives to the much-criticized rule, which
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Topic Archives: Product Liability

New Settlement Highlights FDA’s Diminishing Power Over Off-Label Promotion

By: Erin M. Bosman, Julie Y. Park and Brittany Scheinok

Sixth Circuit Sweeps State-Law Design Defect Claims Under the Rug of Impossibility Preemption

By: Erin M. Bosman and Julie Y. Park

Consumer Products “Either/Or”: California Issues Guidance on Alternatives Analysis for Safer Products

By: William F. Tarantino

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

CPSC Will Launch Electronic Filing System Pilot Program for Imported Products

By: Erin M. Bosman and Julie Y. Park

Recall, Enforce, Repeat! CPSC and DOJ Team Up for Another Enforcement Action

By: Erin M. Bosman and Julie Y. Park

California Greenhouse Gas Mandates Keep Coming— Governor Orders 40 Percent Reductions Below 1990 Levels by 2030

Alabama Legislature Says No to Innovator Liability

By: Erin M. Bosman and Julie Y. Park

California’s Green Chemistry Agency Issues New Guidance to Identify Future Consumer Products for Regulation

By: William F. Tarantino

FDA Proposed Rule in Flux?

By: Erin M. Bosman and Julie Y. Park