The last weeks of March brought us two interesting and seemingly contradictory opinions that show the many tools the U.S. Consumer Product Safety Commission has at its disposal to enforce its own regulations. These orders...more
The last weeks of March brought us two interesting and seemingly contradictory opinions that show the many tools that the Consumer Product Safety Commission (CPSC) has at its disposal to enforce its own regulations. These...more
Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. Cerveny v. Aventis, Inc., 2016 U.S. Dist. LEXIS 34182 (D. Utah Mar. 16, 2016). The...more
Earlier this month, CPSC Chair Elliot Kaye told regulators, industry, and lawyers about the CPSC’s priorities for the coming year. At the top of the list were increased civil penalties for failure to report potentially...more
The FDA’s recently issued draft guidance on “Postmarket Management of Cybersecurity in Medical Devices” seeks to address some of the increasing concerns that medical device providers, regulators, and consumers have about...more
Earlier this month, a federal district court in Illinois denied GlaxoSmithKline’s (GSK) renewed summary judgment motion based on federal preemption of failure-to-warn claims in an opinion setting tough standards for brand...more
Litigation often involves lengthy battles over the proper scope of discovery. Defendants with substantial resources frequently find themselves on the receiving end of unreasonable discovery requests in an attempt to overwhelm...more
Businesses face a daunting task when attempting to comply with the U.S. Consumer Product Safety Commission’s (CPSC) reporting requirements. In an effort to simplify and streamline the process for consumer products providers,...more
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...more
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...more
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. The...more
10/5/2015
/ Civil Liability ,
Civil Monetary Penalty ,
Consumer Product Safety Act (CPSA) ,
Consumer Product Safety Commission (CPSC) ,
Cooperation ,
Corporate Crimes ,
Corporate Fraud ,
Corporate Officers ,
Corporate Veil ,
Criminal Penalties ,
Department of Justice (DOJ) ,
Government Investigations ,
Individual Accountability ,
Internal Investigations ,
Personal Liability ,
Reporting Requirements ,
Self-Disclosure Requirements ,
White Collar Crimes ,
Yates Memorandum
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...more
The U.S. Consumer Product Safety Commission continues to escalate its enforcement efforts. Recently, the U.S. Department of Justice, on behalf of the CPSC, filed suit against Spectrum Brands Inc. See United States v. Spectrum...more
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....more
6/23/2015
/ Civil Monetary Penalty ,
Consumer Product Safety Act (CPSA) ,
Consumer Product Safety Commission (CPSC) ,
Department of Justice (DOJ) ,
Enforcement ,
Enforcement Actions ,
Manufacturers ,
Notice Requirements ,
Product Defects ,
Product Recalls ,
Spectrum
On May 1, 2015, Alabama Gov. Robert Bentley signed into law a bill to “provide that a manufacturer is not liable ... for damages resulting from a product it did not design, manufacture, sell, or lease.” Sponsored by state...more
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...more
Last week, the U.S. Department of Justice, on behalf of the United States Consumer Product Safety Commission (CPSC), filed suit against Michaels Stores, Inc. (“Michaels”) in the Northern District of Texas. United States of...more
At the end of last year, we reported that the U.S. Consumer Product Safety Commission issued $12.2 million in civil penalties in 2014, more than double the amount issued in 2013. The number of companies fined increased as...more
At the end of last year, we reported that the Consumer Products Safety Commission (CPSC) issued $12.2 million in civil penalties in 2014, more than double the amount issued in 2013. The number of companies fined increased as...more
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...more
On Jan. 16, 2015, the U.S. Food and Drug Administration promulgated a much-anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest attempt...more
On Jan. 20, 2015, the U.S. Supreme Court declined to hear an appeal involving failure-to-warn claims against generic pharmaceutical manufacturers. Teva Pharms. USA Inc. v. Super. Ct., No. 13-956 (U.S. Jan. 20, 2015). This...more
On January 16, 2015, the Food and Drug Administration (FDA) promulgated a much - anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest...more
On January 20, 2015, the Supreme Court declined to hear an appeal involving failure-to-warn claims against generic pharmaceutical manufacturers. Teva Pharms. USA Inc. v. Super. Ct., No. 13-956, 2015 WL 231967 (U.S. Jan. 20,...more
The Consumer Product Safety Commission (CPSC) recently announced the latest penalties imposed on companies in 2014 for failure to report potential product defects. The first, announced on October 28, 2014, was the largest...more