Erin M. Bosman

Erin M. Bosman

Morrison & Foerster LLP

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CPSC Could Be Coming Around On A Litigation Strategy

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

7/9/2015 - Civil Monetary Penalty CPSC DOJ Enforcement Actions Injunctive Relief Manufacturers Product Defects Reporting Requirements

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

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 CPSC DOJ Enforcement Enforcement Actions Manufacturers Notice Requirements Product Defects Product Recalls Spectrum

Sweet Home No More, Innovator Liability Leaves Alabama

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

5/20/2015 - Generic Drugs Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs

Alabama Legislature Says No to Innovator Liability

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

5/3/2015 - Drug Manufacturers Generic Drugs Innovation Labeling Liability

Consumer Products: The CPSC Files Suit Seeking Civil Penalties Against Michaels Stores for Failures of Reporting and Material...

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

5/2/2015 - Civil Monetary Penalty CPSC Enforcement Actions Investigations Michaels Misrepresentation Product Recalls Reporting Requirements Retailers Safety Violations

CPSC Civil Penalty Trend Continues

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

4/1/2015 - Civil Monetary Penalty Consumer Product Safety Commission Consumer Product Safety Improvement Act CPSC General Electric Manufacturers Penalties

CPSC Penalties to Increase Beyond “Cost of Doing Business”

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

3/5/2015 - Civil Monetary Penalty CPSC CPSIA Enforcement Statistics General Electric Strategic Enforcement Plan

FDA Proposed Rule in Flux?

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

2/20/2015 - Drug Manufacturers Failure To Warn FDA Generic Drugs Labeling Manufacturers Pharmaceutical Pharmaceutical Manufacturers Preemption Prescription Drugs

FDA Policy On Wellness Products Is Healthy For Industry

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

1/29/2015 - Draft Guidance FDA Medical Device Accessories Medical Devices Wellness Programs

Generic Drug Cos. Face Failure-To-Warn Claims In Calif.

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

1/29/2015 - Appeals Failure To Warn FDA Generic Drugs Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs Teva Pharmaceuticals

Regulating a Healthy Lifestyle? FDA Distributes New Draft Guidance on “General Wellness Products”

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

1/27/2015 - Draft Guidance FDA Fitness Medical Devices Privacy Concerns Wearable Technology Wellness Programs

Generic Drug Manufacturers to Face Failure-to-Warn Claims in California

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

1/23/2015 - Failure To Warn FDA Generic Drugs Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs Teva Pharmaceuticals

CPSC Imposes Record-High Penalties in 2014

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

11/12/2014 - CPSC Fines Manufacturing Defects Reporting Requirements Williams-Sonoma

"Generic" Logic Helps Branded Drug Achieve Dismissal

A federal district court has held that design defect claims against a brand pharmaceutical manufacturer are preempted by federal law. Booker v. Johnson & Johnson, No. 3:12 oe 40000, 2014 WL 5113305 (N.D. Ohio Oct. 10,...more

11/7/2014 - Generic Drugs Johnson & Johnson Patent Litigation Patents Pharmaceutical Manufacturers Pharmaceutical Patents Preemption Prescription Drugs

Engle: a mass tort run amok

In This Issue: -Facts -2006 Florida Supreme Court decision -Failure to investigate -Eleventh Court decision -Comment The Eleventh Circuit's recent decision in In re Engle Cases...more

10/31/2014 - Class Action Investigations Loss of Consortium Mass Tort Litigation Wrongful Death

Innovator Liability Finds Sweet Home In Ala.

Earlier this month, the Supreme Court of Alabama confirmed its January 2013 holding in Weeks v. Wyeth Inc. that manufacturers of brand drugs can be liable for injuries caused by generic drugs. Though the recent ruling puts...more

9/8/2014 - Drug Manufacturers Generic Drugs Liability Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs Wyeth

Weeks II: Innovator Liability Finds a Sweet Home in Alabama

Last week, the Supreme Court of Alabama confirmed its January 2013 holding that manufacturers of brand drugs can be liable for injuries caused by generic drugs. Weeks v. Wyeth, Inc., No. 1101397, slip op. (Ala. Aug. 15,...more

8/21/2014 - Drug Manufacturers Generic Drugs Innovation Pharmaceutical Prescription Drugs

Socially Aware - Volume 5, Issue 5 - August 2014

In This Issue: - Data for the Taking: Using the Computer Fraud and Abuse Act to Combat Web Scraping - Google Glass Into Europe: A Small Step or a Giant Leap? - Drugs and the Internet: FDA Distributes New...more

8/19/2014 - ABC v Aereo Accessibility Rules Computer Fraud and Abuse Act DMCA EU FDA Google Glass Prescription Drugs Social Networks Web Scraping Website Accessibility

Drugs and the Internet: draft guidance on social media platforms and prescription drugs

The Food and Drug Administration (FDA) recently promulgated two much-anticipated draft guidance documents on the use of social media to present information about prescription drugs and medical devices. The draft guidance...more

7/25/2014 - Draft Guidance FDA FDCA Medical Devices Prescription Drugs Social Media

The Ghosts of Litigation Holds Past

Earlier this year, in the widely followed In re: Actos (Pioglitazone) Products Liability Litigation matter, a Louisiana federal jury ordered a drug manufacturer to pay $6 billion in punitive damages and $1.5 million in actual...more

7/25/2014 - Damages Drug Manufacturers Litigation Hold Manufacturers Multidistrict Litigation Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs Punitive Damages Spoliation

Drugs and the Internet: FDA Distributes New Draft Guidance Regarding Social Media Platforms and Prescription Drugs

Last week the Food and Drug Administration (FDA) promulgated two much-anticipated draft guidance documents on using social media to present information about prescription drugs and medical devices. The draft guidance...more

6/26/2014 - Advertising FDA Marketing Prescription Drugs Social Media

CPSC Emphasizes Internet Presence with New Monthly Progress Reporting Template

NEW MONTHLY PROGRESS REPORT - In May 2014, the Consumer Product Safety Commission (CPSC) rolled out a new monthly progress report for companies executing a product recall. The form is available here. The new template...more

6/19/2014 - Compliance CPSC Internet Notice Requirements Reporting Requirements

Launch of openFDA Increases Accessibility to Adverse Drug Event Reports

On June 2, 2014, the Food and Drug Administration launched openFDA, a program designed to improve access to publicly available data beginning with adverse event reports. While greater accessibility to adverse event reports...more

6/18/2014 - Adverse Events Databases FDA FOIA HHS openFDA Pharmaceutical Prescription Drugs Reporting Requirements Transparency

The Epic Buckyballs® Saga Settles

May 2014 brought an ordinary end to a series of extraordinary events, with the Consumer Product Safety Commission (CPSC) settling an unprecedented proceeding against Craig Zucker, the former CEO of Buckyballs® manufacturer...more

6/2/2014 - Buckyballs CPSC Fifth Amendment First Amendment Personal Liability Product Recalls

Looking to Litigate in Secret? Fourth Circuit Creates Hurdles for Product Manufacturers

In April, the Fourth Circuit ruled in Company Doe v. Public Citizen that a manufacturer could not hide behind a veil of secrecy even after successfully enjoining the Consumer Product Safety Commission (CPSC) from publishing...more

5/21/2014 - CPSC CPSIA Manufacturers Transparency

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