Julie Y. Park

Julie Y. Park

Morrison & Foerster LLP

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CPSC Launches “Regulatory Robot”

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

1/15/2016 - Consumer Product Safety Commission (CPSC) New Guidance Reporting Requirements

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

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

12/18/2015 - Amarin Caronia FDA FDCA First Amendment Off-Label Promotion Popular Preliminary Injunctions Prescription Drugs Settlement

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

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

12/16/2015 - Design Defects Failure To Warn FDA Approval Janssen Pharmaceuticals Manufacturing Defects Mutual Pharmaceuticals v Bartlett Pharmaceutical Industry Preemption

CPSC Will Launch Electronic Filing System Pilot Program for Imported Products

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

8/21/2015 - Consumer Product Safety Commission (CPSC) Electronic Filing Importers

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 (CPSA) Consumer Product Safety Commission (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 Industry 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 - Generic Drugs Innovation Labeling Pharmaceutical Industry

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 (CPSC) Consumer Product Safety Improvement Act (CPSIA) 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 Consumer Product Safety Commission (CPSC) Consumer Product Safety Improvement Act (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 - Failure To Warn FDA Generic Drugs Labeling Manufacturers Pharmaceutical Industry Preemption Prescription Drugs

CPSC’s Proposed Rule Would Expand Phthalate Ban

The Consumer Product Safety Commission (CPSC) recently published a long-awaited proposed rule that, if finalized in its current form, would permanently ban certain additional phthalates from children’s toys and child care...more

2/2/2015 - Chemicals Children's Products Children's Toys Consumer Product Safety Commission (CPSC)

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 Industry Prescription Drugs Teva Pharmaceuticals

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 Industry 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 - Consumer Product Safety Commission (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 Industry 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

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 - Generic Drugs Innovation Pharmaceutical Industry Prescription Drugs

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 Consumer Product Safety Commission (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 Industry 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 Consumer Product Safety Commission (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 - Consumer Product Safety Commission (CPSC) Consumer Product Safety Improvement Act (CPSIA) Manufacturers Transparency

“Brand” New Law: Illinois Court Holds Brand Manufacturers Owe Duty of Care to Generic Users

Last week, a federal district court in Illinois held that GlaxoSmithKline (GSK), a branded drug manufacturer, owed a duty of care to a patient who took the generic version of its drug. Dolin v. SmithKline Beecham Corp., No....more

3/17/2014 - Brand Generic Drugs GlaxoSmithKline Pharmaceutical Industry Prescription Drugs

$4 billion price tag? FDA's proposed generic drug labelling rule

An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, will allow...more

3/14/2014 - FDA Generic Drugs Labeling Pharmaceutical Industry Prescription Drugs

$4 Billion Price Tag for Pleasing Plaintiffs' Bar? New Study Estimates Costs of FDA's Proposed Rule on Generic Drug Labeling

An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, would allow...more

2/27/2014 - FDA Generic Drugs Labeling PLIVA v Mensing Prescription Drugs SCOTUS

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