Julie Y. Park

Julie Y. Park

Morrison & Foerster LLP

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Statute of Limitations Taking the Steam out of CPSC-Backed Enforcement Action

It is no secret that the U.S. Consumer Product Safety Commission (CPSC) is ramping up its efforts to enforce various aspects of the Consumer Product Safety Act (CPSA), especially the provisions about a company’s failure to...more

5/11/2016 - Civil Monetary Penalty Consumer Product Safety Commission (CPSC) Corporate Counsel Enforcement Actions Spectrum Statute of Limitations Summary Judgment

Defendants Secure Rare Summary Judgment in Zoloft MDL

In an unusual turn of events, U.S. District Judge Cynthia Rufe recently granted defendants’ motion for summary judgment as to over 300 cases in the Zoloft MDL. These cases were consolidated in 2012 and involved allegations...more

5/5/2016 - Birth Defects Causation Daubert Hearing Drug Safety Evidence Expert Testimony Multidistrict Litigation Pharmaceutical Industry Pregnancy Prescription Drugs Summary Judgment Zoloft

CPSC Definitely Not Zen About High-Powered Magnets

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

4/19/2016 - Consumer Product Safety Commission (CPSC) Product Recalls Zen Magnets

Definitely Not Zen – Magnets Attract Unprecedented Action from CPSC

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

4/12/2016 - ALJ Consumer Product Safety Commission (CPSC) Enforcement Authority Rulemaking Process Zen Magnets

Federal Preemption Claims: Clear Evidence and an Unclear Standard

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

4/1/2016 - Birth Defects Failure To Warn FDA Labeling Pharmaceutical Industry Preemption Prescription Drugs Summary Judgment

CPSC Pledges Higher Penalties

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

3/25/2016 - Civil Monetary Penalty Consumer Product Safety Commission (CPSC) Corrective Actions Failure to Report Hazardous Substances

FDA Embraces Internet of Things: New Draft Guidance on Postmarket Cybersecurity for Medical Devices

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

3/2/2016 - Cybersecurity Draft Guidance Executive Orders FDA Healthcare Facilities Internet of Things Manufacturers Medical Devices NIST Popular

Liability for Brand Drug Manufacturers All But Clear

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

2/26/2016 - Burden of Proof Evidence Failure To Warn FDA FDA Approval GlaxoSmithKline Pharmaceutical Industry Preemption Prescription Drugs Warning Labels

Defendants Find Relief from Burdensome Discovery Requests

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

2/10/2016 - Amended Regulation Corporate Counsel Discovery Federal Rules of Civil Procedure FRCP 26 Personnel Records Proportionality Scope of Discovery Requests

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

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