Julie Y. Park

Julie Y. Park

Morrison & Foerster LLP

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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

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

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

“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 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 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

New Jersey punitive damages analysis ignores established precedent

Since 2008 New Jersey law has effectively granted pharmaceutical manufacturers immunity from punitive damages claims. While New Jersey state courts continue to recognise and enforce that immunity, some recent federal court...more

1/28/2014 - Damages FDA Fraud Prescription Drugs Punitive Damages

Buckyballs® Strike Back: Former CEO Sues CPSC

In May 2013, the Consumer Product Safety Commission (CPSC) took the unprecedented step of naming Craig Zucker in an administrative complaint against Maxfield and Oberton Holdings, LLC, the manufacturer of Buckyballs®, in...more

11/19/2013 - CPSC Fifth Amendment First Amendment Product Recalls

Goodbye to Generic Preemption? FDA Publishes Proposed Rule

Today, the U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule in the Federal Register in an effort to “create parity” between brand-name and generic manufacturers for their labeling obligations. 78...more

11/14/2013 - Drug Manufacturers FDA Generic Pharmaceutical Preemption Prescription Drugs

A victory for generics suppliers

In late June the Supreme Court issued its ruling in the much-anticipated Mutual Pharms. Co. v. Bartlett, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). As we...more

8/7/2013 - DNA Drug Manufacturers Genetic Materials Human Genes Pharmaceutical

Mutual v. Bartlett Further Shields Generic Drug Manufacturers from Liability

Yesterday, the Supreme Court issued its ruling in the much-anticipated Mutual Pharms. Co. v. Bartlett, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). As we...more

6/25/2013 - Design Defects Generic Drugs Mutual Pharmaceuticals v Bartlett Preemption Prescription Drugs SCOTUS Warning Labels

FDA Letter to Mobile App Developer Signals Regulatory Scheme

Last week, the U.S. Food and Drug Administration (FDA) sent an enforcement letter to a mobile medical app developer for failing to obtain a 510(k) clearance before marketing the app, which the FDA said appears to be a...more

6/3/2013 - FDA FDCA Healthcare Medical Devices Mobile Apps Telemedicine

CPSC Seeks to Hold Former CEO Responsible for Buckyballs® Recall

Last week the Consumer Product Safety Commission (CPSC) obtained an unprecedented ruling when Administrative Law Judge (ALJ) Dean Metry granted leave to name Craig Zucker in an administrative complaint against Maxfield and...more

5/10/2013 - Buckyballs CEOs CPSC Liability Manufacturers Officers Penalties Product Recalls

A Narrow Exception To The Mensing Preemption Defense

The Sixth Circuit recently held that a failure-to-warn claim could proceed against a generic manufacturer that had failed to timely follow the brand-name label. Fulgenzi v. Pliva Inc., Case No. 12-3504 (6th Cir. March 13,...more

4/8/2013 - Failure To Warn FDA FDCA Generic Drugs Labeling Manufacturers PLIVA v Mensing Preemption SCOTUS

Breaking Down The Bartlett Oral Argument

The U.S. Supreme Court has heard oral argument in the much-anticipated Mutual Pharmaceuticals v. Bartlett case, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). The...more

4/5/2013 - Design Defects FDA Generic Drugs Manufacturers Preemption SCOTUS Warning Labels

Driving on Both Sides of the Road: Supreme Court Hears Bartlett Oral Argument

The Supreme Court heard oral argument yesterday in the much-anticipated Mutual Pharmaceuticals v. Bartlett case, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). The...more

3/21/2013 - Design Defects Generic Drugs Manufacturers Mutual Pharmaceuticals v Bartlett Preemption SCOTUS

Mind the Gap: Sixth Circuit Finds Room for Suit Against Generic Manufacturers After Mensing

Yesterday, the Sixth Circuit issued its decision in Fulgenzi v. PLIVA, Inc., a case involving a state law claim for failure to warn against a generic drug manufacturer. Case No. 12-3504 (6th Cir. March 13, 2013). The court...more

3/15/2013 - Drug Manufacturers Failure To Warn FDCA Generic Drugs Labeling PLIVA v Mensing Preemption

Weeks Defies Years of Jurisprudence, Allowing Innovator Liability for Generic Drugs

Last week the Alabama Supreme Court adopted brand-name manufacturer liability for a generic drug sold by another company, becoming the first state supreme court to do so. Wyeth, Inc. v. Weeks, No. 1101397 (Ala. Jan. 11,...more

1/18/2013 - Drug Manufacturers Failure To Warn Generic Drugs Inc v Weeks Manufacturers Mensing Pharmaceutical Wyeth

Stengel Tangles MDA Preemption: Ninth Circuit Decision Creates Split on Buckman Preemption of Post-Market Reporting Requirements

Last week the Ninth Circuit created a new state-law cause of action against medical device manufacturers: “failure to warn the FDA.” The en banc opinion in Stengel v. Medtronic Inc., __ F.3d __, 2013 WL 106144, 13 C.D.O.S....more

1/15/2013 - Drug Manufacturers FDA FDCA Generic Drugs Manufacturers Medical Device Amendments Medical Devices Medtronics Mensing Preemption

Supreme Court to Hear Design Defect Preemption Case

Generic drug manufacturers were encouraged on Friday when the Supreme Court granted certiorari in the case of Mutual Pharmaceutical Co. v. Bartlett, No. 12-142 (on appeal from the First Circuit, Bartlett v. Mutual Pham. Co.,...more

12/4/2012 - Design Defects Drug Manufacturers Generic Drugs Labeling Preemption SCOTUS

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