Julie Y. Park

Julie Y. Park

Morrison & Foerster LLP


Latest Publications

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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

Lone Pine Order Forces Plaintiffs to Ante Up

Last week, the court in In re: Fosamax Products Liability Litigation granted Defendant Merck & Co.’s motion for a Lone Pine order. No. 06 MD 1789 (S.D.N.Y. Nov. 20, 2012). Lone Pine orders are valuable tools in defending mass...more

11/30/2012 - Evidence Expert Witness Lone Pine Order

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