Julie Y. Park

Julie Y. Park

Morrison & Foerster LLP

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Latest Publications


Expanding Duties and Eroding Protections for Medical Device Manufacturers

Earlier this month, the Washington Supreme Court saddled medical device manufacturers with a new duty to warn under Washington law—the duty to warn hospitals about potential risks their products may pose—and eroded exemptions...more

2/20/2017 - Duty to Warn Manufacturers Medical Devices Pharmaceutical Industry

Plaintiffs’ Fraudulent Joinder Tactic Results in Dismissal

Defendants successfully argued “fraudulent joinder” in Bahalim v. Ferring Pharmaceuticals, Inc., winning dismissal of the case in its entirety. The case was decided on Plaintiffs’ motion to remand and Defendants’ motions to...more

2/7/2017 - Diversity Jurisdiction Fraudulent Joinder Medical Devices Pharmaceutical Industry Product Recalls

New CPSC Safety Standard on Baby Slings

In early January, the U.S. Consumer Product Safety Commission (CPSC) adopted a new federal safety standard for infant sling carriers. 82 Fed. Reg. 2326-1 (Jan. 9, 2017). CPSC’s new rule follows its 2010 warning that baby...more

1/27/2017 - Baby Products Consumer Product Safety Commission (CPSC) Consumer Product Safety Improvement Act (CPSIA) Product Recalls Safety Standards Warning Labels

Small Magnets, Big Trouble – Zen Successfully Challenges CPSC Rulemaking in the 10th Circuit

The United States Court of Appeals for the Tenth Circuit recently vacated the Consumer Product Safety Commission’s (CPSC) 2014 rulemaking that prohibits the importation and distribution of high-powered, small, rare earth...more

1/24/2017 - Consumer Product Safety Commission (CPSC) Enforcement Actions Safety Standards Zen Magnets

Rare Court Decision in CPSC-Backed Enforcement Action

A federal district court in Wisconsin recently ruled against a product manufacturer, finding it liable for failing to report timely in a rare U.S. Consumer Product Safety Commission (CPSC)-backed lawsuit. United States v....more

12/12/2016 - Civil Monetary Penalty Consumer Product Safety Act (CPSA) Consumer Product Safety Commission (CPSC) Corporate Counsel Due Process Fair Notice Manufacturers Product Recalls Spectrum Statute of Limitations

California Adopts the Sophisticated Intermediary Doctrine

In a recent opinion, the Supreme Court of California formally adopted the Sophisticated Intermediary Doctrine, clarifying what circumstances may permit a raw materials supplier to discharge its duty to warn consumers. Webb...more

8/2/2016 - Asbestos Burden of Proof CA Supreme Court Component Parts Doctrine Duty to Warn Hazardous Substances Judgment Notwithstanding the Verdict (JNOV) Reversal Sophisticated User Doctrine Suppliers

FDA Releases Draft Guidance For Updating Generic Drug Labels

The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug application (ANDA) labels. In particular, the draft guidance...more

7/21/2016 - ANDA Draft Guidance FDA Generic Drugs Pharmaceutical Industry Product Labels

Still Waiting—FDA Delays Rulemaking

The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...more

6/16/2016 - Failure To Warn FDA Generic Drugs Health Safety Labeling Pharmaceutical Industry PLIVA v Mensing Prescription Drugs SCOTUS Warning Labels

Generalized Products Liability Claims Not Viable Post-Spokeo

The Supreme Court case Spokeo, Inc. v. Robins reaffirmed and clarified the requirements necessary for plaintiffs to establish standing. As evidenced by the recent First Circuit case Hochendoner v. Genzyme Corp., the analysis...more

6/10/2016 - Article III Class Action Injury-in-Fact Pharmaceutical Industry Prescription Drugs Product Defects Spokeo Standing

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

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