News & Analysis as of

Product Recalls

Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership

by Hogan Lovells on

Under the Trump administration, foreign device manufacturers may see new compliance pressures and increased inspections by the FDA. In this video, Michael Heyl discusses this growing trend and shares insights on how foreign...more

Popular ATVs Going Up in Flames

by Howard Ankin on

Popular all-terrain vehicles (ATVs) and recreational off-highway vehicles (ROVs) manufactured by Polaris Industries are putting riders at risk for serious injuries and even death. Although the company has recently issued a...more

CPSC Recall Snapshot - Annual Report

by Alston & Bird on

Welcome to the July edition of the Alston & Bird CPSC Recall Snapshot. Last month, the CPSC released its 2016 Annual Report. The Annual Report was divided among five key strategies: (1) hazard identification and...more

Medtronic's Recent Interactions with the FDA

by Knobbe Martens on

It has been a busy couple of months between Medtronic and the Food and Drug Administration (FDA), with Medtronic experiencing both recalls and approvals from the government agency. Below is a brief summary of some recent of...more

CPSC Recall Snapshot: The New Norm in Civil Penalties and Fidget Spinners in the Crosshairs

by Alston & Bird on

Welcome to the June edition of the Alston & Bird CPSC Recall Snapshot. Earlier this month, the CPSC announced a $5.2 million civil penalty against a recreational vehicle manufacturer for alleged “failure to report...more

CPSC Recall Snapshot - Tensions Rise on Mandatory Standards

by Alston & Bird on

Welcome to the May edition of the Alston & Bird CPSC Recall Snapshot. In late April, the CPSC voted 3-2 to issue a notice of proposed rulemaking (NPR) “to address the risk of blade-contact injuries on table saws.”...more

What Parents Need to Know About the Spike in Child Product Safety Recalls

A recent report published by Kids in Danger (KID), a non-profit group dedicated to protecting child safety through recalls, indicates that child product safety recalls rose in 2016 over the previous year, peaking to its...more

Greatbatch Medical Recalls Hip-Replacement Instrument Which Has Potential To Infect Patients

The U.S. Food and Drug Administration has issued a Class 1 recall for a handheld instrument used during hip-replacement surgery. The device failed sterility tests....more

Hoverboard Fire - A Tragedy that Should Not Have Happened

Tragedy recently struck a Harrisburg, Pennsylvania family when a fire caused by a recharging hoverboard consumed their home, killing a 3-year-old girl, injuring several others and almost bringing the structure to the ground....more

Health Care E-Note - April 2017

by Burr & Forman on

An often overlooked and under publicized provision of the False Claims Act (“FCA”) is the retaliatory discharge prohibition. This is probably because retaliatory discharge claims do not grab headlines by winning multimillion...more

CPSC Recall Snapshot: April 2017

by Alston & Bird on

Welcome to the April edition of the Alston & Bird CPSC Recall Snapshot. In March, the CPSC approved a new federal standard for infant bathtubs. The CPSC stated that the new standard, which incorporates the most ...more

Question: When Is a $3 Million Attorney Fee Award Painful?

by Benesch on

Answer: When your fee request was $25 million higher. And so it was in In Re: Volkswagen “Clean Diesel” Marketing, Sales Practices, and Products Liability Litigation, pending in federal court in San Francisco. ...more

Anaphylaxis Possible Risk of Recalled EpiPen Auto-Injector, Epi-Pen Jr Auto-Injector

A company beneath the umbrella of pharmaceutical giant Pfizer has initiated a clawback of its recalled EpiPen Auto-Injector and EpiPen Jr Auto-Injector for failing to activate in time of need....more

Lithium-Ion Batteries: Hoverboard Suspected in Fatal Fire

by Wilson Elser on

Since our last blog post on lithium-ion batteries, there has been a report that a self-balancing scooter, known as a hoverboard, is the suspected cause for a March 10, 2017, fatal fire that occurred in Harrisburg,...more

Product Liability & Complex Litigation Vol. 1, No. 1

by Butler Snow LLP on

We are pleased to provide you with this edition of the firm’s Product Liability & Complex Litigation Update. This edition contains several articles by our attorneys that we hope you find interesting and informative from...more

Recalls: What Information Should Be On Your Social Media Forums?

by Nilan Johnson Lewis PA on

With the increased number of recalls, there is a hot button issue facing manufacturers and retailers: going forward, should your company implement a practice that includes announcing all recalls on its Facebook, Twitter, and...more

CPSC Recall Snapshot: March 2017

by Alston & Bird on

Welcome to the March edition of the Alston & Bird CPSC Recall Snapshot. This past month, Republican Commissioner Ann Marie Buerkle was named acting chairman of the CPSC. Buerkle was confirmed as a...more

[Webinar] Keeping Up with the Consumer Product Safety Commission: Update on Recent CPSC Developments - March 29th, 12:00pm EST

by Kelley Drye & Warren LLP on

With the complexity of today’s product safety regulatory environment and the civil penalty amounts for failure to report safety hazards, it is more important than ever for manufacturers and retailers to identify and resolve...more

Lithium-Ion Battery Failures: Suggestions For Product Manufacturers to Mitigate Liability Risk

by K&L Gates LLP on

Originally published in Bloomberg Law, vol. 45, no. 10 - March 6th, 2017. Highly publicized incidents involving lithium-ion battery fires have necessitated large-scale and costly recalls, or highly publicized...more

FDA Enforcement Activities Update for FY 2016: CDRH Warning Letters Fall to 8-Year Low

by Hogan Lovells on

The Food and Drug Administration (FDA) recently released statitistics regarding its enforcement actvities for FY 2016. Of note, the number of warning letters issued by the Center for Devices and Radiological Health (CDRH),...more

Keurig Settlement An Expensive Reminder About Product Defect Reporting Obligations

The United States Consumer Product Safety Commission (CPSC) recently announced a $5.8 million agreement with Keurig Green Mountain, Inc. settling claims that Keurig failed to report a product defect that posed an unreasonable...more

International Product Liability Review - Issue 65

by Hogan Lovells on

The International Product Liability Review provides quality updates and comment from around the world on legal developments in the field of product liability and product safety. Please see full Publication below for more...more

CFDA Amends Medical Device Recall Rules

by Ropes & Gray LLP on

Recently China’s Food and Drug Administration (“CFDA”) released the Provisions for Medical Device Recall (“New Recall Rules”). The New Recall Rules, becoming effective on May 1, 2017, will replace the existing Interim...more

CPSC Recall Snapshot: February 2017

by Alston & Bird on

Welcome to the February edition of the Alston & Bird CPSC Recall Snapshot. This month, CPSC Chairman Elliot Kaye announced that the CPSC will not follow President Trump’s Executive Order requiring two regulations be ...more

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

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