Blog Archives

Lack of Specificity May Kill Parallel State Law Product Claims, But Not Fraud Claim

A Michigan district court judge determined last week that product liability claims against an FDA approved medical device manufacturer were preempted by federal law, but allowed the plaintiff’s claim of fraud against the manufacturer, Medtronic, Inc., to proceed at the

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Posted in FDA, Manufacturer

Words Matter: Product Claims Can Trigger Regulatory Application And Corrective Action

Most of us understand that the facts that give rise to the legal issues we face are sometimes sewn far in advance.  This is certainly true in the area of product claims or statements.  As is discussed below, careful consideration

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Posted in FDA

The Harbor Might Not Be Safe: Failure To Update Generic Drug Labels Can Invite a Storm of State-Law Claims

The New Jersey Supreme Court ruled on August 22 that consumers’ state-law claims that manufacturers of a generic Reglan, a heartburn medication, did not adequately warn about its risks are not preempted by federal law.[1] Under the Federal Food, Drug,

Posted in FDA

FDA Issues New Draft Guidance Requiring Modifications to Medical Device Tracking Labels

The Food and Drug Administration released draft guidance last week revealing its intent to better track medical devices, from pacemakers to condoms, through an amendment to its 2013 “UDI (unique device identifier) Rule”.  The draft guidance is intended to assist

Posted in FDA

New FDA Draft Guidance on Updates to Certain Generic Labeling

On July 8, 2016, the U.S. Food and Drug Administration released draft guidance amending the process for manufacturers to update labeling of generic drugs in situations where the reference drug labeling has been withdrawn for reasons other than safety or

Posted in FDA

FDA Issues Final Ruling Allowing Medical Device Manufacturers to Use Stand-Alone Symbols on Labels

This week, on June 14, 2016, the FDA issued a final ruling revising its medical device and certain biological product labeling regulations to allow, for the first time, manufacturers to use graphical representations of information on its labeling without adjacent

Posted in FDA

Olympus Duodenoscope Recall: Lessons Learned on How to Manage a Class II Device Failure

Earlier this year Olympus Corp. (“Olympus”) announced that it would recall and redesign its TJF-Q180V duodenoscope following its link to deadly patient infections in the United States and abroad.  This situation presents an important cautionary tale and one that is

Posted in FDA, Manufacturer, Recalls

Sweet Victory: Whole Foods Uses FDA Regulations to Dismiss Complaint in Greek Yogurt MDL

This month, United States District Judge Sam Sparks of the Western District of Texas dismissed a Second Amended Consolidated Complaint in an MDL styled In re: Whole Foods Market, Inc., Greek Yogurt Marketing and Sales Practices Litigation.  At issue in

Posted in FDA, Food

Whose Choice Is It Anyway? Split Decisions Over Choice of Law and The Impact On Your Defense Strategy

Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson, has been embroiled in a mass tort MDL in Philadelphia for its anti-psychotic drug, Risperdal, for almost a year now.  So far in 2015, the juries have split – three in

Posted in Choice of Law, FDA

When Good Food Goes Bad: Contamination and Product Liability

Last week, lunch came back to bite dozens of unsuspecting diners throughout Washington and Oregon. Something in Chipotle’s fresh, healthy, and responsibly-sourced fast food caused uncharacteristic sickness for those partaking. The likely culprit, E. coli bacteria, left Chipotle patrons seriously

Posted in FDA, Food
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Products Liability Prevention & Defense
Our attorneys represent foreign and domestic designers, manufacturers, and distributors of a diverse array of products, from food and drugs to industrial equipment and building materials. We help clients respond to major personal injury and property damage claims in the form of single-product cases, class actions, mass torts, and multidistrict litigation, as well as all types of congressional, regulatory, or criminal investigations. Our team works closely with corporate counsel to minimize a company’s overall liability and establish efficient protocols for fielding claims and advise on labeling, marketing, manuals and instructions, supply and distribution contracts, and insurance and indemnification issues.
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