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ALERT: U.S. Supreme Court Grants Certiori to Decide Whether FDA Excluded Warnings Pre-Empt State Law Claims

The U.S. Supreme Court today agreed to consider a Third Circuit ruling that revived litigation over Merck’s alleged failure to warn about a risk of femoral fractures from its osteoporosis drug Fosamax.  The precise question presented on appeal is “whether

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Posted in Duty To Warn, FDA

FDA releases draft guidance on expansion of abbreviated 510(k) Program

On April 12, the FDA released draft guidance discussing an expansion of its Abbreviated 510(k) program for medical devices. This new guidance would allow a submitter to establish substantial equivalence by demonstrating that a new medical device meets certain performance

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The Legality of Cannabidiol and Concerns Regarding False Advertising

The legality of marijuana (also known as cannabis) has been a popular topic in recent years with thirty states and the District of Columbia having laws that legalize marijuana in some form.  However, under federal law, marijuana is a Schedule

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Posted in FDA

Proposed Legislation to Relax Rules on Medical Device Reporting Passes U.S. House

On July 13, 2017, the U.S. House of Representatives passed a bill that would triple the amount of time in which medical device manufacturers are required to report certain malfunctions of some products to the Food and Drug Administration.  Companies

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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
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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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