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Read Products Liability updates, alerts, news, and legal analysis from leading lawyers and law firms:

PhRMA Comment on the FDA’s Proposed Off-label Rule: The Rule of Law is the Best Medicine

by Reed Smith on

The FDA cannot get out of its own way on the issue of off-label communications. Its power to punish off-label promotion comes from an odd regulatory two-step, whereby off-label promotions are said to prove an indicated use...more

Law Review Article on Off-label is On Target

by Reed Smith on

More than once we’ve said that we read law review articles so you don’t have to. We separate the wheat from the chaff. The wheat is scarce. That is because law review articles usually drown the little bits of objective...more

Speaking of the First Amendment...

by Reed Smith on

Now that Dr. Scott Gottlieb is safely installed as FDA Commissioner, we at DDLaw can end our moratorium on blogposts about First Amendment issues. There was no way we wanted to give his opponents any ammunition by saying nice...more

N.D. Alabama Issues Mixed Bag of Branded Preemption Rulings

by Reed Smith on

We like bright lines in the law. They streamline arguments for lawyers and, more important, they make it easier for non-lawyers to conduct their affairs with some degree of predictability. Rear-end a car and you’re liable,...more

FDA Off-Label Promotion Memo Should Affect §510k Preemption & Evidence

by Reed Smith on

Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the §510k “substantially equivalence” medical device clearance as non-preemptive because it was supposedly “focused on equivalence, not safety”? Id. at...more

Breaking News – Supreme Court Takes BMS Personal Jurisdiction Case

by Reed Smith on

The United States Supreme Court today granted certiorari in Bristol-Myers Squibb Co. v. Superior Court. Here is a link to the order. The California Supreme Court decision in this case was our worst case for all of 2016. ...more

3D Printing of Manufactured Goods: An Updated Analysis

by Reed Smith on

(NEW YORK) December 15, 2016 – Reed Smith LLP today released “3D Printing of Manufactured Goods: An Updated Analysis,” a comprehensive new white paper that provides in-house counsel and industry leaders with an in-depth look...more

Update on Prosecution for Truthful Off-Label Promotion

by Reed Smith on

We have been following issues related to the interplay of off-label use, manufacturer statements about off-label use, the First Amendment, and FDA enforcement for a long time. (Like here, here, and here, among many posts.) ...more

Off-Label Marketing – Industry Groups Step into the Breach

by Reed Smith on

We have been waiting, literally for years, for the FDA to revise, clarify, update, or simply pay attention to, its off-label promotion regulatory position in light of repeated governmental First Amendment losses in Sorrell v....more

The Supreme Court - June 2016 #7

by Dorsey & Whitney LLP on

The Supreme Court of the United States issued decisions in three cases today: McDonnell v. United States, No. 15-474: Former Virginia Governor Robert McDonnell and his wife, Maureen McDonnell, were federally indicted...more

Food and Drug Newsletter - December 2015

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

The Only Surprise Is That It Took This Long...The First Ebola Class Action Has Been Filed

by Dorsey & Whitney LLP on

I am always amused by the manner in which class action lawyers attempt to capitalize on current events and public fears in bringing a “cutting edge” lawsuit that will garner a great amount of media attention. Although the...more

Class Action Claims: Gluing Together Systemwide Judicial Relief

by Best Best & Krieger LLP on

The award of class action certification is often the gateway for obtaining lifesaving systemwide judicial relief in broken correctional health care systems. It also can be the beginning of a decades-long, burdensome and...more

Par Pharmaceutical vs USA - Off-Label Promotion and the First Amendment

by Michael Walsh on

Par filed suit seeking a judgment declaring FDA’s regulations unconstitutional and preventing FDA from deeming lawful First Amendment protected speech as evidence of criminal intent. In response, FDA is seeking early...more

Two More From The Supreme Court

by Dechert LLP on

Generic Manufacturers Win Preemption In Mensing The Court decided 5-4 in favor of generic preemption today in Pliva, Inc. v. Mensing, No. 09–993, slip op. (U.S. June 23, 2011). We’d like to talk about Mensing, but it’s a...more

Advertising Law Newsletter - January 31, 2011

In this issue: U.S. Supreme Court to Decide Marketing Consent Law; NAD Weighs In on Toning Shoes; ‘Well-Known’ Robocaller Banned from Telemarketing; FTC Settles False Environmental Certification Claims; and Kellogg Settles...more

An Ad Hoc Inquiry Into the Feasibilities and Impracticalities Associated With Class Certification Of Blood Glucose Monitor Users

by Kleyman & Associates, PC on

Recent developments in pre-emption law have outlined the requirements for bringing an action against a manufacturer of an FDA approved medical device. Specifically, devices that undergo the 510(k) approval process remain a...more

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