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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

Justice Thomas’ Concurring Opinion in Microsoft Corp. v. Baker: A Useful Reminder

by Pierce Atwood LLP on

On June 12th, the Supreme Court issued its unsurprising decision in Microsoft Corp. v. Baker, addressing a relatively recent twist concerning the appealability of orders denying class certification. The case resulted in...more

U.S. Supreme Court’s Narrow Application Of Specific Jurisdiction Will Impede Forum Shopping In Class Actions

by Seyfarth Shaw LLP on

Seyfarth Synopsis: In Bristol-Myers Squibb Company v. Superior Court of California, et al., No. 16-466 (U.S. June 19, 2017), the U.S. Supreme Court articulated the narrow circumstances under which specific jurisdiction will...more

SCOTUS Squashes Class Action Plaintiff Attempt to Obtain Review of Class Certification

by Moore & Van Allen PLLC on

The reality of class action litigation is that what is supposed to be the court’s preliminary decision of whether to certify a case as a class action is often the end of the litigation. In many cases, plaintiffs will not...more

Class Action Defendants Win Home Court Advantage in Supreme Court Ruling on Specific Jurisdiction in Bristol-Myers Case

by Fenwick & West LLP on

In a decisive 8-1 vote, the U.S. Supreme Court rejected a theory of specific jurisdiction that would allow a state court to assert specific jurisdiction over the claims of out-of-state plaintiffs whose claims were not...more

U.S. Supreme Court Limits the Exercise of Specific Personal Jurisdiction by State Courts

by Dickinson Wright on

The U.S. Supreme Court recently tightened the reins when it comes to state courts’ exercise of case-based, specific personal jurisdiction over out-of-state companies. In Bristol-Myers Squibb Co. v. Superior Court of...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

Getting Specific about Specific Jurisdiction: Bristol-Myers Squibb

On June 19, the United States Supreme reaffirmed some basic principles of personal jurisdiction in Bristol-Meyers Squibb Co. v. Superior Court of California, 528 U.S. __ (2017). In a bloody-good 8-1 decision (with only...more

Multi-State Class Actions After the Supreme Court’s Decision in Bristol-Myers Squibb Co. v. Superior Court

by Pierce Atwood LLP on

On June 19th, the Supreme Court issued a decision that could have important consequences for multi-state class actions. In Bristol-Myers Squibb Co. v. Superior Court, the Court addressed the question whether a California...more

SCOTUS Rules CA Courts Lack Specific Jurisdiction to Entertain Injury Claims by Non-Residents (Bristol-Myers)

by Selman Breitman LLP on

The U.S. Supreme Court has struck down the ability of non-California residents to sue defendants in California courts for injury claims that have no connection to California, even where defendants have extensive business...more

Daimler Here to Stay: SCOTUS Overturns California Court’s Exercise of Jurisdiction Over Out-of-State Plaintiffs

by Ballard Spahr LLP on

Following on the heels of BNSF Railway Company v. Tyrrell last month, the Supreme Court, by an 8-1 margin in Bristol-Myers Squibb v. Superior Court of California, has reaffirmed the jurisdictional holding of its 2014 Daimler...more

Supreme Court Closes The Door On A Tactic Used By Plaintiffs To Appeal Denials of Class Certification

The Supreme Court recently decided a case involving an Xbox 360, although the issue before them had nothing in particular to do with the video game system itself. It got me wondering, however, how many justices would you...more

Game Over – SCOTUS Holds a Voluntary Dismissal With Prejudice Is Not a Viable Means to Appeal a Denial of Class Certification

by Carlton Fields on

A group of plaintiffs hoped to hit the reset button on the Ninth Circuit’s denial of their Rule 23(f) petition to appeal from an order striking class allegations in their case against Microsoft, the maker of the popular Xbox...more

U.S. Supreme Court Rules That Plaintiffs’ Voluntary Dismissal Does Not Transform A Decision Denying Class Certification Into An...

by Seyfarth Shaw LLP on

Seyfarth Synopsis: In Microsoft Corp. v. Baker, No. 15-457 (U.S. June 12, 2017), the U.S. Supreme Court ruled on a procedural issue that is of importance in any class action in terms of when and in what circumstances a...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

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

Anything Worthwhile For Product Liability Defendants In The 21st Century Cures Act?

by Reed Smith on

We blogged about possibly interesting nuggets in the 21st Century Cures Act (“21CCA”) back in February, 2015 – when it was only 400 pages long. In true congressional fashion, it’s now twice as long and loaded up with enough...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

Book Review: The World According to Star Wars

by Reed Smith on

It was right after our selfie with Minion Captain America that we saw it. We were marching up and down the aisles, dodging empire storm troopers. Bright lights and backbone-rattling sounds shot out of the Nickelodeon and Star...more

A One-Two Punch Case With An Off-Label Twist

by Reed Smith on

When we were young(er), we had a pretty good memory. It is not bad now, as far as we recall, particularly when it comes to pulling up bits of esoteric nonsense. For more important stuff, we find qualifiers like “vague” and...more

Another Off-Label Promotion Third Party Payor Case Lacks Causation

by Reed Smith on

July in D.C. is hot and sticky. When scorching day follows scorching day, area residents look forward to evening thunderstorms, not just to water otherwise thirsty lawns and gardens but to cool things down. Lightning can be...more

Guest Post – Corn, Justice Brandeis, Litigation Tourism and the Dormant Commerce Clause

by Reed Smith on

We have another guest post for our readers today, this time courtesy of Richard Dean of Tucker Ellis. His point involves personal jurisdiction. As we’ve discussed, some courts have allowed “general jurisdiction by consent”...more

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