News & Analysis as of

Preliminary Injunctions Settlement

FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more

Amarin Settles Off-Label Promotion Case Against the FDA

by Latham & Watkins LLP on

The Amarin settlement represents another important development in the FDA’s enforcement of off-label promotion. On March 8, 2016, US District Court Judge Paul A. Engelmayer entered a Stipulation & Order of Settlement in...more

Amarin/FDA Settlement: A Significant First Amendment Victory for Off-Label Marketing

On March 8, 2016, Amarin Pharma, Inc. and FDA entered into a formal settlement, close to a year after the U.S. District Court for the Southern District of New York granted a preliminary injunction against FDA’s threats to...more

New Settlement Highlights FDA’s Diminishing Power Over Off-Label Promotion

by Morrison & Foerster LLP on

In a surprising turn of events, Pacira Pharmaceuticals, Inc. and the Food and Drug Administration (FDA) announced that they have settled their dispute regarding the off-label promotion of Exparel, one of Pacira’s anesthetic...more

Procter & Gamble Must Say Goodbye to Proposed Amended Claim against Hello, while Hello Says Goodbye to Lawsuit

A lawsuit between Procter & Gamble (“P&G”) and Hello Products (“Hello”) – a toothpaste start up that promotes its products as “naturally friendly” – settled last week with the entry of a stipulated injunction, but Hello might...more

ZTE Enjoined From Further Breaching NDA Entered For Settlement Discussions (Vringo V. ZTE)

by Kelley Drye & Warren LLP on

Judge Kaplan of S.D. New York recently issued a preliminary injunction to enjoin ZTE from further disclosing information subject to a non-disclosure agreement (NDA) that ZTE had entered with Vringo to potentially settle...more

Target and Card Issuers Dispute Use of MasterCard Settlement to Resolve Data Breach Claims

In the wake of Target’s April 15 announcement of a private $19 million settlement of the data breach claims of MasterCard-issuing banks, counsel representing the putative card issuer class in the consolidated Target data...more

Proxy Season Brings a Third Wave of “Gotcha” Shareholder Litigation

Proxy season is upon us and the plaintiffs’ bar is demonstrating its resourcefulness by bringing a third wave of shareholder litigation. This new wave, which has not crested yet, consists of a return to derivative shareholder...more

Delaware Supreme Court Allows Opt-Out Right in Securities Case Certified on Equitable Grounds

by BakerHostetler on

In In Re Celera Corporation Shareholder Litigation, No. 212, 2012 (Del. Dec. 27, 2012), the Delaware Supreme Court reversed the lower Court of Chancery and ruled that a large holder of Celera Corporation (“Celera”) shares...more

Delaware Supreme Court Addresses Settlement of Class Action Deal Litigation

In the final days of 2012, the Delaware Supreme Court resolved an appeal arising out of class action litigation concerning the sale of Celera Corporation to Quest Diagnostics, Inc. The litigation was settled by agreement of...more

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