News & Analysis as of

Off-Label Promotion

Blog: Two Enacted State Laws Permit Truthful Off-Label Promotion

by Cooley LLP on

Earlier this month, Tennessee House Bill 2220 (substituted for Senate Bill 2361) (Tennessee Law) was enacted, which provides, “A pharmaceutical manufacturer or its representatives may engage in the truthful promotion of...more

Ninth Circuit, in Solis, Reaffirms Two-Prong Approach to “Original Source” Exception Under Former FCA

The Ninth Circuit recently reversed in part the district court’s dismissal of relator Frank Solis’ claims against his former employers for alleged False Claims Act (“FCA”) violations. According to Solis, the drug companies...more

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

Don’t You Forget About Me: FDA Kicks off 2018 with Letters on Promotional Activities

by Arnall Golden Gregory LLP on

FDA’s Office of Prescription Drug Promotion (OPDP) issued only five letters in 2017 (compared to eleven in 2016 and nine in 2015). This relatively slow year left some prescription drug manufacturers wondering if, to quote the...more

Will High Court Provide Clarity On 'Clear Evidence'?

by Morrison & Foerster LLP on

The U.S. Supreme Court may soon revisit one of its seminal decisions defining products liability law for pharmaceutical manufacturers. That decision — Wyeth v. Levine — addressed whether a branded manufacturer could be held...more

DOJ Issues Guidelines for Enforcement Related to Off-Label Promotion

by Foley & Lardner LLP on

On February 28, 2018, Ethan P. Davis, the Deputy Assistant Attorney General for the Consumer Protection Branch, addressed the life sciences community regarding off-label promotion. In his remarks, Deputy Assistant Attorney...more

3d Circuit Clarifies Standard in FCA Retaliation Cases

In a precedential decision, the Third Circuit Court of Appeals held that the “but-for” standard applies in retaliation cases filed under the False Claims Act (FCA). The False Claims Act prohibits retaliation against employee...more

EU Court ruling on how off-label use is to be analysed under competition law

by White & Case LLP on

On 23 January 2018, the Grand Chamber of the Court of Justice ("ECJ") delivered its judgment on preliminary reference from the Italian State Council in the Roche case, which concerns the off-label use of Avastin for the...more

Off-Label Marketing MDL Winds Down With Some Summary Judgment

by Reed Smith on

We have written extensively on the travesty of the Neurontin trilogy and noted how the plaintiffs’ efforts to fit cases based on alleged off-label promotion of the prescription SSRIs Celexa and Lexapro into the same rubric...more

More Legislation To Watch

by Reed Smith on

Like a lot of large firms, Reed Smith has a number of blogs. We don’t mention them much because, DDL has product liability pretty well covered, and the others mostly don’t overlap a lot with what we do. But occasionally…....more

Third Circuit Requires But-for Causation for False Claims Act/Off Label Retaliatory Claim  

by Reed Smith on

Today we are talking about a case that is not exactly in the heartland of what we generally examine. It is not a product liability or mass tort case. But it is reasonably close. It is kind of an off label promotion/False...more

The State AG Report Weekly Update

by Cozen O'Connor on

Consumer Protection- Washington Attorney General Amends Lawsuit Against Cable and Internet Provider, Alleges More Deceptive Conduct- Washington AG Bob Ferguson amended his lawsuit against cable and internet service...more

A Dialogue With Corporate Counsel: Skadden’s Seventh Annual Pharmaceutical and Medical Device Seminar

Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more

Sixth Circuit Reinforces "Stringent" Pleading Standard in False Claims Act Cases

by Jones Day on

The Sixth Circuit's recent decision in U.S. ex rel. Ibanez v. Bristol-Myers Squibb Co. reinforced Federal Rule of Civil Procedure 9(b)'s requirement that plaintiffs plead fraud "with particularity" in False Claims Act cases....more

Here Is Why The False Claims Act Is An “Awkward Vehicle” In Pharma Cases

by Reed Smith on

We have always thought that the False Claims Act resides in some sort of alternate universe when it comes to pharmaceutical products. The central concept behind the FCA is easy: The FCA penalizes anyone who presents, or...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 5

In this post, I will be focusing on the intersection of off-label communications with government enforcement of health care fraud through the False Claims Act. Over the past eight years, the U.S. Department of Justice (“DOJ”)...more

Double Preemption Win in Amiodarone Litigation

by Reed Smith on

With PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), preemption arguments in cases involving generic prescription drugs has become a little like shooting fish in...more

Value-Based Contracting for Prescription Drugs and Medical Devices: An Innovative Solution Impaired by Outdated Regulations

by Pepper Hamilton LLP on

Often lost in the cacophony of headlines surrounding rising health care costs is the promise that value-based contracting offers as a possible solution. In contrast to the traditional fee-for-service model, value-based...more

Off-Label Marketing Case Tossed

by Reed Smith on

Implied Preemption. Off-label promotion. TwIqbal. They make up a core of our posts, yet we never seem to tire of them. Maybe our readers, especially interlopers from the other side of the v., tire of reading about them,...more

Aegerion Settles Criminal and Civil Probe of Promotional Practices, REMS and HIPAA Compliance, and Patient Assistance Programs

On September 22, 2017, Aegerion Pharmaceuticals resolved a wide-ranging probe by the Department of Justice (DOJ) regarding the company’s U.S. commercial activities relating to Juxtapid, a lipid-lowering agent for the...more

FDA Weighs in on Off-Label Use and Preemption

by Reed Smith on

Back in 2013, Ramirez v. Medtronic Inc., 961 F. Supp.2d 977 (D. Ariz. 2013), made it to #9 on our worst cases of the year list – which is pretty good (actually, pretty bad) for a trial court decision. Purporting to apply...more

False Claims Act Relators Be Warned: Rule 54’s Taxable Costs Award Lies Ahead for the Overeager Relator

by Liskow & Lewis on

In a published opinion last week, the Fifth Circuit sent a reminder to would-be False Claims Act (“FCA”) relators that they better think carefully before filing suit because while they may be seeking treble damages, they may...more

The Devil is Really in the Details: FDA Issues Warning Letter to a Drug Company for Disseminating False and Misleading Information

by Arnall Golden Gregory LLP on

They’re back. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP), which has been relatively quiet on the enforcement front, issued a Warning Letter to a pharmaceutical company for distributing...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 4

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not...more

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

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