Off-Label Promotion

News & Analysis as of

Blog: Court Holds Corporate Integrity Agreement May Be Basis for Reverse False Claim Liability

This week, a federal district court denied Cephalon Inc.’s (Cephalon) motion to dismiss a third amended complaint filed under the False Claims Act (FCA) by three qui tam relators in United States ex rel. Boise v. Cephalon,...more

A Couple of Law Review Articles We Actually Like

The last couple of times we’ve commented on new law review articles, we haven’t liked what we’ve seen very much. We’re gluttons for punishment, however, and this time we were rewarded. We found a couple of recent law review...more

GlaxoSmithKline Files Motion To Consolidate Zofran Litigation In Philadelphia

Zofran was developed to prevent nausea and vomiting caused by cancer chemotherapy. However, doctors prescribed it for the treatment of morning sickness in pregnant women. GlaxoSmithKline is the world’s seventh largest...more

Officer/Director Liability for Violations of the US Federal Food, Drug, and Cosmetic Act

Officers and directors of Irish and Northern Irish companies whose products would be regulated by the US Food and Drug Administration (life sciences companies, specifically) should be aware of developments on the issue of...more

The Elephant in the Room in Alabama

Six months ago, we praised two Alabama federal court decisions for refraining from extending the poorly reasoned decisions in Weeks—that is, Wyeth, Inc. v. Weeks, 2013 WL 135753 (Ala. Jan. 11, 2013) (withdrawn and...more

Evening The Score On Off-Label Use Information

Two stories in 360 yesterday – the timing was pure coincidence – have us thinking again about the FDA’s muddled and increasingly untenable position on truthful off-label “promotion” – broadly defined as any accurate...more

Whistleblower Lawsuit Rests on Allegedly Withheld Documents

On June 19, the whistleblower in a False Claims Act suit argued that the court should take action to secure documents that demonstrate Abbott Laboratories encouraged off-label marketing and doctor kickbacks. The whistleblower...more

Amarin Pharma v. FDA – More Briefs Filed Regarding Off-Label Promotion And The First Amendment

Our prior posts looked at the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit, which raises issues regarding the First Amendment and how it applies to speech by drug and device manufacturers...more

Amarin Pharma v. FDA – More Briefs Filed Regarding Off-Label Promotion And The First Amendment

Our prior posts looked at the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit, which raises issues regarding the First Amendment and how it applies to speech by drug and device manufacturers...more

FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it...more

Public Statements Made by Pharmaceutical and Biotech Company Executives May Raise FDA’s Hackles if They Do Not Meet Basic...

For players in the highly regulated pharmaceutical and health care industries, it is common knowledge that manufacturers and distributors of FDA-regulated products are required to promote their products in compliance with the...more

Drug Manufacturer Sues FDA Over Constitutional Right To Discuss Off-Label Uses

The FDA has long sought to ban drug manufacturers from promoting off-label uses for approved drugs. The ban – which applies only to manufacturers and their agents – is intended to safeguard the public against misbranded...more

Blog: Case to Watch: Amarin Pharma v. FDA

A potentially significant case being watched by the pharmaceutical industry is Amarin Pharma, et al., v. U.S. Food and Drug Administration, et al., Civ. A. 15-cv-3588 (S.D.N.Y.). The complaint, filed in May 2015, is a “First...more

FDA Regulatory and Compliance Monthly Recap – May 2015

In This Issue: - FDA puts out guidance to require submissions in ICH’s electronic format for certain pharmaceutical product applications within two years - OPDP warns Otsuka over improper marketing of antipsychotic...more

More Drake Dreck – Vermont Federal Court Refuses to Overturn Botched Botox Verdict

“We’ve seen this movie before.” That is something people say when they encounter something that seems simultaneously dreadful and predictable. That is how we felt upon reading the latest dismal opinion out of the Drake...more

Is This The End of RICO?

The short answer is “no.” We are just borrowing a line from one of the original gangster movies, “Little Caesar,” which readers other than McConnell would most likely know from references in “The Sopranos,” if they know it...more

21st Century Cures Markup Underway; Offsets Released

Today the House Energy and Commerce Committee is marking up H.R. 6, the 21st Century Cures Act, a high-profile, bipartisan bill that seeks to accelerate the pace of medical cures in the United States through a variety of...more

Tenth Circuit affirms federal preemption of state law tort claims for medical devices

In Caplinger v. Medtronic, __ F.3d __ (10th Cir. 2015), the Tenth Circuit Court of Appeals affirmed dismissal of a patient’s state law tort claims against a medical device manufacturer as preempted by federal law. The Tenth...more

Amarin Pharma Sues FDA Over Constitutional Right to Discuss Off-Label Uses

Drug makers and the Food and Drug Administration (FDA) have often disagreed over whether drug makers can discuss unapproved uses for their products with physicians. While courts have sided with drug makers in certain...more

Federal District Court Rules Favorably for Medical Device Manufacturer in Off-Label Promotion Lawsuits

On April 13, 2015, in the case of Kathleen Hafer v. Medtronic, Inc., the United States District Court for the Western District of Tennessee issued a favorable opinion to a medical device manufacturer in the context of...more

Some Plaintiffs Just Have No Class

We’ve been thinking a lot about class actions lately. One reason is that the Rule 23 Subcommittee of the (federal) Advisory Committee on Civil Rules just came out with a “sketch” of possible amendments – and from the defense...more

Court Declines to Certify Class Alleging Off-Label Marketing of Cancer Drug

Third party payors (“TPPs”) responsible for paying the costs of prescriptions for their beneficiaries sued Cephalon, Inc., alleging that it engaged in unlawful off-label marketing of Actiq, a drug approved to manage...more

An Atypical View of Causation and Harm from South Carolina

We have had some time now to ruminate over the South Carolina Supreme Court’s opinion in State of South Carolina ex rel. Wilson v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., No. 2012-206987, 2015 WL 775094 (S.C. Feb. 25,...more

Notes From The Off-Label Underground

Keeping track of litigation over off-label use/promotion frequently sends us off on tangents. We’ve wandered into abortion cases, securities law cases, criminal cases – even cases brought by criminals....more

There’s No Such Thing as Bad Publicity

As of March 3, Solvay Pharmaceuticals is ready to second P.T. Barnum’s famous dictum that there’s no such thing as bad publicity. That’s the day a federal court in Texas dismissed a qui tam action against Solvay....more

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