Off-Label Use

News & Analysis as of

Another Off-Label Promotion Third Party Payor Case Lacks Causation

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

A Blow Against False Claims Act Liability For Off-Label Promotion

Recently, we noted that one of the first decisions we wrote a post about had been affirmed by the Second Circuit. Of the district court decision, we had penned “It is nice to see a judge with a proper understanding of how...more

Mass Appeal of Off Label Use

Hardly a week goes by without our blogging about accusations of off label promotion. This week is no exception. On Monday, we discussed a nice New York opinion rejecting a plaintiff argument that off label promotion saved a...more

Settle or Fight FDA/DOJ Off-Label Use Allegations? WSJ Editorial Looks at Vascular Solutions Trial Win and Asks What's Next?

In an editorial this weekend entitled “No Justice for Business,” The Wall Street Journal hailed a recent trial win by medical device maker Vascular Solutions, Inc. (VSI) as a “victory for common sense and the First Amendment”...more

Summary Judgment for Defendants in FCA Action: No Admissible Evidence of False Claims

How much is “enough?” Will we have enough money to retire someday? Did the Drug and Device Law College Sophomore study enough for her computer science midterm? Is there enough salt in the matzo ball soup? In the realm of...more

In 10-1 Verdict, Jury Finds No FCA Violation by Abbott Laboratories

On April 7, 2016, after just three hours of deliberations following a three-week trial, a federal jury dismissed False Claims Act (“FCA”) claims against Abbott Laboratories brought by a whistleblowing former employee.  The...more

Another Outlier From California On Innovator Liability

We have closely followed the development (or perhaps more accurately, stagnation) of so-called “innovator liability.” It started with the wrongly reasoned and wrongly decided opinion from the California Court of Appeal in...more

Guest Post - Narrowing the Scope of What Constitutes Off-Label Promotion

Here is another guest post, one expressly not emanating from the Dechert side of the blog. Rather it is written by Reed Smith's Elizabeth Graham Minerd. As always with our guest posts, she is entitled to all the credit from...more

"Financial Relationships Likely to Be a Focus in Life Sciences Enforcement and Litigation"

For more than a decade, the Department of Justice (DOJ) has zealously pursued enforcement actions against the health care industry. Given the continued growth in government spending on health care and the billions of dollars...more

Latest First Amendment Off-Label Notes - Has DoJ Finally Come Around?

As we mentioned before (when we provided a discount) Bexis spoke earlier this week at the ACI Promotional Review Summit on the “Brave New World . . . Post-Amarin” – that is to say, about the First Amendment and off-label...more

FDA Regulatory and Compliance Monthly Recap — December 2015

Pacira secures expanded marketing for painkiller medication as FDA agrees to settle lawsuit, revoke warning letter - The pharmaceutical industry won in its latest bid for more leeway to promote drugs for unapproved uses,...more

Zofran Morning Sickness Lawsuit and Birth Defects

If you took Zofran to treat the symptoms of morning sickness during your pregnancy and your baby has a serious birth defect, you may be able to file a product liability claim. According to a recent article in Reuters, federal...more

Food and Drug Newsletter - December 2015

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 Ghost of Bendectin – Exorcized by the FDA?

Not quite two years ago, we posted about how, under Wyeth v. Levine, 555 U.S. 555 (2009), and subsequent Supreme Court cases, private plaintiffs can’t make claims that so-and-so should have warned about such-and-such with...more

Happy Veteran’s Day/In Praise of Free Speech and a SD Fla. Decision

Yesterday was Veteran’s Day. This is a holiday that escapes the attention of too many people – until they stare at their empty mailboxes in puzzlement. It is a federal holiday, but most of us go about our usual business....more

Philly Court Applies Michigan Law to Dismiss Risperdal Cases

Delve into the crime stories of Elmore Leonard, whether in the form of the books, movies, or television shows, and you are likely to spend considerable time in Michigan and Florida. True, Justified was set in Kentucky. But...more

AdvaMed 2015 Highlights – Part One of Two

On October 5-7, 2015, the Advanced Medical Technology Association (“AdvaMed”) held its 40th Annual Meeting for the first time on the West Coast—San Diego, California. This year also signaled a change of AdvaMed’s membership...more

Plaintiffs Allege GSK Hid Risk of Birth Defects

The Food and Drug Administration approved Zofran in 1991 for use in cancer patients who required chemotherapy or radiation therapy. The two women have sued GlaxoSmithKline (GSK), the maker of Zofran, accusing it of promoting...more

First Amendment Notes: Amicus Briefs In Pacira & Application of IMS v. Sorrell

Here we discuss a couple of developments involving (actually or potentially) the application of the First Amendment to the FDA’s increasingly battered prohibition against truthful promotion of off-label use....more

Going on Offense against State Deceptive Trade Practices AG Actions

We have posted many times about cases where a manufacturer of a regulated product is sued over alleged violations of a state consumer protection or deceptive trade practices act because of something allegedly amiss in the...more

The FDA Tiptoes – and Congress Splashes Into – the 21st Century

Here are a couple of non-litigation related matters that we thought our readers need to know about. First, the FDA. We’ve pointed out before that the FDA’s “intended use” regulations for drugs (21 C.F.R. §201.128) and...more

Southern District of New York Finds Amarin Pharma, Inc.’s Off-Label Promotion Is Protected Speech; Company Cannot Be Prosecuted...

Pharmaceutical industry and constitutional buffs have been closely watching Amarin Pharma Inc. v. U.S. Food and Drug Administration. The case presented the (not wholly novel) question whether the First Amendment protects...more

It’s Déjà Vu All Over Again: FDA Sued Again in Off-Label Promotion Case

To quote the late Yogi Berra, it must feel like déjà vu all over again for the Food and Drug Administration (FDA) (or, if you prefer, Crosby, Stills, Nash & Young’s song, “Déjà Vu” (“We have all been here before”)). Fresh off...more

First Amendment Right to Off-Label Promotion – Has Pandora’s Box Been Opened for FDA?

A handful of recent court decisions, including one issued just last month, seems to have potentially cracked open the door for pharmaceutical manufacturers to have more leeway to promote off-label uses of their products....more

Anything in the New Clinical Trial Rules of Interest to Product Liability? Not Really.

An inter-agency taskforce is proposing a comprehensive overhaul of “Federal Policy for the Protection of Human Subjects” in today’s issue of the Federal Register (comments close on 12/7/2015). See 80 Fed. Reg. 53933 (Sept....more

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