Off-label drug marketing, pharma fraud, patient harm, whistleblowing

The authors are former prosecutors who now represent whistleblowers / Renée Brooker (former Assistant Director for Civil Frauds) (202) 288-1295 / Eva Gunasekera (former Senior Counsel for Health Care Fraud)

The Department of Justice needs whistleblowers to report fraud involving off-label drug marketing, which can lead to patient harm.

Sandoz Can’t Duck Off-Label Promotion Claims Over Woman’s Death

Posted April 1, 2019, 1:28 PM

Drug allegedly approved only as last resort for fatal conditions

Off-label marketing, warning claims not preempted

Most claims will proceed against Sandoz Inc. and its unit Eon Labs Inc. over the off-label promotion of a generic heart drug that allegedly caused a woman’s death, a federal court in Illinois ruled.

Federal law blocks, or preempts, the state-law claims over amiodarone only to the extent they challenge the adequacy of the generic drug’s labels, which are locked in by the brand-name maker’s labels, the court said March 29.

But the claims here are at least partly premised on Sandoz’s alleged off-label marketing and on its alleged failure to provide Linda Lempa with a medication guide explaining the drug’s risks, the court said. Those aren’t preempted, it said.

Amiodarone is government-approved only for potentially fatal heart conditions, and only as a last resort, according to the U.S. District Court for the Southern District of Illinois.

But Lempa was prescribed it as a “first-line” treatment for a non-life-threatening condition, atrial fibrillation, her husband alleges. That was in line with Sandoz’s off-label promotion of amiodarone, Lawrence Lempa says in his complaint.

And Sandoz didn’t warn doctors of its dangers for those uses, including respiratory failure, he says. Linda Lempa, who previously had no respiratory trouble, allegedly died of acute hypoxic respiratory failure.

Sandoz also allegedly didn’t warn prescribing physicians of the danger, the court said.

The drugmaker’s defense that a learned intermediary (the doctor) relieved it of an obligation to warn the patient therefore doesn’t apply at an early stage of the litigation, the court said.

One claim, for fraudulent concealment, wasn’t pleaded with the necessary level of detail, the court said.

Latherow & Duignan represented the plaintiff.

Greenberg Traurig LLP represented Sandoz and Eon.

The case is Lempa v. Eon Labs, Inc., N.D. Ill., 18 C 3821, 3/29/19.

To contact the reporter on this story: Martina Barash in Washington at

To contact the editor responsible for this story: Jo-el J. Meyer at