Off-label Drug Prescriptions

United States ex rel. Ibanez v. Bristol-Myers Squibb Co., 874 F.3d 905 (6th Cir. 2017)
Sidney Hillman Health Ctr. of Rochester v. Abbott Labs., 873 F.3d 574 (7th Cir. 2017)

The following two cases both involved off-label drug prescriptions and improper promotion practices.

United States ex rel. Ibanez v. Bristol-Myers Squibb Co., 874 F.3d 905 (6th Cir. 2017)

Two former sales representatives of Bristol-Myers Squibb Co. (BMS) filed a qui tam action alleging improper promotion of Abilify. The district court had dismissed the complaint in part and denied the relators’ motion to amend. On review, the Sixth Circuit noted the long chain of causal links the relators alleged “reveals just what an awkward vehicle the [False Claims Act] is for punishing off-label promotion schemes,” but ultimately upheld the lower court’s rulings because the relators could not adequately amend the complaint to meet the requirements of the FCA (such as providing a representative claim). Judge Stranch concurred with one part of the court’s holding but dissented regarding many of its other findings about the relators’ claim sufficiency, noting the importance of combating health care fraud.

Sidney Hillman Health Ctr. of Rochester v. Abbott Labs., 873 F.3d 574 (7th Cir. 2017).

In 2012, Abbott Laboratories pleaded guilty to unlawful promotion and paid $1.6 billion for undercover promotion activities that encouraged off-label use of Depakote. In 2013, two welfare-benefit plans (Payors) filed suit seeking damages under the Racketeer Influenced and Corrupt Organizations (RICO) Act. As relevant here, a district judge dismissed the complaint, ruling that Payors could not hope to show proximate causation as required under RICO. On appeal, Payors claimed that Abbott’s activities directly injured them, but the Seventh Circuit noted that it was “not at all clear that they are the initially injured parties, let alone the sole injured parties.” The court noted that patients suffer most directly and expressed skepticism in Payors’ claimed ability to show damages using statistical and other means to identify how Abbott’s practices led to specific instances of Payors spending money on off-label Depakote prescriptions.

Found in DMHL Volume 37, Issue 1