Law.com Subscribers SAVE 30%

Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.

Drug & Device News

By ljnstaff | Law Journal Newsletters
April 02, 2017

Off-Label Suit

In the case of Caltagirone v. Cephalon, Philadelphia Court of Common Pleas Judge Denis P. Cohen has granted the plaintiff the right to subpoena documents concerning pharmaceuticals manufacturer Cephalon from the U.S. Attorney's Office for the Eastern Dirstrict of Pennsylvania. The civil suit is being brought by a man who claims his son's methadone overdose can be traced back to an addiction he developed from using Cephalon's fentanyl-laced lollipops, marketed under the name Actiq. Although these lollipops were approved for use only by cancer patients who had been prescribed them for pain relief by oncologists specially trained in dealing with Schedule II opioids, the plaintiff contends that Cephalon sales representatives marketed Actiq to doctors for a number of other uses, including the relief of migraine headaches. Among these, according to the claim, was the plaintiff's decedent's doctor, who prescribed Actiq to him for treatment of migraines in 2005. The plaintiff's decedent became addicted, states the claim, and after consuming nearly 6,000 lollipops between 2005 and 2011, he began taking methadone to combat the addiction. The son died of a methadone overdose in May 2014.

This premium content is locked for LJN Newsletters subscribers only

  • Stay current on the latest information, rulings, regulations, and trends
  • Includes practical, must-have information on copyrights, royalties, AI, and more
  • Tap into expert guidance from top entertainment lawyers and experts

For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473

Read These Next
The DOJ's Corporate Enforcement Policy: One Year Later Image

The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.

The DOJ's New Parameters for Evaluating Corporate Compliance Programs Image

The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.

Use of Deferred Prosecution Agreements In White Collar Investigations Image

This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.

Bankruptcy Sales: Finding a Diamond In the Rough Image

There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.

A Lawyer's System for Active Reading Image

Active reading comprises many daily tasks lawyers engage in, including highlighting, annotating, note taking, comparing and searching texts. It demands more than flipping or turning pages.