A Kansas case in which a doctor is accused of unlawfully prescribing Cephalon (CEPH)'s Actiq painkiller among other drugs, leading to the fatal overdoses of fifty-six patients, sheds some light on the damage that can be caused by unapproved "off-label" drug sales.
In 2007, Cephalon paid $425 million to the Department of Justice in a settlement for illegal promotion of Actiq, a plastic lollipop filled with highly addictive fentanyl. The company pled guilty to a single federal misdemeanor violation. That deal highlighted the business side of off-label sales: 80 percent of Actiq's sales were off-label (it's supposed to be for cancer pain) and the company was promoting it as "an ER on a stick."
The indictment in the Kansas case, against Dr. Stephen Schneider and his wife, Linda, covers the human side, i.e. it describes who was on the other end of those sales. The Schneiders operated a "pill mill" that became so notorious among addicts that the doctor came to be known as "Schneider the writer," prosecutors allege. In addition to the 56 deaths, the Schneiders' practice allegedly sent 94 patients to the emergency room with overdoses; all other doctors in the area sent fewer than five each. Schneider's clinic was staffed with physician's assistants who had no specific training in pain management, and they were given pre-signed prescription pads by Schneider, the feds claim.
The mother of Robin Geist-Wick, one of the alleged victims, is a defense witness for Schneider. She has testified that her daughter's migraines were so bad she visited the ER 16 times before seeing Schneider, who was the only physician to provide her relief.
Geist-Wick's father, Robert Wick, sees it differently. He's suing both Schneider and Cephalon in a medical malpractice suit. That suit is not mentioned in Cephalon's Q1 2010 10-Q filing with the SEC, in which the company is supposed to list any legal action that might have a material effect on its finances. I guess Cephalon is confident its total liabilities in this matter are low.
Image by Flickr user Pink Sherbert Photograpy, CC. Related: