The family of a Philadelphia man who died of an overdose two years ago filed suit against Cephalon Inc. on Monday, arguing that the drugmaker’s aggressive marketing of a powerful painkiller – the fentanyl lollipop Actiq — for conditions it was not approved to treat led to his addiction.
The suit against Cephalon and Teva Pharmaceuticals, which acquired it in 2011, is intended to target manufacturers for their role in an epidemic that has resulted in more than 165,000 deaths since 1999. Government regulators have acted against drugmakers' marketing tactics, but legal experts said the strategy was uncommon for a civil case brought by an estate, and could not think of any similar action that had succeeded.
But the culture around opioids and addiction has changed dramatically in the last few years. One in four families has been personally touched by the prescription drug crisis, and surveys suggest many Americans believe pharmaceutical companies are partly to blame. Investigations have turned up evidence of illegal, profit-driven behavior by manufacturers — Cephalon pleaded guilty to a criminal charge involving Actiq eight years ago — that ran campaigns to convince physicians that their products were less risky and more effective than evidence had shown. Other industry actions, such as repeated price hikes on products like the EpiPen, have added to public anger.
"The pharmaceutical companies act like they aren't doing anything," said Donna Shaffer, whose 39-year-old son, Joey Caltagirone, died of an overdose after years on multiple prescription medicines ranging from OxyContin to Percocet and the Actiq brand of fentanyl. "They are making legal prescription junkies — that's what I call them — out of innocent people who are injured."
Fentanyl is the drug that killed Prince. It is 50 to 100 times stronger than morphine. The illicit form, usually synthesized by overseas drug cartels and mixed with heroin, has been linked to a recent spike in fatal overdoses across the country, including 99 in Philadelphia during just the first four months of this year.
The pharmaceutical form of fentanyl is used in surgery and for acute pain. Actiq, a fast-acting version that is absorbed as a lozenge-on-a-stick twirled in the mouth, was approved by the U.S. Food and Drug Administration in 1998.
The agency was so concerned about safety that it included a boxed warning to the package insert – “Actiq is indicated only for the management of breakthrough cancer pain” – and expanded it several times. It added a contraindication specifically for migraines in 2009. The FDA also required the company to submit quarterly reports alerting the agency if large numbers of doctors other than oncology and pain specialists were prescribing the drug.
Cephalon promoted the medication to family practitioners and a range of specialists for conditions ranging from headaches to wound dressing changes, according to the government memorandum that accompanied the company’s 2008 guilty plea involving Actiq and two other drugs. At the time, the $425 million in criminal and civil fines was the largest health-related settlement by the U.S. Attorney’s Office in Philadelphia.
Investigators said the company produced a document titled “Actiq in Migraine” and flew doctors to seminars, where it promoted small studies by researchers it had funded that found benefits for headache patients.
An article about one of those research studies ended up in Joey Caltagirone’s medical file at the Center City office of a family doctor who was treating him for migraines. Attorney Richard Hollawell found it last year while preparing a malpractice lawsuit over the patient's death. Hollawell, a partner in the Marlton firm Console & Hollawell, had previously won settlements against physician Thomas C. Barone after two former patients, both friends from the lawyer's childhood in the Northeast, died of overdoses.
Investigators for the state later found a fourth patient death and the Pennsylvania Board of Osteopathic Medicine, in a consent agreement, required Barone to get additional training and a skills assessment during an 18-month suspension of his medical license.
The Caltagirone malpractice suit was settled this year for $975,000 from the doctor’s insurer and $165,000 from CVS Pharmacy.
But Hollawell argues in the lawsuit against Teva and Cephalon, filed in Philadelphia Common Pleas Court, that its illegal marketing for migraines led the doctor to prescribe 5,918 fentanyl lollipops to Caltagirone from August 2005 through December 2011, and that Actiq was largely responsible for his addiction. He died three years later from an overdose of methadone, also prescribed by Barone.
The doctor, who maintained at a license reinstatement hearing two weeks ago that his opioid prescribing was largely in line with accepted medical practice, could not be reached for comment about the Cephalon suit.
A spokeswoman for Israel-based Teva, which acquired Cephalon for $6.8 billion in 2011, said the company would have no comment on the suit. Teva's North America headquarters are in North Wales, Montgomery County.
Hollawell believes that a key to stopping the epidemic of opioid addiction is making inappropriate promotion of the products less lucrative for drug companies. According to the lawsuit, sales of Actiq grew from $15 million to $570 million between 2000 and 2006, as Cephalon’s off-label marketing to physicians ramped up.
Many drugs can be used to treat multiple conditions, and doctors often prescribe them “off label,” for purposes not approved by the FDA.
“Most of the drugs that we use to treat pain are off-label,” said Michael Ashburn, director of pain medicine for the University of Pennsylvania Health System. (He said that fentanyl “should rarely if ever be used for migraine headaches,” and that opioids in general frequently make migraines worse.)
But companies are limited in how they may promote drugs for off-label use and have settled numerous cases with state and federal governments for doing so.
Rick Collier, an adjunct professor of drug and medical device law at Temple University and former general counsel for four pharmaceutical companies, said he thought a civil suit that extended those charges to an individual patient’s death would be tough to win because “causation will be a hotly contested issue,” with proof required for each link in the chain from company to sales rep to doctor to patient.
Roseann B. Termini, the author of Food and Drug Law, a multi-volume text on different regulatory areas, agreed. Neither attorney was familiar with Hollawell’s suit or anything similar.
As the government steps up investigations into industry marketing tactics, however, Termini said there may be more evidence for private attorneys to work with.
“I think these cases are going to become more common because of the opioid crisis,” said Termini, an adjunct professor at Widener University Delaware Law School.