Grieving Pennsylvania Family Sues Drugmaker After Son's Overdose Death

By Keri Blakinger 09/28/16

Yet another major pharmaceutical company is under fire for marketing products for unapproved uses to boost sales.

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Grieving Pennsylvania Family Sues Drugmaker After Son's Overdose Death

The family of a Pennsylvania man who died of an overdose has launched a lawsuit against the drug maker of Actiq fentanyl lollipops, according to the Philadelphia Inquirer

The legal action filed Monday targets Cephalon and its parent company, Teva Pharmaceuticals, for allegedly marketing the drug for uses not approved by the Food and Drug Administration. 

The highly addictive painkiller was only approved for “breakthrough cancer pain,” but the drug company is accused of pushing it to family practitioners for migraine treatment—which is how Joey Caltagirone ended up with a prescription and eventually an addiction. 

When Caltagirone died two years ago at age 39—after overdosing on methadone prescribed to him by the same doctor, Thomas C. Barone—attorney Richard Hollawell found an article promoting the use of Actiq for migraine treatment stuffed into his medical file. That article was allegedly based on company-funded research, the sort of thing Cephalon had already landed in legal trouble for promoting. 

In the largest health-related legal settlement by federal prosecutors in Philadelphia, the company in 2008 agreed to pay $425 million in criminal and civil fines for its marketing of Actiq and two other drugs. 

Hollawell already won the grieving family a malpractice suit settled for just over $1 million earlier this year. Before that, he’d won settlements against Dr. Barone after two other former patients died of overdoses. 

The state eventually suspended Barone’s medical license for 18 months and demanded he get more training and a skills assessment. 

But now, Hollawell is once again behind the lawsuit against Cephalon, which is a rare attempt by an estate seeking to bring a civil case against a drug company for its marketing. The family contends that it was the drug maker's aggressive marketing of the fentanyl lollipops that eventually caused Caltagirone to become dependent on prescription opioids. In addition to the Actiq lollipops, he also spent years on multiple prescription painkillers including OxyContin and Percocet.

Prescribing drugs for off-label uses is not uncommon, but there are strict limitations on how companies are allowed to promote those uses. And in the case of Actiq, the concerted marketing for unapproved uses coincides with a massive boost in sales, from $15 million to $570 million over a six-year period. 

Hollawell hopes that the suit will make aggressive marketing of highly addictive substances a less lucrative proposition for pharmaceutical companies, while Caltagirone’s family hopes the legal action could teach drug makers a lesson.

"The pharmaceutical companies act like they aren't doing anything," Caltagirone's mother, Donna Shaffer, told the Philadelphia Inquirer. "They are making legal prescription junkies—that's what I call them—out of innocent people who are injured."

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Keri Blakinger is a former drug user and current reporter living in Texas. She covers breaking news for the Houston Chronicle and previously worked for the New York Daily News and the Ithaca Times. She has written about drugs and criminal justice for the Washington Post, Salon, Quartz and more. She loves dogs and is not impressed by rodeo food. Find Keri on LinkedIn and Twitter.

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