Insys's 'reckless' Subsys marketing led to patient's death, lawsuit alleges

Justice statue with sword and scales
A new lawsuit claims Insys Therapeutic's promo tactics for Subsys led to a patient's death.

Embroiled in a web of allegations and investigations over Subsys marketing, Insys Therapeutics faces a new lawsuit from parents who said their daughter’s death stemmed from “false, fraudulent and misleading” sales tactics. In a new marketing twist, the suit alleged an Insys salesperson met with Sarah Fuller directly to entice her to switch to the company’s powerful painkiller.

Subsys, approved by the FDA to treat cancer-related pain, has been the focus of an intense investigation for months, with authorities arresting multiple former Insys employees and execs along the way.

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According to the suit, Insys salespeople targeted doctors they knew weren’t treating patients with cancer pain. More more than 80% of Subsys scripts were off-label by the end of 2015, the suit claims.

The plaintiffs said an Insys representative met with Fuller—who suffered from back and neck pain—plus her father and doctor in early 2015 at a visit to the doctor's office. At the meeting, Fuller wasn’t warned about about Subsys risks or that her Subsys use would be off-label, according to the document.

Fuller’s doctor “recklessly acquiesced” to the company’s promo strategy and prescribed 200 mcg of Subsys every four hours for Fuller’s pain, the suit further states, in addition to her Percocet and Oxycontin prescriptions. Later that month, “upon the urging of the Insys sales representative” and in violation of risk mitigation practices, Fuller’s doctor tripled the prescription to 600 mcg, according to the plaintiffs. The Subsys shipments were sent right to Fuller’s door, according to the lawsuit, and Insys stood to gain from higher-dose prescriptions.

RELATED: Feds arrest ex-sales manager at Insys on kickbacks charges

In addition to Insys, the suit names Fuller’s doctor and the pharmacy Linden Care as defendants.

In October 2015, Fuller had to be hospitalized from hypersedation with hypoxia secondary to narcotics and sedatives. Hospital staff told her to discontinue use of Subsys and wean off OxyContin, but Fuller’s doctor kept prescribing the meds for several months until March 2016, when Fuller passed away, according to the suit.

The suit alleges negligence leading to wrongful death, fraud, negligent misrepresentation, and demands damages and judgements against the defendants.

Insys did not immediately return a request to comment.