Subsys was first approved by the U.S. Food & Drug Administration (FDA) in January 2012, and has since risen to become the most widely prescribed transmucosal pain medication for immediate pain relief, according to documents filed by Insys Therapeutics, the company that manufactures the drug. Unfortunately, many of these prescriptions may have been generated illegally, as Insys has been accused of marketing Subsys for unapproved or “off-label” purposes.
Free Confidential Lawsuit Evaluation: If you or a loved one has been injured by Subsys or another opioid medication, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
What is Subsys?
Subsys is a potent form of fentanyl designed to be administered by spray under the tongue for the management of breakthrough cancer pain (BTCP). Fentanyl belongs to a class of drugs known as opioid (narcotic) analgesics that work in the brain to change how the body feels and responds to pain.
Insys Accused of ‘Off-Label’ Marketing
Former Insys employees have recently come forward claiming they were instructed to lie to insurance companies so they would approve Subsys prescriptions. Patty Nixon, a former Insys sales representative, said she would call insurance companies on behalf of doctors’ offices and claim that Subsys was medically necessary based on made-up oncology reports and diagnoses.
“Absolutely genius,” Nixon said. “It was wrong, but it was genius.”
Additionally, it has been reported that Insys paid doctors to write prescriptions for Subsys to patients who didn’t need the drug. The top prescribers were then allegedly paid large speaking fees. Many of these doctors now face criminal charges or professional misconduct complaints.
During 2013 and 2014 alone, Insys allegedly paid an estimated $10 million to about 3,000 doctors for “sham” speaking engagements. During this same time, these same doctors wrote approximately $30 million worth of Subsys Medicare prescriptions.
Fueling an Epidemic: Insys Therapeutics and the Systemic Manipulation of Prior Authorization
In Sept. 2017, U.S. Senator Claire McCaskill (D-MO) released the first offering from her wide-ranging investigation into opioid manufacturers and distributors. The video, “Fueling an Epidemic: Insys Therapeutics and the Systemic Manipulation of Prior Authorization,” describes how Insys Therapeutics bolstered approvals for Subsys — including marketing the drug for illegal, “off-label” uses — and presents an audio recording in which an Insys sales representative misidentifies herself and uses language designed to circumvent the prior authorization process.
Subsys Overdose Symptoms
Because it is a powerful opioid medication, Subsys has a high potential for abuse, dependence and addiction. People that become addicted to Subsys may suffer from an accidental overdose, whose symptoms may include:
- Slowed heartbeat
- Slowed breathing
- Pinpoint pupils
- Cold, clammy skin
- Skin rash
- Upset Stomach
- Stomach pain
- Difficulty urinating
Court Approves Bankruptcy Sale of Subsys
Insys has been granted approval to sell the rights to Subsys following an agreement with state officials requiring tighter restrictions on future sales of the drug, according to Bloomberg. U.S. Bankruptcy Judge Kevin Gross said the new restrictions specify that BTcB Pharma, LLC, the company purchasing Subsys, can only market the highly-addictive opioid to cancer specialists, not doctors in general. Insys was the first pharmaceutical company forced to declare bankruptcy as a result of lawsuits filed over the opioid addiction crisis.
Do I Have a Subsys Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Subsys lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Case Evaluation: Again, if you or a loved one suffered an unintentional opioid overdose, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.