In January 2012, the FDA approved a new form of a fentanyl painkiller called Subsys. Instead of putting it on the skin, patients would spray the drug under the tongue. Researchers linked fentanyl drugs like Subsys to hundreds of deaths and hospitalizations. Subsys is 100 times more potent than morphine. For this reason, doctors prescribe the drug for pain relief of terminal cancer patients. Shockingly, however, the manufacturer, Insys Therapeutics has been pushing doctors to use this powerful opioid in people without cancer. This is called “off-label” use, and this means it has not been approved by the FDA.
By the end of 2015, more than 80% of Subsys prescriptions were off-label.
FBI Arrest Subsys Executives
In December 2016, FBI agents arrested Insys Therapeutics CEO Michael Babich along with five other high-level executives. The FBI has evidence indicating that these executives were bribing doctors to prescribe the extremely addicting, Subsys to patients who didn’t need it. The Insys executives created a nationwide conspiracy to give healthcare providers kickbacks in exchange for improperly prescribing the powerful opioid. Subsys contains the highly addictive substance known as fentanyl, which many consider to be more dangerous than other pain medications like Vicodin.
Presently, the charges are racketeering, conspiracy along with mail and wire fraud.
Many are aware that opioid drugs are particularly addictive. Due to this, doctors normally hesitate before prescribing them. However, many people received the drug for migraines and other unnecessary ailments. A single package of Subsys ranges from $300 to $9,000. This provided a growing incentive for Insys to increase public demand. Therefore, Subsys sales soar to over $90 million in the third quarter of 2015 alone. This came with a hefty price. Hundreds have died from overdosing or had long hospital stays over being unnecessarily prescribed this powerful drug.
Subsys Side Effects
At the present time, patients and doctors have reported to the FDA serious, life-threatening, or fatal respiratory depression with the use of Subsys. Respiratory depression may lead to respiratory arrest and death. Fatal respiratory depression can occur at any time during the use of Subsys. Many people who use Subsys are at risk for a fatal overdose, especially with the first dose. An overdose can also cause a lengthy hospital stay.
- Respiratory depression
- Opioid overdose
Black Box Warnings
In 2016, the FDA strengthened warnings on nearly 400 opioid painkillers. Every day, 44 people die from a prescription opioid overdose. Subsys has a black box warning. Overall, this is the most serious warning the FDA can give a medication. Subsys’ warning notifies users that use of the drug can cause fatal respiratory depression. This drug also exposes users to the risk of addiction, abuse, and misuse.
We Want to Help Victims
It is your right to be informed about the long-term risks associated with the medications you take, and it is the responsibility of drug companies to provide this information. If you or a loved one died after using Subsys, you should demand accountability from Insys Therapeutics. Why didn’t Insys tell you?
We want to help send a message that this is not acceptable. We are advocates for consumers who have been harmed by dangerous products, and we have the experience necessary to successfully litigate these cases.
Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is no obligation.
How We Can Help
When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. A court may award you compensation for your injuries and damages. The types of losses that can be recovered include:
- Past and future medical expenses
- Lost wages
- Loss of an ability to work; and
- Pain and suffering
If a person dies from complications from a drug, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
Therefore, if a jury finds the conduct of a drug company in manufacturing and selling a drug to be highly reckless, they may award punitive damages to punish the company and deter similar conduct in the future. If you or a loved one overdosed or died after using Subsys, please speak to us to learn more about your rights.