Insys Therapeutics has been at the center of controversies for the past few years. Consumer lawsuits were filed against Subsys after state investigations revealed the company had paid millions to doctors.
Lawsuits against Insys allege that the company had bribed doctors to write prescriptions of its main product named Subsys – a spray form of prescription opioid medication fentanyl.(1) Prosecutors call the program a kickback scheme for the illegal promotion of the drug.
The Arizona-based pharmaceutical company has also been accused of aggressively marketing one of its products for usage, which was not approved by the Federal Food and Drug Administration (FDA).(2)
Background of the Lawsuits Against Insys
Lawsuits against Insys revolve around its main product called Subsys. The drug contains the active ingredient fentanyl that is highly addictive and proves fatal if overdosed. Experts consider fentanyl to be more addictive as compared to heroin.
As a powerful opioid painkiller, fentanyl can only be prescribed to cancer patients for relief from severe pain. However, the product is often abused and overdosed.
The United States is in the midst of an opioid epidemic. Nearly 20,000 Americans have died since 2010 due to opioid overdose.(3) In 2015 alone, there were about 9,500 opioid-related deaths.
Subsys has contributed to the opioid epidemic risking the lives of countless individuals. The product gained approval of the FDA in 2012 for pain relief among cancer patients. The drug is the most widely prescribed immediate-release fentanyl medication since 2015.(4)
Dangerous Health Effects of Using Subsys
Subsys shares similar characteristics to other addictive medications such as heroin and morphine. Patients who use the medication can become addicted and physically dependent on it over time.
Addiction to opioid medication leads to dangerous effects. Patients may feel the need for increased dosage with time to get the same results. This raises the possibility of an overdose that often proves fatal.
Patients who become addicted to opioid medication such as Subsys can experience different psychological and behavioral symptoms. These include the feeling of euphoria, irritability, and depression, rapid mood swings, and difficulty in sleeping.
Over time, addiction to opioid medication can result in various harmful health effects, some of which include the following.
- Low blood pressure
- Difficulty breathing
- Slurred speech
- Dizziness and shakiness
- Difficulty in walking
Despite knowing about the dangers of Subsys, Insys aggressively marketed the drug to non-cancer patients that some claim contributed to the opioid epidemic in the US.
Details of the Lawsuit Against Insys
The Department of Justice started an investigation against Insys in 2013. The investigation was initiated after receiving complaints about illegal promotional tactics involving Subsys. State attorneys in different states have filed class-action lawsuits against the pharmaceutical company. The company is facing lawsuits in many states including Maryland, New York, Illinois, and New Jersey.
The lawsuits against Insys claim that the company used illegal marketing and sales activities to promote the prescription of Subsys in different states. In Illinois alone, the company is alleged to have sold about $12 million dollars worth of prescription between April 2012 and March 2015.(5)
The high-volume sales of the prescription drug in such a short period raised suspicion because the medication was approved in 2012. FDA approved the sale of Subsys on the condition that only pain specialist and oncologist can prescribe the opioid medication. Furthermore, the prescribing medical specialists were required to get specialized training before being allowed to prescribe the medication to patients.
As part of the Subsys Risk Evaluation and Mitigation Strategy (REMS), the doctors were also asked to sign an agreement stating that they understood the risks related to the prescription of the medication.
Later investigations revealed that only a small number of oncologists and pain specialists prescribed Subsys to their patients. Most of the prescriptions were made by general physicians, podiatrists, and even dentists.
In 2016, the Department of Justice (DOJ) received indictment charges against six former executives for bribing doctors to prescribe Subsys sprays to patients. The lawsuit also named 10 healthcare professionals as taking part in the conspiracy to promote the prescription of the drug.
According to the lawsuits, the executives at Insys had paid doctors illegal ‘speaking fees’ for prescription of the Subsys spray. Moreover, the lawsuits allege that certain medical professionals conspired with the reimbursement unit of the company to craft insurance claims that claimed that the medication was being used for the treatment of cancer patients legally.(6)
Settlement Awards Against Insys
A number of lawsuits have been filed against Insys for using illegal marketing techniques to promote Subsys. The lawsuits specifically target Insys officials and the company for the use of illegal marketing techniques for Subsys.
In 2015, an out-of-court settlement of about $1.1 million was reached between Insys and an Oregon attorney. A similar settlement was reached in January 2017 with the state of New Hampshire.
An ex-manager at Insys had pleaded guilty to the charges of wire fraud in June 2017.(7) She admitted that she instructed the Insys employees to lie to insurance adjusters about the use of the medication.
Moreover, John Kapoor, the founder and majority owner of the company, stepped down after being charged with conspiracy in 2017. In May 2019, a federal jury had found Mr. Kapoor and four other ex-executives guilty of racketeering conspiracy related to the prescription of Subsys.(8)
The largest settlement to date was in 2019 when Insys agreed to pay nearly $150 million to settle a series of complaints. The company has stated that it may have to file for bankruptcy since its liquid assets were only worth $87.6 million as of May 2019. This announcement plummeted the stock prices to just $1 per share.
Insys has played a key role in contributing to the opioid epidemic by using unethical and aggressive marketing tactics. Subsys is a highly addictive drug that can lead to devastating health effects. Family members often had to watch their loved ones suffer due to the highly addictive drug.
If you or your loved one has suffered after taking Subsys, you should contact an attorney for evaluating your case. An experienced attorney will guide you in navigating through the complex legal landscape related to the drug. The attorney will look at your case to determine your eligibility for compensation. If eligible, you can recover the present and future medical costs due to the dangerous drug.
Many factors will consider your eligibility for a lawsuit against Insys. Some of the factors that determine whether you can file a lawsuit against the pharmaceutical company include the following:
- Prescribed Subsys for a reason not approved by US FDA
- Suffered serious complications due to the use of Subsys
- Bought Subsys with a prescription from a medical professional
You can recover different costs by pursuing a lawsuit against the drug manufacturer. You can seek compensation for medical costs, including ambulance transportation, hospital stay, doctor’s appointments, and other related costs. You can also recover compensation for medications required for managing the adverse effects of Subsys such as low blood pressure or breathing problems.