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Is Subsys Safe?

Subsys is a pain-relief medication alleged to carry a risk of addiction and fatal overdosesYou need pain relief and you need it quickly, but is your pain medication safe?

If you, or a loved one, have been prescribed Subsys then it is important to know more about this potentially dangerous drug.

Subsys has been approved by the Food and Drug Administration to treat breakthrough cancer pain in adults. It is meant to provide quick relief for significant pain that occurs between doses of other opioid pain medications.

Yet only 1% of Subsys prescriptions are written by oncologists. Chronic pain doctors are, overwhelmingly, the most frequent prescribers of Subsys and it is often patients who are addicted to opioids who receive the prescriptions. Subsys is not approved for this purpose and can lead to overdose and death.

What Is Subsys?

The primary ingredient in Subsys is fentanyl. It is administered as a sublingual spray—meaning that a patient sprays the medication under the tongue for quick relief. It is currently the fastest way to get pain relief without having an injection.

In January 2012, Subsys was approved by the FDA only “for the management of breakthrough pain in adult cancer patients who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.” At that time, the most commonly recognized side effects included nausea, vomiting, constipation, difficulty breathing, and extreme fatigue. Since its approval, the FDA has received hundreds of reports of adverse events related to Subsys—including dozens of deaths.

Subsys is made by Insys Therapeutics, Inc., located in Chandler, Arizona. As of June 2017, Subsys is the only Insys product that is on the market in the United States. However, the company does have FDA approval for a second drug known as Syndros which has been approved to treat anorexia and weight loss in AIDS patients and nausea and vomiting associated with chemotherapy in cancer patients when conventional medications have failed.

In April 2017, Insys reported a 32% decline in Subsys prescriptions during the fourth quarter of 2016. During the same quarter, the company’s revenue fell by more than 41%. Reuters reports that the decline in Subsys prescriptions and the resulting decline in revenue are caused by a fall in demand for the product. The fall in demand has occurred as safety concerns about Subsys continue to grow.

How Subsys Has Reached so Many Non-Cancer Patients

“Absolutely genius…It was wrong, but it was genius.” That is how Patty Nixon, a former Insys sales representative, referred to the marketing of Subsys in recent years.

Ms. Nixon claims that it was her job to lie to insurance companies in order to get them to approve Subsys prescriptions. She told NBC that 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.

Insys sales representatives were allegedly paid higher commissions if they could convince doctors to write prescriptions for higher doses of Subsys (which are more expensive for patients and more profitable for Insys), and they were reportedly directed to market the drug to doctors who did not treat cancer patients. FDA regulations allow doctors to prescribe medication for off-label uses, but they specifically prohibit pharmaceutical companies from marketing their medications for any use that does not have FDA approval.

Additionally, it has been reported that Insys paid doctors to write Subsys prescriptions. The top Subsys prescribers in the country were allegedly paid large speaking fees. Many of these doctors now face criminal charges or professional misconduct complaints. It is alleged that during 2013 and 2014, Insys paid approximately $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.

Subsys Lawsuits

The federal government, several state governments, and private citizens have filed lawsuits against Insys and doctors who prescribed Subsys in recent years. These cases include:

A Federal Criminal Case Against Two Insys Employees

In 2016, two former Insys employees—a sales manager and a former sales representative—were arrested and charged with violating anti-kickback laws. Specifically, they were accused of paying doctors to participate in “sham” speaking engagements. The doctors were reportedly paid thousands of dollars to speak at nice restaurants—often to their friends. In exchange for this, the doctors were expected to write significant Subsys prescriptions for patients. The employees pleaded not guilty and as of June 2017 the case is still pending in federal court in the Southern District of New York.

A Federal Criminal Case Against an Insys Sales Representative, Natalie Perhacs

In 2016, an Insys sales representative, Natalie Reed Perhacs, pleaded guilty to conspiracy to commit fraud charges in an Alabama federal court. Specifically, she pleaded guilty to conspiracy to commit healthcare fraud which included kickbacks. According to her plea agreement, Ms. Perhacs alleges that she was employed by Insys as a kickback to an Alabama physician who was a large Subsys prescriber. She alleges that Dr. Xiulu Ruan recommended her for the job and asked about her dating status—a claim Dr. Ruan denies. Dr. Ruan and his partner were also charged with fraud and have pleaded not guilty.

A Federal Criminal Case Against Forer Insys Executives

In late 2016, the federal government charged the former Insys CEO and other high-level executives with engaging in a nationwide conspiracy to bribe doctors to increase Subsys prescriptions. Some of the charges included in the indictment were charges of conspiracy to commit racketeering, conspiracy to commit wire and mail fraud, and conspiracy to violate the anti-kickback law. According to Stat, Harold Show, the head of the FBI office in Boston, the actions of these executives, “contributed to the growing opioid epidemic and placed profit before patient safety.”

A Federal Criminal Case Against a Connecticut Nurse

In 2015, a Connecticut nurse pleaded guilty to accepting $83,000 worth of kickbacks from Insys for prescribing Subsys. The nurse admitted that she as paid for speaking at events that were often attended only by her colleagues and friends. She says these payments influenced her decision about when to prescribe Subsys, and that many of the patients to whom she provided prescriptions did not have cancer. Her sentencing has been delayed because she is cooperating with the government in other investigations, but it could come as early as July 2017.

A Case Brought Against Insys by the State of Illinois

In 2016, the Illinois Attorney General filed a lawsuit alleging that Insys deceptively marketed Subsys to doctors who treated non-cancer patients who suffered from neck and back pain. According to the Chicago Tribune, the Illinois Attorney General said, “This drug company’s desire for increased profits led it to disregard patients’ health and push addictive opioids for non-FDA approved purposes…It’s this type of reprehensible and illegal conduct that feeds the dangerous opioid epidemic and is another low for the pharmaceutical industry.” The lawsuit asks the court for civil penalties, for equitable relief, and to stop Insys from doing business in Illinois unless it changes its marketing practices.

A Settlement Reached Between the State of Oregon and Insys

In 2015, the state of Oregon reached a $1.1 million settlement with Insys. The state had alleged that Insys was marketed for off-label uses, including the treatment of neck and back pain that was unrelated to cancer. In addition to the financial settlement, Insys must comply with all applicable marketing laws in the future in order to continue doing business in Oregon.

A Settlement Reached Between the State of New Hampshire and Insys

In early 2017, New Hampshire settled its unlawful marketing lawsuit against Insys for $2.9 million. The Union Leader quotes the New Hampshire Attorney General as saying, “The settlement represents an important first step in our investigation of the marketing practices of opioid manufacturers…Understating or misrepresenting the addictive nature of opioids can and has led to addiction and, in far too many cases, overdose deaths in our state.” New Hampshire currently has the highest per-capita fentanyl related death rate in the United States. At least 369 people died from drug overdoses in New Hampshire during 2016 and at least 269 of those deaths involved fentanyl—the active ingredient in Subsys.

A Wrongful Death Case Against Insys and Others After the Overdose Death of Sarah Fuller

In 2015, 32-year-old Sarah Fuller had a meeting with her father, her doctor, and an Insys representative. The meeting was held to discuss management of her chronic non-cancer related pain. The family’s lawyer calls the inclusion of the Insys representative in that meeting both unusual and unethical. According to the lawsuit that was filed, Insys sales representatives targeted doctors they knew were not treating cancer patients and that more than 80% of Subsys prescriptions were off-label by the end of 2015. It is alleged that Sarah was not warned about the risks of taking Subsys or that she was taking the drug off-label. Each month, her Subsys would be delivered to her home. Her prescription kept getting stronger. She died of an overdose.

A Civil Lawsuit Against Insys and Others After McKenzie Colby Became Addicted to Subsys

In January 2017, McKenzie Colby filed a civil lawsuit against Insys and others in New Hampshire. Ms. Colby alleges that she became addicted to Subsys after a physician’s assistant prescribed the medication to treat her non-cancer-related back pain. It is alleged that more than 80% of Subsys prescriptions written in New Hampshire were written by this physician’s assistant until he came under investigation by the state Board of Medicine. At that time, Ms. Colby’s Subsys prescription stopped being delivered to her home and she suffered significant withdrawal symptoms without medical help. As in other cases, Insys allegedly paid the physician’s assistant to speak at “sham” speaking engagements in exchange for prescribing Subsys.

A Civil Lawsuit Brought by a Private Company in Florida

In 2016, Wayne Automatic Fire Sprinklers filed a lawsuit against Insys alleging that the pharmaceutical company had engaged in “a massive fraud scheme and criminal enterprise utilized to obtain money from Wayne for illegally prescribed pain killers through Wayne’s employee health insurance plan.” The patient’s health insurance was through her husband’s employer—Wayne Automatic Fire Sprinklers. It is alleged that the patient did not have cancer and, therefore, did not have breakthrough cancer pain and that several Florida laws, including Florida’s Anti-Kickback Law, were violated.

Of course, these were not the only people who have been hurt or killed by the allegedly illegal marketing practices of Insys.

What to Do if Your Loved One Has Died From a Subsys Overdose

If your loved one has been a victim of an accidental overdose caused by Subsys, then you may be able to file a lawsuit against Insys or the doctor or hospital that prescribed the drug. Contact us any time via this website or by phone to schedule a free, no-obligation consultation with an experienced lawyer so that you can make sure that your family’s rights are protected.