South Carolina Subsys Injury Lawsuits
Experienced defective drug attorneys fighting for families
If you were prescribed Subsys as a form of pain management, and you did not have cancer, you could be entitled to compensation for any additional injuries you sustained while taking the drug. McGowan, Hood & Felder is actively pursuing product liability claims against doctors and the drug’s manufacturer, Insys Therapeutics, for fraudulent marketing practices. Please contact us to speak with a South Carolina dangerous opioid drug lawyer about your experience to see if you could be eligible for compensation.
What is Subsys?
Subsys is a fentanyl-based pain reliever. Subsys was approved by the FDA in 2012. It is a sublingual (under the tongue) fentanyl spray approved for the treatment of break-through pain for cancer patients.
Why is Subsys dangerous?
Subsys is 50x more powerful than heroin and 100x more powerful than morphine. Because the medication is absorbed into the bloodstream immediately, patients experience instant relief from intense pain. However, as Daniel P. Alford, professor at Boston University School of Medicine and the director of the school’s opioid education program, told Philly.com, such a drug should not be used long term. He said, “I can’t imagine a reason to use transmucosal fentanyl for chronic pain management.”
Subsys is ONLY supposed to be prescribed to patients with breakthrough cancer pain—pain that is not resolved by the pain medications they are already taking. Instead, it was being marketed, distributed, prescribed, and provided to patients with non-cancer related chronic pain, such as back and hip pain. This is NOT what this drug was approved to be prescribed for.
The problem with Subsys is that it was overprescribed to people who did not have cancer and did not need such an intense level of pain relief. Those people quickly, and predictably, became dependent on and addicted to Subsys. People’s lives were ruined when they became addicted to a very expensive, very powerful opioid pain killer.
Insys Therapeutics engaged in fraud
Because the subset of cancer patients with breakthrough cancer pain was so small, executives at Insys allegedly decided to bribe doctors to prescribe Subsys for patients with other kinds of pain. The Department of Justice alleges that Insys deceived insurance companies so that they would pay for Subsys by claiming that the patients had cancer even when they did not. Some of the doctors who were paid by Insys received hundreds of thousands of dollars in exchange for prescribing Subsys to patients who largely did not need it.
Insys employees posed as doctors and other healthcare professionals and lied to insurance companies to get approval for reimbursement for the drug. As one employee told Fusion TV, “10 percent of the patients — the charts that came over — or less were cancer patients. That’s not a lot of money. Nobody’s going to get rich off that. But you have this whole other world of everybody. That ‘my back hurts’ money. ‘My knee hurts’ money.”
Through a complex web of kickbacks and bribery, Insys Therapeutics made $3 billion for its investors. But now, executives, former Insys sales representatives, employees, and doctors are facing racketeering charges, have been convicted, or have pled guilty for their roles in the Insys scheme:
- May 2019: John Kapoor, founder and majority owner of Insys, convicted of racketeering
- November 2018: Alec Burlakoff, the former VP, pled guilty to racketeering
- December of 2018: former CEO Michael Babich pled guilty to participating in a bribery scheme.
“It’s immoral. It’s unethical. And it just has to be stopped.”
Insys Therapeutics made millions off of patients suffering chronic pain. Their deceptive marketing practices for Subsys, a fentanyl opioid spray meant only for cancer patients, was prescribed to people throughout the country, who became addicted to the powerful drug. 9 Investigates looked into this story more, and interviewed Randy Hood, partner at McGowan, Hood & Felder, LLC, for the piece.
Which doctors accepted payments from Insys Therapeutics?
ProPublica, an independent newsroom of investigative journalists, created Dollars for Docs, a list of how much money doctors have accepted or received from various drug and medical device companies. From the ProPublica list, we know that Insys made 62,359 payments totaling $16.3 million between August 2013 and December 2015. The top 10 doctors listed on ProPublica’s site as receiving the most in “speakers” fees were also, coincidentally, some of the largest prescribers of Subsys. In these top 10, only one is a licensed oncologist.
McGowan, Hood & Felder Files Lawsuits Against Insys Therapeutics, Inc
In June 2017, Randall Hood, Shawn B. Deery, and James L. Ward, Jr. filed a lawsuit on behalf of their clients, the Cantones, against Insys Therapeutics, Inc., Linden Care, LLC, Aathirayen Thiyagarajah, M.D., and Spine and Pain, LLC alleging medical malpractice, negligence, and violation of the South Carolina Unfair Trade Practices Act for prescribing Mrs. Cantone Subsys she should not have been prescribed, and for mispresenting the drug’s approved use and efficacy. McGowan, Hood & Felder now represents numerous Subsys patients in four states.
Subsys is a Transmucosal Immediate-Release Fentanyl (“TIRF”) and a Schedule II narcotic. It is an extremely dangerous, addictive, and lethal synthetic opioid that is 100 times more powerful than morphine. Subsys was approved by the FDA in 2012 for the management of “breakthrough cancer pain” in cancer patients over age 18 and who were already tolerant to opioids therapy for their persistent cancer pain.
None of McGowan, Hood & Felder’s clients had cancer. They had hip pain, arthritis, and other chronic conditions. They all ended up addicted to opioid pain killers, often with a price tag of more than $10,000 a month for a drug they never should have been given in the first place.
The lawsuits allege that Insys blatantly disregarded the FDA regulations as it systematically planned and successfully executed an unlawful, false, deceptive, and reckless pattern of marketing, promoting and selling Subsys to treat pain in a wide range of conditions for which the drug was contraindicated and potentially deadly.
The FDA recognizes the dangers of Subsys
Subsys is a liquid form of fentanyl applied under the tongue (sublingual spray), and it is rapidly distributed to the heart, brain, lungs, kidney, and spleen. The FDA required Subsys to be dispensed with a “black box” warning label to alert the user to the serious dangers of the drug. The FDA has a Transmucosal Immediate-Release Fentanyl Risk Evaluation and Mitigation Strategy Program (“TIRF-REMS“) to oversee the use of the drug and protect users from misuse, abuse, addiction, and overdose. The FDA also requires Insys to submit and implement a REMS access program with which prescribers and pharmacists/dispensers of Subsys must comply. The initial dosage of Subsys was to be limited to 100 micrograms (mcg) and subsequent increases in the dosage were to be limited to 100 mcg increments.
Holding Insys accountable
Insys had a product that sold at a massive price, but in the limited cancer pain market. Insys seems to have appealed to the greedy nature of doctors who were willing to prescribe a dangerous drug to their patients for conditions other than cancer pain because of the huge profit potential.
Insys developed a convoluted scheme involving misinformation, kickbacks, and financial rewards in order to enrich itself while enticing doctors to prescribe Subsys for inappropriate uses. It developed a “Speakers Program” in which doctors would ostensibly market Subsys to other doctors at lavish dinners in exchange for kickbacks from Insys. In reality, the dinners were usually attended only by the doctor receiving the kickbacks and his family, friends, or staff.
Dr. Aathirayen Thiyagarajah, the doctor who prescribed Subsys to Mrs. Cantone, had received more than $200,000 from Insys for serving in the Speaker’s Program. The doctors in the Speaker’s Program created the opportunity for their patients to become addicted to a wildly addictive opioid pain medication and increased the dosages because doing so increased their profits.
Despite the dangers of addiction and overdose, Insys encouraged and incentivized doctors to prescribe at higher than the recommended dose (between 600 mcg and 1600 mcg) and for applications that were knowingly off-label. As a result, numerous Insys executives and employees and doctors who received kickbacks have been indicted, pleaded guilty, or convicted of various crimes.
The federal government and many states have also filed lawsuits against Insys. For example, in January 2018, Attorney General Josh Stein of North Carolina filed a lawsuit against Insys Therapeutics.
At this point, it is unknown how many people’s lives were put at risk, and how many may still be in danger, thanks to Insys Therapeutics and the doctors who accepted its bribes. That is why the dangerous drug attorneys of McGowan, Hood & Felder are currently accepting cases in South Carolina and around the country on behalf of those non-cancer patients who have suffered because they were prescribed Subsys by a doctor in the Speaker’s Program, became addicted, and suffered losses as a result. We are here to protect your right to recover compensation for your injuries that were caused by the negligence of Insys and these unscrupulous doctors.
- Fentanyl, the Pain Patch and Subsys Dangers
- Subsys, a Drug for Treating Cancer, is Being Used for Dangerous Reasons
- Insys Seeks to Resolve U.S. Probe of Subsys Spray
- Dangerous Drug Alert: What You Must Know about the Opioid Drug Subsys and the Way It Was Marketed to Users
- Pharma Company Agrees to Pull Widely-Abused Opiate from Market
- FDA Asks Endo Pharmaceuticals to Pull Opana ER Painkiller from the Market
- New Jersey Gets Heat for Selective Scrutiny of Fentanyl Drug
Contact our team if you have been prescribed Subsys to manage your non-cancer pain
Living in constant pain is a sad reality for people around this country. Taking advantage of them is unconscionable. McGowan, Hood & Felder will fight to protect your rights and your future. To learn more about how our dangerous drug and medical negligence lawyers can protect you, please call 803-327-7800. Or fill out our contact form. We are currently accepting cases in South Carolina and throughout the country. We maintain offices in offices in Charleston, Greenville, Columbia, Rock Hill, Sumter, and Georgetown.