McGowan, Hood, Felder & Phillips Files Lawsuit Against Insys Therapeutics, Inc. for Pushing Deadly Fentanyl for Off-Label Use

Randall Hood, Shawn B. Deery and James L. Ward, Jr. have 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 medial malpractice, negligence, and violation of the South Carolina Unfair Trade Practices Act for prescribing Mrs. Cantone a dangerous fentanyl drug, Subsys, she should not have been prescribed and for mispresenting drug’s approved use and efficacy.

The lawsuit

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 eighty (80) 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.

Mrs. Cantone did not have cancer. She had hip pain. She became a patient of Dr. Thiyagarajah to manage her pain. Instead, she ended up addicted to opioid pain killers with a $10,000 a month price tag. That is $120,000 a year on a drug she never should have been given in the first place.

The lawsuit alleges 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.

You can watch the 9 Investigates story here.

The FDA recognizes the dangers of Subsys

Subsys is a liquid form of fentanyl which is applied under the tongue (sublingual spray), and it is rapidly distributed to the heart, brain, lungs, kidney and spleen. The U.S. Food and Drug Administration (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 seemed to be 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 lawsuit was filed in Greenville, South Carolina in June 2017.

Read more:

• Dangerous Drug Alert: What You Must Know about the Opioid Drug Subsys and the Way It Was Marketed to Users
• New Jersey Gets Heat for Selective Scrutiny of Fentanyl Drug
• Dangerous Drug Attorneys Investigating the Deadly Opioid Drug Subsys

It is terrible that in going to Dr. Thiyagarajah to get some relief for her hip pain, Mrs. Cantone was sucked into a world of fraud and deceit that left her impoverished and addicted. Her husband is seeking compensation for the loss of companionship, comfort and support of his wife. The Cantones are also seeking punitive damages against the defendants, due to their reckless and grossly negligent conduct.

At McGowan, Hood, Felder & Phillips, LLC, we are strong advocates for our clients who have suffered injury due to medical malpractice. You are invited to call 803-327-7800, or fill out our contact form, and schedule your free initial consultation with one of our skilled medical malpractice attorneys today.