An Iraq War veteran. A New Jersey woman planning her wedding. A grandmother from Jacksonville. A firefighter’s wife in South Carolina.
All were prescribed a powerful spray fentanyl painkiller called Subsys, approved by the Food and Drug Administration only for breakthrough cancer pain. None had cancer. But many of their doctors received hundreds of thousands from the manufacturer of the drug, Arizona-based Insys Therapeutics, as they prescribed the medicine for routine pain.
Several executives and managers are charged with operating a kickback program.
The company faces a bevy of lawsuits from families who lost loved ones after being prescribed Subsys as well as patients who said they became unwittingly addicted.
Sarah Fuller: ‘A death wish for our daughter in exchange for profit’
Deborah Fuller never heard of Subsys before her daughter was prescribed the medication.
Sarah Fuller, 32, suffered from back pain and fibromyalgia and was no stranger to opioids, becoming dependent upon them during a previous treatment. The New Jersey resident suffered from injuries in two car crashes.
Her parents accompanied her when she sought relief through Dr. Vivienne Matalon in Cherry Hill. They told the doctor under no circumstances should Sarah be prescribed an opioid painkiller.
The effort to protect their daughter was in vain.
In less than two months, Matalon put Sarah Fuller on OxyContin and Percocet, prescribing 550 pills of the powerful opioids in a three-month period, according to the Fullers’ lawsuit against Insys and Matalon.
Then, during a visit to the doctor in January 2015, Matalon introduced Sarah and her father, David, to Insys sales rep Melina Ebu-Issak, the lawsuit states. Father and daughter were told Subsys was a safe alternative.
They were told it was an opioid, according to their lawsuit, but they were never told that it was approved only for breakthrough cancer pain.
The Fullers’ attorneys obtained audio of the call made by the company’s prior authorization department to an insurer to get her prescription approved after it was rejected by a pharmacy. The Insys employee said she was calling from Dr. Matalon’s office and that Fuller needed the drug for breakthrough cancer pain. Neither was true.
“That call was Insys’ death wish for our daughter in exchange for profit,” Deborah Fuller told a congressional roundtable on Insys convened by U.S. Sen. Claire McCaskill, D-Mo.
Fuller said that while on Subsys her daughter spent days in her pajamas. She lost all interest in socializing. She would pass out while she went to the bathroom, banging her head on the bathtub.
Matalon started the former certified nurse’s aide at 200 micrograms of Subsys every four hours in addition to the opioid painkillers Oxycontin and Percocet but increased the dosage to 600 micrograms 20 days later — at the urging of the sales rep, the suit claims. Sarah Fuller landed in the hospital with hyper-sedation in October 2015. The hospital told Sarah to discontinue Subsys.
When told Sarah Fuller was hospitalized, Matalon told her parents that Sarah’s body just needed to get used to Subsys and the side effects would go away. They didn’t.
Still, according to the lawsuit, the physician kept her patient on the fentanyl spray. Sarah Fuller was found dead by her fiancé on March 25, 2016.
“Losing a child is agonizing, but then learning that Sarah died from a drug she should never have been prescribed has caused us so much more anguish and outrage,” Deborah Fuller testified.
“Learning of the massive fraud in which Insys was engaged to get people like Sarah to take Subsys really has made us question humanity.”
Matalon’s medical license has been suspended, but unlike many doctors named in suits involving Insys, she received less than $1,000 from the company’s speakers program.
The lawsuit claims Medicare was billed as much as $24,000 per month for her Subsys prescriptions.
Attorney Richard J. Hollawell, who represents the Fullers, said the recording of the Insys employee seeking to gain approval for the prescription is a “smoking gun.”
“In fact, everything they were doing is why Sarah Fuller ended up getting this drug,” Hollawell said. “I thought once they were provided with the audio call that they would have some feeling of sorrow and a little bit of remorse, but they have not.”
In September 2016, Sarah Fuller had been scheduled to get married.
Her folks went to her grave. They placed two champagne flutes and a wedding cake topper on it, her mother said.
“We believe that Sarah’s death certificate should be changed to indicate her death was a homicide and the cause of death should be changed to corporate greed.”
Carolyn ‘Susie’ Markland: ‘Deep sadness on a daily basis’
Carolyn “Susie” Markland, a Jacksonville grandmother and retired environmental engineer, loved animals and rescued many. “She had one of the biggest and most tender hearts ever,” her obituary read in The Florida Times-Union.
Like many Americans, she suffered from back pain due to degenerative disc disease.
Markland sought treatment from Dr. Orlando Florete, who received more than $120,000 from Insys in speaker fees.
Markland received her last dose of Subsys at Florete’s office and went into respiratory arrest hours later, according to a lawsuit filed by her husband, Robert, against Insys.
She died at the hospital on July 3, 2014, of drug toxicity at age 56.
Insys’ resolve to fight these lawsuits bore fruit. The lawsuit was dismissed on a technicality.
U.S. District Judge Marcia Morales Howard ruled Florida law specifically bars using state negligence actions to seek recovery for violations of federal law. The case is under appeal.
“The court does not question for a moment the grievous nature of Carolyn Markland’s death, nor the deep sadness Mr. Markland must face on a daily basis as a result of his wife’s untimely passing,” Howard wrote in her ruling. “Nonetheless, the court must act within the bounds of the law.”
Florete settled a malpractice claim with the Markland family for $200,000 in September.
Other families suing Insys are keeping a close eye on the Markland appeal. Hollawell, the Fuller family’s attorney, called Howard’s decision in the Markland case “dead wrong.”
Insys paid Florete more than “$100,000 to prescribe its drug,” he said. “The judge just OK’d that. It’s so legally incorrect and disturbing on a human level,” he said.
Florete’s disciplinary record remains clear, but another one of his patients is getting ready to sue.
Mother of three: ‘No one else needs to die’
A Jacksonville mother of three and former law student didn’t want her full name published until her lawsuit against Insys is filed. She ended up on Subsys in 2013 for a variety of ailments, including fibromyalgia, lupus and arthritis.
“I don’t want anyone else to go through what myself and my family has gone through,” the woman told The Palm Beach Post. “The reason I really want to help and do something and speak out is almost like a survivor guilt kind of thing. I know how high my doses were.”
She said that Florete told her she would be put on Subsys as part of a study by Linden Care, a concierge pharmacy service. Sales reps encouraged doctors not to follow FDA requirements that they start patients on the lowest possible dose of Subsys, lawsuits by families and shareholders allege.
“The thing is that I know I was at the very highest dose. Not the lower end,” the woman told The Post.
While on Subsys, the woman said she ended up in the hospital six times for pneumonia. Her lung collapsed. She became so lethargic her husband had to pick her up out of bed to put her on the toilet. She no longer could care for her children, one of whom has autism.
While hospitalized she went off Subsys, and got better, only to return to her prescription and end up again with respiratory distress. It wasn’t until she consulted another doctor and read up on Subsys that she weaned herself off the drug.
“I was more and more revolted the more I learned,” she said. “No one else needs to die. No one else needs to be scammed. No family needs to be robbed of time with their loved ones.”
Florete didn’t return a phone message left with his office.
Jeffrey Buchalter: ‘Absent from life without knowing why or how’
Iraq War vet Jeffrey Buchalter served two tours in Iraq, surviving multiple bomb blasts. He struggled with a number of physical and mental ailments.
Then he met Dr. William Tham of Annapolis, Md., who prescribed Subsys.
“Dr. Tham and Insys became the unknown enemy and Subsys became the weapon,” said Buchalter, also testifying at McCaskill’s roundtable.
“I had become a full-blown addict and didn’t even know it. I became absent from life and again without knowing why or how.”
Tham received more than $35,000 from Insys in nearly 2 ½ years through the speaker program prosecutors call a “sham,” federal data shows. He remains in practice with a clean disciplinary record. A message left for Tham was not returned.
Buchalter said Tham prescribed Buchalter the equivalent of 5,000 Percocet pills a day in Subsys.
In 2016, Buchalter was admitted to Fort Belvoir’s intensive care unit for detox. Doctors in the Virginia military hospital were “astonished” at the “unprecedented” prescribing of opioids for the veteran, Buchalter’s lawsuit against Tham states.
Buchalter’s attorney, Aaron Moore, called it a miracle that his client survived. Buchalter by himself made Insys at least $1 million, he said.
“He is an addict, and he is going to be treated as an addict in all likelihood for the remainder of his life,” Moore said.
Angela Cantone: Made funeral plans but lived
Angela Cantone’s father died in the 9/11 attacks on the Twin Towers and her husband was a firefighter who responded that day. The Greenville County, S.C., woman ended up on Subsys when she told a doctor treating her for hip pain about her additional discomfort associated with Crohn’s disease, an inflammation of the bowel.
The physician, Dr. Aathirayen Thiyagarajah — he goes by Dr. Thiyaga — received more than $200,000 from Insys from August 2013 through 2015 — the 10th highest paid physician nationally by Insys through the speaker program.
Cantone said she had no idea that the medication prescribed to her was highly addictive fentanyl.
“It was explained that this would be a life-altering cure for me,” she said. “It was never explained, the dangers.”
After starting on Subsys, Cantone started fainting and suffering stroke-like episodes, with one side of her body going numb. She felt she was dying and even made arrangements for her funeral.
“It made me felt like a zombie,” she said. “I couldn’t walk. I could barely talk.”
Cantone had no idea what was wrong with her, thinking it was some new ailment. Another doctor finally looked at the red flags and determined the culprit was pharmaceutical. It was Subsys.
“She was basically in a stupor for two years. Her husband was having to care for everything,” said S. Randall Hood, who represents Cantone.
“These people are regular people. They are not typical drug addicts.”
Cantone has sued Insys and Thiyagarajah. The mother of three children — two special-needs — said one of the most hurtful memories of her time on Subsys was when her daughter gave her a Mother’s Day card that said: “Best of all mother likes to sleep.”
“That was my 3-year-old’s way to put into words how I would pass out on the kitchen floor, the pantry, on the front lawn,” Cantone said.
PAY TO PRESCRIBE? THE FENTANYL SCANDAL
Part 2: Coming April 11
Data reporters Mike Stucka and Mahima Singh, staff researcher Melanie Mena and digital editor Michele Kelley contributed to this story.