A McHenry County family is facing a gut-wrenching decision: leave a risky medical device inside their 9-year old daughter, or risk the intense surgery to remove it?
Avery de Groh has a rare heart condition called Long QT Syndrome, which carries with it the risk of sudden death. A defibrillator in her chest can provide Avery life-saving shocks if her heart stops. But now, the device there to save her life may also be endangering it, as the St. Jude Riata leads, or wires, inside Avery are being recalled due to reports of failures in patients across the country.
The news of the recall was bad enough, but the de Groh family said they were stunned at how they learned the news: by accident.
"I was reading my email one day; a newsletter we get. I saw there had been a recalled device by a St Jude product. I scrambled to look, got out her medical cards, went to FDA website, [and] lo and behold, it was her device," said de Groh's mother, Molly de Groh. “It was like it was a secret, nobody wanted to tell me. Nobody wanted to talk about it.”
The Class One recall is the most serious of its kind, categorized that way by the Food and Drug Administration because the recalled product carries the potential of causing serious injury or death. Yet, the de Grohs say, a full year passed after the recall without anyone notifying them of the hazard.
"To say I was mad is an understatement," the mother said, adding that everywhere she looked for answers, the blame was passed to someone else.
"The manufacturer was saying maybe the FDA should tell us, the FDA was saying the manufacturer should tell us. The manufacturer was saying the doctor should tell us," she said.
When a device goes bad, whose duty is it to tell a patient like Avery de Groh? NBC Chicago posed that question to the Food and Drug Administration, which oversees recalls. In a statement, the FDA pointed to the company issuing a recall, in this case St. Jude Medical, saying:
"When a company decides to initiate a recall, it must notify FDA of this action. The company is also responsible for promptly notifying health care professionals and patients that may be impacted by the recall."
But St. Jude Medical said the onus is on the health care provider.
In a statement, SJM said:
"We continue to provide detailed information directly to health care providers, because clinical decisions need to be individualized based upon specific patient conditions and circumstances and we share the belief that physicians are in the best position to manage their individual patients’ care."
NBC Chicago also circled back to the health care providers in the family’s case. Avery de Groh's cardiologist did not respond to our question, but Advocate Children’s Hospital did in a statement.
"Our commitment is to be transparent with parents and families, who we are privileged to serve. In the case of recalls, the individualized circumstances and patient plan dictates who contacts patients and families directly. We take this matter very seriously and are currently investigating this incident and will use it as a learning opportunity."
"It should not have happened that way," cardiologist Dr. Robert Hauser said.
Hauser was one of the first critics to warn of St. Jude Medical lead failures. When he heard about Avery de Groh's situation and the way in which her parents learned about the recall, he said the family had good reason to be upset. He said both the device maker and the physician have a duty to inform a patient, and that manufacturers need to be watched more closely by regulators.
"We need stricter regulations," Hauser said. "These leads do not undergo any human testing. Many are surprised to hear that. It gives them the shivers- and it should."
It’s not the first time the fourth grader’s family has faced this choice.
Three years ago, then-6-year-old Avery de Groh talked about the day her defibrillator misfired.
"I said the monsters were getting me," she said back in September 2009.
In her chest to combat a hereditary heart condition, which her mom and two little brothers also have, the defective wire had to be replaced in surgery. The part was subsequently recalled by device maker Medtronic.
The de Groh family incurred more than $30,000 in bills related to the surgery. They could not recover their costs because of a pre-emption law that prohibits lawsuits against makers of certain FDA-approved devices.
Chicago attorney Todd Smith worked with the de Grohs after the girl’s first surgery due to a defective part. Three years later, he said he was frustrated to hear about the newest struggle facing the family.
"If a manufacturer has a problem, it’s their responsibility to make sure the information gets to the consumer. These are potentially devastating, causing death or injury. Patients have the right to know,” Smith said.