Rewards, not penalties
As deaths and recalls mounted, HeartWare and Medtronic touted additional FDA approval to treat more patients and their attempts to develop new cutting-edge devices.
With the company on notice under the 2014 warning letter, HeartWare geared up to begin human trials on a smaller heart pump, called the MVAD or Miniaturized Ventricular Assist Device. It would be powered by a new algorithm to more efficiently pump blood. Industry analysts predicted robust sales.
In July 2015, implantations were set to begin on a select group of 60 patients in Europe and Australia. But they were abruptly stopped less than two months later after only 11 implants. Patients experienced numerous adverse events, including major bleeding, infection and device malfunction, according to published data.
HeartWare’s stock price plummeted from about $85 to $35 by October 2015. The next year, Medtronic bought HeartWare for $1.1 billion, replacing much of the company’s leadership shortly after.
Some former HeartWare investors filed a class action lawsuit in January 2016 alleging deception in the development of the MVAD.
According to the accounts of six anonymous former employees in the lawsuit, the details mirror the scandal surrounding Theranos, the former blood test company charged with fraud for raising more than $700 million by allegedly lying about its technology.
Where Theranos made empty promises of a test that only needed a few drops of blood, the suit alleges HeartWare promoted a life-sustaining medical device that former employees said had many problems and actually worsened blood flow, increasing clotting risks.
“Nothing really worked right,” one former HeartWare manager said in the lawsuit, citing “improper alarms, improper touch screen performance, gibberish on display screens — just so many alerts and problems.”
Leadership proceeded with human testing anyway, the suit alleges.
Months later, at an investor conference, HeartWare leadership acknowledged the pump and algorithm led to multiple adverse events. For two patients in particular, the algorithm would direct the pump to speed up so fast that it would try to suck up more blood than was available inside the heart for prolonged periods of time.
HeartWare and Medtronic settled the investor suit for $54.5 million in 2018, admitting no fault.
None of the allegations slowed the FDA as it gave Medtronic additional approval and support for its heart pump technologies.
In September 2017, the agency approved the HVAD as “destination therapy” for patients who were not heart transplant candidates and would rely on the device for the rest of their lives.
“We’re really excited about our HVAD destination therapy approval,” a Medtronic executive said on an investor earnings call. “That’s a real game changer for us in that market.”
Two years later, Medtronic announced it was developing a fully implantable version of the HVAD that would no longer need a cable coming through the waist to connect to power.
Even though issues with the HeartWare device had been unresolved for five years at that point, the FDA accepted the pitch into its new fast-track approval process for high-risk devices.
“Slipped Through The Cracks”
After Johnson Keelen’s pump failed in February, she found a news story about the recall notice sent to medical providers two months prior.
It said the company had identified a problem with pump restarts that could cause heart attacks or serious patient harm. Nineteen patients had been seriously injured so far, and two people had died. The recall warned that patients should be careful to avoid disconnecting the device’s power sources.
“I kept seeing Medtronic on record saying they notified patients,” Johnson Keelen said. “Who did they contact? No one told me.”
Her doctor later told her she must have “slipped through the cracks,” she said.
The current system for informing patients of new safety concerns with high-risk devices relies on a communication chain that can easily break. The device company contacts the FDA and health care providers that work with device patients. The FDA typically issues a public notice, while health professionals contact their patients.
But the agency admits most patients don’t know to look for formal FDA postings. And, experts say, the medical system can lose track of who needs to be notified, especially if a patient moves or switches primary care physicians.
Tina Winkler still wonders why she was never told about FDA-known safety issues with the HVAD. She said her husband’s medical team “had to teach me how to clean his wound, how to change his batteries and what to do if alarms go off. And they never mentioned any of this.”
She said, “If we had all the facts, there’s no way he would have gotten that device implanted in his heart.”
When FDA inspectors find serious safety issues with a medical device, inspection reports are not posted online or sent to patients. The public can obtain reports through a Freedom of Information Act request, but the agency’s records department has said new requests can be stuck behind a year-long backlog.
Patients can find warning letters online in a searchable database of thousands of letters from different FDA divisions, including the center for devices. But HeartWare’s 2014 letter is no longer available for public review because the website purges letters older than five years.
There are also few documents available in state courts about faulty products, because of restrictions on lawsuits related to medical devices. The restrictions date back to a 2008 Supreme Court decision in a case against Medtronic. The court found that U.S. law bars patients and their survivors from suing device makers in state court, essentially because their products go through such a rigorous FDA approval process.
Two recent patient lawsuits against HeartWare and Medtronic, including one filed by Tina Winkler, were moved from state court to federal court. In both cases, Medtronic filed to dismiss the cases because of the U.S. law that protects device companies. Medtronic and the families reached private settlements soon after.
Winkler and an attorney for the other family said they could not comment on their settlements.
Johnson Keelen, with a decommissioned HVAD still attached to her heart, wonders what that means for her and other patients’ chances of recourse.
“Why isn’t anyone now stepping up for the patient?” she asked. “They are now liable for taking care of us because we relied on them.”