The Society of Professional Journalists announced on Wednesday that ProPublica’s series “HeartWare: Deadly Malfunctions, FDA Inaction and Vulnerable Patients” is a winner of this year’s Sunshine Award. The annual prize recognizes individuals and groups for their notable contributions to reporting on open government.
The series by reporter Neil Bedi, along with engagement reporters Maryam Jameel and Maya Miller, examined the HeartWare Ventricular Assist Device, a mechanical heart pump that thousands of desperate people with severe cardiac failure had surgically embedded. The U.S. Food and Drug Administration and the device maker, Medtronic, agreed to take the unusual step of removing the HeartWare device from the market in June 2021, noting that a competing pump had better patient outcomes. But Bedi knew that wasn’t the full story.
Bedi conducted multiple analyses and found that the FDA had received thousands of reports of suspicious deaths and injuries that had been linked to the HeartWare device. He then sifted through more than 1,000 anonymized reports to identify horrific deaths caused by sudden device malfunctions. Among the cases he found: a teenage patient who vomited blood as his mother struggled to restart a defective pump and a patient whose heart tissue was left charred after the device short-circuited and overheated.
Bedi also found that the government knew about problems with the device for years. In page after page of reports from the FDA, federal inspectors warned of potentially deadly device problems that patients were never told about.
The journalists reached out to current HeartWare patients through online communities and support groups. These patients could not replace the devices with alternative pumps because of the risks of the required open-heart surgery.
After the stories were published, Medtronic updated its website and reached out to patients to offer expanded financial assistance for costs like transportation and co-pays.
See a list of all this year’s Sunshine Award winners here.
