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To understand the breakdowns that led to one of the most tumultuous medical device recalls in generations, ProPublica and the Pittsburgh Post-Gazette spent a year probing what happened inside Philips Respironics after the company first learned that contaminants were turning up in breathing machines designed to save lives.
The news organizations also tracked what has happened since the recall as the company claimed that its devices were safe despite multiple test reports showing that foam embedded inside them to reduce noise could break down and send dangerous particles and chemicals into the masks of patients. Millions of ventilators, continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) machines were impacted by the recall.
Reporters for the two news outlets collaborated with Mediahuis NRC in Amsterdam, where Philips’ parent company, Royal Philips, is headquartered, as well as with student journalists from Northwestern University’s Medill Investigative Lab.
Reporters obtained newly unsealed court records, internal documents, text messages and public records in the United States and other countries to track Philips’ and its parent company’s response to the problem. Those documents included records from four tests conducted by independent labs brought on by Philips that describe the chemicals released by the foam.
The reporting team also drew on thousands of complaint reports spanning 13 years that were submitted to a national repository known as the Manufacturer and User Facility Device Experience database. The records are maintained by the Food and Drug Administration and describe reports of patient deaths and injuries as well as device malfunctions.
To better sort and examine the reports from MAUDE, the team used a proprietary system called Device Events, a search engine developed by former FDA analyst Madris Kinard.
Over the course of months, reporters pulled every report about the recalled machines. More than 100,000 had been filed with Philips or the government since 2010 by patients, doctors and others. (It is possible that some patients or events were referenced in more than one report.)
Because the records include the date the company received each complaint, reporters were able to determine how long it took Philips to submit them to the FDA.
Federal law requires device makers to turn over to the government within 30 days all reports of patient injuries, deaths and malfunctions that have the potential to cause harm.
The reports described thousands of cases of cancer, liver and kidney conditions, respiratory infections and other illnesses among device users. Some users or their family members directly tied those illnesses to the use of recalled machines. Others simply reported illnesses without elaborating.
The methodology used by ProPublica and the Post-Gazette was reviewed by Kinard and by Ross Meisner, the chief commercial officer of Basil Systems, a research platform for quality, safety and regulatory analysis.
Philips has said new tests on its DreamStation CPAP machine show that the machines are “unlikely to result in an appreciable harm to health in patients” and that testing on ventilators is ongoing. The company has also said that it properly responded to complaints about the foam and launched a recall when the problem became clear.
Testing to determine the level of health risk posed by the foam could take years. The FDA has declared the recall as a Class 1, which is for device defects capable of causing severe injury or death.
The reporting team interviewed more than 200 people in the United States and a dozen other countries, including former Philips employees who described lapses inside the company that allowed problems to go unaddressed for years.
Reporters traveled the country to interview doctors, researchers, patients and the family members of those who died, and consulted public health researchers and physicians on risks posed by the devices. Dr. Ronald Chervin, director of the University of Michigan Sleep Disorders Centers, and Dr. Radhika Breaden, a sleep medicine specialist in Oregon, provided guidance on the science behind sleep apnea and CPAP machines.
The news organizations have requested dozens of additional documents from the FDA. In April, ProPublica and the Post-Gazette sued the FDA in federal court in New York over the agency’s refusal to expeditiously release the records. The case is ongoing.
Reporting was contributed by Monica Sager, Molly Burke, Margaret Fleming, Susanti Sarkar, Nicole Tan, Claire Gardner, Bridgette Adu-Wadier, Aidan Johnstone, Kelly Adkins, Haajrah Gilani, Juliann Ventura and Grant Schwab of Northwestern University’s Medill Investigative Lab, and Ryann Grochowski Jones of ProPublica contributed data analysis.
