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Device Makers Label Thousands of Patient Deaths as Injuries Malfunctions

Aug 26, 2016

Thousands of cases in which medical device manufacturers have been permitted to classify patient deaths as less serious injuries have occurred allegedly because the U.S. Food and Drug Administration allows manufacturers to make determinations on causality at their discretion.

According to NBC New York, in what one stent maker described as a "malfunction," a patient died just hours after being implanted with a cardiac stent described as "damaged and stretched." A second patient developed a fatal, septic infection following a knee injection. The injection product maker described the death as an "injury." In a third example, a patient died falling out of a hospital safety bed. While hospital staff said the bed's alert system failed, the bed manufacturer labeled the incident as "malfunction" and not a "death." FDA spokeswoman, Angela Stark, said that, "the reports were likely classified correctly," despite that the patient deaths occurred around a medical device malfunctions and problem.

In yet another case, a patient diagnosed with epilepsy died in 2010 after implantation with the Vagus Nerve Stimulator (VNS), a device meant to emit small shocks to block seizures. In less than 48 hours after complaining of abnormally painful shocks, the patient's family said she collapsed and died on the bathroom floor. Her family has learned that Cyberonics, the maker of the nerve stimulator, classified dozens of patient deaths as less serious injuries and malfunctions, NBC New York wrote.

Although the family's lawsuit was not successful, in 2001 and 2004, the FDA sent Cyberonics warning letters that accused it of failing to investigate and report patient deaths in a timely manner, according to NBC New York. After NBC New York and CNBC spoke with Cyberonics about other, recent patient deaths classified as injuries and malfunctions, Cyberonics conducted an internal review and discovered 108 misclassified deaths. A spokeswoman for Cyberonics' parent company, Liva Nova, said the misclassifications were a combination of unintentional human and procedural errors.

Madris Tomes, a former consultant for the FDA, said the labels "death," "injury," and "malfunction" are significant given that public health analysts must prioritize their work, according to NBC New York. "The way that the FDA reviews the [safety] reports is in order of importance by the classification that is checked on the form," Tomes said. "So if it is an injury or malfunction, it could take them weeks to months to get to reading them."

Federal regulators note that analysts will prioritize death reports; however, other criteria are used to review safety data and identify patient fatalities. Meanwhile, in 2009, an investigation by the Inspector General for the Department of Health and Human Services, found that most of the unread safety reports involved events that were classified as "malfunctions"; the FDA's software assigned just about 10 percent of malfunction reports to analysts for review.

According to data that compiled by Tomes, between 2011 and 2015, device makers classified over 4,000 patient deaths as "injuries" or "malfunctions."

"Are physicians misreporting? Are companies misclassifying? I think the FDA is in the best position to answer those questions, and they should. And I don't think they have, to date," said Representative Michael Fitzpatrick (Republican-Pennsylvania).

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