I-Team: Health Firms Label Thousands of Patient Deaths 'Injuries' - NBC New York
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I-Team: Health Firms Label Thousands of Patient Deaths 'Injuries'

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    A joint investigation by the I-Team and CNBC found more than 4,000 patient deaths have been classified as less serious events in FDA safety reports. It turns out health companies are allowed to label some fatalities as injuries. Chris Glorioso has more. (Published Monday, Aug. 22, 2016)

    One patient died a few hours after being implanted with a cardiac stent that was "damaged and stretched." The stent maker called it a "malfunction."

    Another patient developed a fatal, septic infection after receiving a knee injection. The maker of the injection product labeled the death an "injury."

    In a third case, a patient died on the floor after falling out of a hospital safety bed. Hospital staff said the bed's alert system failed, but the bed manufacturer labeled the incident a "malfunction" instead of a "death."

    These are just three of the thousands of cases where medical device manufacturers have been allowed to classify patient fatalities as less serious injuries because the U.S. Food and Drug Administration allows companies to make their own determinations on causality.

    Medical Companies Accused of Classifying Patient Deaths as Injuries

    [NY] Medical Companies Accused of Classifying Patient Deaths as Injuries
    The I-Team is looking into thousands of deaths classified as injuries by medical companies. Chris Glorioso reports.
    (Published Thursday, Aug. 18, 2016)

    Even though those patient fatalities happened in close proximity to medical device malfunctions and problems, Angela Stark, an FDA spokeswoman said "the reports were likely classified correctly."

    The notion that a patient's death could be correctly classified as an injury is a perplexing prospect to the family of Oklahoma's Shelly Wilhite.

    She was an epilepsy patient who died in 2010 after being implanted with the Vagus Nerve Stimulator (VNS), a device that emits small shocks intended to block seizures. Less than 48 hours after complaining of abnormally painful shocks, Wilhite's family says she collapsed and died on the bathroom floor. Since then, her loved ones have come to learn Cyberonics, the manufacturer of the nerve stimulator, has classified dozens of patient deaths as less serious injuries and malfunctions.

    "I would like to say to the company to start being honest and to let all of the numbers really reflect the people who have died from this," said Connie Walton, Wilhite's mother.

    Wilhite's family filed a lawsuit against Cyberonics, alleging the Vagus Nerve Stimulator caused her death. But the case was dismissed because the device passed through the FDA's most stringent approval process, which insulates the company from product liability suits.

    In 2001 and 2004, the FDA sent Cyberonics warning letters, accusing the manufacturer of failing to investigate and report patient deaths in a timely manner. The firm said all the issues in those letters were corrected.

    But after NBC New York and CNBC asked Cyberonics about a number of more recent patient deaths that were classified as injuries and malfunctions, the company did an internal review, finding a total of 108 misclassified deaths. Karen King, a spokeswoman for Cyberonics parent company Liva Nova, said the misclassifications were a mix of unintentional human and procedural errors. The company said the errors are being fixed and noted they make up less than one percent of the 34,728 safety reports filed for alleged problems with the Vagus Nerve Stimulator.

    "Aside from the rare instances described above, there have not been any significant misclassifications of reports," King wrote. She declined to address allegations in the Shelly Wilhite's death suit, but said more than 90,000 patients have been implanted with the Vagus Nerve Stimulator and the company categorically denies manipulating safety data.

    Madris Tomes, a former consultant for the FDA, said the labels "death," "injury," and "malfunction" matter a great deal because public health analysts must prioritize their work.

    "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."

    The FDA said analysts do often prioritize death reports, but they also use other criteria to review safety data and identify patient fatalities.

    In 2009, an investigation by the Inspector General for the Department of Health and Human Services, found the vast majority of unread safety reports were events classified as "malfunctions" and the FDA's software only assigned about 10 percent of malfunction reports to analysts for review.

    Since the Inspector General report, the FDA has made investments to better track safety problems with medical devices. The agency is currently upgrading its software platform for reporting problems. The new system would link data on health risks from several different sources including clinical registries, electronic health records, medical billing claims and data transmitted from devices.

    After leaving her work consulting for the FDA, Tomes launched Device Events, a company that offers clients a streamlined way to search FDA safety reports about every medical contraption.

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

    FDA reporting rules say manufacturers are supposed to report any event that "reasonably suggests a device may have caused or contributed to a death or serious injury."

    Just because a patient death occurs it doesn't mean a medical device is at fault and the FDA says there is often insufficient evidence linking a device to a fatality.

    Typically the FDA allows manufacturers the discretion to decide when and if their product is related to a death.

    For example, in five separate cases, Vagus Nerve Stimulator patients were found to have died of pneumonia. Although the Vagus Nerve Stimulator instruction manual warns the nerve stimulator could cause patients to aspirate liquid into their lungs – a known pneumonia risk - Cyberonics reasoned three of the patient deaths were properly classified properly as "injuries" or "malfunctions" because medical professionals attested the device was not related to the pneumonia.

    In the other two fatal pneumonia cases, Cyberonics said human errors resulted in reporting mistakes.

    Some lawmakers have criticized the FDA for relying on the judgment of industry players when those companies - and the doctors who use their products - have a financial interest in minimizing the appearance of medical risk.

    "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 Rep. Michael Fitzpatrick (R-Pennsylvania).

    Fitzpatrick has criticized the FDA for its handling of complaints about the permanent birth control implant Essure. Bayer, the device maker, has reported more than 300 miscarriages experienced by patients who became pregnant in spite of the implant. But instructions on filling out the FDA safety reports explicitly say not to check the "death" box if "a fetus is aborted because of a congenital anomaly, or is miscarried."

    Catrice Jones, an Essure patient who experienced two miscarriages, said the reporting rules obscure patient harm and favor companies over consumers.

    "Once a woman is pregnant, she's pregnant. That's a baby. And if she loses it, whether it's ten weeks, or fifteen weeks, or twenty-four weeks, that's a life that was taken away," Jones said. "And they're not being labeled as deaths."

    Tara DiFlumeri, a spokeswoman for Bayer, said the company reports all adverse events according to FDA rules. She stressed just because a pregnancy fails, doesn't mean the Essure implant caused the demise.

    "All of the Essure data from postmarketing monitoring show that pregnancy-related adverse events are within the background rate for similarly aged populations," DiFlumeri wrote in an email.

    Jones and other Essure patients have tried to launch product liability lawsuits against Bayer with limited success because, like the nerve stimulator, the birth control device has passed through the toughest approval process and has broad immunity from most legal claims.

    Without the ability to sue, both Essure and Vagus Nerve Stimulator patients must rely on health regulators to insure the products are safe.

    The FDA said when it comes to balancing the interests of the medical device industry and consumers, regulators favor the public.

    "The FDA considers patients to be our first and primary customer," Stark said.

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