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Medical Device Makers Label. Device makers are labeling thousands of patient deaths as “injuries” or “malfunctions”. Furthermore, it appears that these actions are in accordance with U.S. Food and Drug Administration (FDA) guidelines. Specifically, an NBC News investigation found that miscarriages associated with Bayer’s Essure permanent birth control and deaths associated with Cyberonics’ Vagus […]
Medical Device Makers Label. Device makers are labeling thousands of patient deaths as “injuries” or “malfunctions”. Furthermore, it appears that these actions are in accordance with U.S. Food and Drug Administration (FDA) guidelines.
Specifically, an NBC News investigation found that miscarriages associated with Bayer’s Essure permanent birth control and deaths associated with Cyberonics’ Vagus Nerve Stimulator were not labeled as deaths.
The mislabeling however, is not limited to these medical devices. An anaelysis shows that over 4,000 patient deaths were labeled as “injuries” or “malfunctions” between 2011 and 2015. Why are patient deaths being classified as less serious events, and should the FDA be allowing this? At Parker Waichman, it is our main goal to fight for patient rights and advocate for safety. If you or someone you know was injured by a medical device, contact our firm today.
According to an investigative report by NBC News, data compiled by former FDA consultant Madris Tomes shows that device makers labeled over 4,000 patient deaths as “injuries” or “malfunctions” between 2011 and 2015.
Regulations say the manufacturers must report any incident that “reasonably suggests a device may have caused or contributed to a death or serious injury.” If a patient used a medical device and dies, it does not necessarily mean that the device caused the death; the FDA says in many cases there is not enough evidence linking the fatality to the device.
However, the agency lets the device maker themselves determine whether a patient’s death was related to the use of a product, a point that has been criticized by lawmakers and patient advocates.
NBC reports one case of a woman who was implanted with the Cyberonics’ Vagus Nerve Stimulator (VNS) in 2010, which administers small shocks to treat epilepsy. Her family says she complained of abnormally painful shocks, and died less than 48 hours later. They later learned that Cyberonics labeled dozens of patient deaths as injuries and malfunctions.
The FDA has warned Cyberonics over these types of issues in the past. In 2001 and 2004, the agency sent letters stating that the company failed to investigate and report patient deaths in a timely manner. The company said those problems have been remedied. However, Cyberonics identified a total of 108 misclassified deaths after NBC New York and CNBC inquired about the issue.
Tomes says the classification of “death” versus “injury” and “malfunction” have important implications because public health analysts prioritize their work based on severity of events. Putting a less severe label on a patient death can cause delays in review.
“The way that the FDA reviews the reports is in order of importance by the classification that is checked on the form,” said Tomes. “So if it is an injury or malfunction, it could take them weeks to months to get to reading them.”
NBC cites five separate cases involving the Vagus Nerve Stimulator where patients died of pneumonia. The device manual warns that the nerve stimulator could cause patients to aspirate liquid into their lungs, which can lead to pneumonia.
In three cases however, Cyberonics classified the incidents as “injuries” or “malfunctions” because medical professionals allegedly stated that the pneumonia was not linked to the device. Human reporting errors resulted in the other two classifications, Cyberonics said.
Rep. Michael Fitzpatrick (R-PA) has taken issue with the fact that the FDA lets the industry decide how to label an event because clearly, it is in their financial interest to minimize any risks. He called for more transparency, stating “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,”.
In particular, Fitzpatrick has been critical of how the FDA managed complaints over Essure, Bayer’s permanent birth control device. The device, composed of two metal springs inserted into the fallopian tubes, is supposed to cause sterilization.
Yet there are over 300 reports of women getting pregnant after receiving Essure and subsequently suffering a miscarriage. When filling out the FDA safety reports, however, instructions say the “death” box does not apply if the pregnancy was terminated due to congenital anomaly or if miscarriage occurred.
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