When someone in Pennsylvania or elsewhere dies after using a medical device, the manufacturer of the device is required to report the death to the U.S. Food and Drug Administration. However, manufacturers know that such reports may negatively impact their ability to market and sell the products. Additionally, reporting that people have died as a result of a problem with a product may leave the manufacturer open to products liability claims. Some companies have found a way to protect themselves from these negative consequences.
One woman suffering from epilepsy was implanted with a device manufactured to block seizures. The device was designed to emit small electrical shocks — undetectable by the patient — to stimulate part of the nervous system. However, hours after her implant, the patient complained of painful shocks, and within days she collapsed and died. The manufacturer of the implant classified her death as a malfunction. By using less serious categories, such as “malfunction” or “injury,” the company projects the image that fewer deaths are caused by the product.
The FDA prioritizes safety reports by the classification that is marked on the form. Reports marked as deaths are reviewed long before those that have the injury box checked. In fact, reports labeled as injury or malfunction may not be looked at for months, if at all. After NBC and CNBC questioned one company about recent deaths linked to its device, the company did an internal investigation and found that over 100 deaths had been misclassified.
One former FDA employee says that from 2011 to 2015, over 4,000 deaths linked to medical devices were classified as lesser causes. Patients in Pennsylvania may not have all the information they need to make informed decisions about medical devices. When someone’s death seems to be related to the recent use of a medical device, that person’s loved ones may contact an attorney for help in filing a products liability claim.
This blog entry was posted on behalf of Hof & Reid LLC, and does not necessarily reflect the views or opinions of the firm or its attorneys. The information presented in this blog is for informational purposes only and is not intended to be legal advice.
Source: cnbc.com, “Health companies label thousands of patient deaths as ‘injuries’“, Chris Glorioso, Jennifer Schlesinger & Evan Stulberger, Aug. 19, 2016