The Food and Drug Administration (FDA) has warned drug maker, Johnson & Johnson, that they could face penalties for selling faulty insulin pumps and withholding warnings regarding the dangers they pose to users. According to WHTM 27 News and other sources, the company failed to report three incident cases within an allotted 30-day window where the device may have caused or contributed to a death or injury.
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The agency says that a warning letter was sent to Johnson & Johnson on December 27 regarding the reporting discrepancies that inspectors uncovered during an audit of the company. They say that the company failed to report one incident of “serious patient injury” and delayed releasing the reports on two other patients who were hospitalized with high blood sugar, respiratory failure, and coma.
The problem with the devices seems to stem from issues with keypads on the pumps. Reports show that several of the incidents occurred because of faulty keypads that deteriorated overtime or patient error with the buttons.
While the letter did not ask for the products to be pulled from shelves, it did specify that the company could face seizures of assets, injunctions, fines, and loss of contracts from federal agencies if the problems are not resolved promptly.