Invacare Corp. (NYSE:IVC) has been slapped with a warning letter by federal regulators for failing to adequately investigate reports of fires and sparks from electric beds that in some cases allegedly resulted in patient deaths.
The warning letter from the U.S. Food and Drug Administration contains several disturbing consumer complaints related to Invacare’s adjustable beds, including one in April about a fire that started at the foot of a bed and resulted in a consumer’s death. One complaint from June involved an Invacare bariatric bed that caught fire, resulting in two patients being taken to the hospital and treated for smoke inhalation and chest pain. “Visible flames were observed. However, when the unit was unplugged the fire went out,” the letter stated.
The letter, addressed to Invacare Chairman A. Malachi Mixon III, is dated Dec. 15, but was posted on the FDA’s website Tuesday morning. The news sent Invacare’s shares tumbling about 4 percent, to $29.32, in mid-day trading.
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Invacare issued a statement saying it fully stands behind the safety of its products. “The FDA warning letter does not state that our products are unsafe nor has it impacted our production,” CEO Gerald Blouch said. “The letter is related to documentation procedures.”
In addition to sparks and flames, Invacare’s adjustable beds were the target of complaints after consumers apparently became trapped in the beds’ rails. One complaint involved the “bed entrapment death” of an 11-year-old child, according to the letter.
An Invacare spokeswoman stressed that the consumer complaints detailed in the warning letter were “allegations.”
Warning letters generally are considered by the FDA to be informal and advisory. The letters are a fairly routine part of doing business for medical device firms. However, the grisly nature of some of the complaints relating to Invacare’s beds indicates that this affair may not fade away as quickly as the company no doubt wishes it would.
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The violations cited by the FDA came to light during an August inspection of a plant in Sanford, Florida. Invacare was cited for a host of record-keeping violations at the plant, including failing to document the manufacturing steps needed to prevent the production of faulty or “nonconforming” product.
After the inspection that uncovered the violations, Invacare addressed the issues with the FDA. However, the letter repeatedly states that Invacare’s response “is not adequate,” because the company in some cases didn’t document what corrective actions it would take.
The FDA’s letter gave Invacare 15 days to respond with a list of steps taken to address the violations. Failure to do so could result in punishment from the FDA that could include fines, seizure or injunction.
Invacare said it would submit a response to the agency.
