Law360, New York (August 31, 2016, 4:59 PM ET) — A North Carolina man who passed out behind the wheel and crashed when his blood sugar monitor allegedly failed to alert him of low blood sugar levels hit Dexcom Inc. with what’s believed to be the first suit over the recalled device in state court on Tuesday.
The U.S. Food and Drug Administration in April recalled all models of the monitor made since 2011, about 260,000 units nationwide, according to the complaint. The FDA issued a Class I recall, the most serious type of recall, as relying on the device may cause serious injury or death, Hunter said.
Hunter’s suit is apparently the first against Dexcom over the device, according to the firm representing him, Conley Griggs Partin LLP.
Dexcom had previously landed in hot water with the FDA — in 2014, the agency hit the company with a warning letter rebuking it over its failure to properly report complaints from patients experiencing hypoglycemia and electrical shocks while using its products.
That was the second time the FDA took Dexcom to task in four years over noncompliance with adverse event-reporting requirements.
After the accident, Hunter said that his endocrinologist downloaded the monitor and determined that the device had appropriately sensed the low blood sugar prior to the wreck and the appropriate alarms were turned on.
“However, Mr. Hunter never knew the device had sensed a low blood sugar level, because the audio alarm did not sound,” the complaint said.
On the same day as the accident, Hunter told his Dexcom sales representative about the wreck and how the device malfunctioned, according to the complaint.
A company representative called him that evening and told him that the company needed to check the monitor to see if there were any problems with it, Hunter said. He was also told he would be receiving a replacement monitor and that he should send the defective monitor back to Dexcom, according to the complaint.
“The representative also told Mr. Hunter that he would get back to him immediately with the results of the testing,” Hunter said. “Mr. Hunter sent the defective monitor to Dexcom as instructed and awaited word from Dexcom on the testing of the device.”
But for weeks afterwards, Hunter didn’t hear back from the company and his doctor’s calls and emails went unreturned, according to the complaint.
He then asked a lawyer friend to write a letter to Dexcom on his behalf, according to the complaint.
“Within just a few days, on January 21, 2016, Jake Leach, Senior V.P. of Research & Development at Dexcom sent an email to Mr. Hunter and stated that the defective monitor ‘passed all of the tests including the audio alert test indicating that it is functioning properly,’” Hunter said. “Despite this claim that the device was functioning properly, Dexcom did not return the device to Mr. Hunter.”
Then in February, Hunter received a letter from Dexcom’s CEO, Kevin Sayer, titled “Important Customer Notification – Please Read,” according to the complaint.
Dexcom said in the letter that it had received an increase in complaints about malfunctioning alarms and alerts with the blood sugar monitor and told its customers that their audible alarms might not go off, according to Hunter.
“This letter, however, was sent nearly two years after Dexcom’s first warning from the FDA about the unsafe nature of the defective monitor,” Hunter said.