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Byline: Ken Armstrong and Justin Mayo
Dec. 17--Sylvia Lane, a diabetic, lay in her apartment bed in Lynnwood, comatose and alone, her blood and brain in desperate need of sugar.
But the medical device she'd just received instead kept pumping insulin into her body, pumping and pumping, starving her brain and making it more unlikely she would ever wake up. Lane was 17 weeks pregnant. Her husband was on an aircraft carrier, halfway round the world. Relatives were calling but getting no answer. The pump, about the size of a cellphone, had a safety feature designed to stop the insulin flow in emergencies like this. But the feature wasn't on. The pump had been shipped to Lane with the option turned off, and the device's instructional video devoted only 15 seconds to it, saying nothing about why the feature should be used. Ultimately, Lane suffered severe and permanent brain damage. Her family sued Medtronic Inc. -- the parent company of the pump's manufacturer -- alleging the pump was unsafe. Medtronic had already sold 150,000 insulin pumps in the United States. What happened to Sylvia Lane could have yielded insight into the pump's design and instructions, alerting patients and health-care providers to the importance of this safety feature, originally called a "Deadman's Switch." But when Medtronic settled the lawsuit three years ago, the entire court file was improperly sealed, hiding every allegation and discovery behind an electronic password.
What's more, Medtronic failed to disclose Lane's injury to the federal government, which uses such reports to spot problems with medical devices and to protect the public. Lawsuits and regulatory reports allow patterns to emerge and warnings to sound. Here, there was merely secrecy and silence. The Seattle Times got this file opened three months ago as part of a continuing investigation of improperly sealed court records. Lane's family also sued the state of Washington, alleging the University of Washington Medical Center committed medical malpractice while instructing Sylvia on the pump's use. The state settled, using taxpayer dollars. But the UW, despite being asked for all its records a year ago, has yet to reveal the amount. The following account relies on the court file. The lawyer for Lane's family said he cannot comment, nor can the family, because the parties agreed to confidentiality as a condition of settlement. Medtronic also declined comment, citing the settlement agreement and Lane's privacy. A pump that mimics the pancreas Michael Lane and Sylvia got married in 1989, then moved about as his Navy career dictated. In 1995, they were living in Naples, Italy. That's when Sylvia learned she had type 1 diabetes. Her pancreas didn't work. It wasn't producing …