A Washington woman with Type 1 diabetes suffered severe and permanent brain damage. Her family sued Medtronic Inc. — the parent company of the insulin pump's manufacturer — alleging the pump was unsafe. Medtronic had already sold 150,000 insulin pumps in the United States.

The pump, about the size of a cell phone, had a safety feature designed to stop the insulin flow in emergencies. But the feature wasn't on. The pump had been shipped to the woman with the option turned off. The device's instructional video devoted only 15 seconds to it, saying nothing about why the feature should be used.

What happened to the woman 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 dead man'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 the woman’s injury to the federal government, which uses such reports to spot problems with medical devices and to protect the public.

Nationally, other lawsuits have also accused Medtronic of reporting lapses. Medtronic, a Fortune 500 company with annual sales of $11 billion, makes all kinds of medical devices. Other lawsuits have alleged that Medtronic failed to make timely warnings to the public and physicians about problems with implantable heart defibrillators and with the tubing on insulin pumps.

According to the U.S. Justice Department, the company agreed last summer to pay a $40 million fine to settle civil allegations that it provided kickbacks to doctors, to encourage them to use its spinal products. The kickbacks included sham consulting and royalty agreements, as well as lavish trips. (Full Story)