Millions of people with chronic heart conditions, epilepsy, diabetes, obesity, and even depression depend on Implantable Medical Devices (IMDs) for their lives but the software that enables the delivery of crucial treatment remains hidden from patients and their doctors. Despite strong evidence linking critical device failures to source code defects, software is considered the exclusive property of its manufacturers and is almost never reviewed preemptively by the regulators responsible for ensuring its safety.
In 2008, the Supreme Court of the United States eliminated the only consumer safeguard protecting patients from negligence on the part of device manufacturers by prohibiting people from seeking damages in product liability lawsuits. Today, people with chronic conditions that require IMD treatment are now faced with a stark choice: trust manufacturers entirely or risk their lives by opting against life-saving treatment.
The SFLC’s full report is available here.
I first heard about this issue when reading an article in Linux Weekly News about Karen Sandler’s presentation at this year’s LinuxCon North America. Sandler, a lawyer for the SFLC, has a heart condition that requires her to have an IMD.
For anyone who still doubts the willingness of our political and legal systems to prioritize corporate profits over people’s health (even where the risk to people is real but that to profit is merely theoretical) this report should provide yet another pile of disturbing evidence that things are going in the wrong direction.
UPDATE: A more recent (2012) version of Karen’s talk can be found here.