“Gentlemen, we can rebuild him. We have the technology. We have the capability to build the world’s first bionic man.”
That was the opening narration for the 1970’s TV show “The Six Million Dollar Man”. The story line was that science could replace an injured astronaut’s damaged body parts with nuclear-powered limbs and an eye that could see for miles. Equipped with the powers that his new parts provided, Steve Austin became a secret agent who could run faster and see farther than any other man.In the 1970s, medical implants were just becoming popular. The first knee replacement had taken place in 1968, and while the idea was gaining acceptance, surgery to replace body parts was not yet common.
Today, the technology behind medical devices and implants has improved spectacularly, and science truly is rebuilding human bodies. By some estimates, 25 million Americans are walking, and even bicycling competitively with a medical implant.
Pacemakers for the heart, insuln pumps for diabetics, artificial lenses for cataract sufferers, and hip and knee replacements are just a few of the popular uses for medical implants. Former Vice President Dick Cheyney spent most of his two terms in Washington with such a pacemaker.
At its best, the medical device industry is a marvel of research, design, and micro-manufacturing. Modern medical devices aren’t actually nuclear-powered, but they do improve life for most of the people who receive them. However, for a variety of completely preventable reasons, many recipients suffer unnecessary harm or even death. Insufficient testing, manufacturing defects, improper sterilization, and mislabeling are examples of the carelessness and callousness that create the problems.
Some devices are just bad designs that seem to harm everyone who uses them. Defective medical devices threaten everyone, and two of the worst medical products ever approved have harmed women exclusively.
A major reason why dangerous medical devices are on the market is that the FDA has the exclusive power to approve them. The FDA‘s Center for Devices and Radiological Health (CDRH) is supposed to guarantee the safety of medical devices, just as other branches of the agency are supposed to regulate foods and drugs. The CDRH has an obligation to inspect manufacturing plants in the United States and across the world, but it doesn’t fulfill that obligation.
The FDA does just as poor a job of assuring Americans that medical devices are safe as it does of assuring the safety of foods and drugs. So it’s hardly surprising that some of the drugs approved for use in surgery are also linked to patient deaths.
And the situation now has the potential to become much worse. In a scary ruling that threatens both the health and the individual rights of every American, the Supreme Court has decreed that if the FDA has approved a device, a person injured by it cannot sue the manufacturer for damages in state court.
This ruling gives totalitarian power to an agency found to be inept and corrupt by both the General Accountability Office (GAO) and by a group of scientists who work for the FDA. In a letter to President Obama that was completely open and honest, nine scientists who work in the CDRH detailed problems with the FDA and urged the Obama administration to clean up the entire agency. As expected, the people in power at the FDA said that all is well, and that no one has any need to worry.
Everyone who receives a medical device should feel safe, and it’s scary that those scientists had to write their letter, but their willingness to stand up against their own dangerous agency is a hopeful sign.
The Medical Device Safety Act of 2009, if passed into law, will have a major impact on the health and safety of millions of Americans. This is a vital piece of legislation, and its passage is necessary to assure the highest level of safety in the manufacturing and sale medical devices such as pacemakers, defibrillator cables, catheters, and infusion pumps. And when that does not happen, consumers who trusted defective devices should be allowed full recourse in court, something which presently is only allowed for defective drugs. Defective medical devices and defective drugs should be treated the same. This law will make sure that is the case.
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Onward,
Richard Alexander
