Wednesday, April 1, 2009
Comment on preemption, legislation proposal and the report on medical devices
Yesterday I reported on a new report on injuries caused by medical devices. Today, here is a link to a comment on it published in The Huffington Post. It states in part: "According to a report released yesterday by the Center for Justice and Democracy, a shocking 573 recall notices were issued between 1992 and 2002, covering more than two million implants which had already been sold to doctors--and in many cases implanted into patients. Every one of these recalled devices were approved by an FDA approval process which is wholly inadequate to the task of protecting American consumers without significant help from private lawsuits. The FDA can barely keep up with the volume of work it faces. In 2005 alone, the FDA approved nearly 3,200 applications to market a new device to physicians and patients. . . . Lacking sufficient resources to monitor thousands of medical devices on their own, the FDA relies on the industry itself to disclose potential problems in the devices it regulates. Needless to say, device manufacturers are not always forthcoming. . . . As unwilling as the industry is to disclose damning information about their products, there is a simple way to learn the secrets that medical device makers do not want doctors to know: lawsuits. When an injured patient--or their begrieved survivors--sues a medical device maker, they have a right to discover how the company's product is made, and to uncover evidence that it is defective. They can find information that was long kept secret from the FDA, and they can often provide this hidden information to consumers and the medical profession. If they win their case, they impose a financial consequence on the manufacturer--sending an important message to profit-driven companies: if you hide key facts from the public, you will pay for it. Shockingly, however, a recent Supreme Court decision declares that medical device makers have almost total lawsuit immunity--meaning that one of the most reliable means of dislodging information from secretive companies no longer exists. . . . Fortunately, there is a way to fix this problem. Congress is currently considering a bill called the Medical Device Safety Act, . . . Until this bill passes, the FDA's lackluster screening process is the only thing standing between the millions of Americans who rely on medical devices to save their lives . . ."