There is always an uneasy set of interests to be balanced when it comes to proper regulation of medical devices. On one hand, it is important for consumers to have access to necessary products that can improve their lives on as a sufficient a schedule as possible. However, on the other hand, failure to ensure complete safety of these devices can lead to thousands upon thousands of unnecessary complications and billions of dollars in added costs. It is a fine line that needs to be debated and discussed fairly and honestly by those in a position to make the rules. The importance of this question has been made particular clear to our Chicago personal injury attorneys over the last year as we’ve worked with victims of the DePuy hip recall fiasco.
Blog readers are likely aware of the details of the DePuy case. The metal-on-metal hip replacement devices were recalled last year among a growing body of data which found that they failed at a significant rate. Thousands of patients across the country, including in our area, unknowingly had the devices installed and many have suffered complications. Many DePuy hip failure lawsuits have been filed since the problem was uncovered. In addition, the situation has led many observers to question whether oversight needed to be improved at the U.S. Food and Drug Administration.
However, some members of Congress are also calling for an easing of the current approval process. For example, last spring a Minnesota congressman urged Congress to make it easier for the FDA to send new products to market and ultimately into patients. It should come as no surprise that after his plea, the congressman took in tens of thousands of dollars in campaign contributions from those businessmen with a stake in the medical device industry. As the New York Times described last week, venture capitalists in particular (those who loan money to companies with new ideas seeking to make a profit in the end) are becoming influential allies of members of Congress working to change the approval process for medical devices.
This push to remove current regulations has alarmed many patient advocates and doctors who have actually been calling for the opposite-an increase in the oversight process to ensure mistakes like the hip failures are not repeated. One academic explains that the venture capitalists involved in these efforts, “have this unwritten assumption that every new device is innovative.” However, she explained that some of these so-called innovative devices “are killing people or causing significant harm.”
The Illinois medical malpractice attorneys at Levin & Perconti have closely followed the DePuy hip recall, particularly as it has affected patients in Illinois. We understand the need to ensure proper accountability on the part of the makers of these devices. Of course we all hope that medical and technological advances are put to use for the benefit of patients. However, that goal must be tempered with logical, fair, clear-sighted security measures that prevent over-zealous capitalists from pushing their product onto patients with serious ramifications down the road. Congress must fairly balance the issues and not capitulate from strong pressure from any single rich or powerful interests group.
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