Bipartisan legislation has been introduced in the Senate on Wednesday, December 14th that would force manufacturers to track the performance of products such as artificial hips and medical devices. This particular legislation comes after the numerous problems that continue to grow each day with hip implants.
According to the New York Times writer Barry Meier, this legislation would allow the FDA to force companies to track their implants that are within a category that does not require any type of human testing for the medical device to be approved.
This proposed legislation is intended to address the many complaints received by patient advocates and institutions such as the Institute of Medicine. The current process for certain medical implants like artificial joints to become approved is to show that the device is “substantially similar” to a product already on the market. Absolutely no human testing is necessary for the brand new product to be first approved! As a result of the lack of requirements to ensure consumer safety, thousands of metal-on-metal hip implants are failing in patients where the medical device was approved with this system.
The new proposed legislation would not require human testing but broadens the FDA’s post approval oversight. The FDA would be allowed to compel companies to collect date on medical device performance.
It was Herb Kohl of Wisconsin and Richard Blumenthal of Connecticut, two Democrats alongside Charles Grassley of Iowa and a Republican who sponsored this proposed legislation. Blumenthal said, “There is clearly a need for scrutiny once products are implanted or used on patients.” Letters were sent by these Senators to five major producers of medical devices—Johnson & Johnson, Zimmer Holdings, Boston Scientific, C.R. Bard, and Medtronic. The Senators wanted documents from the companies about how they track product safety and how they decide to recall devices.
Karen Riley, a spokeswoman for the FDA, told sources that the Obama administration does not have a position on the proposed legislation.
A point of interest that many want to know in regards to Johnson & Johnson is when they were warned about one of its metal hip implants, the Articular Surface Replacement and how they tracked the problems. After some 93,000 patients worldwide were implanted with the hip implant, the company recalled the product.
Currently, there are about 3,500 lawsuits filed against Johnson & Johnson. These lawsuits pertain to the ASR. If you or someone you love have fallen victim to the failed DePuy ASR hip implant, contact CSS Firm for a free case evaluation and consultation for your defective hip implant. Our hip implant recall lawyers continue to review claims all over the country in an effort to help those affected by this dangerous product. Our experienced hip implant lawyers at Childers, Schlueter & Smith will work closely with you to ensure you get the care and justice you deserve.