The chief of the U.S. Food and Drug Administration is pressing Congress for more muscle to block defective medical products to help prevent serious injury and death.
The request follows a slew of cases of severe injury and even death caused by faulty vaginal mesh and hip implants.
Our defective medical product attorneys understand that essentially, what the FDA is dealing with is a loophole. The agency is asking to have the authority to veto the sale of products with designs similar to those that have already been singled out or recalled for deficiencies in safety. A bill granting this authority was introduced in the House of Representatives late last month.
Sponsors of the bill are specifically citing the cases in which products such as the vaginal implants and hip replacements, which were made by Johnson & Johnson, were approved by the FDA, even though there had been concerns raised about earlier versions of the products.
FDA Chief Jeffrey Shuren hasn’t come out in full support of the House bill, but said there is a definite need for some sort of legislative remedy. In an interview with Bloomberg News, he said patients and companies need to have confidence in the products they purchase. Right now, the problem is that even if safety issues are identified, that won’t stop a product from being replicated.
The vaginal mesh implants, which were approved by the FDA in October, were using essentially the same technology and design as a product that had previously been recalled. With more than 300,000 of the new products sold in an effort to treat weak pelvic muscles. After the products were implanted, however, they caused incontinence, internal injuries and painful sex.
The program that the bill targets is the 510(k) program. This is a system that is used to review the vast majority of the medical products that hit the U.S. market every year. The process for approval doesn’t require human testing if the agency determines that there are previously approved products that are “substantially equivalent.”
Right now, the FDA must approve products that fall under this category unless they have been removed from shelves by a court order. However, most companies will issue a voluntary recall before that ever happens. That means that those faulty products can continue to be used as a jumping off point for spin-off products that use the same technology.
Bloomberg reports that in an average year, the FDA clears nearly 30 products that have been known to use technology that has already been recalled. It would seem a small number in comparison to the 3,000 products that agency reviews each year, but it’s enough to rattle consumer faith.
This bill, which was introduced by Democrats, would additionally mandate
that manufacturers supply the FDA with any information about recalls of
products they would be using as a basis for their own product approval.
Then the FDA would have to analyze these older products to determine if
the safety issues were significant enough to halt the sale of the new product.
The Ferraro Law Firm represents people injured by recalled or defective products throughout the country. Call (888) 554-2030 for a free and confidential consultation. Offices in Miami, Washington, D.C., and New York City.