Last month, the U.S. Food and Drug Administration (FDA) proposed a policy which, if adopted, could significantly increase the oversight and safety of the medical device industry. Under the proposal, each individual device would receive its own identification number, allowing medical professionals and manufacturers to better track defective products, determine the cause of the problems and alert other patients who are using the same device.
Earlier this week, the U.S. House of Representatives approved a bill that secures the funding for the Food and Drug Administration (FDA) for the next several years. Last week, the U.S. Senate passed a similar version of the bill, and leaders from the chambers will now work to come to a consensus, reportedly aiming for July 4 as a deadline to finalize the bill.
Earlier this week, we wrote about Johnson & Johnson unit DePuy Orthopaedics and the contention that its A.S.R. hip replacement implant is a defective product. When the A.S.R. was introduced, it was promoted as a major breakthrough, and as an implant that would last much longer than similar products. When the allegations were first brought against DePuy, the company maintained its self-promotion, claiming that surgical mistake was behind patients' pain and injury, not the product itself. Recently, however, DePuy announced that it is phasing out the A.S.R. device, but not for safety reasons. Instead, the company claims that lagging sales are behind the recall.
Over the last year, health care product manufacturer Johnson & Johnson has come under scrutiny after multiple allegations of injuries caused by various products. On this blog alone, we have written about the harm reportedly caused by the birth control patch and children's over-the-counter cold medicines, both of which have given rise to products liability litigation. Recently, a new controversy has risen after claims that an artificial replacement hip manufactured by DePuy Orthopaedics, a unit of Johnson & Johnson, was not only failing, but causing serious and lasting harm to patients.