The litigation sparked by DePuy Orthopaedics’ ASR hip implant recall could cost Johnson & Johnson as much as $1 billion. According to a recent report from The Wall Street Journal, that estimate came from a Wells Fargo analyst addressing the impact the massive number of ASR hip implant lawsuits could have on the medical products firm’s bottom line.
It’s been a tough couple of years for Johnson & Johnson, which has been hit by an unusual number of recalls. In addition to the DePuy ASR hip implant, various Johnson & Johnson units have issued recalls for a number of medical products, including more than 200 million bottles of over-the-counter medications for musty orders and other problems. According to The Wall Street Journal, the recalls cost the company around $900 million last year.
That bill will get much bigger thanks to the DePuy ASR hip implant recall if the Wells Fargo analyst is right. According to the Journal, Johnson & Johnson recently upped product-liability reserves to $570 million last year. It has also allotted $280 million to cover medical bills for DePuy ASR hip implant recipients who have to have the implants removed.
More than 1,000 DePuy ASR hip implant lawsuits are currently pending in federal courts across the country. As we’ve reported previously, many have been consolidated in a multidistrict litigation in U.S. District Court for the Northern District of Ohio. According to the Journal, some plaintiffs’ lawyers want the lawsuits certified as a single class action complaint.
The DePuy ASR hip implant lawsuits claim Johnson & Johnson failed to warn patients and doctors of problems with the implant and was negligent in designing, manufacturing and selling the product.
DePuy Orthopaedics recalled the ASR Hip Resurfacing System and DePuy ASR Acetabular System last August, after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years of receiving. The company had actually begun phasing out the devices in March of 2010, citing slow sales. But as we reported previously, that same month the company sent letters to doctors warning that data from the Australian medical device registry showed a higher-than-expected failure rate, especially in smaller patients or those with weak bones.
Only the DePuy ASR Acetabular System was sold in the U.S. That device was approved by the U.S. Food & Drug Administration (FDA) via the 510(K) process, which allows a manufacturer to obtain market approval with very little clinical testing of a device – including no human testing – if it is “substantially similar” to another product already on the market. The 510(k) approval process has received a great deal of criticism in recent years. In fact, shortly after the DePuy hip implant recall was issued, an internal FDA review found numerous flaws with the process. Just this past February, a study published in the Archives of Internal Medicine found that the majority of high risk medical device recalls over the past five years involved products subject to the streamlined 510(K) approval process.
