More reports on: Pharmaceuticals

Johnson & Johnson ordered to pay $1.04 bn over faulty hip implants

news
02 December 2016

A federal jury in Dallas yesterday ordered Johnson & Johnson (J&J) to pay $1.04 billion to six patients who said they were injured by Pinnacle hip implants made by its subsidiary DePuy Orthopaedics.

In lawsuits that were combined in a trial, the federal jury concluding that J&J misled patients and their doctors about the safety of the Pinnacle hip implant.

Officials of DePuy were aware that the Pinnacle hip implants were defective, but failed to properly warn doctors and patients about the risk they would fail.

The patients, residents of California, alleged that DePuy knew that its Pinnacle hip implants drained cobalt and chromium material into their bloodstreams, leading to the device failures and had to be surgically removed.

DePuy was selling two models of the ASR Hip System, ASR XL Acetabular System and the ASR Hip Resurfacing System.

The ASR XL Acetabular System is a concave metal piece used to provide a smooth lining for the acetabulum, the bowl-shaped socket in the pelvis, while the ASR Hip Resurfacing System replaces the ball portion of the hip and has a metal stem that fits into the top of the hip bone, or femur.

The ASR XL Acetabular System first became available in 2005 in the US after the FDA gave J&J a special clearance in 2005 to market the ASR devices without first performing clinical trials to determine the safety of the products.

But since 2008, the FDA has received approximately 400 complaints from patients who received ASR hip replacements and at the beginning of 2010 DePuy said it was phasing out the ASR Hip Implant because of declining sales, but never mentioned the high failure rate data in the US, UK and Australia.

In August 2010, DePuy issued a global recall of two models of the ASR Hip System after finding that more people than expected who underwent hip replacement surgeries experienced pain and other symptoms that led to a second hip replacement surgery, called a revision surgery.

The recall was issued more than a year and a half after the first lawsuit was filed. Many experts had said at that time that DePuy should have issued the recall sooner, due to the high number of complaints about the devices.

According to Warsaw, Indiana-based DePuy, five years after implantation, approximately 12 per cent of patients who had received the ASR resurfacing device and 13 per cent of patients who had received the ASR total hip replacement needed to have a revision surgery.

DePuy stopped selling the metal-on-metal Pinnacle devices in 2013 after the US Food and Drug Administration strengthened its artificial hip regulations.

J&J and DePuy also paid $2.5 billion that year to settle more than 7,000 lawsuits over its ASR metal-on-metal hip devices.

J&J has around 8,900 lawsuits pending because of the implants, including from patients who were crippled by the faulty hip implants, according to a May filing with the US Securities and Exchange Commission.

The latest award included $1 billion in punitive damages and $40 million in compensatory damages.

''Anyone who sees the evidence will be appalled at the conduct of J&J,'' said lead plaintiffs attorney Mark Lanier of The Lanier Law Firm in Houston. ''These cases are not hard to try. J&J needs to get responsible and settle these cases. Thousands are hurting.''





 search domain-b
  go