Orthopaedic Alerts - Implant Recall

After a two-week delay, the first federal trial over Johnson & Johnson’s recalled ASR hip implants is set to begin Monday, Sept. 23, in an Ohio courtroom. The case, brought by 58-year-old Ann McCracken of Rochester, N.Y., could set a precedent for thousands of other plaintiffs who say they also were injured by the devices.

The bellwether case, which is being heard in the U. S. District Court for Northern District of Ohio in Toledo, is the first of 7,860 similar federal lawsuits against Johnson & Johnson’s DePuy Orthopaedics unit to go before a jury. More than 3,600 additional ASR lawsuits against the company are pending in state courts.

The problems with the ASR stem from the design: a metal cup (socket) and a metal ball. Both components are made from chromium and cobalt, and grind against each other during normal movements. This releases metal debris into the patient’s tissues, and can cause metal poisoning and serious tissue and bone damage. To address these complications, patients often require a second surgery, known as revision surgery.

“There are a significant subset of clients who got very badly hurt by the device, and their injuries are much more than a simple revision,” Matthew Davis, a lawyer at Walkup Melodia Kelly & Schoenberger in San Francisco, told Bloomberg. “If those cases went to trial and there was a finding of liability, a jury would award them general damages in the seven figures.”

A verdict in favor of McCracken could dictate how Johnson & Johnson (J&J) handles other plaintiffs’ cases. Bloomberg recently reported that the company is considering a record $3 billion global settlement with plaintiffs – or an average of $300,000 per case.

Patient’s Struggles

McCracken had hip replacement surgery in August 2009 and received an ASR implant, which was recalled just a year later. In her complaint, she calls the device “defective” and “not reasonably safe.” She also says the device caused her so much pain and so many mobility issues that she had to have two revision hip surgeries — in January 2011 and October 2011. The lawsuit claims the first revision surgery was due to the device’s failure, and the second was the result of ongoing injuries she suffered from the ASR hip implant.

The lawsuit also claims that DePuy was negligent in performing proper clinical trials to determine the safety of the implant before putting it on the market in 2005. It goes on to say that DePuy knew the device was defective and yet failed to warn doctors and patients. McCracken is seeking in excess of $75,000 in actual damages. The jury can also consider punitive damages, if it finds the manufacturer liable.

Johnson & Johnson’s Liability at Issue

U.S. District Judge David Katz is overseeing McCracken’s lawsuit as well as the other federal cases, which have been consolidated into multidistrict litigation (MDL) . The first few trials are known as “bellwether trials” or “test trials.” These cases are intended to provide insight into the manufacturer’s liability or lack thereof.

McCracken’s lawsuit claims:

• The DePuy device had design flaws that not only caused it to fail in a reasonably short period of time, but also released toxic metal particles into the patient’s blood stream.
• The manufacturer failed to warn patients that the implant contained defects, even after finding out about complications.
• DePuy was negligent by inadequately testing the products, and putting the implants on the market without knowing the risks and dangers of their product.
• The company continued marketing the product even after it became aware of complications.

DePuy has faced split decisions in state courts — losing one case and winning one. In March, DePuy lost its first ASR lawsuit and was ordered to pay a Montana man $8.3 million in damages. The company is appealing that ruling, and is denying liability.

“We believe ASR XL was properly designed, and that DePuy’s actions concerning the product were appropriate and responsible,” DePuy spokeswoman Lori Gawreluk said after that verdict.

In April, an Illinois jury ruled in favor of Johnson & Johnson after a woman claimed her ASR implant failed three years after implantation, causing her painful side effects. The jury ruled her injury was a result of her health issues and not a defective device.

Evidence from those cases is likely to resurface at next week’s trial.