The first of more than 1,800 lawsuits against the Johnson & Johnson (J&J) subsidiary DePuy Orthopaedics for alleged injuries stemming from their Pinnacle Acetabular Cup System metal hip implants will be heard in test trials, also known as bellwether trials, on May 6 and July 8, 2013 in Texas.
Bellwether trials involving about 6,000 cases on DePuy’s ASR implants in Ohio will also come to trial in 2013.
Bellwether trials are closely watched by both sides, as they are early indicators of how juries will tend to rule in those and all following cases. The outcomes of bellwether trials often create an incentive for parties to settle. DePuy has recently begun to settle cases over its recalled ASR metal hip implants in Nevada, even before courtroom trials have begun.
These trials are part of Multidistrict Litigation (MDL) where hundreds or thousands of similar cases are consolidated under a single federal judge. MDLs allow plaintiffs’ attorneys to share in pre-trial discovery, but unlike class action suits, allow each case to move forward individually.
In Texas, the Honorable Judge James E. Kinkeade is overseeing more than 1,100 cases concerning the Pinnacle metal hip product, including four just added from California and Maryland. In Ohio, Judge David A. Katz is overseeing more than 6,000 cases concerning DePuy’s ASR metal hip implants.
J&J recalled the DePuy ASR products in August 2010, affecting nearly 100,000 patients nationwide after the National Joint Registry of England and Wales and Australia showed devices in as many as 1 in every 8 patients failed. More recent data suggests the failure rate could be much higher. After the ASR recall, the FDA received complaints that the earlier Pinnacle hip-replacements also were failing.
Unfortunately, the U.S. does not have a joint registry to be able to uncover medical device failures before mass numbers of patients are harmed. It’s sort of a head-in-the sand approach to medical device regulation.
According to the journal Orthopedics, metal-on-metal hip replacement joints have been found to “exhibit increased serum cobalt and chromium ion levels.” According to the journal Chemical Communications, these ions may impact cellular genetic material. Studies also show all-metal hip implants can cause metal poisoning of nearby tissues, and the metal debris has been linked to cancer.
J&J recently settled three ASR cases in Nevada for about $200,000 each, as the pharmaceutical and medical device giant continues to vigorously defend its Pinnacle product.
In June, the Food and Drug Administration (FDA) convened a panel to recommend whether additional warnings were needed for metal hip systems. Because early hip implants were already on the market before the FDA began regulating medical devices in 1976, none of these devices has gone through clinical trials. Manufacturers are only required to show the devices are similar to earlier ones.
The FDA panel is not discussing regulatory changes at this time so it is truly buyer beware.
It’s predicted that the personal injuries patients are suffering from metal debris, repeated revision surgeries, and painful and debilitating infections will eventually force J&J to pay at least $2 billion to settle the ASR product liability cases.