The first federal bellwether trial against Johnson & Johnson’s DePuy subsidiary for its allegedly defective Pinnacle Hip Implant has been underway for the past 3 weeks in Dallas, Texas.
The U.S. District Court for the Northern District of Texas oversaw jury selection on September 2 and over the past three weeks there has been a parade of company executives, paid doctor consultants and defense experts subjected to withering cross examination by the plaintiffs team of lawyers.
DePuy Orthopedics Inc., is facing the first bellwether trial over allegations that the Pinnacle metal-on-metal hip was defectively designed and caused metallosis. According to the plaintiff Kathleen Herlihy-Paoli, the cobalt-and-chromium alloy caused an infection that resulted in the artificial hips to be removed.
Testimony: J&J Knew As Early as 2001 of Pinnacle Problems
According to court testimony, Johnson & Johnson knew as early as 2001 the metal-on-metal version of its Pinnacle artificial hips might generate debris that could cause metal poisoning.
A doctor who consulted with J&J’s DePuy unit on the Pinnacle hip made the company aware in February 2001 that the device would require extensive testing of implant patients to see whether they had metal debris in their bloodstreams.
In an internal memo, DePuy officials said Dr. Thomas Schmalzried warned the potential release of metal ions was a “major issue for metal-on-metal hips.” Schmalzried had said the extent of the metal-hip patient’s tissue damage was “alarming and concerning.” DePuy officials said in the e-mails that they planned to tell colleagues to “keep quiet for now” about the case Schmalzried highlighted.
Smoking Gun Internal Documents
Internal files from 2012 showed DePuy officials found the metal Pinnacle hips had a 15 percent failure rate after five years of use. Company officials had expected a failure rate of 5 percent over that time period. The company failed to warn patients and doctors or the FDA. No recall has been issued for DePuy Pinnacle line of metal on metal
The Hits Keep Coming for Johnson and Johnson (J&J)
Johnson & Johnson set aside $2.5 billion last year to settle claims that 8,000 of its DePuy ASR hips were defective. The pharmaceutical and medical device giant company is now exposed to allegations that its Pinnacle line of hip implants also were failing prematurely and causing metallosis or metal poisoning.
DePuy ASR SettlementThe J&J’s $2.5 billion settlement of ASR claims, only addressed the ASR line of hips. Here the plaintiffs claimed that its ASR hip devices caused premature hip implant failure, dislocations, pain and required surgical removal because of metallosis.
Metallosis Caused by ASR Implants
In many cases, chromium and cobalt debris from the metal-on-metal grinding between the cup and the ball components of the ASR hips caused local muscle and tissue death and increased Cobalt and Chromium blood levels.
According to medical experts the long term side effects of heavy metal poisoning is unclear, with some stating that it can cause bladder and kidney cancer many years down the road.
DePuy ASR Recall August 2010
J&J, the world’s largest health-care company, issued a worldwide recall of 93,000 ASR hip implants in August 2010, saying 12 percent failed within five years.
But, according to internal J&J documents unearthed during litigation, 37 percent of ASR hips failed after 4.6 years. In 2012, the failure rate in Australia was 44 percent within seven years.
Herlihy-Paoli Severe Metallosis
According to Herlihy-Paoli, aged 58, she two Pinnacle hips in 2009 and began to complain of pain from the devices. Blood tests before the 2011 removal surgeries found the “implants had released dangerous levels of cobalt and chromium into her bloodstream. Mrs. Paoli’s cobalt blood serum levels were 85 times higher than normal.”
Once surgeons removed Herlihy-Paoli’s left hip, they “discovered the implant had turned black with metallosis.”
J&J Quits the Metal on Metal Hip Business
J&J stopped selling the metal-on-metal version of the Pinnacle hip in August 2013 after the U.S. Food and Drug Administration said it would require device makers to submit new versions of the artificial hips for pre-market approval.
J&J had advertised the metal-on-metal implants, as a design that would last 20 years and offer greater range of motion.
The case is Herlihy-Paoli v. DePuy Orthopaedics Inc., 11-cv-3590, U.S. District Court; Northern District of Texas (Dallas).