Summer may have ended elsewhere but it is still hot in Dallas, Texas for the DePuy Pinnacle executives that are facing an unrelenting summer barbeque grilling over their defective DePuy Pinnacle line of metal on metal hips. The first federal bellwether trial against Johnson & Johnson’s DePuy subsidiary for its allegedly defective Pinnacle Hip Implant is heading into its fourth week in Dallas, Texas.
In the U.S. District Court for the Northern District of Texas, there has been a rogues gallery parade of company executives, paid doctor consultants and defense experts who have been subjected to withering cross examination by the plaintiffs team of lawyers.
The plaintiff, Kathleen Herlihy-Paoli and others allege that the company failed to warn patients and doctors about the device’s risks, instead marketing them as safe. Herlihy-Paoli, received two Pinnacle hips in 2009, and alleged in her lawsuit that defects in the devices led the level of cobalt in her blood to explode to 85 times the normal level. Once surgeons removed Herlihy-Paoli’s left hip, they “discovered the implant had turned black with metallosis.”
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.
Pamela Plouhar, the worldwide vice president of clinical research at DePuy, was in the hot seat this week being hammered by Mark Lanier, a lawyer for Herlihy-Paoli during the first trial among more than 6,000 lawsuits over the Pinnacle hips that have been consolidated in Dallas federal court.
Plouhar unsuccessfully defended the company’s assessment of safety risks associated with metal-on-metal Pinnacle hip implants and claimed that the company had performed critical safety testing.
Lanier, slammed Plouhar over what studies DePuy had performed on the implants, in an attempt to show jurors that the company had been negligent in gathering clinical data on the devices before they were approved by the U.S. Food and Drug Administration in 2000.
Plouhar said there was “no human study that looked at” the health effects of metal debris for the Pinnacle hips before 2001. According to court testimony, Lanier showed that DePuy neglected to gather enough safety data on the devices, particularly regarding the risk of metal debris reaching the bloodstream, and that research showed as early as 1974 that there were problems with the metal-on-metal implants
DePuy Doctor: “Major Issue for Metal-on-Metal Hips”
A doctor who consulted with J&J’s DePuy unit on the Pinnacle hip alerted the company 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 knew that 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 either the patients and doctors or the FDA.
According to the plaintiffs, the failure rates for the implant were unacceptably high – more than 14 percent over seven years. While the DePuy Pinnacle implant has not been recalled, Johnson & Johnson (J&J) stopped selling metal liners for the devices last year after the FDA said it would require device makers to submit new versions of the artificial hips for pre-market approval.
Metal on Metal Hips On the Hit Parade
J&J 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 similar allegations that its Pinnacle line of hip implants also were failing prematurely and causing metallosis or metal poisoning.
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.
All metal on metal (MoM) hip manufacturers are exposed to similar allegation of premature hip failure and metallosis. In February of this year, Biomet agreed to settle 1,000 lawsuits over its MoM M2A Magnum implants. Zimmer has also faced litigation over its Durom MoM device, as has Stryker’s Trident, Rejuvenate and ABG II MoM devices. Smith & Nephew, which started the MoM craze with its Birmingham line of MoM devices is also under the gun as well as Wright’s line of Conserve MoM hip implants.
Metallosis Caused by MoM Implants
In many cases, chromium and cobalt debris from the metal-on-metal grinding between the cup and the ball components of the MoM hips caused local muscle, bone, 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.
The case is Herlihy-Paoli v. DePuy Orthopaedics Inc., 11-cv-3590, U.S. District Court; Northern District of Texas (Dallas).
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