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Shezad Malik MD JD
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J&J DePuy Pinnacle First Texas Bellwether Trial Starts

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Johnson & Johnson’s DePuy subsidiary is facing the first bellwether trial over allegations that the Pinnacle metal-on-metal hip was defectively designed and caused metallosis. According to Kathleen Herlihy-Paoli, the cobalt-and-chromium alloy caused an infection that resulted in the artificial hips to be removed.

DePuy ASR Metallosis Injury AttorneyThe 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 a new round of allegations that its Pinnacle line of hip implants also were failing prematurely and causing metallosis or metal poisoning.

First Texas Bellwether Pinnacle Trial

Jury selection is set to begin today in Herlihy-Paoli’s lawsuit, the first of more than 6,000 cases. The cases have been consolidated before U.S. District Judge Ed Kinkeade in Dallas for pretrial information exchanges.

The benefits of bellwether trials are many fold, the chief of which is that if successful for the plaintiffs, it can pave the way to a global settlement like the DePuy ASR cases.

DePuy ASR Settlement

The 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.

8,000 DePuy ASR Lawsuits

The ASR settlement addressed about 8,000 U.S. claims against DePuy and offered an average of about $250,000 for each metal hip removal surgery, as well as covering related medical costs. This deal was announced in November 2013.

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.

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.”

Allegations: DePuy Misled Doctors and Patients

According to Herlihy-Paoli, DePuy officials misled patients and their doctors about the safety of the artificial hips and sponsored a nationwide satellite telecast to orthopedic doctors to push the advantages of the Pinnacle Device.

Allegations: DePuy Aggressive Marketing of Defective Hips

Herlihy-Paoli claims that the DePuy company aggressively marketed the knowingly defective Pinnacle hips. If jurors find DePuy officials recklessly endangered patients lives, then the company could be exposed to tremendous punitive damages, as much as $5.78 billion according to some experts.

The case is Herlihy-Paoli v. DePuy Orthopaedics Inc., 11-cv-3590, U.S. District Court; Northern District of Texas (Dallas).