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DePuy Moved Forward with its Pinnacle hip Device Despite a lack of data About the Implant’s Possible Risks

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DePuy Orthopaedics did not analyze any human studies that looked at the health effects of metal debris for the company’s Pinnacle hip implant before 2001 because none existed, an executive for the Johnson & Johnson (J&J) subsidiary told a jury on Monday.

Pamela Plouhar, the worldwide vice president of clinical research at DePuy, testified in defense of the company in the first trial of more than 6,000 lawsuits filed over the Pinnacle metal-on-metal (MoM) implant. The cases have been consolidated before U.S. District Judge Ed Kinkeade in the U.S. District Court for the Northern District of Texas in Dallas. The lawsuits allege DePuy failed to comprehend and warn patients and doctors about the dangers of the device, marketing them as safe, Reuters reported.

During a line of questioning from DePuy’s attorney about what studies DePuy performed on the Pinnacle device prior to its 2000 approval from the U.S. Food and Drug Administration (FDA), Plouhar told the court there was “no human study that looked at” the health problems that may accompany the device. The patient’s attorney said that research from as far back as 1974 showed the devices could be troublesome, according to Reuters.

The patient’s lawyer produced documents Monday that showed Dr. Thomas Schmalzried, a Los Angeles surgeon who had consulted with DePuy on the Pinnacle device, told the company in 2001 that more information was needed to determine the risks of metal debris shed by the hips. Plouhar told the jury that DePuy followed industry standards and when asked if the device maker had performed the “necessary studies” on the risks of metal ions, Plouhar said they did, Reuters reported.

The patient, implanted with two Pinnacle hips in 2009, claims she started suffering pain shortly after she received the devices. In 2011, an infection allegedly caused by metal shavings shed by the hips forced her to undergo revision surgery. Court filings show that blood tests performed before the implants were removed indicated the woman’s cobalt blood serum levels were 85 times higher than normal. The patient alleges her injuries were caused by the defective design of the Pinnacle hip, according to Reuters.

The lawsuit alleges that J&J marketed the Pinnacle in a deceiving and dangerous manner. The company told doctors that the device was successful 99.9 percent of the time, while ignoring evidence of its risks, the patient’s attorney purports.

In a statement obtained by Reuters, DePuy spokeswoman Mindy Tinsley said J&J undertook a comprehensive review of MoM devices before launching the Pinnacle to the market.

DePuy recalled 93,000 of its ASR hip systems in 2010 amid a growing mountain of reports that the device failed prematurely. DePuy estimated the ASR had a failure rate of 12 percent in five years, but internal documents estimated the failure rate at 37 in 4.6 years. In Australia, the reported failure rate was 44 percent in seven years. The company agreed to pay $2.5 billion last year to settle more than 7,000 ASR lawsuits.

breakinglawsuitnews.com disclaimer: This article: DePuy Moved Forward with its Pinnacle hip Device Despite a lack of data About the Implant’s Possible Risks was posted on Wednesday, September 17th, 2014 at 4:01 pm at breakinglawsuitnews.com and is filed under Medical Device Lawsuits.

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