DePuy Pinnacle Hip Bellwether Trials to Proceed Before Jury

A federal judge has blocked several last ditch efforts by DePuy Orthopaedics attorneys to stop a lawsuit over the Pinnacle hip replacement system from proceeding to trial next month. 

Three rulings were issued last month by U.S. District Judge Ed Kinkeade, who is presiding over the coordinated pretrial proceedings for thousands of DePuy Pinnacle hip lawsuits in the federal court system, rejecting motions by the manufacturer that sought to dismiss lawsuits filed by Kathleen Herlihy-Paoli and Toni M. Lay, which are scheduled for trial to begin on September 1.

The Herlihy-Paoli and Lay cases were selected as the first bellwether trials in the litigation, which are designed to help the parties gauge how juries are likely to respond to certain evidence and testimony that may be repeated throughout a large number of cases.

DePuy currently faces more than 6,500 hip replacement lawsuits over the Pinnacle implant in the federal court system, which are all centralized before Judge Kinkeade in the Northern District of Texas as part of an MDL, or multidistrict litigation.

All of the cases involve similar allegations that the Depuy Pinnacle metal-on-metal hip replacement system was defectively designed, indicating that the cobalt and chromium implants can shed metal debris into the body, causing metal blood poisoning, or metallosis, tumors, tissue death and eventually catastrophic hip implant failure.

After denying motion to exclude plaintiffs’ expert testimony (PDF), motion to quash plantiffs’ notices for deposition of two orthopedic surgeons (PDF) and motion to dismiss (PDF), the cases have been cleared to proceed before a jury.

Motions Found To Be Without Merit

In one of the motions, the DePuy attempted to declare expert witnesses designed by the plaintiff as unqualified to testify regarding the Pinnacle hip. The company argued that Dr. John Abramson is a family doctor who should not be permitted to provide expert witness testimony in the Pinnacle litigation. However, Judge Kinkeade noted in his analysis and rejection of the motion that the defense was significantly downplaying Dr. Abramson’s qualifications, and that he was testifying specifically on claims of deceptive marketing by DePuy over the safety and efficacy of the Pinnacle hip.

“In 1997, he was appointed a clinical instructor at Harvard Medical School, and in 2009, he was appointed lecturer in Harvard’s Department of Health Care Policy. While at Harvard, he taught and lectured extensively on the challenge to clinicians in trying to make informed decisions about parmacotherapy care and how to interpret and integrate medical literature and data into a risk/benefit analysis in choosing appropriate treatments for patients,” Judge Kinkeade pointed out. “He has written extensively about the integrity of information that doctors rely upon in making clinical decisions. In 2002 he left his clinical practice to conduct full-time research in this area and has written a book on this issue.”

Judge Kineade declared that Abramson was “more than qualified” to testify as an expert witness. He ruled the same way on a list of other expert witnesses DePuy’s attorneys objected against.

“DePuy has made no credible argument that any of the Plaintiffs’ expert testimony is being offered by unqualified experts or is unreliable or irrelevant,” the judge ruled.

The motion for summary judgment claimed that the plaintiffs did not have sufficient evidence to make a reasonable case. Judge Kinkeade rejected that as well, finding that a reasonable jury could return a verdict for the plaintiffs.

DePuy Metal-on-Metal Hip Problems

The metal-on-metal configuration of the DePuy Pinnacle hip was used as the basis for the approval of the controversial DePuy ASR hip implant in 2005, with the Johnson & Johnson subsidiary obtaining “fast track” 510k approval by maintaining that the DePuy ASR and DePuy Pinnacle metal-on-metal hips feature “substantially similar” designs.

A DePuy ASR recall was issued in August 2010, after the manufacturer acknowledged that the implant carried a higher-than-expected rate of failures. Johnson & Johnson recently agreed to pay more than $2.4 billion to settle DePuy ASR lawsuits filed on behalf of about 12,000 people who received the implants.

DePuy has already begun dispensing payments for ASR hip settlements, and some reports indicate they have paid out $250 million to plaintiffs so far. However, the manufacturer has indicated that it intends to defend against the lawsuits over DePuy Pinnacle hips.

Other manufacturers of metal-on-metal implants face similar allegations that they failed to adequately research the design or warn about the risk of problems. Additional MDLs have been established in the federal court system for Biomet M2A Magnum metal hip lawsuits and Wright Medical Conserve Cup metal hip lawsuits.

In January 2013, the FDA released new guidance for metal-on-metal hip replacements, indicating that doctors should only use the design if other artificial hip implants are not appropriate. The agency also determined that future metal-on-metal hip designs will be required to undergo extensive human clinical trials before they will be approved.

7 Comments

  • kennyOctober 20, 2014 at 6:20 pm

    I believe the fda and depuy knew a long time ago that these products were bad, and did nothing to correct or stop the selling of these products. I received a pinnacle in 2010 at first it was good. Three months in, and I'm having lots of pain, had to get back on pain meds. I'm complaining to my Dr over and over, finally he did blood test, colbolt was at ,7.4 and cronyum was 4.3. Normal levels are l[Show More]I believe the fda and depuy knew a long time ago that these products were bad, and did nothing to correct or stop the selling of these products. I received a pinnacle in 2010 at first it was good. Three months in, and I'm having lots of pain, had to get back on pain meds. I'm complaining to my Dr over and over, finally he did blood test, colbolt was at ,7.4 and cronyum was 4.3. Normal levels are less than .01. Still my Dr was saying that those levels are safe. Well found out that those level r not safe and demanded a revision surgery. Finally I got it done one month ago. And the pain has not got any better. I'm only 50yrs old and can't work,and walking is really painful. I'm just tired of the bullshit and cover ups the big company's hide behind. I'm really hoping these jury's will see that and make them pay big time. The money won't make me better, maybe then I won't have to struggle to get by.

  • GeraldSeptember 26, 2014 at 1:23 pm

    What I still can’t understand is why the FDA hasn’t recalled the Pinnacle unit. After my replacement 2009, I too had to turn around in 2010 and have a full revision. The chronic pain after 15 or so dislocations is an ongoing pelage. Because; the product failed creating a ramp for my dislocations and now we can’t even get justice in a timely fashion. PROFIT, J&J are buying their way into the next q[Show More]What I still can’t understand is why the FDA hasn’t recalled the Pinnacle unit. After my replacement 2009, I too had to turn around in 2010 and have a full revision. The chronic pain after 15 or so dislocations is an ongoing pelage. Because; the product failed creating a ramp for my dislocations and now we can’t even get justice in a timely fashion. PROFIT, J&J are buying their way into the next quarter before they offer people a little chump change to those of us that have suffered.

  • stuAugust 28, 2014 at 4:34 am

    Your 100 percent on target but your forgeting the larger factor in play which is greed and money!!!

  • stuAugust 25, 2014 at 12:35 am

    Your 100 percent on target but your forgeting the larger factor in play which is greed and money!!!

  • stuAugust 23, 2014 at 3:45 pm

    I agree..

  • MartyGAugust 21, 2014 at 3:06 pm

    Prior to my 2nd total hip replacement in Nov 2009, performed in a V.A. hospital (again), the FDA had received approximately 1,000 adverse reports involving my DePuy Pinnacle metal-on-metal implant. The 1,000 or so reports filed are not the true number as filing these reports are voluntary and time consuming. Most surgeons have an aversion to doing additional paperwork, especially when not requir[Show More]Prior to my 2nd total hip replacement in Nov 2009, performed in a V.A. hospital (again), the FDA had received approximately 1,000 adverse reports involving my DePuy Pinnacle metal-on-metal implant. The 1,000 or so reports filed are not the true number as filing these reports are voluntary and time consuming. Most surgeons have an aversion to doing additional paperwork, especially when not required. My questions to the FDA are: Had this been a drug causing serious adverse affects to the prescribed patient, would they have ignored the 1,000 reports and not acted for years. Would they have ignored mounting physicians' complaints of serious interactions for years. If you're having an adverse interaction to a prescribed drug, you can simply stop taking it. When you're disabled by an implant, you must undergo another risky and painful surgery followed by an even longer rehab and recovery afterwards. The FDA cleared/approved the DePuy ASR in 2005 because DePuy claimed it was "substantially similar" to the DePuy Pinnacle metal-on-metal cleared/approved in 2000. When DePuy/FDA issued a recall of the ASR in 2010, then WHY wasn't the Pinnacle m-o-m implant also recalled when DePuy claimed the ASR to be "substantially similar" to the Pinnacle originally?

  • OliverAugust 17, 2014 at 4:23 am

    U ROCK JUDGE KINKEADE!!!!

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