Friday, July 27, 2012

Recent Reports on Problems with the DePuy Pinnacle Hip Implant

Although Johnson & Johnson and its subsidiary DePuy—the manufacturer of a variety of medical hip implant devices—are likely to settle with recipients of the recalled ASR hip device they are taking a hard line in defense of the Pinnacle metal-on-metal claims. The company refuses to budge in their belief that the Pinnacle performs better than all other metal-on-metal hip devices largely due to the Pinnacle’s smaller head, believed to minimize the friction between the metal cup and ball. Legal experts feel Johnson and Johnson could merely be engaging in a roll of the dice in order to see how the first few lawsuits evolve—a common strategy in pharmaceutical litigation.

Johnson and Johnson could actually benefit from the fact that there is a lack of any American program which tracks the performance of medical devices which are implanted into patient’s bodies. Unlike the ASR device, the Pinnacle brand name encompasses metal-on-metal implants as well as metal-on-polyethylene and metal-on-ceramic. Johnson and Johnson and DePuy could be fighting so hard against Pinnacle allegations in order to protect the other two products which do not implement the metal-on-metal design but are sold under the Pinnacle name. Because DePuy has refused to publicly disclose the number of metal-on-metal Pinnacle implants, there is no hard data regarding the failure rate. A DePuy executive placed the number at 4-4.5 % failure rate within five years which is well within the acceptable limits. A UK study of approximately 1000 patients showed a failure rate of 8 percent at five years for the Pinnacle, climbing to 16% after six-and-a-half years.

Since there has been no recall of the Pinnacle as there was with the ASR, any problems with metal-on-metal Pinnacle systems are being reported in a hit and miss fashion. Most of those involved with the ASR litigation believe we will begin seeing overly high levels of cobalt and chromium in Pinnacle recipients as more of the patients begin getting blood tests after hearing about metallosis occurrences in ASR patients. Despite an order from the FDA in May, 2011, for all metal-on-metal device manufacturers to conduct follow-up studies in those cases in which an implant failure led to serious consequences, there has been some serious dragging of feet. Companies were expected to take blood samples from metal-on-metal hip implant recipients in order to measure metal ion levels in the bloodstream. As of this date, study protocols have been implemented for less than 25% of the devices and few of the study plans—including those of DePuy—have been finalized.

In May of this year the presiding judge of the Pinnacle MDL signed three documents which could significantly impact the future of Pinnacle metal-on-metal hip litigation. One of these documents is a Stipulated Protective Order of Confidentiality which applies to all documents, materials and information and states that no protected document may be used or disclosed other than to specified attorneys, consultants, experts, defendants or plaintiffs. The second document governs the production of relevant documents to the MDL and the third remanded one lawsuit which improperly addressed the ASR implant rather than the Pinnacle.

Andrew Sullo, Managing Partner and Class Action Lead Counsel of Sullo & Sullo, LLP believes that the Pinnacle litigation will run approximately 12-18 months behind the ASR litigation. The scores of boxes of discovery provided in the ASR cases will likely be identical in many ways to the impending Pinnacle litigation, meaning the ASR litigation will essentially pave the way for the future Pinnacle lawsuits. Sullo expresses that Johnson and Johnson’s stated intention to begin trying the Pinnacle cases could potentially “…turn out to be a big, big mistake. It’s a risky play for Johnson and Johnson, however if they play it right they may get out of the Pinnacle litigation for a lot less money than the ASR since the Pinnacle was not recalled.”

Since it is possible that recipients of the Pinnacle could end up with many of the same adverse health effects as those with the ASR implant, it is important that all those with a Pinnacle implant seek legal advice and assistance. Even if you have not yet experienced any ill effects from the Pinnacle device, you should nevertheless consult an attorney who has a broad range of knowledge on the metal-on-metal hip implant and the resulting litigation. At this point it is largely unknown what effects the cobalt and chromium which migrates into surrounding tissue and the bloodstream of the implant recipient will have on future health, and in the case of the ASR even those recipients who felt relatively fine found out later their levels of metal ions were abnormally high. Andrew Sullo wants all Pinnacle or ASR recipients to know that “Sullo & Sullo currently has dozens of DePuy ASR and Pinnacle clients,” and that the experienced and responsive attorneys of the firm will work hard to ensure all their hip implant clients are fully protected.

Author: Sullo & Sullo Attorneys

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