First Pinnacle Bellwether Trail To Start Today

Jury selection is set to begin today in the first bellwether case in the DePuy Pinnacle MDL. It is among more than 6,000 cases currently pending in the MDL. The cases have been consolidated before U.S. District Judge Ed Kinkeade in Dallas. Judge Kinkeade will preside over the trial.

Depuy is a subsidiary of Johnson & Johnson (“J&J”). The plaintiffs allege metal-on-metal version of the Pinnacle hip was defectively designed and caused metal debris to leech into patients’ bloodstreams. 

J&J had heavily touted the metal-on-metal implants, first sold in the U.S. in 2005, as a design that would last 20 years and offer greater range of motion. However, 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.

The Pinnacle line of hips wasn’t covered by J&J’s $2.5 billion settlement of claims that its ASR hip devices shed chromium and cobalt debris from the metal-on-metal which caused tissue death and increased metal ions in the blood. Other complications from the ASR hip devices included dislocations, pain, and required surgical removal.

It is estimated the trial will last up to six weeks.

Smith & Nephew Voluntary Withdrawal of Metal Hip Liner

Smith & Nephew PLC said Friday that it is pulling a metal liner used in hip replacements from the market. The London company said the device is the optional metal liner for its R3 Acetabular System hip devices. Smith & Nephew said it is "not satisfied with the clinical results" of the liner because some patients needed an additional surgery to have the liner removed. It described the move as a precaution.

The U.K.-based device and medical technology company disclosed what it termed as a "voluntary market withdrawal" of an "optional metal liner component" for its R3 Acetabular system, which serves as the "socket" portion of a hip implant. The withdrawal encompasses the optional metal liner, or cup, component. Surgeons, however, will still be able to use the system using alternative non-metal liners and the company said it did not anticipate any delays to surgery.

A small number of patients experienced problems including infections, fractures and dislocations - but there was no evidence of "metallosis", or the build-up of metallic debris in the body, a corporate spokesman said. The veracity of this statement is yet to be determined.

Smith & Nephew said about 7,700 metal liners have been implanted since the piece first became available in 2007, mostly for stemmed total hip replacements. The component launched globally in 2009. Patients who have the liner as part of their implant are being urged to talk to their surgeons if they are dealing with any unusual symptoms.

A Smith & Nephew spokesman said that U.S. and European regulators have been notified of the company's voluntary action, which was based on clinical data from multiple sources. Among them: The U.K. National Joint Registry shows a revision rate of 6.3% after four years for the part, and the Australian National Joint Replacement Registry shows a revision rate of 4.96% after two years.

The company cautioned in its statement that other R3 system liners, made of polyethylene (and ceramic outside the U.S.) aren't affected by the market withdrawal. Smith & Nephew also downplayed the impact it would face taking the component off the market, noting that the company reported $4.27 billion in revenue in 2011 and claims less than 1 percent of that revenue came from procedures involving the recalled component.

The R3 system itself has been an issue for the company in the past. In December of 2010, the FDA issued Smith & Nephew a warning letter regarding the company's Tuttlingen, Germany facility that produces the implant. The FDA said that the company had not performed adequate tests and that it failed to establish and maintain a process that would correct manufacturing problems. At the time, Smith & Nephew said it took initial action to resolve any FDA issues. (Other sites in the U.K. and U.S. also manufacture the device.)

The voluntary recall will only add to concerns about the safety of metal-on-metal hips. Metal-on-metal hips were developed to be more durable than traditional implants, which combine a ceramic or metal ball with a plastic socket. Smith & Nephew, through a company spokesman said the issues with its system were different to those seen with some other all-metal implants, such as the high-profile recall of the DePuy metal-on-metal ASR system.

If you or a loved one have had hip replacement surgery and have been implanted with a defective Smith & Nephew R3 Acetabular system, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries. Our firm is currently investigating claims for those people who have been implanted with the Smith & Nephew R3 metal liner. If you would like a free case evaluation, please contact Booth Samuels toll free at 1-866-515-8880 or at booths@pittmandutton.com.

DEPUY PINNACLE RECALL ON THE HORIZON???

In the fall of 2010, a recall was implemented for the DePuy ASR hip replacement system, causing the public to question DePuy’s reliability as the leading medical device manufacturer in the world. DePuy is a subsidiary of Johnson & Johnson. When the recall was initiated, the failure rate of the ASR system was estimated to be 12-13% among patients. DePuy has another hip replacement system called the Pinnacle which is similar to the recalled ASR model.

The U.S. Food and Drug Administration (FDA) allowed the marketing of the DePuy ASR system to the public through the 510(k) approval process on the basis that the device was substantially equivalent to the DePuy Pinnacle hip replacement system already approved for distribution. The 510(k) approval process allows a medical device to be placed on the market without being subjected to necessary clinical trials. The ASR system is a metal-on-metal hip replacement device that utilizes a metal ball and metal lined cup to replicate the natural movement of a hip joint. Some Pinnacle hips are also metal-on-metal because the device can include a metal liner. DePuy claimed that metal-on-metal hip replacements have increased durability.

The most prevalent and serious problem associated with metal-on-metal hips is metallosis, which can lead to soft-tissue damage, rashes and pseudo-tumors. Another common complaint of the DePuy Pinnacle hip replacement system is loosening of the device. One of the more serious complications is bacterial infection, occurring more often in elderly or obese patients. In addition, blood clot formation is another life-threatening condition, especially if the clot travels through the bloodstream and causes a stroke.

Although a DePuy Pinnacle hip recall has not been issued, patients who have been implanted with the DePuy Pinnacle Acetabular Cup System may have legal recourse. Several DePuy Pinnacle lawsuits have already been filed, and patients experiencing DePuy Pinnacle problems with the metal-on-metal systems may be able to participate in a similar legal action. Our firm is currently investigating claims for those people who have been implanted with DePuy hip replacement devices, both ASR and Pinnacle. If you would like a free case evaluation, please contact Booth Samuels at toll free 1-866-515-8880 or at booths@pittmandutton.com.