First Pinnacle Hip Replacement Lawsuit

Jurors are hearing the first Pinnacle hip replacement lawsuit of a 58-year old Montana woman. In September 2006, she received a Pinnacle hip system on her right side, and left side in April 2007, respectively.

After suffering from complications, she underwent revision surgery in 2010, and subsequently has undergone additional procedures since, according to court documents. In January 2013, the U.S. Food and Drug Administration (FDA) issued a warning that metal-on-metal hips were more likely to fail compared to other options.

J & J and its subsidiary, DePuy Orthopaedics, announced that the company would discontinue sales of its all-metal hip implants in May 2013, including those related to the Pinnacle Hip System.

The lawsuit alleges surgeons discovered that the hip turned black due to metallosis upon removal. Additionally, the device allegedly caused her to suffer elevated levels of cobalt in the blood, allegedly as a result of the Pinnacle’s defective design.

Metal-on-metal Hip Systems

Metal-on-metal hip systems are regulated under the Food and Drug Administration (FDA) 510(k) premarket notification program and classified as Class III (higher risk) devices. In addition, the medical devices are not required to undergo premarket testing or clinical trials before they are used in patients. Under the 510(k) program, manufacturers simply have to state that their medical devices are similar to medical devices already on the market.

In May 2011, the FDA ordered 21 prosthesis manufacturers to conduct post-market studies on their metal-on-metal hip systems. A year later, an FDA panel concluded that there is little benefit for surgeons to continue using metal-on-metal hip implant systems. The FDA said “a decision on the proper classification of metal-on-metal hip systems is forthcoming.”

This fails to bring comfort to those seriously injured by these all-metal implant systems. People are stunned to learn Congress entrusted the FDA with protecting the general public. However, the FDA’s actions appear to be favorable to business, but offers little protection for those injured by metal-on-metal hip implants with the 510 (k) premarket approval.


Most manufacturers have already pulled their metal-on-metal hip implants from the market due to the growing number of patient injuries. These widespread patient injuries prompted an increased regulatory focus, numerous medical studies, and negative publicity. In addition, manufacturers are also faced with thousands of product liability lawsuits from patients seeking compensation for their injuries. Some manufactures have agreed to settle these hip replacement lawsuits. For instance, DePuy Orthopedics, a subsidiary of Johnson & Johnson, reportedly agreed to settle some 8,000 lawsuits for an estimated $2.5 billion.

Nearly one-third of surgeries performed in the U. S. have been with metal-on-metal hip implants over the past several years. This is a vital concern because hundreds of thousands of hip recipient’s undergo hip replacement surgery in the U.S. each year. The manufacturers of these devices taunted in the past that the chromium and cobalt pieces that make up the ball and socket joints are more durable than other similar implants.

This option became quite attractive for many younger patients with the desire to have an active lifestyle and improved quality of life. However, the metal-on-metal hip implants have recently come under fire by many critics with voiced concerns that all-metal hip implants may be responsible for tissue and bone damage. The tissue and bone damage has led to the need for revision procedures for hip recipients much sooner than surgeons originally projected. Revision procedures are not only risky for patients but costly as well.


Metal-on-metal (MoM) hips were originally marketed as an alternative to the traditional ceramic or plastic hips and were targeted for the younger, more active patients. Many of these younger patients are in their 40s and 50s, faced with a lifetime of injury and complications ahead. Patients with a lifetime injury and complications allegedly caused by the metal-on-metal hips are likely to endure a longer recovery process after revision surgery.

Many hip recipients with hip replacement failure have reported numerous problems. These problems include: breakage (primarily caused by constant weight-bearing stress), fractures (typically near the artificial joint), loosening of the attachment between the bone and the artificial device (both in cemented and un-cemented artificial joints), wear and tear on the parts, pain and stiffness caused by the loosening of the attachment between the implant and bone, instability (typically occurs when the artificial joint dislocates), and infection.

These problems can lead to the need for revision surgery, and may require a lengthy recovery process. There are no guarantees revision surgery will ever fix the problem (s). Your surgeon will explain this to you during your surgical consultation.

Memorial Day 2014

Memorial Day is a time to remember and honor those that have risked their lives to protect us and our country. It is also a day for us to remember our fallen heroes, our loved ones who served and pay respects to our servicemen and women who have donned the uniform of the United States Armed Forces.

Each one put service before self. It is because of their selfless contributions that missions are completed, battles won, and our nation continues to thrive in freedom. This weekend will reflect on our Nation’s history and core values with great pride. We often hear the words, “Freedom isn’t free.”

Today, we remember those heroes who preserve our freedoms by supporting and defending, and at times sacrificing their lives for the guarantee of rights, liberties, and pursuit of happiness to every American citizen. There is absolutely no greater sacrifice than paying the price with one’s life for their country. As we go about our daily lives, please take a moment to thank those who paid the ultimate price. May God Bless, God Speed, Hurry Home.


According to British Medical Journal (2012), hundreds of thousands of patients around the world are suffering the consequences of failing metal hip implants. These people may have been exposed to dangerous levels of toxic metals. Patients who receive metal-on-metal implants risk cobalt and chromium ions leaking into the tissue, which can result in local reactions that damage bone and muscle, causing long-term disability in some cases.

Studies have shown if metal ions seep into the bloodstream that they can spread into the kidneys, lymph nodes, spleen and liver, before exiting the body in urine. Some experts have concerns whether there might be chromosome destruction, leading to genetic alterations. Scientist first described in detail a link between local tissue reaction and metal ions in 1975. Regardless of the harmful risk, makers continue to produce metal-on-metal implants despite increasing evidence of risk.


As recently as 2010, it was estimated that as many as one-third of the 250,000 hip replacement surgeries performed each year in the U.S. involved the use of metal-on-metal hip replacements. Such devices were marketed to younger, more active patients, and it was believed that they would prove to be more durable than hip implants constructed of other materials.

However, the U.S. Food & Drug Administration (FDA) allowed metal-on-metal hip replacements to come to market under its 510(k) approval process, which doesn’t require any human testing for medical devices that are shown to be “substantially equivalent” in design to a product already approved by the agency. Unfortunately, this type of FDA clearance means that any problems with a medical device are not usually detected until it has been used in hundreds, if not thousands, of patients.

DePuy Pinnacle Lawsuits Increase

The numbers of DePuy Pinnacle lawsuits continue to grow in the federal litigation established in the Northern District of Texas. Over 5,700 DePuy Pinnacle hip lawsuits have been filed in the proceedings on behalf of individuals who have been seriously injured by these implants, allegedly due to the metal-on-metal version of DePuy Orthopaedics’ Pinnacle Hip Replacement System. Court documents indicate that the number of filings have increased by more than 150 since the Court issued its previous update in late January 2014.


We have recently made a difficult decision to close our store as we change suppliers. We feel that God is leading us in another direction. We believe our supplier should be veteran-owned to better suit our needs. This is not a decision made lightly, and we certainly appreciate all your prayers and support, and earnestly desire your prayers right now. We want to fulfill our mission, and we need wisdom for all the decisions involved in this transition.

God has been very good to us. We are one step closer to securing our veteran’s home from foreclosure. This is truly a gift from above considering our veteran is also recovering from revision hip surgery. The additional stress is definitely something he does not need at this point. Please pray for God’s healing and wisdom concerning the upcoming decisions we need to make during this transition.


Several medical groups, including the American Association of Hip and Knee Surgeons, the American Academy of Orthopaedic Surgeons, and The Hip Society, have issued a Consensus Statement regarding the management of patients with metal-on-metal (MoM) hip implants. The purpose of their statement is to inform and educate patients, and the public at large, about the issues surrounding metal-on-metal hip replacements.

A vast majority of patients who have hip replacements have experienced positive results and are quite pleased with their surgical outcome, but some hip replacements fail. Hip replacements can fail because of various reasons, such as the implants become loose in the bone, the hip comes out of the socket (dislocation), the joint becoming infected and the surface of the joint replacement wears out. The debris generated by wear of the joint replacement can damage the surrounding bone and soft tissues (muscles, tendons, ligaments, and hip capsule).

Some recent scientific studies have reported a higher than expected failure rate of metal-on-metal hip replacement design. Although the exact number of MoM hip replacements performed to date in the United States is unknown, nearly 40,000 all-metal hip replacements were performed during a 12-month period from 2005 to 2006 in the United States. An estimated 32% of all hip replacements were allegedly performed in the country during that timeframe.

It is worth noting that adverse periprosthetic tissue reactions involving the hip joint have emerged as an important reason for metal-on-metal hip implant failure. The Consensus Statement was published jointly in the January issue of the Journal of Bone and Joint Surgery. The findings pertaining to failure rates and adverse tissue reactions associated with metal-on-metal hips noted in the Consensus Statement is consistent with the allegations put forth in DePuy Pinnacle lawsuits.