Updated Schedule for Pending DePuy Pinnacle and Wright Conserve Hip Cases

The next DePuy Pinnacle trial is set for January 2016 in Dallas, Texas. The first Wright trial is tentatively set for August 2015 in Atlanta, Georgia. Additionally, a second Wright trial is set for November 2015 in Los Angeles, California.

Additionally, two Zimmer Durom Cup (another metal on metal hip) cases are headed to trial this month in Los Angeles, California and Newark, New Jersey. Both Depuy and Wright will be watching these Zimmer trials, which hopefully will result in positive outcomes for Plaintiffs that have had a mixed track record in metal on metal hip trials to date.

Metal-on-Metal Hips Linked to Illness

Patients with metal-on-metal hips around the world have growing concerns about the problems associated with the all-metal devices. When first introduced to the market, metal hips were touted as being more durable and suitable for relatively younger aged or more active patients, with the promise of lasting 20 to 25 years, but many have failed prematurely.

In recent years, metal-on-metal hip implants have been used in about one-third of the approximate 250,000 hip replacements performed annually in this country. “The devices, whose ball-and-socket joints are made from metals like cobalt and chromium, became widely used in the belief that they would be more durable than previous types of implants.”

The Sydney Morning Herald reports that hundreds of Australians with metal hip implants are worried about their hips leaching cobalt and chromium particles into their bodies. Many patients report similar symptoms, including nausea, vertigo, headaches, heart problems and more. Some injured patients have joined a class-action lawsuit underway in Federal Court. The lawsuit has been filed against Johnson & Johnson over its DePuy ASR hip implant, which the company recalled in August 2010, due to higher than expected failure rate. Many other patients with other brands of all-metal hip implants have complained of the same issues, although they are not involved in this litigation.

The cause and the scope of the problem are not clear. But recent studies indicate that in some cases the devices can quickly begin to wear, generating high volumes of metallic debris that is absorbed into a patient’s body. That situation can touch off inflammatory reactions that cause pain in the groin, death of tissue in the hip joint and loss of surrounding bone.

The Sydney Morning Herald reports on the story of Di Harvey, a former nurse who was implanted with a Birmingham Hip Resurfacing system in 2003. In 2010, she went to see an orthopedic surgeon for back pain. She had been suffering from the pain for years; it had been attributed to a “pinched nerve”. The surgeon, however, told Harvey her pain was transferred pain from her hip implant. The metal hip failed and needed to be replaced through a “revision” surgery. Harvey was implanted with a ceramic device but her problems continued..Her right hip caused her to favor the left leg, causing knee pain; she later received a knee implant as well.

Harvey’s following symptoms were worrisome. “I developed a hacking cough,” she said. “I got very sick, began vomiting bile every day. I had heart palpitations. I felt if I over-exerted myself I would drop dead.” She researched her symptoms further and learned about the growing concern of metal poisoning with metal hips. In June 2011, the Medical Journal of Australia published an article stating that it was an “emerging clinical problem”. The authors wrote that the metal devices released “a variety of metal ions into local tissue and [into] the general circulation…” and higher levels of cobalt were linked to hand tremors, depression, vertigo, hearing loss and heart problems.

“I have got rid of my BHR hip, but I have been told that once the cobalt and chromium get into your body the damage has been done.” Harvey says.

S & N Field Safety Notice Issued for Certain Sub-groups of Patients

According to the Food & Drug Administration (FDA), metal-on-metal hip implants have unique risks in addition to the risks of all hip implants. The metal “ball” and socket” grinds together as the patient implanted with a metal hip system walks or runs. The implant can shed tiny particles of chromium and cobalt around the hip or particles can potentially enter into the patient’s bloodstream. Over time, additional complications like inflammation, chronic pain, decreased mobility, tissue death, and bone loss may force a patient to undergo revision surgery.

Smith & Nephew is a medical device company that manufacturers the Birmingham Hip Resurfacing (BHR) system. The BHR is a metal-on-metal hip system, also the first metal hip implant to be approved in the United States. Other manufacturers have mimicked the BHR hip system, and currently faced with thousands of metal hip implant lawsuits.

In January 2015, Smith & Nephew released an urgent field safety notice for its BHR system. The field safety corrective action was undertaken as certain sub-groups have been identified to be at increased risk of adverse outcomes if fitted with the system. The safety notice informed patients that more information would be available on the company website. Patients who visited the website could not find any information or mention of the urgent field safety notice issued by the company.

It seems rather suspicious an urgent field safety notice would be issued directing patients to the company website and then, have essential information unavailable to the patient.

Metal-on-Metal Hip Implants Pulled From Market

Metal-on-metal hip replacements have recently been associated with serious side effects, including a significantly higher than expected rate of failure compared to other hip implants. The metal-on-metal design may also leak toxic chemicals into the body, increasing a hip recipient’s risk of metal poisoning and hip implant failure. An estimated 500,00 Americans have metal-on-metal hip implants, but many have no clue that they could be at risk of a severe side effect.

High failure rates and toxicity concerns have prompted the U.K. to ban metal-on-metal hip implants in hip replacement surgeries performed at National Health Service (NHS) hospitals. The NHS is the publicly funded health care system in the U.K.

The National Institute for Health and Care Excellence (NICE), issued the guidance to hospitals following alarming results from a recent study, according to The Telegraph.

The study of 17,000 patients with the devices found that some of the metal-on-metal brands had failure rates as high as 43 percent. Not only do early failures require patients to get follow-up hip replacement surgeries, called revisions, but health care professionals worry the metal hips may release toxic particles into the bloodstream.

New Warnings Issued for Smith & Nephew Birmingham Hip Resurfacing (BHR)

Smith & Nephew has issued a safety alert for its Birmingham Hip Resurfacing (BHR) system. Smith & Nephew issued a notice updating the instruction for use (IFU), after the manufacturer confirmed certain population sub-groups have been identified to be at risk of adverse outcomes if fitted with the product.

The urgent field safety notice (FSN) from Smith & Nephew revealed that women patients, men aged 65 or above and patients requiring an implant size of less than 48mm are at greater risk of requiring revision surgery earlier than expected.

It has been confirmed that the IFU changes are applicable to specific catalog numbers of the BHR Resurfacing Head, BHR Acetabular Cup and the BHR Dysplasia Cup, with more detail being available on the Smith & Nephew website. However, the website currently does not provide any information about the urgent field safety notice.

Kevin Timms, a lawyer at Irwin Mitchell’s London office who specializes in providing support to victims of faulty medical products, said: ” The new guidance issued by Smith & Nephew is a welcome step towards preventing certain sub-groups of patients from being at an earlier-than-expected risk of revision.”

“However, it also raises concerns regarding the number of patients who fall into those categories and may have already been fitted with the affected devices. As such, it is vital that the manufacturer works quickly to provide more information regarding the issues, as well as providing an explanation as to why a recall has still not been issued for small BHR implants and why the instructions for use were not updated in 2012 when a revision rate of 11.76% was confirmed in women with a 42mm femoral component. The delay is clearly unacceptable.”

“An issue of this nature is just the latest in a long line to raise concerns regarding the safety of hip replacement devices and many patients will be concerned to see these further concerns being raised.”

“Patients put great faith and trust in the fact that the devices they are being fitted with are safe for use and meet the required standards. An issue of this nature once again calls into question how specific devices are able to make it to market and whether the regulatory system in place is fit for purpose.”

“Every effort must be made to always put patient safety first and it is clear that there are many questions to be answered regarding these issues.”


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.

Long Road to Recovery

Doctors advised our veteran that he was headed down a long road to recovery following revision. Our veteran had 38 staples removed from the incision two weeks after revision surgery. We are thankful the incision was much smaller than originally anticipated by the surgeons. Doctors continue to take necessary precautions to ensure a favorable outcome.

After hip resurfacing surgery, symptoms surfaced that perhaps indicated something was not right with the metal-on-metal hip implant. Complaints of constant pain surfaced almost immediately after surgery. The doctor said to give the hip resurfacing time to heal. Weeks went by before weeks turned into months, and then months turned into years. The pain gradually intensified and interfered with all daily activities.

Revision surgery was required after 3 plus years of excruciating pain from the initial hip resurfacing procedure. Not even close to the 25 to 30 years of quality life promised by the manufacturer. Lawmakers, device makers, and the FDA should take a closer look at the devastation caused by these medical devices given approval without requiring any clinical testing. The FDA has since recommended changes to its policy, but does little to help those seriously injured by metal-on-metal hip implants.


We are in the process of getting things packed and preparing to make the long trip to the Mayo Clinic. We will have a full day of testing in preparation for hip revision surgery in the coming days. However, we want to thank all of those that have been very loyal and supportive along the way. For those that have gone through this process, you already know the pain associated with the metal-on-metal implants all too well.

No doubt we will be making our dreaded journey and counting down the days. The pain is already so intense that our veteran’s pain medication has been doubled to help control the pain. Watching a loved one go through such excruciating pain is mind-boggling and outrageous to think this is the best healthcare system in the world. Again, the Veteran Administration has repeatedly denied another seriously injured veteran benefits that were rightfully earned from an alleged service-connected disability. Please keep our veteran in your prayers.

WI Disabled Veteran Request for Congressional Hearing

A disabled veteran from Wisconsin has sent a letter to Congressman Reid Ribble requesting a Congressional Hearing before Congress over concerns of regulatory malfeasance at the FDA that led to the metal-on-metal hip replacement debacle. Metal hip devices were allowed to remain on the market without medical providers having any guidelines on how to monitor 500,000 Americans for the periprosthetic and systemic complications of chrome-cobalt metallosis.

The disabled vet received a metal-on-metal hip implant in 2010, and complained of groin pain almost immediately after being implanted with the premarket approval (PMA) hip implant. It is devastating to think that the FDA was formed to protect and ensure the quality of our lives. Yet, the FDA has granted manufacturers of premarket approval medical devices full immunity from patient lawsuits. These same medical devices were not required to undergo any clinical testing.

FDA’s Premarket Approval (PMA) Medical Devices

According to an article written by Cal Warriner, most Americans are unaware that anywhere from 75 to 90 percent of medical devices pass through the 510(k) gate to approval in the U.S. and these are the same devices that are failing in England, Australia and worldwide, as those countries often follow the U.S. lead to approval.

Warriner notes only three metal-on-metal resurfacing hip implants went through the FDA’s premarket approval (PMA) process and were required to provide clinical data to prove safety before they were approved in the U.S. The Birmingham Hip Resurfacing was finally approved in the U.S. in 2006 after initially being denied. It joins the Conserve Plus by Wright Medical, approved by the FDA after a PMA in 2009, and the Cormet by Corin in 2007 – all resurfacing devices.

Unfortunately for the patients who discover after the fact that they are experiencing complications with these PMA devices, they cannot hold the manufacturer accountable due to a U.S. Supreme Court Decision, Riegel v. Medtronics, which gave medical device manufacturers immunity in court if their product received FDA approval.