In 2013, DePuy Orthopaedics, Inc. removed its Pinnacle metal on metal hip implant from the market. The company claims that the device was discontinued due to declining sales. However, some medical experts and safety advocates allege that defects forced the company to remove the device from the market. But how could a medical device approved by the Food and Drug Administration (FDA) have defects? It may be due to the fact that the DePuy Pinnacle was never tested in humans.
Were Pinnacle Hip Implants Tested on Humans? The FDA is viewed as the gatekeeper between the public and medical devices. The agency is supposed to vet the safety of these products. But that testing doesn’t always happen. A process known as the 510(k) regulatory pathway can skirt clinical testing. If a company can prove its medical device is “substantially equivalent” to a similar device that’s already on the market, then it can release it without clinical trials DePuy used this process to get the Pinnacle implant on the market as soon as possible.
Does the DePuy Metal on Metal Pinnacle Implant Have Defects? About 150,000 Americans received Pinnacle hip implants before they were discontinued in 2013. The device was considered the company’s “Billon Dollar Baby,” but complaints about the Pinnacle are increasing. A report from 1995 found that metal on metal hip implants similar to DePuy’s Pinnacle showed signs of “sudden catastrophic breakdown”. And in 2004, a study of DePuy’s metal implant Ultima revealed that the device was releasing metal ions that were destroying bone and soft tissue near the implantation site. In a 2010 email to the company, one of DePuy Pinnacle’s designers warned that the product was hurting patients.
Despite these reports and complaints, DePuy never recalled its Pinnacle hip implants while they were still on the market. This is why many victims have turned to the law for help. The attorneys at Kershaw, Cook & Talley, P.C. represent hundreds of hip replacement patients. Our knowledge and expertise may be the determining factor in winning cases against the manufacturers of defective medical devices. Call (888)522-2372 for a free consultation.
Due to certain health conditions, some people require hip replacement surgeries. Artificial hip replacements are used to relieve hip pain, stiffness and immobility due to deterioration in the hip joint. The components of most hip replacements are made of a combination of metal, ceramic and polyethylene. Metal components, specifically metal-on-metal hips, which are made out of cobalt and chromium, can lead to serious health conditions.
If complications persist, a revision surgery is often needed to replace the defective and/or recalled implant, and repair the surrounding damaged tissue. However, patients are often older and weaker once they need a revision surgery, and severe complications can occur during their recovery.
Types of Hip Replacement Complications from Revision Surgery
Infection. A common complication from any surgery can be an infection. This happens when bacteria attach to the surface of a prothesis or to tissues in the area around an implant. Eliminating an infection deep within the body can be difficult, which can cause serious problems for a patient. Pain, loosening of the implant and drainage can result from this complication. Another revision surgery could be required to deal with the issue.
Pulmonary embolism. This complication can occur due to post-surgical blood clots. If some of that clotting breaks away and travels through the body and into the lungs, it can cause a pulmonary embolism. This can cause serious damage to your lungs, shortness of breath, chest pain and it could even result in death.
Heterotopic ossification. When bone grows in non-skeletal tissues like muscles and tendons it can cause pain and loss of motion. This abnormal growth is referred to as heterotopic ossification, and it can occur after a hip replacement revision surgery. This condition can take up to a year to develop, and treatment options range from movement therapy to medication, surgery or radiation therapy.
Dislocation and loosening. During revision surgery, many parts and even an entire implant can be replaced. However, the trauma from surgery can leave the body unable to properly heal. This means that further instability can occur over time and loosen or even dislocate the components from the replacement. This can result in severe pain and an inability to mobilize your hip joints. Many patients will have to undergo a re-revision surgery to stabilize the hip joint to prevent further dislocations or fix a leg length discrepancy that can occur from a revision surgery.
Metal-on-metal hip implants, including DePuy’s Pinnacle implant, may cause complications that require revision surgeries. Device failure, chronic pain, cobalt toxicity, and pseudotumors could require patients to undergo these procedures. While a revision surgery could alleviate problems caused by a Pinnacle hip implant failure, it also comes with risks. Some of these risks are common to surgical procedures in general, while others are only associated with revision surgeries.
Revision surgeries take longer to perform and are riskier than primary hip replacement procedures. The risks of a hip revision surgery may include, but are not limited to:
Infections. Infections are a risk associated with any type of surgery, including procedures for replacing a hip implant.
Blood clots. Blood clots are possible after a revision surgery. Some individuals may be at risk of developing a pulmonary embolism, which is a blood clot in the lungs.
Bone loss or bone fractures. Bone loss is possible after hip replacement revision surgery. Some patients may suffer bone fractures due to the revision procedure especially if their bone stock was compromised as a result of the metal-on-metal hip implant.
Dislocation. There is an increased risk of dislocation with hip revision surgeries. In such cases, the ball used in the hip replacement device comes out of the socket. The device could also be at risk of loosening after a revision surgery.
Anesthesia complications. Most surgical procedures require some type of anesthesia, either localized or general. Depending on the patient and other factors, anesthesia complications may occur during a hip revision surgery.
Tissue damage: Muscle atrophy and even necrosis (death) are typically seen in patients with MoM hip implants. When atrophy affects the gluteus minimus and/or gluteus medius (certain muscles in the buttocks), the surgeon may have to perform an abductor repair during revision.
Unfortunately, revision surgeries tend to be riskier than the index (initial) hip implant surgery due to the extent of tissue/bone damage caused by the Pinnacle hip implant. There is a further risk of bone loss in removing and replacing the cup. In addition, the surgeon may also have to remove the stem. If it is well-fixed, they may cut the bone (known as a trochanteric osteotomy) and this may also fracture the bone leading to a need for cables and plates. This would potentially require another surgery to remove those cables and plates. Furthermore, the recovery/rehabilitation is longer than the index surgery.
Our website contains questions you can ask your doctor prior to or after a revision surgery. Future blog updates will discuss answers to these questions in more detail. Be sure to continue following our blog for these important updates.
Recovering Compensation for Pinnacle Hip Implant Injuries
The medical device attorneys at Kershaw, Cook & Talley have experience with defective hip implant cases. If a Pinnacle hip implant harmed you or a loved one, then you could speak to our attorneys to learn about possible options for recovering compensation.
In late April 2018, the 5th U.S. Circuit Court of Appeals overturned the $151 million-dollar verdict in the second bellwether trial involving the defective DePuy Pinnacle hip implant. Bellwether trials are aimed at allowing involved parties to gauge the value of remaining legal claims and inform potential settlement talks. The Pinnacle metal-on-metal hip implant has been described as defective and was pulled from the market (but not recalled) after it was discovered that several recipients suffered significant pain, cobalt-chromium toxicity, pseudotumors and even total implant failure.
The initial trial verdict ordered Johnson & Johnson, and their subsidiary DePuy, to pay $502 million to the five bellwether plaintiffs, recipients of the Pinnacle hip implant. Subsequently, the Judge reduced the award to $151 million.
The appellate court overturned the verdict, citing that Judge Ed Kinkeade of the Northern District of Texas allowed the introduction of “inflammatory character evidence” establishing a link between Johnson & Johnson and bribes allegedly paid to Saddam Hussein’s regime in Iraq.
The appellate court decision has now set the stage for a retrial. Plaintiffs’ attorney, Mark Lanier, does not seek an appeal, but rather an immediate retrial. According to an interview, he believes that he will be able to recover an even larger verdict for the plaintiffs this time around. He stated that he believes the court misunderstood the issues and is pushing for a retrial as soon as possible.
Johnson & Johnson has said that it is now facing over 10,000 product liability lawsuits related to the Pinnacle hip implants. DePuy prevailed in the first bellwether trial related to the Pinnacle hip implant but has also been ordered to pay verdicts of $543 million and $247 million in other related trials. The attorneys at Kershaw, Cook & Talley are dedicated to keeping you updated on all proceedings relating to the Pinnacle hip implant litigation. If you had a defective Pinnacle metal-on-metal hip, call our firm for unparalleled legal representation. For a free case evaluation, call (888) 522-2372.