Metal-on-Metal Artificial Hips Are Linked to Failures and Bone and Tissue Damage
The scale of the problems linked to the failure of artificial metal-on-metal hip implants became apparent at the end of 2016 when Johnson & Johnson was ordered to pay more than $1 billion to patients harmed by its Pinnacle artificial hips. Metal-on-metal hip implants have been used since the 1950s when a chrome cobalt metal on metal articulation system was developed. Over the last decade, numerous complications and failures resulted in thousands of lawsuits against the manufacturers.
The Demand for Hip Replacement Devices
As we age our hips can wear out. Conditions such as osteoarthritis, rheumatoid arthritis and osteonecrosis, can lead to a breakdown of the hip joint. The hip is one of the body’s largest joints that bears weight. It’s a ball and socket joint. The ball is the femoral head, which is at the upper end of the thigh bone. The socket is comprised of the acetabulum, which is a portion of the large pelvis bone.
According to Centers for Disease Control and Prevention (CDC), 332,000 hip replacements are performed every year in the United States. Hip replacement is also known as arthroplasty. It’s a surgical procedure in which surgeons removed the damaged or diseased part of the hip joint and replaces it with artificial parts. In the past, hip replacement operations were usually performed on people over 60 who are generally less active. In recent years more younger people have received hip implants, states the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
What Are Metal-on-Metal Artificial Hips?
Metal-on-Metal hip implants offer a durable alternative to implants using plastic or polyethylene. Metals such as titanium alloy, cobalt chromium alloy, or stainless steel have been used since the 1950s. The U.S. Food and Drug Administration (FDA) approved their use in the late 1990s. Metal-on-metal implants potentially reduce wear and tear and cause less bone loss and inflammation than plastic alternatives.
Artificial hip implant devices were approved via the FDA’s controversial “fast track” procedure.
The FDA created these programs in the early 1990s under the Prescription Drug User Fee Act (PDUFA) with the aim of meeting treatment needs for life-threatening or serious medical conditions more quickly.
Hip and knee implant devices are exempt from rigorous testing as long as they are “substantially equivalent” to devices that are already found on the market. Our Virginia defective medical devices lawyers have seen many instances of devices that use the fast track procedure resulting in lawsuits. They include transvaginal mesh products. Both the ball and socket are made of metal in Metal-on-Metal (MoM) artificial hip implants. The ball is larger than is the case with plastic implants, making the hip joint more stable and less likely to dislocate.
The Side Effects of Metal-on-Metal Artificial Hips
The metal surfaces of the artificial hip can give off small particles of debris. Metal can also corrode, transferring metal ions to the body. Metal particles and ions can enter the space around the implant, as well as the transplant recipient’s bloodstream. The transferal of metal can cause pain or swelling in the area around the artificial hip, osteolysis, and symptoms in other parts of the body in rare instances.
The body can react to these foreign particles, and cause the device to move, leading the implant to fail. The failure of metal-on-metal hip implants is not only painful but it typically requires additional surgery. The main side effects recorded in transplant recipients that have led to lawsuits include:
- Metallosis that can lead to bone and tissue death;
- Osteolysis that leads to the loss of bone around the implant;
- Pain and swelling;
- Conditions not linked to the hip in a small number of cases;
- Failure of the metal-on-metal artificial hips leading to further surgery. A second surgery is called a revision surgery. There may be inherent complications.
Updates on Metal-on-Metal Hip Implants from the FDA
On May 6, 2011, the FDA issued a postmarket surveillance study of total metal-on-metal hip replacement devices. The FDA ordered manufacturers to further study the safety of these implants. On January 17, 2013, the FDA updated its public health message related to metal-on-metal artificial hip implants. In 2016, the FDA issued new patient advice for people who received metal-on-metal hip transplants.
Lawsuits Over Failures of Metal-on-Metal Artificial Hips
Several manufacturers of metal-on-metal hip implants are facing large-scale lawsuits that allege they failed to warn the public about the risks of the devices. Johnson & Johnson’s DePuy unit has been hit by more than 12,000 lawsuits. The pharmaceutical company paid almost $2.5 billion to settle claims over its ASR device in 2013. Devices that were prone to failure were recalled by companies including DePuy, Biomet, Smith & Nephew, Stryker, Wright and Zimmer.
These all-metal devices were meant to last far longer than they did for many recipients.
A jury ordered DePuy to pay $502 million to five plaintiffs who said their Pinnacle Ultramet implants failed in March, 2015. In late 2016, DePuy was ordered to pay more than $1 billion to six patients who claimed they were harmed by Pinnacle artificial hips. The verdict in Dallas included $30 million in actual damages and $1 billion in punitive damages.
Johnson & Johnson faces almost 9,000 more lawsuits related to the Pinnacle product that was withdrawn in 2013.
Many other manufacturers’ metal-on-metal (MoM) implants are linked to a wide range of complications that required painful and risk-fraught surgeries to correct problems and replace the implants. They are also facing lawsuits. Litigation against Stryker is consolidated into multicounty litigation (MCL) in the Superior Court in Bergen County, New Jersey., and in the U.S. District Court of Minnesota. The consolidation of cases expedites hearings. In 2014, Stryker agreed to settle thousands of claims for $1.43 billion. Many of these lawsuits have honed in on the design of the implants which can lead to early failure and metallosis.
Hurt by a Faulty Hip Implant? What You Should Do?
When metal-on-metal artificial hips fail, the patient can suffer severe pain and discomfort, health impacts and the need for a dangerous revision surgery.
The big drug and medical device companies put profit above patient safety. Often, these products have not been rigorously tested before they are used in procedures. The massive awards by juries reflect the disdain held for these practices. At Cooper Hurley Injury Lawyers, we have helped people who have been injured by defective metal-on-metal hip implants and we can ensure you join a mass tort action.
Time may be running out to make claims as some of the settlements will close to “new” cases in the near future. Call us today at 757.455.0077 or toll free at 866-455-6657 for a free consultation.