Hip replacements are surgical procedures to replace damaged or worn hip joints with an artificial replacement joint. Hip joint replacement procedures are fairly common and are done after the patient has experienced joint degradation due to injury or more commonly, simply because the joint has “worn out”.
Hip replacement surgeries can involve either the removal and replacement of the entire joint or the removal and replacement of only a part of the joint. Partial replacement can be done on the “ball” of the hip joint or femur head, or it can be done on the “socket” portion of the hip joint, also called the acetabulum. In less severe cases, some patients will undergo “hip resurfacing” in which an artificial cup is placed in the socket portion of the acetabulum and a cap is placed over the femur head.
Hip replacement surgeries have restored mobility to hundreds of thousands of patients but unfortunately, thousands of patients have not had positive results. Hip replacement procedures can cause a number of side effects, some of which are severe. The FDA has received thousands of complaints and severe adverse event reports involving a number of faulty hip replacement devices.
The models of hip replacement devices most commonly included in FDA complaints include:
- Pinnacle and ASR hip replacement systems – DePuy Orthopaedics and Johnson & Johnson
- Rejuvenate and ABG hip replacement systems – Stryker Orthopaedics
- Durom and M2a Magnum hip replacement devices – Zimmer Holdings Inc. and Biomet
- R3 Acetabular System – Smith & Nephew
- Conserve and Profemure hip replacement devices – Wright Medical Technology Inc.
A large percentage of hip replacement failures have been caused due to the design of certain devices with Metal on Metal (MoM) design. Unlike devices made with plastic components MoM, allows for the components to grate against one another producing metal ions which may be toxic.
Other device failures may be caused by Metal on Plastic (MoP) devices which allow for shedding of plastic particles into the joint or may be caused by dislocation, detachment or degradation of the artificial joint.
Thousands of Lawsuits have been filed because of hip replacement devices which caused medical injuries, the need for revision surgery, permanent disability and even death. Some of these lawsuits have been settled but many more remain in federal, state and local courts and more lawsuits may be expected.
Hip Replacement Side Effects
Any medical procedure may result in side effects, including hip replacement. Other side effects are more severe and warrant additional medical treatment.
Some of the common side effects include:
- Pain and inflammation
- Muscle loss
- Painful recovery
Side effects that are more severe are commonly the result of metallic or plastic debris which has been shed from the device and may lodge in the joint area. In addition to localized damage from plastic, or localized poisoning from metal (known as Metallosis), the patient may also experience systemic or body-wide poisoning from metal.
Other patients may have an implant which exhibits early failure due to detachment or dislocation of the device.
Severe side effects may include:
- Osteolysis – bone dissolution
- Necrosis – bone and tissue death
- Pseudotumor formation – false tumor formation in surrounding tissue
- Bone fractures – due to weakened bones in hip or femur
- Joint dislocation – artificial joint loosens or separates from healthy bone
Most patients who experience serious side effects must undergo revision or replacement surgery to remove the faulty device and replace it with a new one. Some patients with extensive damage may also require one or more reconstructive surgeries to repair fractures or other bone deformities.
Components of Metal on Metal hip implant devices may grate against one another and allow metal particles to be shed into the surrounding tissue. When fragments are lodged in the joint tissue, a condition known as Metallosis develops and is essentially “poisoning” of the surrounding tissue. All faulty hip implant devices may shed metal fragments, but MoM devices are the worst offenders.
Many of the severe side effects of hip devices which show early failure rates can be attributed to Metallosis including and most of these patients will be required to undergo revision surgery and may require reconstructive surgery as well, depending on the severity of bone damage.
Very small metal fragments or ions may be absorbed into the bloodstream, causing patients to have a series of flu-like symptoms such as:
- Body Aches
Systemic metal poisoning may also result in an immune crisis or neurological damage which may be severe.
Hip Revision Surgery
When a hip device has shown early failure, severe complications may result. In most cases, the patient will be required to undergo another surgical procedure to remove and replace the faulty device.
Hip revision surgery is often much more invasive and painful than the original surgery and poses additional risks to the patient. Patients will often experience more pain and require a significantly longer recovery time.
If damage to previously healthy bone tissue is severe, patients may also be required to undergo reconstructive surgery to repair degraded or fractured bone with titanium screws and rods or with bone grafts. In many cases, a reconstructive surgery is required before the replacement or revision surgery. Each time the patient undergoes an additional surgical procedure, the risk of complications including infection, pain and lengthy recovery time will increase.
FDA Approval Process
All of the hip replacement devices available in recent history, including those still on the market, were approved using the FDA’s 510(k) pathway. This is a “shortcut” approval process which allows the manufacturer to skip costly clinical trials.
A manufacturer of a medical device is allowed to claim that the new device is similar to devices already on the market. This allows the manufacturer to market a new device without ever testing it in human subjects. Some experts have blamed the adverse event rate of MoM and other devices on this shortened pathway and have urged the FDA to close the 510(k) loophole.
Hip Recalls and Lawsuits
Several of the hip implant devices named in lawsuits have been recalled. The majority of these are MoM type hip replacement devices and all of them were approved under the FDA 510(k) marketing pathway.
DePuy Orthopaedics is a subsidiary of the pharmaceutical giant Johnson & Johnson which has estimated annual sales of more the $72 billion. DePuy manufactures three hip devices which have resulted in thousands of medical injury lawsuits, primarily due to MoM construction:
- Pinnacle Hip Replacement System
- ASR XL Acetabular System
- ASR Hip Resurfacing System
The two ASR systems were recalled in 2010, while the Pinnacle system was discontinued without being recalled. More than 17,000 lawsuits have been filed against DePuy and many more are expected.
The first ASR lawsuit was filed in California for an implant procedure which occurred in 2007. In 2013, the couple filing the lawsuit received $8.3 million in damages for significant injury including loss of marital relations. Federal lawsuits for ASR devices were consolidated into multidistrict litigation (MDL) in Ohio. The first bellwether or test trial was set to begin in September of 2013 but was settled out of court. Shortly after that settlement, Johnson & Johnson agreed to settle approximately 7,500 lawsuits for a total of $2.5 billion (approximately $250,000 each). Bloomberg reported that the company has also agreed to settle another 1,400 lawsuits for $420 million.
Over 7,100 federal lawsuits for the Pinnacle devices were consolidated into MDL in Texas. The first bellwether trial, held in October 2014 resulted in a judgement for the defense but 10 additional bellwether trials are scheduled to begin in 2015.
Stryker Orthopaedics is the largest global orthopedics company and manufactured the first MoM device. Two hip replacement devices manufactured by Stryker have resulted in thousands of lawsuits against the company.
- ABG II System
- Rejuvenate System
In 2012, both of the systems were recalled a few months after Stryker had issued warnings to physicians about metallosis, necrosis and other complications that would result in revision surgery. The first lawsuit was filed in New Jersey in 2012 and hundreds of NJ lawsuits have been consolidated into multi-county litigation. Federal cases were consolidated into multidistrict legislation (MDL) in Minnesota. Many more lawsuits have followed and more are expected.
The first four NJ cases were settled out-of-court in 2013 with an additional eight cases settled in 2014. In November of 2014, Stryker offered plaintiffs in both MCL and MDL cases a total settlement of $1.43 billion or approximately $600,000 each.
The first lawsuits regarding Stryker’s faulty Rejuvenate and ABG II hip implants were filed in August of 2012 in federal court. Those initial lawsuits and hundreds that followed were consolidated into multidistrict litigation (MDL) in the U.S. District Court for the District of Minnesota. Hundreds of lawsuits filed in New Jersey courts were consolidated into multi-county litigation and many more have been filed in other state and local courts.
Zimmer Holdings is set to acquire Biomet by July 2015. The acquisition will create the second largest hip device manufacturer. Zimmer and Biomet both have manufactured hip devices which have resulted in thousands of lawsuits.
- Durom Acetabular Component (Durom Cup)
- Magnum M2A Implant
The Zimmer Durom Cup was temporarily recalled but remains on the market and the Biomet Magnum M2A hip implant also remains on market. Zimmer has already paid $400 million to settle thousands of lawsuits regarding the Durom Cup and expects to pay at least $200 million more.
Biomet federal lawsuits were consolidated in MDL and 1,140 cases have been settled for $56 million or up to $200,000 each, however the company has also faced claims by the Securities and Exchange Commission (SEC) and was found guilty of bribing doctors in China, Brazil, and Argentina to use its hip replacement. Biomet paid $22.9 million in 2012 to settle these charges.
Smith & Nephew manufactured one device with all metal construction which has been the subject of of hundreds of injury-related lawsuits.
- R3 Acetabular System
The R3 Acetabular system recalled in 2012 as the first of its kind and has shown a failure rate of over 6 percent. It was recalled in 2013 with nearly 8,000 patients having received the device and now being at risk for revision surgery. Smith & Nephew is facing numerous medical injury lawsuits and the company has also paid $28.9 million in fines to the USDOJ but none of the hip lawsuits have been settled.
Wright Medical Technology Inc. manufactures hip joint replacement devices, some of which are similar to DePuy products.
- Conserve Total Hip Implant System,
- Conserve Total A-Class Advanced Metal Hip Implant System
- Conserve Resurfacing System.
- Profemure Z Stem hip device
Over 10,000 of these devices have been implanted and they remain on the market, despite multiple complaints of early failure. Because of these failures, Wright is facing multiple lawsuits
Federal Conserve lawsuits have been consolidated into MDL in Georgia but only one lawsuit has been settled for an undisclosed amount. Wright also has paid $7.9 million to settle bribery charges.
Thousands of lawsuits filed against hip device manufactures claim that the companies constructed faulty devices, did not adequately warn the medical community and public about risks of the devices, and aggressively promoted their devices with many companies also accused of paying doctors to use them. Many more hip replacement lawsuits may be expected.