Faulty Hip Replacements
Premature failures, faulty components and contaminated devices have prompted hip implant manufacturers to issue safety alerts and recalls of their products. In many cases, patients needed to undergo additional surgeries to correct the faulty hip replacements. Even then, full recovery was not guaranteed.
Hip replacement is the surgical removal and replacement of a damaged hip joint with an artificial joint. Hip replacement surgery is often recommended if pain and stiffness interfere with a patient’s normal ability to do everyday activities and after other treatments have not helped.
Common Conditions That Can Damage Hip Joints
There are many medical conditions that can damage hip joints. The most common reason for hip replacement is osteoarthritis, a condition that occurs when the cartilage covering the ends of the bones where they meet to form joints breaks down. This causes the bones of the joint to rub together, creating growths of bone spurs around the joint. These spurs can cause great pain and stiffness.
Other possible causes include:
- Bone tumors
- Rheumatoid arthritis (the body’s immune system attacks the membrane that lines the joint)
- Osteonecrosis (blood supply to the bone is cut off, causing the bone to die)
Hip Implant Complaints and Recalls
Defective hip replacement implants have been the subject of numerous safety alerts and recalls over the last several years. As early as 2001, the Food & Drug Administration (FDA) announced that several U.S. medical device firms would voluntarily recall hip implants because of various problems.
According to the FDA, the following symptoms may indicate that a hip implant is not functioning properly; this is especially true if these symptoms are experienced three or more months after surgery. They include, but are not limited to:
- Pain in the hip, leg or groin
- Sounds from the hip joint (such as popping, grinding, clicking or squeaking)
- Noticeable limp
- Change in mobility
Lawsuits Have Been Filed Against Major Manufacturers
Recipients of hip implant devices have filed numerous lawsuits seeking compensation for medical expenses and physical pain due to their hip implant issues. Furthermore, plaintiffs are filing these suits to hold medical device manufacturers accountable for their actions of releasing these allegedly faulty devices into the market.
Conditions that plaintiffs claim have lead to:
- Severe pain
- Dislocation of joint
- Nerve damage
- Additional surgery
These lawsuits make a number of allegations against the manufacturers, including that they:
- Failed to warn of the risks
- Failed to properly test the device before selling it
- Improperly marketed the device
- Released inaccurate and misleading statements about the device’s safety and effectiveness
- Unfairly profited from sales
- Failed to properly warn doctors and patients about the dangers of the device, including heavy metal toxicity and early corrosion and deterioration
- Systems had design and manufacturing defects that could cause serious and permanent damage to patients
- Systems release could heavy metals into patients’ bodies, leading to destruction of bone and tissue
- Failed to warn of an increased need for additional surgeries
- Failed to warn of possible kidney function impairment
- Failed to warn of possible thyroid, neck, weight, and fatigue problems
- Failed to warn of possible psychological issues such as depression and cognitive skills impairment
- Failed to warn of possible skin issues
- Failed to warn of possible vision and/or hearing problems
- Failed to warn of possible weakening and enlargement of heart muscle (cardiomyopathy)
Those who have suffered similar injuries from hip implants may be eligible to receive compensation for:
- Medical bills
- Pain & suffering
- Loss of income
- Loss of consortium
- Punitive damages
Defective Hip Implants Lawsuits
Lawsuits in the U.S. have centered around three major manufacturers:
- Johnson & Johnson’s DePuy Orthopaedics, makers of the DePuy ASR hip implant
- Stryker Orthopedics, manufacturers of Rejuvenate and ABG II
- Zimmer Holdings Inc., makers of the Durom Cup
Johnson & Johnson
Johnson & Johnson’s DePuy Orthopaedics unit was already phasing out it’s ASR hip replacement implant system when it acknowledged in 2010 that the device was prone to early failure, including loosening of the various components in the implant; Necrosis (premature death of body tissue); and elevated cobalt and chromium levels in the blood.
By that time, the FDA had received hundreds of reports describing early failure of the DePuy ASR hip implant system. Symptoms included (but were not limited to):
- Severe pain radiating into the groin and/or back
- Various radiographic changes such as loosening, lysis and osteolysis
- Fluid collections around the joint
The warning from DePuy followed more than two years of reports that the device was failing in patients only a few years after implant, often requiring replacement operations.
Just months before it issued the ASR warning, DePuy announced the device was being phased out of the market. The company claimed the decision was made because sales of the ASR were declining.
The ASR is a type of device known as a metal-on-metal implant. In fact, all major orthopedic manufacturers make and market metal-on-metal hip implants. While this type of hip implant has been used in about one-third of all hip replacements performed annually in this country, many of the nation’s leading orthopedic surgeons have reduced or stopped using all-metal implants because of concerns that they can cause severe tissue and bone damage.
Studies indicate that all-metal devices can quickly begin to wear. This creates a large amount of metallic debris that’s absorbed into a patient’s body. The metallic debris can cause inflammatory reactions that lead to pain in the groin, death of tissue in the hip joint and loss of surrounding bone.
Faced with such a large number of lawsuits, last year Johnson & Johnson agreed to pay at least $2.5 billion to settle litigation over its ASR metal-on-metal hip device.
The Zimmer Durom Cup uses a component called the zirconia ceramic femoral head, which is the ball portion of hip implants. This component was allegedly prone to fracture, causing serious and painful complications that often required surgical replacement. X-rays often showed that the socket was separating from bone, rather than fusing with it. Many recipients reported that they were in much worse shape after their surgery than before. In July 2008, Zimmer Holdings announced it was suspending sales due to a high number of complaints, but reintroduced the product to the market a few months later.
Zimmer set aside millions of dollars to compensate patients who filed lawsuits after received Durom implants and later required revision surgery after suffering serious complications. Zimmer already paid close to $400 million in settlements to people injured by the Durom Cup. In addition, it expects to pay more than $200 million more to settle pending lawsuits.
In November 2007, Stryker received a warning letter from the FDA regarding complaints about hip replacement components. Those complaints included hip joints that did not fit properly, causing recipients to experience pain, difficulty walking and “squeaky” joints. Some patients reported that pieces had broken off and/or others had worn unevenly.
Stryker elected to voluntarily recall two metal hip replacement components in 2012, due to concerns that the implants could cause swelling, pain, and possible physical harm to body tissue.
Faced with nearly 1,800 cases consolidated before a U.S. District Judge in Minnesota and about 2,100 lawsuits before a New Jersey state judge, Stryker has agreed to pay more than $1 billion to resolve lawsuits over it’s hip implants. Some lawsuits, however, will remain and Stryker has said that it will continue to defend against remaining claims.
Contact Eglet Law Group
Evidence continues to mount that metal-on-metal hip implants are causing serious side effects, strengthening plaintiffs’ claims that these devices are defective. There is a time limit for filing a claim, so do not hesitate to contact us today for a free consultation.