DePuy and Stryker Hip Replacement Lawsuits
After the Stryker and DePuy Hip replacement systems’ recall in 2010 and 2012, many patients filed a lawsuit because the devices corroded inside their bodies. If you or your loved ones suffered any injury caused by the adverse reactions of these devices, you might seek monetary compensation by filing a personal injury claim. Discuss your legal options with our expert lawyers and receive a free case review now.
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What is a Hip replacement system?
The ABG II Modular-Neck Hip Stems and Stryker Rejuvenate and are two medical devices used to replace a patient’s hip joint with a prosthetic implant. Originally ideated to facilitate mobility in younger and more physically active patients, the ASR Hip Resurfacing System, ASR XL Acetabular System and Pinnacle total hip replacement systems were globally marketed as the most advanced artificial implants available on the market. Compared to the standard monoblock, neck-and-stem artificial hip systems built as a single-piece replacement, the Stryker’s ABG II, and Rejuvenate system consisted of up to 16 interchangeable modular necks that articulated themselves with up to 8 different stems.
Thanks to this innovative design, surgeons were able to choose the perfect pair of device parts that would adapt to the patient’s unique anatomy, providing them with superior flexibility and mobility. Individual performance was coupled with a stronger articular support and superior stability, reducing bone stress on the long-term thanks to the robust metal-on-metal structure. The specific titanium, iron, zirconium and molybdenum alloy used to manufacture them, in fact, was engineered to be more resistant to breakage and wearing than the old metal-on-ceramic or metal-on-plastic prostheses.
The risks associated with Hip Replacement devices
Although the devices were built to last longer than older prosthetic implants, many patients experienced serious adverse reactions after they fragmented and broke. Natural body movement did, in fact, produce an unexpected mechanical stress on the metal parts, leading to corrosion, fretting and wearing. Debris of the defective devices loosened and was released into the bloodstream causing heavy metal poisoning and metallosis, and many patients needed additional surgery such as bone reconstruction after the implant was removed and substituted. According to research published in the journal Orthopedics, at least 13 percent of patients who were implanted with DePuy ASR XL hip replacements, needed revision surgery within five years. Serious common complications also included joint dislocation, inflammation and swelling, wound infections and increased risk of bone fractures.
What is metallosis?
Friction and wearing of prosthetic implant may cause corrosion and fretting, releasing metal ions into the space around the joint. These substances may cause local toxic reactions causing bone tissue to die, so even if the patient is implanted with a new prosthesis later, susceptibility to constant dislocation and fractures will be higher. Exposure to metal ions may also cause harmful health effects by negatively interacting with the immune system causing either stimulation of immune cell activity or immunosuppression. This may lead to swelling, constant pain and chronic inflammation that may eventually loosen the joint replacements. Chromium and cobalt poisoning are also linked with thyroid dysfunction, hearing and vision loss, and cardiovascular disorders. Patients suffering from metal hypersensitivity have an increased risk of allergic reactions and additional complications.
Stryker hip replacement recalled after the FDA warnings
In just a few years, patients and healthcare providers reported to the U.S. Food and Drug Administration (FDA) hundreds of serious adverse reactions linked to the use of malfunctioning Stryker hip replacements. The regulatory agency reacted by sending numerous warning letters to the manufacturer, accusing the company of fraudulent marketing practices and negligent production of defective devices. Several other joint replacement implants marketed by Stryker such as the rHead Lateral Stem elbow replacement, the EIUS Unicompartmental Knee Systems, and the Accolade TMZF Hip stem showed similar issues. On July 6, 2012, the company opted to recall the ABG II and Rejuvenate modular-neck stems voluntarily.
Defective hip replacements complications
- Metal sensitivity (hypersensitivity)
- Chromium and cobalt poisoning
- Swelling and inflammation
- Abnormal accumulation of fluids
- Joint dislocation
- Implant loosening
- Extreme pain
- Bone fractures
- Recurring infections
- Problems in the nervous system
- Confusion and Fatigue
- Gastrointestinal problems
Filing a Hip Replacement lawsuit – Verdicts and Settlements
After suffering grievous injuries and many surgical interventions, thousands of patients decided to sue Stryker Orthopaedics and DePuy Synthes. The devices manufactured by both those companies were approved through the FDA’s 510(k) fast-track program, and plaintiffs allege that they were negligently tested before seeking clearance. Manufacturers are also accused of misleading the public since the implants were falsely advertised as more durable than their competitors. According to the terms of the recall, Stryker claimed that patients would be reimbursed for the medical costs required to receive a new implant. However, many victims suffered permanent damage even after revision surgery and will need to pay substantial medical bills for the rest of their lives. Filing a lawsuit is the only way to seek monetary compensation for pain and punitive damages, lost wages, and future medical expenses.
Stryker Corp. started settling the first four lawsuits back in 2013, by spending over $510 million in related costs. On November 03, 2014, agreed to pay $1.4 billion to settle thousands of other litigations in New Jersey’s Bergen County Superior Court. To date, many more cases have been filed in court states across the country, and this settlement only includes all claimants who had revision surgery before November 2014. DePuy, a Johnson & Johnson’s subsidiary, decided to settle 7,500 of the over 12,000 litigations filed by paying a $2.5 billion settlement in 2013. In March 2015, the company paid additional $502 million to five claimants who suffered severe damage after their Pinnacle Ultramet implant broke prematurely. Some individual lawsuit were awarded up to $8.3 million, such as Loren Kransky, who received this hefty sum of money after the jury verdict found J&J liable for all the damage he had to endure. Future litigations can be negotiated for all other plaintiffs through the next few years, so you’re still in time to file a dispute and be eligible for compensation.
The latest Stryker recall: the LFIT Anatomic CoCr V40 Femoral Heads
On August 2016, Stryker warned orthopedic surgeons and consumers that another one of its products could be defective: the LFIT Anatomic CoCr V40 Femoral Heads. Shortly after the company voluntarily sent a letter where it explained that device was associated with a “higher than expected” incidence of taper lock failure, Health Canada issued an immediate product recall of all the heads manufactured prior to 2011. The artificial femoral head replaces the patient’s natural one and should fit directly on the hip bone itself to form a new joint. However, this device is locked into the femur (thigh bone) itself through a taper lock, and this portion is the one that is corroding and breaking at an alarming rate. If the joint replacement loosens or fractures, additional surgery may be required to replace it, and the patient is at risk for serious complications such as necrosis of surrounding tissues and cobalt or chromium toxicity.
Who should receive a hip replacement implant?
Patients who suffer from rheumatoid arthritis, osteoarthritis or osteoporosis may need to replace their hip joint with orthopedic surgery (arthroplasty). Prosthetic hip implants are also used to provide relief to chronic pain or rebuild broken bones after severe fractures and trauma. Usually, during arthroplasty only the femoral head is replaced, although the acetabulum may also be substituted to improve long-term stability. Common complications of this type of intervention are more frequent during the first 8-12 weeks after surgery and include dislocation and wound infection.
Article written by Dr. Claudio Butticè, Pharm.D.