Parker Waichman is offering free legal consultations to individuals seeking to file a Smith & Nephew metal-on-metal hip implant lawsuit. On June 1, 2012, Smith & Nephew recalled a component of their metal-on-metal hip implants. When a medical device is recalled, it means that there is a chance that it may cause health problems. In this case, Smith & Nephew recalled the metal liners for its R3 acetabular systems because a higher-than-expected number of patients suffered from complications that required a second surgery. In fact, metal-on-metal hip implants, in general, are associated with high rates of so-called “revision surgeries.”
All-metal hip replacements became a public safety concern in August 2010, when DePuy Orthopedics, a unit of Johnson & Johnson, globally recalled its ASR hip implants. Metal-on-metal hip implants are hip systems that use all-metal surfaces. When these surfaces rub together, they may cause problems by shedding metal particles into the patient’s blood and tissue. Resulting complications may include metal poisoning, tissue death near the implant, and bone and muscle damage. If you or someone you know is interested in filing a Smith &Nephew metal-on-metal hip implant lawsuit, contact an attorney at Parker Waichman LLP today.
Metal-on-Metal Hip Implant Injuries and Complications
Smith & Nephew is one of several device makers enshrouded in recalls, safety concerns, and litigation regarding metal-on-metal hip implants and related components. Hip replacements may be made of several different materials, including metal, plastic, and ceramic. The contacting surfaces of metal-on-metal hip implants, are all made of metal. When these devices first hit the market, they were introduced as being better suited for younger, more active patients.
With a total hip replacement, the implant consists of a ball-and-socket device that replaces both the acetabular cup (hip socket) and the top of the femur (thighbone). In a hip resurfacing implant, the top of the thighbone is not removed. Instead, the bone is trimmed and a cap is placed over the top of the femur. A shell is used to replace the hip socket as with a traditional total hip implant.
In recent years, however, metal-on-metal hip implants have come under intense scrutiny due to high-profile recalls and safety concerns. Metal-on-metal hip implant issues especially made headlines when DePuy Orthopaedics recalled its ASR hip system in 2010. Since then, other manufacturers, including Smith & Nephew, have recalled their metal hip components.
Metal-on-metal hip implants may cause complications when the surfaces of the device rub together, releasing metallic debris into the body. This may lead to a host of complications, including:
- Bone damage
- Soft tissue reaction (adverse local tissue reaction)
- Joint dislocation
- Difficulty walking
- Metal poisoning (metallosis), including high levels of cobalt or chromium ions
- Revision surgery
Revision surgery is performed when a medical device fails; the old device is removed and replaced. In general, hip replacements are expected to last at least 10 or 15 years. Metal-on-metal hip implants were often recalled because patients were experiencing failure much sooner, after only a few years, leading to the need for an early revision surgery. Device failure is often preceded by metal-on-metal hip implant complications such as metallosis, in which patients have high blood levels of cobalt or chromium. The release of metal ions may also cause local tissue reaction and tissue death.
In 2012, the U.S. Food and Drug Administration’s (FDA) Orthopaedic and Rehabilitation Devices Advisory Panel concluded that metal-on-metal hip implants carried “unique risks.” Regulators stated, “In metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running. Metal can also be released from other parts of the implant where two implant components connect. Metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint. This is sometimes referred to as an ‘adverse local tissue reaction (ALTR)’ or an ‘adverse reaction to metal debris (ARMD).'”
Plaintiffs and safety experts note that metal-on-metal hip implants were approved through the 510(k) fast-track approval process that allows devices onto the market without rigorous clinical testing. Devices cleared through the 510(k) route only need to be as safe as, or “substantially equivalent,” to a previously approved device. The 510(k) route has come under criticism because it was used to approve some controversial medical devices, including metal-on-metal hip implants.
Smith & Nephew BHR and R3 Hip Implant Lawsuits
In June 2012, Smith & Nephew recalled the R3 optional metal liner due to a high rate of failure. The liner is used with the R3 Acetabular System, the company’s total hip replacement device. The recall affected at least 7,700 patients. The FDA indicated that the R3 liner was not approved for the R3 Acetabular System. Regulators only approved the liner for the Birmingham Hip Resurfacing (BHR) System.
In 2015, Smith & Nephew voluntarily removed the BHR from the market. Based on post-market surveillance data from the National Joint Registry of England and Wales (NJREW), BHR femoral head sizes 46mm or smaller in men and all women patients have a higher rate of revision surgery than the benchmark established by the U.K. National Institute for Health and Care Excellence (NICE). “Based on this information, Smith & Nephew considers that these patient groups may be at a greater risk of revision surgery than previously believed, and is therefore removing small sizes and updating the IFU (instructions for use) to contraindicate the BHR for women,” the device maker wrote.
In April 2017, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated Smith & Nephew BHR and R3 metal-on-metal hip implant lawsuits into a federal multidistrict litigation (MDL). According to the Transfer Order, cases were transferred to the District of Maryland before the Honorable Catherine C. Blake, MDL No. 2775 [In re: Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation].
MDLs are established for complex litigation cases, when there are a growing number of lawsuits sharing common factual allegations. Consolidating cases into an MDL makes the litigation move along more quickly and efficiently because the MDL streamlines the legal process and eliminates the need for pretrial proceedings, such as the discovery phase. MDLs also prevent inconsistent pretrial rulings and conserve court resources. Plaintiffs in an MDL are treated separately and lawsuits are filed individually. Injuries may vary in severity among plaintiffs.
Plaintiffs suing over the BHR and R3 commonly allege that the metal-on-metal hip implant is defective, causing injuries. Smith & Nephew metal hip lawsuits allege that the company was aware of the risks but failed to warn patients or the medical community. Specifically, as with other metal-on-metal hip implant litigation, plaintiffs allege that the all-metal devices cause complications by releasing metallic debris. Alleged injuries include pain, adverse local tissue reaction, pseudotumors, bone and tissue necrosis, metallosis, and other symptoms necessitating revision surgery. Plaintiffs allege that, if they had been fully informed of the risks, they would not have agreed to the metal-on-metal hip implant.
In creating the MDL, the JPML indicated that, “These actions share factual questions concerning the design, manufacture, marketing, or performance of Smith & Nephew’s BHR system. Specifically, plaintiffs focus on complications arising from the use of a cobalt-chromium alloy in the manufacture of the BHR components.
“Plaintiffs allege that they have suffered pain, adverse local tissue reaction, pseudotumors, bone and tissue necrosis, metallosis, or other symptoms, often necessitating revision surgery. Centralization will eliminate duplicative discovery; prevent inconsistent pretrial rulings (including with respect to discovery, privilege, and Daubert motion practice); and conserve the resources of the parties, their counsel, and the judiciary.”
Filing a Smith & Nephew Metal-on-Metal Hip Implant Lawsuit
If you or someone you know has been implanted with a Smith & Nephew metal-on-metal hip implant system, you may have valuable legal rights. Our firm offers free, no-obligation case evaluations. For more information, please complete our online form or call us at 1(800)-YOURLAWYER (1-800-968-7529) to find out more today.
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