Smith & Nephew, PLC, is a British-based multinational medical equipment company headquartered in London. It is the world’s fourth-largest producer of orthopedic reconstruction products, and its products are sold in 90 countries. The company’s business strategy is based on researching, developing, manufacturing and marketing technically innovative and advanced medical devices.
In September 2007, Smith & Nephew, PLC, along with Biomet Inc., DePuy Orthopedics, Inc., and Zimmer Holdings, Inc. entered into settlement agreements, under which they agreed to pay up to $300 million in total to adopt industry overhauls and undertake corporate monitoring to avoid criminal charges of conspiracy. In February 2012, Smith & Nephew, PLC agreed to pay $22.2 million to settle US Foreign Corrupt Practices Act (FCPA) offenses committed by its U.S. and German subsidiaries.
Smith & Nephew’s Birmingham Hip Resurfacing (BHR) System was approved by the Federal Drug Administration (FDA) on May 9, 2006. The BHR is a metal-on-metal resurfacing artificial hip replacement system, surgically implanted to replace the hip joint. The BHR is called a resurfacing prosthesis because only the surface of the femoral head is removed to implant the resurfacing unit. The BHR system is supposed to relieve pain and improve hip function.
The BHR has two parts: a socket in the shape of a shallow cup (acetabular component), and a cap in the form of a ball head (femoral resurfacing component).
The Smith & Nephew R3 Acetabular System is a modular hip implant system. This means the surgeon can choose the individual components based on the needs of the patient. Smith & Nephew began marketing this system in Europe in 2007 and it was made available in the United States and the rest of the world in 2009. On June 1, 2012, just five years after its initial release, Smith & Nephew initiated a recall of the metal liner in its R3 Acetabular System after reports of loosening, pain, device failure, infection, metal sensitivity, and dislocation. These hip replacements are associated with higher than normal revision surgery rates.
Complications and problems relating to the metal liner of the R3 Acetabular System may be the result of its metal-on-metal design. The metal liner is made of cobalt and chromium, which have shown to release carcinogenic ions linked to blood poisoning and DNA damage. The deterioration of bone and muscle around the implant can lead to loosening and device failures. All these complications have been known to lead to metal poisoning. After the recall, the company sent out “hazard alert” letters to doctors who had implanted the metal liners, claiming the recall was a “precautionary step.” Smith & Nephew also said it was unable to identify one single reason for the device failure, but there were reports of “infection, dislocation, metal sensitivity, loosening, and fracture.” The letter further instructed doctors to follow up with their patients if they had received the liner.
Almost 4,000 of the R3 Acetabular metal liners were used in the U.S. between 2009 and the June 1, 2012 recall. Because of its metal liner, people who received this implant have suffered a number of complications. Studies have already shown that a high number of R3 Acetabular Systems with metal liners failed prematurely and required revision surgery. Patients who received the recalled device may have legal options against Smith & Nephew to receive compensation for revision surgery costs incurred and any pain suffered. Recipients of the metal liner option in this device are encouraged to evaluate their legal options even if they’re not experiencing complications, since metal ions in the blood may not always manifest symptoms in early stages.
Designers, manufacturers, distributors, and resellers of products and goods must be held accountable for the damage a defective product can cause to you, a family member or a loved one. These are complicated cases and require the experienced representation of the attorneys at Graves McLain.
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