As of September 2018, a total of 442 lawsuits over Smith & Nephew’s Birmingham Hip Resurfacing (BHR) hip implants were pending in multidistrict litigation (MDL) in a Maryland federal court.
The MDL was created in April 2017 when the U.S. Judicial Panel on Multidistrict Litigation combined the first 28 cases. It involves lawsuits from across the U.S. and has the potential to include a large number of new cases in the months to come.
Attorneys also have been filing claims over Smith & Nephew’s Modular SMF and Modular Redapt Revision Femoral Hip. The company recalled 2,000 of the devices in 2016.
Separately, Smith & Nephew quietly settled some individual actions over its R3 Acetabular Hip System in 2013. The company had recalled several thousand units.
‘Metal Shedding Debris’ Blamed for Complications
Like many other hip replacements in major litigations, Smith & Nephew BHR systems use a metal-on-metal design. Studies have found the wear between metal parts can release metal ions into the body. Elevated metal levels can cause a condition called metallosis which, in turn, can lead to other serious complications. People who filed lawsuits cited metallosis in their complaints.
Complaint Claims 288 ‘Device Problems’ at Time of Recall
In January 2011, Alberto Grazia received a Smith & Nephew hip implant at Euclid Hospital in Euclid, Ohio. A Birmingham Hip Resurfacing (BHR) system replaced his right hip. Grazia’s left hip was also replaced with a BHR system in July 2011.
Grazia endured severe pain after his second hip implant. It was so bad that surgeons had to replace his left hip implant in April 2016.
In December 2016, Grazia filed a lawsuit against Smith & Nephew. It was later included in the MDL over BHR implants. He claimed “metal shedding debris” from friction between the hip-replacement parts led to his persistent pain.
The lawsuit claimed at the time of the device’s recall in 2015, there had been 288 “‘device problems’ with the BHR, including numerous safety problems related to ‘metal shedding debris’ and other symptoms typical of metal-on-metal device failure.”
Metallosis Leads to Revision Surgery, Surgeon Says
Lonnie Taylor of Boca Raton, Florida, had his left hip replaced with BHR system in April 2009. He had his right hip replaced with a BHR system in June of that same year.
In 2018, Taylor needed revision surgery to remove and replace the BHR implants because of severe pain. Surgeons replaced the right hip in January and the left one in May.
Taylor filed a lawsuit in August 2018. It is part of the MDL.
At the time of the right hip revision, Taylor’s surgeon “documented extensive damage to Mr. Taylor‘s right hip anatomy due to severe metallosis,” according to his lawsuit.
“Although Smith & Nephew was aware of the risks associated with the BHR for many years, it did not inform [Taylor] or his healthcare providers until 2015 when it was too late for Plaintiff to avoid the BHR product,” his lawsuit claimed.
Roughly 6,000 Hip Implants Recalled
Smith & Nephew issued a field-safety notice on its BHR implants in 2015, saying the devices posed a risk of dislocation, fractures and other complications that could require surgery to correct.
In addition, the UK-based company recalled its R3 Acetabular Hip Systems in 2012, and its Modular SMF and Modular Redapt Revision in 2016, over issues serious enough to spark more potential lawsuits.
Smith & Nephew recalls 4,000 R3 Acetabular Hip Systems in the U.S. after reports of failures and complications.
First lawsuits over the R3 Acetabular Hip Systems are filed; the company quietly settles most R3 cases.
The company’s annual report shows it set aside $203 million to cover lawsuit costs.
Smith & Nephew recalls 2,000 Modular SMF and Modular Redapt Revision Femoral Hip Systems.
Eight people injured by Smith & Nephew hips ask a federal panel to combine their lawsuits into an MDL.
U.S. Judicial Panel on Multidistrict Litigation combines 28 lawsuits over BHR system into an MDL.
The MDL grows to 442 lawsuits.
Recalled Models Named in Lawsuits
Smith & Nephew hip implants named in lawsuits have been the subject of recalls or reports of serious complications such as loosening, fractures or the need for revision surgery. At least five models have been the subject of individual lawsuits since 2013. The BHR system is the only one currently involved in a mass litigation.
|Smith & Nephew Hip Model||Problems Reported|
|Birmingham Hip Resurfacing (BHR) System||Infections, fractures, dislocation, metallosis, pseudo-tumors and other issues requiring revision surgery|
|R3 Acetabular System||Reports of loosening, pain, device failure, infection, metal sensitivity and dislocation associated with the device|
|Modular SMF||“Higher than anticipated complaint and adverse event trend”|
|Redapt Revision Femoral System||“Higher than anticipated complaint and adverse event trend”|
|Emperion Hip System||Reports of failures resulting in fractures and need for revision surgery|
Feds Claimed Company Paid Kickbacks, Broke Contract
Smith & Nephew has paid more than $40 million to settle past claims of wrongdoing brought by the U.S. Department of Justice.
In 2007, the company paid $28.9 million to resolve an alleged kickback scheme. The federal government had accused the company of paying doctors to use its devices.
In 2014, Smith & Nephew settled another case with the federal government for $11.3 million. The lawsuit involved devices sold to Veterans Affairs hospitals. The contract required components be made in the U.S.
The federal investigators claimed Smith & Nephew passed off Malaysian-made implants claiming the devices were made in America.
Please seek the advice of a medical professional before making health care decisions.