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Smith & Nephew Hip Replacement Lawsuits

People from across the U.S. have filed lawsuits over several models of Smith & Nephew’s hip-replacement implants. More than 400 of those lawsuits have been combined in a major federal litigation and more lawsuits are expected to be added to it.

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.

Timeline of Recalls and Lawsuits
  • June 2012
    Smith & Nephew recalls 4,000 R3 Acetabular Hip Systems in the U.S. after reports of failures and complications.
  • 2013
    First lawsuits over the R3 Acetabular Hip Systems are filed; the company quietly settles most R3 cases.
  • December 2015
    The company’s annual report shows it set aside $203 million to cover lawsuit costs.
  • November 2016
    Smith & Nephew recalls 2,000 Modular SMF and Modular Redapt Revision Femoral Hip Systems.
  • February 2017
    Eight people injured by Smith & Nephew hips ask a federal panel to combine their lawsuits into an MDL.
  • April 2017
    U.S. Judicial Panel on Multidistrict Litigation combines 28 lawsuits over BHR system into an MDL.
  • September 2018
    The MDL grows to 442 lawsuits.
Suffering from Smith & Nephew hip replacement complications? Review Your Legal Options

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.

Terry Turner
Written By Terry Turner Writer

Terry Turner has been writing articles and producing news broadcasts for more than 25 years. He covers FDA policy, proton pump inhibitors, and medical devices such as hernia mesh, IVC filters, and hip and knee implants. An Emmy-winning journalist, he has reported on health and medical policy issues before Congress, the FDA and other federal agencies. Some of his qualifications include:

  • American Medical Writers Association (AMWA) and The Alliance of Professional Health Advocates member
  • Centers for Disease Control and Prevention Health Literacy certificates
  • Original works published or cited in Washington Examiner, MedPage Today and The New York Times
  • Appeared as an expert panelist on hernia mesh lawsuits on the BBC
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14 Cited Research Articles

  1. Pierson, B. (2014, September 4). Smith & Nephew to pay $11 mln in whistleblower suit. Reuters. Retrieved from https://www.reuters.com/article/smith-nephew-settlement-idUSL1N0R52KA20140904
  2. U.S. District Court, Southern District of Florida. (2018, August 15). Taylor v. Smith & Nephew; Case No. 9:18-cv-81088. Retrieved from http://www.pacer.gov
  3. U.S. District Court, Northern District of Ohio. (2016, December 21). Grazia v. Alberto; Case No. 1:16-cv-03051. Retrieved from http://www.pacer.gov
  4. Associated Press. (2012, June 1). Smith & Nephew Withdraws Hip Device Component. Retrieved from http://www.sandiegouniontribune.com/sdut-smith-nephew-withdraws-hip-device-component-2012jun01-story.html
  5. Australian Therapeutic Goods Administration. (2012, June 13). Metal Liner Components of R3 Acetabular System. Retrieved from http://www.tga.gov.au/safety/alerts-device-r3-acetabular-metal-liner-120613.htm
  6. Cohen, D. (2012). How Safe Are Metal-on-metal Hip Implants? Retrieved from http://www.bmj.com/content/344/bmj.e1410
  7. Hirschler, B. (2012, June 1). Smith & Nephew Pulls Metal-on-metal Hip Component. Retrieved from http://articles.chicagotribune.com/2012-06-01/lifestyle/sns-rt-us-smithnephew-hipbre85010j-20120601_1_metal-on-metal-traditional-implants-smith-nephew
  8. Smith & Nephew. (n.d.). R3. Retrieved from http://www.smith-nephew.com/us/professional/products/all-products/r3-acetabular-system/
  9. Smith & Nephew. (2012). Hazard Alert: Metal Liner Components of the R3 Acetabular System. Retrieved from http://www.medsafe.govt.nz/hot/RecallActionNoticesNew/SmithAndNephewR3HipImplantsMetalLinerHazardAlert.pdf
  10. U.S Food and Drug Administration. (2017, January 4). Class 2 Device Recall Modular REDAPT Hip Systems. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=151502
  11. Stride, M. (2013, February 19). Smith & Nephew Sued Over Painful Hip Replacement. Retrieved from https://www.law360.com/articles/416588/smith-nephew-sued-over-painful-hip-replacement
  12. U.S. Food and Drug Administration (FDA). (2010, December 21). Warning letter. Retrieved from http://wayback.archive-it.org/7993/20161022083422/http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm238125.htm
  13. U.S. Food and Drug Administration. (2017, January 4). Class 2 Device Recall Modular Redapt(TM) Hip Systems. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=151502
  14. U.S. Judicial Panel on Multidistrict Litigation. (2018, September 17). MDL Statistics Report - Distribution of Pending MDL Dockets by District. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-September-17-2018.pdf
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