Smith & Nephew lawsuits and federal enforcement actions have cost the British medical device maker more than $300 million in U.S. settlements and penalties since 2007, spanning a kickback scheme involving orthopedic surgeons, foreign bribery in Greece, a whistleblower case over devices sold to the Department of Veterans Affairs, and years of product liability litigation over metal-on-metal hip implants. Most of the major matters are now resolved or effectively closed.
The 2007 Orthopedic Kickback Settlement
On September 27, 2007, the U.S. Attorney’s Office for the District of New Jersey announced settlements with Smith & Nephew and four other orthopedic device makers — Biomet, DePuy Orthopaedics, Zimmer, and Stryker — to resolve allegations that they used sham consulting agreements to pay surgeons for choosing their hip and knee implants.1PMC. Orthopaedic Industry Anti-Kickback Investigation Surgeons received tens to hundreds of thousands of dollars a year, along with trips and other perks, sometimes for work of little or no value.2FBI. Orthopedic Device Companies Deferred Prosecution Agreements
Smith & Nephew paid roughly $28.9 million as its share of the civil resolution.3Drugwatch. Smith and Nephew Lawsuits The company signed a deferred prosecution agreement, a civil settlement, and a five-year corporate integrity agreement with the Office of Inspector General at the Department of Health and Human Services. The conduct at issue ran from 2002 through 2006 inside the company’s Orthopedic Reconstruction Global Business Unit.4U.S. Department of Justice. Smith and Nephew Deferred Prosecution Agreement
The deferred prosecution agreement required Smith & Nephew to overhaul how it selected and paid consulting surgeons, publicly post consultant names and payment amounts, cap consulting fees at $500 per hour at fair market value, and accept an independent federal monitor for 18 months.4U.S. Department of Justice. Smith and Nephew Deferred Prosecution Agreement The criminal conspiracy complaint was dismissed on March 30, 2009, after the company met the terms.2FBI. Orthopedic Device Companies Deferred Prosecution Agreements
The 2012 FCPA Settlement Over Bribes to Greek Doctors
Less than five years later, Smith & Nephew paid $22.2 million to resolve Foreign Corrupt Practices Act charges brought jointly by the SEC and the Department of Justice on February 6, 2012.5Smith & Nephew. Smith and Nephew Reaches Settlement With US Government
The SEC’s complaint, filed as Securities and Exchange Commission v. Smith & Nephew PLC (Civil Action No. 1:12-CV-00187, D.D.C.), alleged that the company’s U.S. and German subsidiaries used a Greek distributor to funnel about $9.4 million through three shell entities in the United Kingdom between 1997 and 2008.6SEC. SEC Litigation Release No. 222527FCPA Professor. Smith and Nephew FCPA Scrutiny The money was booked as “marketing services” that were never performed. The distributor then paid cash bribes directly to publicly employed Greek doctors after surgeries to keep them buying Smith & Nephew products. One email from the distributor to the U.S. subsidiary said he was “paying cash incentives right after each surgery.”8SEC. SEC Charges Smith and Nephew With FCPA Violations Under the FCPA, the Greek doctors qualified as foreign officials because they worked at government-owned hospitals.
The resolution consisted of a $16.8 million criminal fine paid to the DOJ by the U.S. subsidiary and $5.4 million in disgorgement and prejudgment interest paid to the SEC by the parent company. Smith & Nephew settled without admitting or denying the allegations, was permanently enjoined from future FCPA violations, and had to retain an independent compliance monitor for 18 months.6SEC. SEC Litigation Release No. 22252
The 2014 VA Whistleblower Settlement
In 2014, Smith & Nephew paid $11.3 million to settle a qui tam whistleblower lawsuit alleging that it defrauded the Veterans Administration by misrepresenting where its devices were made. The case, United States ex rel. Cox v. Smith and Nephew, Inc. (No. 2:08-CV-02832, W.D. Tenn.), was filed in 2008 by Samuel Cox III, a former IT director at the company’s Tennessee operations.
Cox alleged the company sold the VA devices manufactured in Malaysia while representing them as American-made. Malaysia is not on the approved country list under the Trade Agreements Act. Smith & Nephew later disclosed that components had also been sourced from Thailand and China in violation of the same rules. Cox alleged he was fired in September 2008 in retaliation for trying to report the misconduct internally.9MassDevice. Smith and Nephew Settles Whistleblower Lawsuit
Cox received $2.3 million as his whistleblower share, which was 28% of the recovery, plus $5,000 to resolve his retaliation claim. Smith & Nephew paid an additional $3 million toward his legal fees and admitted no liability.10Sanford Heisler. United States Ex Rel. Cox v. Smith and Nephew
Hip Implant Product Liability Litigation
The Birmingham Hip Resurfacing MDL
The largest consolidated product liability action against Smith & Nephew was In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, MDL No. 2775, before Senior District Judge Catherine C. Blake in the U.S. District Court for the District of Maryland.11U.S. District Court for the District of Maryland. In Re Smith and Nephew Birmingham Hip Resurfacing Hip Implant Products Liability Litigation
The BHR system received FDA premarket approval in 2006 as a Class III high-risk device.12FDA. PMA P040033 – Birmingham Hip Resurfacing System Its metal-on-metal design used a cobalt-chromium alloy. Plaintiffs alleged that metal-on-metal contact caused cobalt and chromium ions to migrate into surrounding tissue, causing pain, metallosis, and bone and tissue destruction. Smith & Nephew voluntarily withdrew the device from the U.S. market in 2015 because of high revision rates.13PMC. Post-Market Surveillance of the Birmingham Hip Resurfacing System
The MDL was consolidated in April 2017 and at its peak held more than 850 cases. No global settlement was reached and no major plaintiff verdicts came out of the litigation. Judge Blake granted summary judgment for Smith & Nephew on causation in a series of rulings, and cases were described as “falling like dominoes” after those decisions.14Drug and Device Law Blog. Another Dismissal in the Birmingham Hip MDL In February 2022, the judge dismissed claims from roughly 175 male plaintiffs while permitting certain misrepresentation and breach of warranty claims to continue. By October 2024 the judge closed the MDL to new transfers, and by April 2025 only one active case remained.3Drugwatch. Smith and Nephew Lawsuits
The 2016 SMF and REDAPT Recalls
In November 2016, Smith & Nephew issued urgent recall notifications for its Modular SMF and Modular REDAPT Revision Femoral Hip Systems. The FDA classified both as Class 2 recalls covering a combined total of roughly 18,265 units and citing “a higher than anticipated complaint and adverse event trend” tied to device design.15FDA. Class 2 Device Recall Modular SMF Hip System16FDA. Class 2 Device Recall Modular REDAPT Revision Femoral Hip System Both recalls were terminated in August 2019. No MDL was created for these products, but individual lawsuits alleging corrosion, mechanical failure, and early device failure have been filed in federal courts and individual settlements have been reported.3Drugwatch. Smith and Nephew Lawsuits
The Canadian R3 Class Action
A proposed Canadian class action was filed in 2013 over the R3 Acetabular System, specifically the R3 Metal Liner Component, alleging negligence in design, manufacture, and post-market monitoring. The proposed class action was discontinued on April 18, 2024.17Koskie Minsky LLP. Smith and Nephew Hip Implants
Employment Discrimination Cases
A 2007 class action, Wooten, et al. v. Smith and Nephew, alleged systemic racial discrimination in violation of Title VII of the Civil Rights Act, claiming managers favored white employees over Black employees in hiring, promotion, training, and compensation. The case settled in July 2008 for $3.4 million along with programmatic reforms.18Sanford Heisler. Smith and Nephew Race Discrimination Class Action
Separately, former quality control worker Zofia Kuc sued the company in Massachusetts federal court alleging a hostile work environment and national-origin discrimination based on her Polish heritage. In February 2022, the court allowed her hostile work environment, retaliation, and national-origin discrimination claims to proceed while dismissing age and sex discrimination claims.19Bloomberg Law. Smith and Nephew Must Face National Origin Discrimination Suit
Where Things Stand Now
As of early 2026, Smith & Nephew’s major U.S. government enforcement matters are resolved and the largest consolidated product liability action against it is effectively closed. The BHR MDL in Maryland remains open only for administrative purposes.3Drugwatch. Smith and Nephew Lawsuits Individual SMF and REDAPT cases and the Kuc employment case remain the pockets of active litigation identified in the record. The company operates from Watford, United Kingdom, under CEO Deepak Nath.20Forbes. Smith and Nephew