Smith & Nephew, the London-based orthopedic and medical device maker, has been the subject of a long line of lawsuits and government enforcement actions covering defective hip implants, foreign bribery, kickbacks to surgeons, whistleblower fraud claims, race discrimination, retirement-plan mismanagement, and a Supreme Court patent fight. The largest active exposure is the multidistrict litigation over the Birmingham Hip Resurfacing system, but the company’s legal record over the past two decades touches nearly every category of corporate liability in the healthcare sector.
Birmingham Hip Resurfacing Implant Litigation
The Birmingham Hip Resurfacing (BHR) system is a metal-on-metal device built from a cobalt-chromium alloy. Patients allege that friction between the metal components sheds cobalt and chromium ions into surrounding tissue, causing pain, metallosis, bone destruction, and the need for revision surgery.
The FDA approved the BHR in 2006. Smith & Nephew added label warnings in 2010 about higher failure risks in women and in men needing smaller femoral head sizes, and in 2015 the company voluntarily recalled certain BHR devices after data showed elevated failure rates in those groups.1GovInfo. In Re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation
In April 2017, federal product liability cases were consolidated into a multidistrict litigation in the U.S. District Court for the District of Maryland (MDL No. 2775). Plaintiffs bring failure-to-warn, negligence, breach of express warranty, and negligent misrepresentation claims. The MDL was later expanded with a Total Hip Arthroplasty track for devices combining BHR and non-BHR components. More than 850 cases remain pending in the MDL according to the most recent filings.2U.S. District Court, District of Maryland. In Re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation
The docket has moved slowly. In a July 2023 ruling the court denied Smith & Nephew’s motion for summary judgment as to patients implanted before October 2009, finding the cases too fact-specific to resolve on the papers while key evidence remained with the defendant. A significant number of earlier cases have already been resolved or closed.1GovInfo. In Re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation In January 2024, a court dismissed at least one individual case, finding that the plaintiff’s causation theory relied on speculation.3Drug and Device Law Blog. Another Dismissal in the Birmingham Hip MDL
Other Hip Implant Recalls and FDA Actions
The BHR is not the only Smith & Nephew hip product to draw regulators or litigants.
R3 Acetabular System
Smith & Nephew recalled the metal liner component of its R3 Acetabular modular hip implant system in 2012 after reports of infections, bone fractures, dislocations, and metal poisoning. An estimated 3,000 to 4,000 U.S. patients received the devices between 2009 and 2012, and many required revision surgery.4FDA. Modular REDAPT Hip System Recall The R3 was also the subject of a December 2010 FDA warning letter to the company’s Tuttlingen, Germany plant citing tests that were never performed and inadequate procedures for correcting production problems.5FierceBiotech. Smith & Nephew Hit With FDA Warning Letter
Modular SMF and REDAPT Systems
In November 2016, Smith & Nephew issued an urgent recall of its Modular SMF and Modular REDAPT hip systems following a higher-than-anticipated complaint and adverse event trend. The FDA classified the action as a Class 2 recall and identified a device design issue as the root cause. A total of 6,266 units had been distributed worldwide. The recall was formally terminated in August 2019.4FDA. Modular REDAPT Hip System Recall
Emperion Femoral Stem
The Emperion titanium femoral stem has been linked to reports of atraumatic fractures. One FDA adverse-event report documented a stress fatigue fracture originating on the outer surface of the stem. Smith & Nephew’s own review found no manufacturing abnormality and stated that corrective action was not indicated, attributing the risk to patient factors such as weight, activity, and anatomy.6FDA. MAUDE Adverse Event Report – Emperion Femoral Stem A published case study described an Emperion stem failure roughly six years after implantation, identifying corrosion at the modular junction as a contributing factor.7National Library of Medicine. Emperion Femoral Stem Fracture Case Report No formal FDA recall has been issued for the Emperion stem.
Morcellator Warning Letter
The FDA issued a warning letter in May 2015 to Smith & Nephew’s Andover, Massachusetts facility over quality-control deficiencies related to its Truclear Ultra 4.0 Reciprocating Morcellators. The letter cited failures to complete corrections for reported problems, the unauthorized release of products that had been placed on hold, a backlog of open complaints exceeding 90 days, labeling errors in suture anchor products, and inadequate internal quality audits. Continued noncompliance, the agency warned, could lead to seizure, injunction, or civil monetary penalties.8MD+DI Online. Smith & Nephew Hit With Warning Letter Over Morcellators
FCPA Bribery Case in Greece
In February 2012, the SEC charged Smith & Nephew with violating the Foreign Corrupt Practices Act. Two of its subsidiaries had spent more than a decade paying bribes to publicly employed doctors in Greece to win product orders. The scheme ran from 1997 through at least mid-2008 and used a Greek distributor to route cash through three shell companies in the United Kingdom, with the payments disguised on the books as fees for marketing services that were never performed.9SEC. Litigation Release No. 22252 The SEC said the company had ignored “numerous red flags of bribery” for years.10SEC. SEC Charges Smith & Nephew PLC With FCPA Violations
Smith & Nephew settled the SEC charges without admitting or denying the allegations, paying roughly $5.4 million in disgorgement and prejudgment interest and accepting a permanent injunction against future FCPA violations. Its U.S. subsidiary, Smith & Nephew Inc., separately entered a three-year deferred prosecution agreement with the Department of Justice on a three-count criminal information covering conspiracy to violate the FCPA, substantive anti-bribery charges, and books-and-records violations, paying a $16.8 million fine and agreeing to an independent compliance monitor.11U.S. Department of Justice. Smith & Nephew Deferred Prosecution Agreement Combined SEC and DOJ penalties exceeded $22 million.10SEC. SEC Charges Smith & Nephew PLC With FCPA Violations
Surgeon Kickback Settlement
In September 2007, Smith & Nephew was one of four major orthopedic device makers that reached a combined $311 million civil settlement with the U.S. Attorney’s Office in New Jersey over alleged violations of the federal Anti-Kickback Statute. Federal prosecutors alleged that from at least 2002 through 2006 the companies used sham consulting agreements to pay surgeons tens to hundreds of thousands of dollars a year, along with trips and other perks, in exchange for exclusive use of their implants. In many cases, the surgeons performed little or no actual consulting work. Smith & Nephew’s share of the civil settlement was $28.9 million.12U.S. Department of Justice. Orthopedic Device Companies Settlement Press Release Then-U.S. Attorney Christopher J. Christie said many surgeons had been “choosing which device to implant by going to the highest bidder.”13The New York Times. Companies in Hip and Knee Implants Settle Kickback Case
Smith & Nephew entered a deferred prosecution agreement on the criminal side and signed a five-year Corporate Integrity Agreement with the HHS Office of Inspector General, which imposed an independent monitor, annual needs assessments for consulting relationships, a general cap on consultant pay, public disclosure of payments to physicians, and adherence to the AdvaMed Code of Ethics.14U.S. Department of Health and Human Services OIG. Smith & Nephew Corporate Integrity Agreement
Trade Agreements Act Whistleblower Case
A former employee, Sam Cox, filed a qui tam whistleblower action in 2008 in the Western District of Tennessee alleging that Smith & Nephew had violated the Trade Agreements Act and the False Claims Act by knowingly selling the U.S. government medical devices manufactured in countries not designated as U.S. trading partners, making the sales ineligible under federal procurement rules. The case settled in September 2014 for $11.3 million. Cox received $2.3 million as his whistleblower share, representing 28 percent of the recovery.15Sanford Heisler Sharp. United States Ex Rel. Cox v. Smith and Nephew
Race Discrimination Class Action
A group of Black employees sued Smith & Nephew in the Western District of Tennessee in 2007, alleging systemic racial discrimination in hiring, job placement, and promotions in violation of Title VII of the Civil Rights Act. The complaint claimed managers consistently favored white employees over more senior or better-qualified Black candidates for promotions, assignments, training, and compensation. After mediation in July 2008, the parties settled for $3.4 million along with programmatic reforms.16Sanford Heisler Sharp. Smith & Nephew Race Discrimination Class Action
401(k) Fee ERISA Class Action
Smith & Nephew was sued in the U.S. District Court for the District of Massachusetts under ERISA, with plaintiffs alleging the company mismanaged its employee retirement plan by improperly using forfeited 401(k) assets, paying unreasonable fees for plan advisory services, and failing to adequately oversee the Plan Committee. The proposed class covers roughly 29,000 participants in the Smith & Nephew US Savings Plan from August 2018 through preliminary approval.17Becker’s Spine Review. Smith & Nephew to Pay $350K to Settle 401(k) Fees Lawsuit
Judge Nathaniel M. Gorton stayed the case in December 2025 after the parties reached a settlement.18Law360. Smith & Nephew Settles 401(k) Fee Dispute A motion for preliminary approval of a $350,000 class settlement was filed in February 2026, representing about 18.4 percent of the total damages plaintiffs had claimed for excessive managed-account fees.17Becker’s Spine Review. Smith & Nephew to Pay $350K to Settle 401(k) Fees Lawsuit
Arthrex Supreme Court Patent Case
Smith & Nephew was a party in a Supreme Court patent case, though not as a defendant in the usual product-liability sense. In Arthrex Inc. v. Smith & Nephew Inc., the Court considered whether administrative patent judges who decide inter partes review proceedings at the Patent Trial and Appeal Board had been properly appointed under the Constitution’s Appointments Clause. On June 21, 2021, the Court ruled 5–4 that the judges’ unreviewable authority was “incompatible with their appointment by the Secretary of Commerce to an inferior office,” vacated the Federal Circuit’s judgment, and remanded the case. Chief Justice John Roberts wrote the opinion.19SCOTUSblog. Arthrex Inc. v. Smith & Nephew Inc.