Smith & Nephew, maker of the Birmingham Hip Resurfacing System, agreed to pay a $22 million fine due to charges of corruption and bribery over illegal payments to doctors for its medical devices.
The metal-on-metal BHR hip system is at the center of growing litigation spearheaded by Jones Ward PLC due to the soaring failure rate of the device. An article in the Journal of Bone and Joint Surgery revealed the BHR has a 26 percent failure rate in women after ten years, and the authors of the article warned that “results in women have been poor and we do not recommend metal-on-metal resurfacing in women.” Smith & Nephew recalled the BHR on September 10, 2015, covering 5,987 units (Recall Number Z-2745-2015), 10,167 units (Recall Number Z-2746-2015) and 624 units (Recall Number Z-2747-2015) in the stream of commerce, due to “revision rates which were higher than established benchmarks” pursuant to 21 CFR § 7.55e.
Smith & Nephew bribery “slush fund” for doctors
Prior to the recall, the U.S. Securities and Exchange Commission issued a complaint against Smith & Nephew’s parent company alleging that its subsidiaries used a distributor to “create a slush fund to make illicit payments to public doctors employed by government hospitals or agencies in Greece.”
“Smith & Nephew’s subsidiaries chose a path of corruption rather than fair and honest competition,” the agency stated. “The SEC will continue to hold companies liable as we investigate the medical device industry for this type of illegal behavior.”
Failure to warn patients
Although Smith & Nephew was aware of the risks associated with the BHR for many years, it did not inform patients or doctors until 2015 when it was too late. But as early as 2008, the Australian Orthopaedic Registry published data from the previous year showing that female resurfacing patients with a femoral head size of less than 50 mm faced a more than three-fold increased risk of revision (HR = 3.22, at 95 percent confidence interval) compared to female patients with a larger head size. Similarly, men with a femoral head size of less than 50 mm faced a far higher risk of revision compared to other male patients with a larger head size (HR = 2.69, at 95 percent confidence interval). Many patients with a failed BHR device must undergo a painful surgery called revision due to metallosis, metal toxicity, pseudotumor and tissue and bone necrosis.
Free case evaluation
Jones Ward PLC’s hip implant attorneys represent more injured Smith & Nephew hip implant victims in federal court than any other law firm in the nation. On February 1, 2017, the hip implant lawyers at Jones Ward filed a petition with the Judicial Panel on Multidistrict Litigation to consolidate all pending federal BHR cases in a single venue. They succeeded and more than 50 cases are now before Judge Catherine C. Blake in Maryland. To read more about the consolidated cases in MDL 2775 click here.