by Emily Cox
A new lawsuit alleges that Smith & Nephew failed to comply with numerous requirements of its Birmingham Hip Resurfacing (BHR) FDA Pre-Market Approval, concealing the hip system’s inherent flaws from the FDA and exposing countless patients to its dangerous defects.
Gary Lunsford filed the claim against Smith & Nephew on June 14th in the Eastern District of California. He alleges that he underwent left hip resurfacing with the BHR system in September 2010. By October 2016, the hip had already failed, requiring revision surgery. The surgeon noted metallic debris and a pseudotumor from the premature failure of the device.
According to the lawsuit, Smith & Nephew knew or should have known that Lunsford’s injuries were a probable outcome from its BHR system. However, the company continued to promote BHR as a safe alternative to other metal-on-metal devices. In fact, Smith & Nephew did not withdraw the device from US markets until 2015. Furthermore, due to PMA non-compliance, the company should not have been selling the device at all.
Smith & Nephew FDA Violations Voids Legal Protection and Approval Status
On May 9, 2006, the FDA granted conditional approval to Smith & Nephew to market the BHR. The agency set strict guidelines that mandated ongoing clinical studies, monitoring, reporting of adverse events, and post-marketing surveillance among other measures. Failure to follow these requirements is a violation of the Federal Food, Drug, and Cosmetic Act and voids any legal protection afforded by PMA status. Also, failure to comply with requirements is grounds for withdrawal of PMA. Furthermore, according to the FDA’s PMA-approval letter, this also disallows continued commercial distribution.
Smith & Nephew Hid Metal Poisoning Risk from FDA, Pointing the Finger
In the first several years after BHR entered the market, Smith & Nephew did not report the risk of metal poisoning, or metallosis, in its adverse events to the FDA. However, the company allegedly knew of dozens and possibly hundreds of such cases. Instead, Smith & Nephew went to great lengths to blame device failure on other sources, such as allergies, generalized pain, and implanting surgeons.
In fact, in August 2011, BHR inventor Dr. Derek McMinn published an article titled “Metal Ions Questions & Answers.” The article placed the blame for the hip system’s failures on surgeons improperly placing the device and even on the patients, themselves, particularly women, who experienced substantially higher failure rates.
Dr. McMinn claimed that women were “pre-sensitized” to metal due to wearing costume jewelry. Consequently, he wrote that their tissues may “over-react” to low levels of metal released from artificial devices. However, Dr. McMinn offered no scientific evidence for his theory about the connection between costume jewelry and BHR failure rates.
While Smith & Nephew tried to hide the true cause of the BHR’s failure rate, clinical data continued to pile up, showing a real risk for patients. For example, the National Join Registry of England and Wales shows the BHR 42mm femoral head component has a seven-year revision rate of 11.76 percent. This is well about the normal acceptable failure rate for this type of device.
Smith & Nephew Failed to Properly Train Surgeons
Smith & Nephew agreed to implement a training program as part of the PMA requirements. The company began a BHR training program as promised. However, it failed to achieve training milestones. In fact, the company didn’t begin widespread training until more than three years after releasing the BHR system. At this time, Smith & Nephew admitted to the FDA that surgeons were implanting the device despite receiving no training at all from Smith & Nephew on how to properly perform the procedure. While it was Smith & Nephew’s responsibility to train physicians, the company did not hesitate to lay the blame on these same inadequately trained surgeons for the device’s failings.
Smith & Nephew Did Not Comply with Clinical Study Requirements
In the first five years, tens of thousands of patients received BHR devices. However, Smith & Nephew only enrolled a small fraction of the required number of patients in its clinical study. Seven years after PMA approval, the company still had only enrolled 269 of the 350 patients in the study.
Men, who have a lower failure rate for resurfacing procedures, made up approximately seventy-five percent of study participants. This prompted the FDA to warn the company about bias in its study results. The agency issued a deficiency notice to this effect. The notice also addressed the company’s failure to reach the 80 percent target follow-up rate with study participants. Smith & Nephew didn’t even bother to respond to the FDA within the required time period.
Smith & Nephew also reported 35 deviations from the study protocol, resulting in poor patient follow-up. This was, in part, due to Smith & Nephew failing to adequately staff study locations with enough research coordinators. These and other problems prompted the FDA to write the medical device company, informing it that the agency was unable to review the adequacy of BHR studies and reports due to “inadequate” information from Smith & Nephew. On several other occasions, the FDA reported that the status of the BHR study was “progress inadequate.” The agency also noted that Smith & Nephew did not meet patient enrollment milestones and failed to submit mandatory reports on time.
The company abruptly closed the study’s US patient database in 2012 before the planned completion date.
Lunsford joins a growing number of individuals filing similar product liability lawsuits against Smith & Nephew, alleging serious harm from its BHR hip system. Experts expect that hundreds, if not thousands, of these lawsuits will eventually pass through the court system.