Wright Medical Inc. took steps in to 2006 to convince the U.S. Food & Drug Administration (FDA) to reject pre-market approval of rival Smith & Nephew’s Birmingham metal-on-metal hip implant. Wright Medical, which makes two metal-on-metal hip replacement devices, the Conserve and the Lieneage device, filed a citizen petition with the FDA in asserting that Smith & Nephew’s pre-market approval application was inadequate to prove safety and effectiveness of the Birmingham.
According to MassDevice.com, the Birmingham metal-on-metal hip implant first came to market in 1997 in the U.K., and was the first all-metal device on the market. It was sold by Midland Medical Technologies, which was acquired by Smith & Nephew in 2004. The launch of the Birmingham prompted other device makers to quickly bring their versions of metal-on-metal hip implants to market, including the Zimmer Durom Cup, and DePuy’s ASR and Pinnacle devices.
In 2006, Smith & Nephew applied for FDA premarket approval of Birmingham devices. According to MassDevice.com, Wright argued that the clinical data behind the Birmingham application was flawed because it covered only a single surgeon’s cases – the inventor of the device, Dr. Derek McMinn. The petition filed by the company read in part:
“The PMA for the BHR – which rests on a retrospective, uncontrolled case series at a single center by a single physician without any protocol and with incomplete follow-up – is not scientifically valid and does not satisfy the agency’s standards for safety and effectiveness.”The FDA eventually granted two pre-market approvals for the Birmingham, first in May 2006 and another in October of that year for additional sizes
“Smith & Nephew tries to create the impression that this was a multi-center trial. Yet, at the [FDA advisory] panel meeting, the acting panel chairperson stated that the data was ‘an unusual PMA based on a retrospective study designed by a single surgeon based on a British data set.”
Since the August 2010 recall of DePuy Orthopaedic’s ASR hip replacement, the entire class of metal-on-metal hip implants has come under scrutiny, as a number of studies have found evidence that that the devices can shed dangerous amounts of chromium and cobalt into patients’ bloodstreams. Last month, the U.S. Food & Drug Administration (FDA) revealed that it had received 16,800 negative event reports involving metal hips between 2000 and 2011. Of those, more than 14,000 involved revision surgeries, in which a defective implant was removed. Recently, the FDA’s Orthopaedic and Rehabilitation Devices Panel recommended that metal-on-metal hip implant patients undergo regular monitoring to ensure their devices are not failing. The panel also called for new warning labels for all-metal hip implants, including warnings regarding their association with the development of pseudotumors and high levels of metal ions in patients’ blood.
There are currently more than 4,000 lawsuits pending against DePuy’s recalled ASR hip implants in a multidistrict litigation underway in U.S. District Court, Northern District of Ohio. A multidistrict litigation for lawsuits involving Wright’s Conserve hip replacement device is underway in the Northern District Journal, while lawsuits over the all-metal version of DePuy’s Pinnacle device have been consolidated in federal court in Texas. Legal claims involving the Zimmer Durom Cup, which was recalled in 2008, have been centralized in federal court in New Jersey. This week, the U.S. Judicial Panel on Multidistrict Litigation (JPML) will hear oral arguments regarding the possible consolidation of lawsuits involving Biomet’s M2a-Magnum Hip Replacement System.