October 15, 2012 by Arezu Sarvestani
Orthopedic device maker Smith & Nephew (FTSE:SN, NYSE:SNN) may be the next to see patient complaints, as adverse event reports gathered from the FDA's MAUDE database progress into lawsuits and then into a collective legal action.
Fellow device maker Biomet has already blazed that trail, with a raft of personal injury lawsuits against its M2A Magnum MoM hips consolidated in a federal court in Indiana, despite the fact that those devices have not been recalled.
The lawsuits against Biomet allege that the MoM hips are defective because they're prone to "generate high levels of metal ions, cause metallosis in the surrounding tissue and/or fail early." Similar warnings have cropped up in the MAUDE database, where physicians as well as patients have submitted complaints about Smith & Nephew hip implants that have required modification or replacement.
Smith & Nephew late last month issued an "Urgent Field Safety Notice" for its Birmingham Hip Modular Head implants, part of the suite of devices that pioneered the metal-on-metal hip field when they 1st hit the market in 1997. Within days of Smith & Nephew's warning, a slew of law firms issued their own press releases, some of them offering free consultations for patients with alleged Birmingham hip implant-induced injuries.
Smith & Nephew's modular head implant is comprised of the Birmingham Acetabular cup, a stem and a Birmingham modular head. The safety notice does not apply to SNN's Birmingham Hip Resurfacing implants, which "are performing to expectation," according to a warning issued by New Zealand regulators this week. But that hasn't stopped legal groups from lumping the Birmingham hip resurfacing system into the larger nationwide metal-on-metal hip controversy.
The firm has yet to file any lawsuits against the company, Burke said, but patient calls have been "in the dozens" and mostly for Smith & Nephew's Birmingham hip resurfacing implants, which were not related to the company's recent warning. There have also been a couple inquiries about the modular head device referenced in SNN's recent warning.
For Burke, the lawsuits are not so much about individual companies and brands, but about targeting a class of devices that he says have proven to be a danger to patients. Many patients who call don't know what company manufactured their metal-on-metal implant, he told us.
The firm is still investigating potential avenues for action against Smith & Nephew, and is accruing information specifically on patients who have had surgery to replace or revise a metal-on-metal hip. The fact that the Birmingham hip has not been recalled doesn't protect the device from litigation, although it may make it more difficult to prove a case against the company, Burke noted.
Fellow device-maker Johnson & Johnson paid as much as $600,000 to 3 patients in the 1st settled lawsuits accusing the company's metal-on-metal implants of causing injuries. Some analysts have predicted that J&J may end up paying up to $1 billion in liability and other costs.
Since J&J's 1st cases were settled out of court, they don't necessarily signify any larger trends for the MoM lawsuits, Burke said.
Defending the BHR
"We are proud of the excellent clinical data The Birmingham hip resurfacing system continues to generate," chief medical officer Any Weymann of Smith & Nephew's advanced surgical devices division told MassDevice.com via email. "Recent data, along with existing registry data, further confirm our position that the BHR Hip stands out as an excellent option for the right patients."
That may not be enough to ward off the slew of law firms that have already set their sights on Smith & Nephew, using hip-related recalls as a launching pad for drawing in patients with complaints.
When Smith & Nephew in June recalled an optional metal liner component of its R3 acetabular system, law firms seized the opportunity to reach out to metal hip patients as a class.
"The Smith & Nephew hip recall adds to the growing frustration linked to metal-on-metal hip implants," the Schmidt Firm wrote in a press release. "The devices have been linked to a wide variety of side effects that are significantly greater than metal-on-plastic or ceramic designs."
The same law firm issued a new release after Smith & Nephew's most recent warning on the MoM modular head implants, again soliciting patients with injuries potentially related to their metal hips to investigation possible legal recourse.
Ultimately, every recall that affects an MoM hip or related component feeds a growing narrative that the devices as a type aren't safe enough for patients, regardless who makes them. An FDA expert panel in June advised physicians against use of MoM implants, but stopped short of recommending a recall.
"Patient safety is always Smith & Nephew's first priority and we closely monitor the available scientific, registry and regulatory data to ensure our products are safe and effective," Smith & Nephew's Weymann told us.
A search of the FDA's MAUDE adverse event reporting system turned up hundreds of results filed over the last year for the Birmingham hip implant suite of products, including the hip resurfacing systems that are not part of the warning and for which failure rates are still within accepted levels.
The MAUDE database isn't a perfect system, however, and is often criticized for under-representing the issue as the database relies on voluntary reporting from patients and physicians.
One report, filed in May 2011 for the Birmingham Hip Resurfacing implant, details results for a patient who experienced repeat infections and immobility over the course of 4 years following his hip implant procedure. The patient eventually had his metal-on-metal Birmingham device replaced, opting instead for a ceramic and plastic total hip replacement.
"This prosthesis problem is very similar to the J&J DePuy," according to the report. "It is possible that pseudo-tumors developed due to metal on metal rubbing together. Was the metal debris released into the bloodstream? These [sic] seems too coincidental to the DePuy case."
In an older report, filed in 2008, another patient also suggested that metal ions released by the rubbing together of the metal components in the Birmingham Hip Resurfacing system were the cause of patient injury.
"I had both hips resurfaced in 2008-2009. I have developed pseudo-tumors in both hips due to metal debris from my BHRs," the patient wrote. "I have elevated levels of chromium and cobalt in my blood ... I have been in considerable pain and other symptoms such as ringing ears, reduced urine stream, fatigue, and depression over the last year."
That patient also opted for a replacement surgery, according to the MAUDE report.
Smith & Nephew did not issue a recall on the device, but updated its indications for countries outside of the U.S. to restrict use to revision surgeries "in cases where a Birmingham Hip Resurfacing femoral component is being revised, the patient shows no signs of metal sensitivity, and it is being implanted in conjunction with an uncemented Synergy stem," according to a Smith & Nephew website. The company noted that, when used strictly with the Smith & Nephew's Synergy stems, the hip implants exhibited a 1.07% failure rate, which is within acceptable limits.
"This modification does not apply to the U.S. market where the Birmingham Hip Modular Head is not approved for use as part of a primary hip replacement procedure,"Smith & Nephew spokesman Joe Metzger told MassDevice.com. "This change does not apply to our BHR resurfacing device, which is performing very well, and is supported by data from several registries and independent, peer-reviewed articles."
In June 2012 Smith & Nephew recalled its R3 metal-on-metal acetabular liners, saying that the company "was not satisfied with the clinical results of this component." The company said at the time that about 7,700 of the metal liners had been implanted since 2007, most with stemmed total hip replacements – amounting to less than 1% of Smith & Nephew's global hip implant revenue.