Medical device maker C.R. Bard is facing two class-action lawsuits claiming its blood clot filter devices are defective and is putting patients at greater risk of serious injuries or death.
According to a Law360.com report, lawsuits have been filed against C.R. Bard in federal courts in Pennsylvania and California. They each claim Bard’s blood clot filter devices are defective and prone to break apart once it is implanted in the body. And though none of the filters have actually caused injuries to the people who’ve filed lawsuits, each claims they must undergo extensive monitoring to ensure they do not suffer those injuries.
Three C.R. Bard devices are named in the lawsuits, including one that’s already been recalled from the market because of known defects: the Recovery Filter System, the G2 Filter, and the G2 Express. The Recovery device was recalled in 2005 and more than 10,000 of all three devices have been implanted in patients since they were approved for use.
The blood clot filter prevents a potential clot from traveling to an organ like the heart or brain that could result in heart attack or stroke.
The claims state, “Each of them is at a significant and likely risk of device failure in the future and this is a risk to which they would not be exposed but for the conduct of the defendants as alleged in this complaint and the implant of the device within their bodies.”
Though the Recovery device was pulled from the market because it was likely to fracture, the same problems have surrounded the safety profile of the two newer devices. These devices fail in a variety of ways. The defect that puts patients at risk of the most severe injuries is struts in the device perforating the walls of the vena cava, potentially leading to severe hemorrhaging.
Reported flaws in the newer G2 and G2 Express include “cracks, flaws, and gouges in the allow which makes up the device(s),” according to the complaints. Bard believes the failure rate of the two newer devices is about 2 percent but the lawsuits claim that is much higher, about 12 percent, meaning more than a thousand recipients face a greater risk of serious injury or death. That failure rate, the lawsuits state, is noted in publicly available data.
At the very least, everyone implanted with these devices will be required to undergo more extensive medical monitoring to look for potential problems that could lead to severe complications.
Additionally, the plaintiffs in the lawsuits claim C.R. Bard is attempting to “cannibalize” the market on blood clot filters by introducing an even newer device, the Eclipse, and offering it at a lower price than the G2 and G2 Express, intentionally raising the prices on those devices to encourage prospective recipients to be implanted with the newest without having to recall the other two devices as they did with the Recovery.
The class-action lawsuits filed in each state seek to include any patient who’s been implanted with either of the three devices.