Medical devices have improved — or saved — the lives of many people. While advancements in this area of technology have proved valuable, flaws in the design or construction of medical devices can prove to be very dangerous.
Recently, a judge ruled that five suits filed against St. Jude Medical could move forward. According to the claims, the medical device manufacturer failed to provide adequate warnings about defects in wire leads used in their Riata heart defibrillator. This particular device was recalled in 2010, but patients weren’t fully warned about the possibility of the leads failing.
According to reports, material surrounding the leads had a tendency to be perforated, exposing electrical wire. The problem is that people received shocks from the wires after they became exposed. As a result of this defective product, more than 30 people suffered injuries, some of which were fatal.
Although there were clear problems with the device, the manufacturer made attempts to have the ongoing legal claims dismissed. Ultimately, a federal judge determined that the lawsuits could stand and should move forward in court.
Documents from the U.S. Food and Drug Administration show that the manufacturer witnessed a 6 percent increase in the number of complaints about problems with the leads between 2002 and 2008. Despite the knowledge of ongoing issues, the device wasn’t recalled until 2010 and consumers weren’t well informed about the possibility of the electrical wires becoming exposed after implantation.
When medical device manufacturers are building a new product, it should undergo thorough testing. Even if trials meet FDA standards for approval, companies have a duty to respond to and report issues that arise after a device hits the market. Patients who depend on a functional, safe device deserve to know the risks they face.
Source: Massachusetts Medical Device Journal, “Riata lawsuit claims stand against St. Jude Medical,” Brad Perriello, Jan. 27, 2014