Lawsuits are being filed against St Jude Medical Inc., the device maker that manufactures the controversial Riata defibrillator leads. The cardiac devices have been associated with numerous reports of deaths and injuries.
The Riata was removed from the market in 2010 following reports of defects and high failure rates, which, as well as emerging lawsuits, allege that the Riata’s conductive ends break free. When this happens, the device either delivers excessive shocks, insufficient shocks, or shocks at the wrong time. The problem stems from the Riata’s exposed ends, which have been linked with internal injury reports that include reports of lacerations. An inferior Riata lead housing was blamed for many of the reported defects and was ultimately changed to a silicone material, called Optim, and released as the Durata lead.
In one case cited by The Wall Street Journal, a 55-year-old plaintiff said she received a number of shocks in a 25-minute period while she was laying on her bed. She underwent surgery to have the faulty lead removed and her physicians said the explanted Riata revealed faulty wiring.
The upcoming lawsuits may challenge current liability protection for medical device makers that was implemented under a 2008 Supreme Court known as Riegel v. Medtronic. Lawsuits have been filed in Los Angeles Superior Court and federal court in the Central District of California. Plaintiffs allege that Riata manufacturing oversight issues were associated with the injuries or deaths of dozens of patients, said the Journal.
Should the new cases succeed, the long closed section of the law could be reopened. Today, that section leaves potential plaintiffs with very limited options when injured by a medical device, especially when injury claims are made over devices that received so-called U.S. Food and Drug Administration (FDA) ‘”fast-tracked” approval, a process known as the 501(k), said the Journal. The 2008 ruling protected these device makers from most liability claims if it was found that the device maker complied with agency standards, including for manufacturing, labeling, and monitoring, the Journal noted. When devices were put through the process appropriately, the companies that manufactured those devices were protected from some lawsuits.
In 1976, a law governing medical devices, for the most part, banned states from trying to regulate devices that are typically governed by federal regulations. The 2008 ruling provided a broad interpretation of these provisions, which has presented serious issues to plaintiffs seeking to pursue claims, the Journal explained. Attorneys handling such claims must work with state laws that address specific agency mandate violations.
Attorneys in the new Riata cases now allege that St. Jude violated FDA regulations in failing to report device flaws, and also violated state product liability laws. This represents a new way in which to attempt to overcome Riegel, said the Journal. Attorneys are also working to show that St. Jude erred in how it manufactured the devices in accordance with agency rules, a method in which many device cases have moved.
Some potential plaintiffs and attorneys shy away from pursuing such cases; however, appeals courts appear to be split over claims blocked by Riegel. And at least one recent ruling found Medtronic had no protection from device liability involving a malfunction in one of its pain medicine pumps. The case alleged, in part, that Medtronic neglected to warn the FDA about the device’s risks, said the Journal. One attorney noted that judges are beginning to notice that consumers have no recourse under current law, and that appears to be changing.