Also called Riata ST leads, the St. Jude Riata defibrillator leads were recalled in December 2011. What happened? The lead wires had insulation problems. These leads connect the heart to the pacemaker or defibrillator. These defibrillators are sometimes called ICDs (Implantable Cardiac Defibrillators). ICDs are designed to monitor the heart's rhythm and to provide life-saving shocks in the event of irregular heartbeats. This particular type of lead wire was created in 2002, and approximately 227,000 have been implanted in patients.Injuries Caused By Defective St. Jude Riata Leads
The recalled Riata leads can cause several injuries for patients. If the wire becomes exposed because of inadequate insulation, the lead is defective. If so, the patient may experience:
- painful and unnecessary shocks to the heart
- failure of the ICD device when life-saving shocks are required
Several news reports and medical journal articles have explained how St. Jude Medical was negligent, both in the manufacture of the leads, and in warning doctors and patients about the defects. Not only will patients have claims for defective design or negligent manufacture, but they will also have claims for failure to warn.Failure to Warn
Many doctors encountered problems with the leads. Physicians from Johns Hopkins in Baltimore, the University of Pittsburgh and the Royal Victoria Hospital, for instance, noticed abrasion from 2009 to 2009. The company line appeared to be that those were all isolated incidents. Despite these warning signs, St. Jude Medical delayed warning letters to doctors until December 2010 and November 2011. The first letter advised doctors that the leads had an abrasion rate of 0.47% over nine years. Abrasion refers to the wearing down of the insulation. Recognizing they had a problem, the first letter also advised doctors that the leads would be recalled before 2011. No St. Jude Riata lead recall occurred, however. The second letter, St. Jude informed doctors that the abrasion rate had increased to 0.63%, but they failed to recall the devices. The FDA later recalled the leads using Category Class I (the most serious category of recall, indicating a reasonable probability of death or other adverse health consequences). Most concerning is that St. Jude performed an internal audit of the Riata leads which concluded in 2008. That audit revealed significant problems, and no action was taken.
The bad news is that these cases settled in 2015 for only $14.25 million. This resolved nearly a 1,000 claims. This litigation is essentially over.More Bad News in 2019
U.S. District Judge David Doty issued a ruling in January 2019 dismissing lawsuits against St. Jude (and Abbott who bought St. Jude 2017). Why? The judge ruled that these state court claims were preempted by federal law. The plaintiffs were not the victims but third-party payers (mostly insurance companies) who had spent hundreds of millions of dollars to monitor and remove these implants because the battery could die without warning.For More Information
- St. Jude Riata Recall: we saw it coming four years before it happened
- Wall Street Journal: St. Jude Riata Heart-Device Flaws Known for Years (October 11, 2012)
- FDA Safety Communication: Premature Insulation Failure in Recalled Riata Implantable Cardioverter Defibrillator (ICD) Leads Manufactured by St. Jude Medical, Inc.