St. Jude Riata Lawsuit Scheduled for Trial in Feb. 2015

A bellwether trial has been scheduled for February 2015, involving two product liability lawsuits filed by individuals who claim they experienced problems with St. Jude Riata defibrillator leads, which were recalled amid reports that the wires were defective.

U.S. District Judge James V. Selna is currently presiding over about a half dozen St. Jude Riata lawsuits filed in the U.S. District Court for the Central District of California.

All of the cases involve similar allegations that the small wires used to connect implantable defibrillators to the heart were defective and prone to failure, which may cause the device to produce unnecessary shocks or fail to work when needed to deliver life-saving jolts.

The St. Jude Riata leads were removed from the market in late 2010, amid reports that the insulation surrounding the wires was prone to corrode and fail, resulting in exposed wires inside the body.

According to a scheduling order (PDF) issued earlier this year, a consolidated trial has been scheduled for February 3, 2015, involving two different cases. It is hoped that the bellwether trial will help the parties gauge how juries may respond to certain evidence and testimony that is likely to be similar to what will be presented throughout the St. Jude Riata litigation.

The parties are scheduled to meet with Judge Selna again next month for a status conference, and a settlement conference has been scheduled for September 12, 2014. Although the outcome of this bellwether trial will not be binding on other cases, it may help facilitate St. Jude Riata settlement agreements in a large number of cases pending throughout the country.

St. Jude Riata Litigation

Although a federal multidistrict litigation (MDL) has not been established for all St. Jude Riata cases pending throughout the country, cases pending in the Central District of California have been centralized before Judge Selna to reduce duplicative discovery, avoid contradictory pretrial rulings from different judges and to serve the convenience of the witnesses, parties and the court.

Judge Selna has ruled that the first trial will be a joint trial of two different cases; a wrongful death lawsuit filed by the parents of Daniel Calise, and an injury lawsuit brought by Michael Thomson.

The Calise complaint (PDF) was filed by Rose and Paul Calise, who claim that their 23-year-old son died on September 17, 2011 from cardiopulmonary arrest due to the failure of his St. Jude Riata lead. They blame the lead’s failure on defective design and manufacturing.

The Thompson complaint (PDF) claims that a doctor advised him in April 2012 that his Riata lead was failing and that it needed to be replaced. Thompson indicates that due to the defective lead, he required risky revision surgery via laser extraction, which has caused him to suffer injury, medical expenses, and other damages.

St. Jude opposed the consolidation of the two cases for one trial, arguing that having the cases go before the same jury would be unduly prejudicial. Judge Selna has indicated that the defendants may request another opportunity to argue for separate trials before the cases begin early next year.

St. Jude Riata Lead Recall

The St. Jude Riata leads are connected to implantable cardiac defibrillators (ICD), to monitor the heart and apply corrective electrical shocks when heart rhythm problems are detected.

Amid reports that suggested the insulation was failing on some leads, the company suspended sales of the St. Jude Riata and Riata ST ICD leads in late 2010. The company then issued a warning to doctors about the risk of St. Jude Riata lead insulation failure in late 2011.

The FDA determined that the actions constituted a St. Jude Riata recall in December 2011.

Approximately 227,000 St. Jude Riata wires were sold worldwide before it was removed from the market, and estimates suggest that more than 70,000 of the leads remain active in patients in the United States, as the process of attempting to remove the lead is very risky and doctors usually recommend keeping the recalled lead in place unless there is evidence that it has failed.

In August 2012, the FDA issued a safety communication in response to concerns among individuals who still have one of the recalled St. Jude Riata or Riata ST leads, recommending that individuals undergo x-ray or other imaging exams to monitor the condition of the leads.

The FDA has ordered the company to conduct additional studies on the potential risk of insulation failures and problems with the debrillator leads, including the newer versions sold under the Riata ST Optim and Durata names.