St. Jude Medical has come under constant fire over its recalled implantable defibrillators and defibrillator leads. Both patients and investors have sued the company, and attorneys are now accepting cases for the latest St. Jude Medical recall.
St. Jude Medical, a Minnesota-based medical device company, has been making small, implantable defibrillators since the 2010s. These devices — implantable cardioverter defibrillators and cardio resynchronization therapy defibrillators — deliver life-saving shocks to the hearts of patients with rapid, slow or irregular heartbeats.
However, in October 2016, St. Jude Medical recalled many of these defibrillators due to defective batteries that caused the devices to fail. At least two deaths, 10 cases of fainting and 37 cases of dizziness were reported globally as a direct result of the failed ICDs and CRT-Ds.
In the months following, many patients with devices under the recall advisory began to file lawsuits against St. Jude Medical. Attorneys are now accepting product injury claims for faulty defibrillators.
St. Jude Medical is no stranger to litigation over its medical devices. The company has been in and out of courtrooms for the past several years facing lawsuits over its defibrillator leads, or wires, and claims that its medical devices are vulnerable to hacking.
St. Jude Defibrillator Litigation
St. Jude Medical faced a significant amount of time and money in court over a recall from 2011 related to some of its defibrillator leads, which are wires that connect the defibrillator to the heart and distribute the electric shocks. The St. Jude Medical Riata and Riata ST silicone leads were found to have degraded insulation. The defect cut the 10-year lifespan of the leads to four years, and the degraded leads were alleged to have caused inappropriate shocks or no shocks to patients’ hearts. An estimated 22 deaths were tied to the Riata leads.
St. Jude Medical stopped selling the devices in 2010. At that time, more than 227,000 Riata leads had been sold worldwide. On Nov. 28, 2011, St. Jude medical and the FDA recalled the Riata leads. After years of facing lawsuits, St. Jude Medical agreed to settle roughly 950 claims for $14.25 million. The settlement excluded three additional lawsuits in the U.S. and one Canadian class-action suit over the Riata leads.
Riata Class Action Lawsuit
St. Jude Medical also settled a class-action lawsuit in relation to the Riata leads in July 2016. The company’s investors filed the lawsuit in December 2012, claiming St. Jude Medical knew about the problems with its Riata and Durata defibrillator leads and misled investors.
Shareholders experienced significant loss of income due to their investment in St. Jude Medical because of both of these products, the lawsuits suggested. After the Riata leads were placed under an FDA Class I recall, stock value in the company plummeted. St. Jude Medical launched a “new and improved” defibrillator lead, the Durata, to replace the Riata. In late 2012, the FDA discovered nearly a dozen problems with the Durata manufacturing process during a plant visit. This also caused St. Jude Medical stock to drop in value — 11 percent in one day.
The settlement paid out $39.25 million to all St. Jude Medical shareholders who had stock in the company between Feb. 5, 2010 to Nov. 20, 2012.
Riata Defibrillator Lead Lawsuit
Robert Loiseau of Southampton, Pennsylvania filed a personal injury claim against St. Jude Medical over the Riata leads. His case was filed on March 21, 2014.
Loiseau had a Riata lead implanted in 2007. After learning the lead may have been defective, he participated in revision surgery in 2012 to remove the lead. In the removal surgery, Loiseau’s doctor discovered the Riata lead had fractured and estimated the device would have malfunctioned should his defibrillator activated. The case alleged Loiseau experienced physical pain, lost income and mental distress.
St. Jude Medical Sues Over Hacking Claims
St. Jude Medical has also filed its own litigation against Muddy Waters, an investment research group, and MedSec, a medical security firm, in September 2016 for defamation and conspiracy. The groups released a report together on Aug. 25, 2016, claiming St. Jude Medical implantable cardiac devices are technically insecure and allow hackers to weaponize the devices.
St. Jude Medical’s lawsuit claims Muddy Waters and MedSec purposefully distributed false information on its products to “wrongfully profit from a drop in share value through a short-selling scheme.” It claims the company’s stock fell 10 percent on the day the report was released.
Muddy Waters filed a second report on the safety of St. Jude Medical’s defibrillators and other devices as evidence in the case. This 53-page report, which was conducted by private cybersecurity firm Bishop Fox, verifies the claims in the original MedSec and Muddy Waters report. According to the Bishop Fox report, the company was able to successfully execute a test attack on a St. Jude Medical cardiac device using a “software defined” radio from 10 feet and as far as 100 feet away.
Collectively, the Muddy Waters reports claim that St. Jude Medical devices are unsafe for human implantation because it is possible to hack into defibrillator programming software and the defibrillators themselves. This hacking could weaponize the devices, causing them to deliver painful and potentially lethal electric shocks to the hearts of patients with the implant. The litigation is ongoing.
Battery Depletion Recall
On Oct. 11, 2016, St. Jude Medical released a recall advisory to patients and healthcare providers who received 13 different models of its ICDs and CRT-Ds. These devices — all manufactured before May 2015 — were found to have defective batteries. Although the lithium-based batteries are designed to last five – 10 years, lithium clusters were forming inside the batteries, causing the devices to fail early.
Compounded with the premature battery depletion, the warning alert system also malfunctioned. Patients are supposed to seek medical attention to evaluate the need for battery replacement within three months of experiencing a small vibration known as an elective replacement indicator. However, according to the FDA recall, some patients with affected defibrillators experienced full battery depletion within 24 hours of experiencing the ERI.
The U.S. Food and Drug Administration administered a recall on affected St. Jude Medical defibrillator models to coincide with the St. Jude Medical recall. The FDA classified it as a Class I recall, meaning the device malfunction is probable to cause serious adverse health effects or death. As of the Oct. 11 FDA report, 841 of the 398,740 total affected devices sold worldwide had been returned.
The FDA also reported several adverse effects, including:
- 2 global deaths, one in the United States
- 10 global reports of fainting, nine in the United States
- 37 global reports of dizziness, 30 in the United States
In response to the problem, the FDA stated it will continue to monitor St. Jude Medical defibrillators. Also, the agency asks patients and healthcare providers to report further incidences to MedWatch, it’s adverse event reporting program.
No class action lawsuits against St. Jude Medical about defibrillator battery failure have been filed yet, but as individual cases are filed they may be consolidated into a multidistrict litigation. In the case of an MDL, one federal judge will combine similar cases to hear evidence at one time before typically making a joint ruling.