St. Jude Medical, a medical device company based in Minnesota, makes the Durata lead. The St. Jude Durata lead is a tiny wire that connects a defibrillator device to the heart.
A defibrillator, located outside the heart, monitors heart rhythm and delivers a high-voltage shock to the heart if serious rhythm abnormalities are detected. Connected directly to the heart tissue, the Durata lead serves to carry information between the heart and the defibrillator and if necessary, the lead also delivers the high-voltage shock.
The St. Jude Durata lead is almost identical to the St. Jude Riata lead, which was recalled in November 2011 after numerous reports of premature failure due to premature corrosion of the insulation that protects the leads. If a defibrillator lead corrodes, it can cause the conducting wires it houses to move deeper into the lead or externalize outside the lead. This can lead to a number of problems that could culminate in cardiac arrest:
- Improper pacing or sensing of the heart rhythm
- Inappropriate delivery of shocks to the heart
- Failure to deliver life-saving shocks to the heart
There is growing concern that similar design defects plague both devices.
To ensure that the Durata lead does not share the Riata lead’s defects the FDA conducted an in-depth inspection of St. Jude Medical’s manufacturing facility in Sylmar, California in late 2012. 11 problems were identified with the manufacturing and quality control protocols at this facility. Based on these findings, the FDA publicly warned St. Jude Medical that a failure to address the problems identified would result in “seizure, injunction, or civil monetary penalties”. The agency also made it clear that they would not approve new, similar medical devices made at this facility, nor would they allow export requests from it until St. Jude Medical fixed the problems at that site.
To date, no St. Jude Durata lead recall has been issued, though the device continues to be investigated.
The FDA has received at least one adverse event report concerning the Durata lead, indicating that a Durata lead had to be removed because the wires were poking through the insulation.
Can I file a lawsuit if I have have been injured by the St. Jude Durata Lead?
Possibly. If a manufacturer produces a dangerous or defective product, it can be held responsible to those who are injured as the result of inadequate warnings, under a legal theory known as “product liability.” Depending upon the particular circumstances of your case, damages may include recovery for any of the following:
- Past and future medical expenses
- Past and future pain and suffering
- Lost wages
- Loss of future earning capacity
- Emotional distress
If you or a loved one has been harmed by the St. Jude Durata Lead, you should contact your doctor immediately. You may also wish to contact an experienced St. Jude Durata Lead lawyer to discuss your legal options. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay.