The FDA issued a warning letter to the medical device company St. Jude’s Medical to address several violations in the manufacturing of defibrillator leads Riata and Durata. St. Jude’s Medical, following an investigation of its manufacturing plant between September 25, and October 17, attempted to show it had corrected the violations found during the FDA’s investigation. The FDA delineated how its actions and responses were either inadequate or questionable to the point where adequacy could not be determined. The letter ultimately ordered St. Jude to correct the ongoing violations, or else face regulatory action, which could include civil fines and injunctions.
If you have a faulty defibrillator that uses a St. Jude or Boston Scientifc Lead, our South Florida products liability attorneys can help you seek compensation.
Riata and Durata are both essential parts of a defibrillator installed in patients to help monitor and correct their heart rates. The defibrillator senses a life threatening irregularity, and a shock is sent to help correct the heart via the Riata or Durata leads. These leads are surrounded by insulation and are expected to last around 10 years, with the insulation wearing out after several years of wear and tear. The Riata and Riata ST leads were eroding at an alarming, hastened rate and were sending unnecessary, jarring electric shocks throughout the patients’ bodies. St. Jude’s recalled the Riata in 2011, and has been under intense scrutiny every since. The Durata has not been recalled, however the FDA decided to subject that product line to a similar investigation, as it is manufactured similarly and performs the same function as the Riata and Riata ST leads.
More than 200,000 Riata leads have been distributed globally, and it is estimated that approximately 79,000 remain in patients in the United States. Even though the Riata leads have been off the market since 2010, the FDA expected St. Jude to bring its manufacturing process up to statutory code. The FDA is still trying to determine how soon the insulation on the leads fail after the lead is implanted, the timeline of the breakdown (when does the inner insulation fail, when does the outer insulation fail, and when do those failures cause the lead’s shock to migrate), and what risk factors contribute to the accelerated dissolution of the lead insulation.
The FDA has recommended doctors to closely monitor any patient with a Riata lead. Doctors may elect to use imaging tests like a fluoroscopy or X-ray to determine whether or not there is any decay in the insulation that could cause externalized shocks, or they could chose to remove and replace the lead. However, this has its own layer of concern, as the lead is threaded throughout the heart and creates a build-up of scar tissue, which makes each removal laden with risk to the patient.
The FDA requests that all doctors and patients who are either experiencing problems with their Riata or Durata lead, or suspect that the lead insulation is eroding too quickly, to report the problem to their agency so they can better track and correct this medical product defect that affects so many.
If you seek assistance in obtaining the compensation needed to heal from a defective defibrillator lead, the law office of Friedman, Rodman, and Frank, P.A. is here to offer their knowledge and experience litigating defective products cases. Call us toll-free at (877) 448-8585, or use our online contact form to schedule your free initial consultation.