St. Jude Problems Continue, as FDA Freezes New Medical Devices

Federal health regulators have stated that they will not approve any new Class III medical devices from St. Jude Medical until the company can fix quality control problems at one of its main manufacturing facilities. 

The FDA issued a warning letter to St. Jude Medical on January 10, indicating that inspections of the company’s Sylmar, California facility had revealed too many problems, and that the company’s responses to the issues discovered there had been inadequate so far.

Class III medical devices are those which are generally classified as the most likely to harm a patient if something goes wrong, as well as devices for which the safety profile has not yet been established. The category includes pacemakers and many other forms of implants, as well as HIV diagnostic tests and automated external defibrillators.

Earlier this month, St. Jude admitted there were problems at the plant and vowed to fix them. The facility manufactures the company’s Durata ICD leads and other products.

The FDA inspected the facility between September 25 and October 17 of last year and found a number of quality control problems that resulted in a warning letter in November. In the latest letter, the FDA said St. Jude had failed to address the problems and failed to provide adequate plans to address the problems.

The original FDA investigation report, which was released by the agency in November 2012, outlined a number of concerns over manufacturing deficiencies where the St. Jude Durata defibrillator leads are made.

The inspection report found that St. Jude failed to adequately test design changes made to the Durata leads following the Riata recall. Among the 11 different deficiencies cited in the inspection, investigators found problems with design verification and validation, how the company responded to complaints, and noted that lead design elements were tested only once, even though the company’s own protocols called for five tests.

The inspection came in the wake of a St. Jude Riata and Riata ST defibrillator lead recall, where the small wires used to connect implantable cardiac defibrillators were poking through the insulation materials, resulting in exposed wires inside some patients.

This may lead to unnecessary shocks or cause the ICD to fail to deliver a life-saving jolt when needed.  As a result of the problems, a number of patients have had to undergo risky surgery to remove and replace the lead wires.

A growing number of individuals throughout the United States are now pursuing a St. Jude Riata product liability lawsuit, alleging that manufacturing defects made the insulation weaker at certain points, allowing the wire to penetrate and become exposed inside the body.