St. Jude, Boston Scientific Face Subpoenas Over Implantable Defibrillators

Two medical device manufacturers reported last week that subpoenas have been received from federal regulators, regarding the effectiveness of some implanted cardiac defibrillators (ICDs).  

Boston Scientific officials indicated that the company received a subpoena from the U.S. Department of Health and Human Services (DHHS) on May 5.

St. Jude, another ICD manufacturer, indicates that it received one in April, from the U.S. Department of Justice, which is looking into whether St. Jude gave kickbacks to physicians for implanting its devices.

The nature of the DHHS investigation is not fully known, but the agency is in charge of ferreting out Medicare fraud.

The subpoenas seek information on performance of the devices as well as the operation of a Physician Guided Learning Program.

The internal defibrillators are designed to be implanted near a patient’s heart, monitoring the heart rhythms and giving life-saving electrical shocks if necessary to restore normal function. However, ICDs have been plagued by problems in recent years.

In October 2013, Boston Scientific agreed to a $30 million settlement over heart implants sold by its Guidant subsidiary, resolving claims that the company knowingly sold defective devices to patients. Guidant sold the ICDs from 2002 to 2005, but Boston Scientific acquired the company, and much of its legal liability, in 2006.

This latest investigation appears to focus on Boston Scientific defibrillators sold under the brand names Cognis and Teligen from 2007 to 2009.

In April 2012, Boston Scientific warned that malfunctions occurring in some Cognis and Teligen ICDs could potentially cause death, but did not recall the devices. The manufacturer indicated that the malfunction occurred during the high-voltage charging cycle of the device, leading to loss of telemetry, bradytherapy, tachytherapy and remote follow-up. At least four patients have reported feeling the device get suddenly hot at the implant site. At least one patient death was linked to the problem.

In December 2011, the FDA announced a St. Jude Riata ICD lead recall, impacting the small wires used to connect an ICD to the heart. The leads were found to be prone to failure, where the insulation surrounding the wires degraded and wore away, posing a risk of unnecessary shocks or causing the ICD to fail to work when needed to deliver a life-saving jolt.

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.

Several hundred patients who received the recalled wires are now pursuing lawsuits over the St. Judge Riata leads, alleging that the manufacturer sold a defective and dangerous medical device and failed to disclose the risk of early failure.