When should a device or drug be pulled from the market? These are questions that were asked and answered by Steven E. Nissen, MD, and Robert G. Hauser, MD, at this year’s ACC.12 during a session entitled, “When Should Devices or Drugs Stop Being Used in Practice.” This week, a recent study by Hauser, published in Heart Rhythm, drew fire from medical device firm St. Jude Medical. The controversy shows that this question is far from resolved.
St. Jude had a bone to pick with the Heart Rhythm Society (HRS) and Hauser et al for a published study regarding data on deaths linked to St. Jude’s Riata and Riata ST implantable cardioverter-defibrillator (ICD) leads.
In the study, covered last week in Cardiovascular Business, Hauser and colleagues questioned whether electrical malfunctions were at fault. The study was a result of a December 2011 statement released by St. Jude that pointed out the potential estimates of failures from its Riata and Riata ST devices and a Class I FDA recall that cited the possible risk of injury or death from these faulty devices.
In Hauser et al’s analysis, data for the Riata and Riata ST were included, as were data on Medtronic’s Quattro Secure model 6947 ICD leads. Hauser et al reported 133 total deaths (71 Riata and Riata ST and 62 Quattro Secure). Twenty-two were reported to be linked to Riata or Riata ST failures vs. five Quattro lead failures.
After the results were published, St. Jude demanded a retraction of the study, accusing Hauser of “substantially undercounting total deaths in the MAUDE database for Quattro Secure.” In addition, the device company called the results “misleading.” St. Jude also said that it was not made aware of the publication.
Hauser told Cardiovascular Business he had no comment, but Medtronic said, “it appears to be nothing more than a dispute with St. Jude and Hauser.” The New York Times reported April 11 that HRS said that the study will not be retracted.
This is not the first time Hauser has stirred up the pot. In fact, Hauser is known for delving further into previous device failures and recalls, previously with Guidant's (now, Boston Scientific) Prizm ICDs and uncovering issues with Medtronic’s Sprint Fidelis (both later recalled). At ACC.12, Hauser outlined the rise and fall of Guidant’s ICD. Hauser and Nissen both agreed that something must be done to stop these incidences as they occur much too often with little consequence.
Nissen said that punishment should be established for these types of failures, and Hauser pointed to the hasty nature of the FDA device approval process, saying that it must be reviewed. However, the medical device companies are protected by federal law. In 2008, the U.S. Supreme Court, in an 8-1 ruling of Riegel v. Medtronic, said federal medical device regulations trump state product-liability lawsuits unless the medical device company violated FDA policy. Regardless, the law and practicing physicians reinforce the need for effective post-market approval studies.
While obviously all things in life have room for some error, how much is too much in the medical field? What do you think will help curb situations that could lead certain patients on a potentially harmful path?
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Cardiovascular Business, associate editor