Were Defective St. Jude Cardiac Defibrillators Implanted Even After Recall?

October 9, 2017, 5:00PM. By Anne Wallace

Washington, DCThe complaint in the ASEA/AFSCME Local 52 Health Benefits Trust defective St Jude cardiac defibrillator lawsuit contains shocking new allegations. The fact-finding that follows may give patients the information they need to seek redress.

The underlying situation is that Greatbatch battery model number QHR2850, which was used in St. Jude’s Fortify Assura, Quadra Assura Unify, Unify Assura and Unify Quadra defibrillators, is defective. The malfunction can be deadly. That’s bad medicine.

But the news story is what increasingly seems to look like a cover-up. What did they know and when did they know it?


ASEA/AFSCME Local 52 Health Benefits Trust v. Abbott Laboratories is a massive class action lawsuit brought, interestingly enough, not by patients who have been hurt by malfunctioning pacemakers, but by insurance funds. In the most basic terms, the insurers claim that they have suffered economic harm because the product and procedures they paid for were faulty, and then sometimes they had to pay again for other procedures. It’s a cold economic argument.

The patients’ perspective is different. Usually, the claim is mostly about harm to health or wrongful death and then only secondarily about pain in the pocketbook. But what is discovered in one context (hopefully well-resourced), may be used in another.

Dig through the documents and there’s some interesting stuff:

Paragraph 83 of the complaint https://www.courthousenews.com/wp-content/uploads/2017/09/StJudePacemakers.pdf states that “The FDA investigators also discovered that Defendants released ten recalled ICDs from its distribution centers after the October 2016 recall had been issued. Between October 14 and October 26, 2016, seven additional recalled ICDs in the control of St. Jude Medical’s U.S. Field Representatives were implanted into patients.”

Paragraph 75 states that “St. Jude Medical had repeated notice of the Battery Depletion Defect and ignored it. Forty-two (42) of the Defendants’ Product Analysis Reports, produced between the years 2011 and 2014, confirmed that there was an issue with premature battery depletion caused by lithium cluster bridging in the Recalled Devices [emphasis in original].”

There are lots of other allegations which point to basic corporate malfeasance – failure to highlight product problems to the board and management, failure to report issues to the FDA in after-market reports, and the temptation to study a problem to death in hopes that everyone will nod off.

Allegations in a complaint should never be taken as fact, although there is a “swearing to the best of my knowledge and information,” caveat that good lawyers pay attention to in filing papers. The interesting stuff comes next. What will the discovery phase of the case discover? It will probably be thorough and it could be a feast for individuals who have been harmed by defective St. Jude cardiac defibrillators.

As always, stay tuned.