Abbott is in hot water with FDA over St. Jude Medical's past mistakes, including what was either a lie of omission - or worse.

Amanda Pedersen

At best, St. Jude Medical management pussyfooted around the truth back in 2014 during the handling of an ICD battery problem that eventually resulted in a major recall last year. At worst, company leaders didn't just omit the truth - they lied.

In a detailed FDA warning letter to Abbott this week, the agency faulted the company for its handling of a lithium cluster bridging problem that caused some implantable cardioverter defibrillator (ICD) batteries to drain prematurely.

FDA said it reviewed 42 of the company's product analysis reports, produced between 2011 and 2014. The agency explained in the warning letter that the company underestimated the occurrence of the "hazardous" situation by evaluating the risk of the problem only on "confirmed" cases of lithium bridges, without considering the potential for "unconfirmed" cases to have been shorts.

The company also delayed acting on the problem until Dec. 18, 2013, and continued to distribute devices containing the defective batteries until October 2016. And even then, FDA said 10 devices subject to the recall were shipped out after the fact, and an additional seven of the recalled ICDS were implanted into patients.

Was it a Lie of Omission, or Worse?

FDA also called the company out for not being entirely upfront with its management review and medical advisory boards (MAB) about its battery depletion issue. Worse, the company appears to have hid the fact that one patient death had been linked to the problem.

FDA said St. Jude management told its review board, and its medical advisory board - during two separate presentations in November 2014 - there had not been any serious injuries or deaths directly related to lithium cluster formations, despite having evidence to the contrary.

FDA said the first death related to the premature battery depletion issue occurred before those presentations, but the company failed to disclose that to either board. In fact, St. Jude had even completed an analysis on that patient's returned device on Aug. 27, 2014 - well before the board presentations.

The company claimed at the time that the cause of premature battery depletion in that case "could not be determined," despite having evidence to the contrary from a supplier, FDA noted.

More 'Mud' in the Water

FDA's warning letter also mentioned the company's response regarding cybersecurity vulnerabilities - which surfaced last year, right in the middle of the Abbott-St. Jude deal.

Short-seller Muddy Waters Capital attacked St. Jude multiple times last year, claiming the company's implantable heart devices were vulnerable to cyberattack, but St. Jude repeatedly denied the claims.

Then, just days after Abbott completed its acquisition of St. Jude, the company released a software patch for its Merlin@home transmitter, intended to reduce the risk that St. Jude's radio frequency-enabled pacemakers and defibrillators could be hacked into.

Although the company sent FDA a summary of corrective actions related to the cybersecurity concerns, the agency said in its warning letter that the company had not confirmed that all required corrective and preventive actions were completed, including a full root cause investigation, and the identification of actions to correct and prevent recurrence of potential cybersecurity vulnerabilities.

Jonathon Hamilton, an Abbott spokesman, told Qmed that FDA began an inspection Feb. 7 of the company's Sylmar, CA facility (formerly run by St. Jude). Abbott responded to the inspector's observations March 13, but the agency's warning letter suggests the response was not quite up to snuff.

"We take these matters seriously, continue to make progress on our corrective actions, will closely review FDA's warning letter, and are committed to fully addressing FDA's concerns," Hamilton said.

Amanda Pedersen is Qmed's news editor. Contact her at [email protected].

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