The FDA Warning Letter RE: St. Jude ICD Batteries One Year Later

Sylmar, CAWe will soon be coming up to the one-year anniversary of the receipt by Abbott Laboratories of a scathing warning letter by the US Food and Drug Administration (FDA). At issue were various allegations and findings of non-compliance and failures to maintain good manufacturing practices determined during an inspection of its facility in Sylmar, California. Of interest to litigants bringing St. Jude ICD and CRT-D device lawsuits, are findings of non-conformity with regard to its cardiac defibrillator line - namely its Fortify, Unify, Assura and Quadra devices.

But more troubling are observations and allegations related to defective St. Jude ICD batteries that were found to fail prematurely, and without warning. The latter is a key issue, in that lithium batteries used to power and maintain implantable defibrillators are designed to last about five years under normal operating conditions. As the battery nears the end of its useful life, it begins to emit gentle vibrations, alerting the patient that the battery is running low of power. The alert prompts the patient to contact his or her medical doctor to arrange for a replacement. In most instances, this is accomplished well before the battery is in danger of failing entirely, thus putting the patient at risk.

As is well-documented by now, a problem with the batteries powering what turned out to be defective St. Jude cardiac defibrillators caused them to fail well in advance of the expected life cycle. But even more troubling, is the tendency for an impacted battery to run down much more quickly than anticipated, providing either little or no warning to the patient, and not giving the patient sufficient opportunity to arrange for a replacement.

The FDA determined that St. Jude was aware of the problem well before the St. Jude recall that was eventually announced in October, 2016 but continued to vend the defibrillators carrying the problematic batteries for some time following identification of the problem.

The FDA took Abbott/St. Jude to task on a number of fronts

"FDA reviewed 42 of your firm's Product Analysis Reports, produced between 2011 and 2014," the official warning letter, dated April 12 of last year, states. "These reports showed, in instances when your supplier's analysis provided evidence that lithium cluster bridging had prematurely drained the battery, your firm repeatedly concluded that the cause of premature depletion of Greatbatch QHR2850 batteries "could not be determined." Your firm later categorized these as "unconfirmed" lithium bridges. Your firm's Corrective Action and Preventive Action (CAPA) Procedure, (b)(4), Revision AA states, in Section 2.0, the level of corrective action and preventive action shall be commensurate with the significance and risk of the nonconformance. Further, Section 5.0 states the risk evaluation of nonconformances is based on three factors: severity, probability, and detectability. By basing your firm's risk evaluation on "confirmed" cases and not considering the potential for "unconfirmed" cases to have been shorts, your firm underestimated the occurrence of the hazardous situation. This delayed initiation of CAPA #13-017 Titled: Lithium Clusters Shorts in M2850 Cells, until December 18, 2013, and your firm continued to distribute devices containing this battery until October 2016."

The recall was enacted in October, 2016.

With regard to good manufacturing practices, the FDA said: "During an inspection of your firm located in Sylmar, CA, on February 7 through February 17, 2017, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Fortify, Unify, Assura (including Quadra) implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, and the Merlin@home monitor. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.

The FDA found problems at the manufacturing facility

"This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820."

The FDA referenced, in several stanzas, that the response of the firm in addressing various concerns could not be determined. Twice, the FDA suggested the firm's response was inadequate.

Various St. Jude lawsuits allege the defective batteries vital to the implantable life-saving and life-maintaining devices put patients at serious risk, and took an emotional toll on their well-being. There has also been at least one death associated with the problem. Plaintiffs allege that St. Jude erred in continuing to distribute the defective devices while knowing there was a problem with the batteries.

It should be noted that lawsuits with regard to defective St. Jude cardiac defibrillators are actually targeted at Abbott Laboratories, which acquired St. Jude in January of last year.

Abbott, as part of their acquisition of St. Jude Medical, inherits its liabilities as well.