Pacemakers—or implantable cardioverter defibrillators (ICDs)—are small devices that are planted in the chest or abdomen of a patient, and use electrical impulses as a means of regulating a person’s heartbeat. Unfortunately, the FDA has recalled nearly 400,000 pacemakers manufactured by St. Jude Medical, Inc.because the devices’ batteries have been found to short circuit or fail at an alarmingly high rate.

ICDs are designed to provide ample warning, usually three months in advance, of potential battery failure. The recalled defibrillator devices produced by St. Jude, however, feature a defective battery design that can short circuit and cause total battery failure in as little as 24 hours. Unfortunately, this failure often does not give patients enough time to seek treatment for the failing battery, and once it dies, the pacemaker is unable to deliver life-saving pacing or shocks, which can result in death.

If you were injured—or if your loved one passed away—due to a defective pacemaker, you are likely to be traumatized and unaware of your legal options. However, a Michigan pacemaker lawyer could help. When a defective medical device causes injuries, a well-versed attorney at Buckfire & Buckfire, P.C. could work to gather evidence and pursue compensation on your behalf.

Signs of a Short-Circuited Defibrillator Battery

Although some ICD batteries can deplete rapidly and die with very little warning, there are some physical symptoms that may appear if a pacemaker battery has short-circuited. Symptoms may include:

  • Lightheaded
  • Dizziness
  • Loss of consciousness
  • Chest pain
  • Shortness of breath

If you rely on a defibrillator—especially those from St. Judge—and you experience any of the above symptoms, you should seek immediate medical attention. Furthermore, if you have incurred an injury, you might wish to reach out to a Michigan pacemaker lawyer for help.

What Causes a Pacemaker Battery to Fail?

The sudden and rapid depletion of the batteries in a pacemaker, such as those that were used in St. Jude’s ICDs, occurs because of lithium clusters that form inside the battery. If these clusters form in a way that connects the two internal terminals of the battery, the battery will short circuit and quickly lose its power. Interestingly, the batteries in the recalled St. Jude units are not the same as the original batteries that powered the devices when they were approved by the FDA.

The recalled batteries were updated later to include what St. Jude called “novel technology” that would increase battery life. The updated batteries were Q High Rate (QHR) batteries, and it is this QHR technology that is suspected to cause the lithium cluster formation. When these or other negligent practices by pacemaker manufacturers cause injuries or death, a dedicated Michigan lawyer could work to hold them accountable.

An Example of Manufacturer Liability

In April 2017, St. Jude received a warning letter from the FDA, stating that they had violated good manufacturing practice requirements. The FDA reprimanded St. Jude for improperly categorized battery failures and waiting so long to recall the devices. The lithium cluster battery failure in these devices was identified by physicians at Duke University in a 2014 publication, and there is evidence that St. Jude knew of the battery problems even before then. However, the company waited until October 2016 to recall the defective devices.

When lithium clusters form in a manner to short circuit a battery, in some cases, the clusters can dissipate back into the electrolyte fluid and leave no trace. This means that the reason for failure is difficult to definitively determine just by a retroactive inspection of the dead battery. This also means that when St. Jude received batteries that had been removed from patients due to premature depletion, in cases where there were no traces of lithium clusters, they categorized the failure as “unconfirmed.”

This allowed the company to underreport the number of failures and justify not recalling the device because of a “low incidence of failures.” They continued to sell the defective devices for more than three years after learning of the problem. When manufacturers conduct business in this way, and injuries result, they could be held liable with the help of a tenacious pacemaker lawyer in Michigan.

Seek the Services of a Michigan Pacemaker Attorney

Manufacturers of pacemakers have a responsibility to ensure that their products are safe and perform as intended. Unfortunately, there is evidence that many companies, such as St. Jude, are aware of glaring defects in their devices but still put them on the market.

If you or a loved one was dependent on a defective ICD and were harmed as a result, you might be entitled to receive compensation. However, because of the nuances involved in demonstrating when a manufacturer is at fault, consulting with a Michigan pacemaker lawyer might prove to be essential. To get started on a claim, retain a seasoned attorney at Buckfire & Buckfire, P.C., today.

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