Report: FDA Warns St. Jude for Failing to Investigate Defibrillator Problems

The U.S. Food and Drug Administration (FDA) has reportedly sent a St. Jude defibrillator warning letter accusing the device manufacturer of failing to adequately investigate problems related to implantable defibrillator batteries as well as cybersecurity issues for its at-home monitoring equipment. Affected patients and their families may be able to seek compensation with the help of a St. Jude defibrillator battery lawsuit attorney.

For more information, contact Attorney Group today. We offer free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a case we can connect you with an affiliated attorney who can assist you throughout the legal process.

The time you have to pursue a claim is limited. Contact us for more information.Get Help Now.

St. Jude Defibrillator Warning Letter Addresses “Systematic” Failures

In a letter addressed to the head of Abbott Laboratories’ cardiovascular device division, the FDA warned the company, and its subsidiary St. Jude Medical, to “take prompt action to correct the violations” related to its implantable defibrillators and that failure to do so “may result in regulatory action being initiated by the FDA without further notice.” According to a report published by the Star Tribune, St. Jude continued to ship implantable defibrillators to hospitals for more than a year after discovering and changing a flaw in the design of the devices’ lithium battery that could potentially cause the defibrillator to quit without warning.

Following the death of two patients and dozens of reported hospitalizations, St. Jude issued a recall affecting approximately 400,000 older versions of its Fortify, Unify and Assura defibrillators in October 2016. Despite initiating the recall, the FDA said that company officials “systematically underestimated” the true risk to patients because their evaluations were based only on “confirmed” cases of battery failures while ignoring other cases of battery shorts and evidence from outside suppliers.

The St. Jude defibrillator warning letter included a separate issue related to the [email protected] device used to remotely monitor implanted cardiac devices. The FDA warned St. Jude of not following its own internal investigation policies when an investment research firm accused the company of skipping basic cybersecurity protections in its at-home monitoring devices. Abbott has 15 days to respond to the letter, the website reported.

How a St. Jude Defibrillator Lawsuit Can Help

Medical device makers have a duty to provide safe products. If there are risks of harm associated with their devices, they also must provide adequate warnings. If a device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.

People injured by a defective St. Jude defibrillator may be eligible to recover money for:

  • Medical Expenses
  • Lost Wages
  • Pain and Suffering

The families of those who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.

The time you have to pursue a claim is limited. Contact us for more information.Get Help Now.

For more information, contact Attorney Group. After you contact us, an attorney will follow up to answer questions that you might have. There is no cost or obligation to speak with us, and any information you provide will be kept confidential.

Please note that the law limits the time you have to pursue a claim or file a lawsuit for an injury. If you think you have a case, you should not delay taking action.