Abbott Faces Class Action Lawsuit Over Defective St. Jude Defib.

Abbott Laboratories subsidiary, St. Jude Medical, are facing a nationwide class action lawsuit, which alleges that the companies knowingly failed to report a risk involving a battery depletion defect in some of its cardiac defibrillators dating back as early as 2011. According to news reports, the lawsuit was filed on behalf of ASEA/AFSCME Local 52 Health Benefits Trust and a collection of other third-party payers. The St. Jude Defibrillator and Therapy device lawsuit seeks $9.9 million in damages related to their coverage of the defective implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices during those intervening years and related medical costs.

St. Jude Allegedly Concealed Vital Information

The lawsuit further alleges that in November 2014, St. Jude Medical’s management review and medical advisory boards were given two separate presentations on the premature battery depletion involving these devices. However, during those meetings, the lawsuit alleges, St. Jude failed to tell its own boards about the full scope of the battery issue and presented false or incomplete information, concealing from the boards evidence of a known death related to this battery effect. In fact, they allegedly informed the boards that there were “no serious injuries or fatalities” linked to the battery defects.

Details in the lawsuit allege that St. Jude concealed a potentially deadly defect in thousands of these medical devices thereby exposing a number of people to severe risks. This conduct caused public and private health insurance payers to pay for the defective devices or caused them to undergo costly and unnecessary surgery.

Have The Devices Be Recalled?

In 2016, St. Jude and the U.S. Food and Drug Administration (FDA) issued a recall for 349,852 defibrillators saying that lithium clusters had caused some batteries to run out within 24 hours of the patient receiving an elective replacement-indicator alert instead of the normal three-month lead time for device replacement. The recall came after two people died due to the faulty devices. Abbott acquired St. Jude in January 2017 and has also been dealing with ongoing cyber security vulnerabilities linked with some of the St. Jude pacemakers. The company issued a software update in August to safeguard patients from hackers gaining access to the device and causing harm.

The devices were introduced in 2010 and are meant to last for seven years or longer, until their batteries are depleted. They are designed to vibrate at regular intervals once power is diminished, a signal to patients that they should visit their doctors for replacements within 90 days. In addition, a home monitoring unit wirelessly reads the battery level and other information and routinely sends details to doctors.

Call Our Firm For Help Today!

Manufacturers of medical devices have a responsibility to make devices that are safe for consumers. Particularly with devices that are implanted into people’s bodies, whose lives could be in peril when a faulty device suddenly stops functioning. Patients in such cases are forced to undergo additional surgery, which means suffering the price of medical expenses, loss of wages, and enduring the physical pain and emotional stress of more surgery. Our experienced personal injury lawyers here at d’Oliveira & Associates are working with St. Jude Defibrillator lawyers who represent victims in these types of cases. Call us toll-free at 1-800-992-6878 or fill out a contact form online, for a free (no-obligation) case consultation.
Source:

• https://www.medscape.com/viewarticle/886026

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