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Allegations Against Abbott Labs Say Implantable Heart Devices are Defective

Defective Medical Device Claims and Abbott Labs

When you receive a surgically-implanted medical device, you hope that the device will function as it is supposed to and that it will not cause unnecessary harm. However, medical device defects can sometimes result in serious and fatal patient injuries. In fact, according to a recent article in the New York Post, Abbott Labs is facing allegations concerning defects in an implantable heart device.

As the article explains, the “medical device company got a warning letter from the Food and Drug Administration . . . that detailed years of St. Jude’s failures to fix scary—and even deadly—defects in its implantable heart devices.” Abbott Labs recently acquired St. Jude Medical in January of this year. Just a few months prior to the acquisition, the FDA’s letter to St. Jude indicated that it was “allowing seven patients to receive the company’s implantable heart devices . . . despite the company issuing a recall on the critical gadgets earlier that month due to a potentially fatal defect that could cause rapid battery acceleration.” That recall led to at least 10 defective implantable heart devices being returned to the company. In those 10 cases, the “defective batteries impaired [the ability of the device] to deliver life-saving shock therapy.”

In October of last year, St. Judge acknowledged the fact that two patients suffered fatal injuries when the battery prematurely depleted in the devices. Another 10 patients fainted as a result of the same defect. Thus far, Abbott Labs has not received any reports or complaints of defects in the implantable heart devices. However, the FDA concluded that St. Jude previously failed to acknowledge patient injuries—including at least one death—that resulted from the defective device. Abbott Labs has indicated a commitment to address concerns about the devices posed by the FDA. In the meantime, however, individuals with this device could potentially be at risk.

Learning More About Medical Device Defects 

According to a report from the U.S. Food and Drug Administration (FDA) concerning medical device defects, the following statistics help to illustrate the problems associated with product liability and medical devices in the country:

  • Between 2003 and 2012, medical device recalls rose by 97%;
  • The highest number of medical device recalls were related to device design, software, and/or non-conforming materials or component issues;
  • Fewer than two-thirds of all Class I recalls—the category of recalls for situations where there is a reasonable probability that continued use of the medical device will cause serious adverse consequences—are conducted on time;
  • Class I recalls make up only a small number of all medical device recalls, yet they are the least likely to be conducted in a timely manner; and
  • In 2012, there were 1,190 adverse events related to medical devices and 2,475 product recall events.

 

If you have been harmed as a result of a defective medical device, contact a  defective medical products lawyer to determine your right to receive financial compensation for your injuries.

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