The HeartMate is a small implanted heart pump, also known as a left ventricular assist device (LVAD), that is used to help pump blood in those with heart failure or weakened hearts.
The system consists of an internal pump that is connected to an external unit containing batteries and controls.
The HeartMate II device, which can cost as much as $330,000 with implantation, has become the most widely used heart pump in the world, with nearly 29,000 devices sold. It was originally approved in 2008 as a temporary treatment for those awaiting heart transplant surgery. However, in 2010 the FDA approved it for permanent use in those who can’t undergo a transplant.
On March 29, 2017, Abbott Laboratories issued a product alert affecting 28,882 HeartMate II controllers worldwide, after receiving at least 70 reports of the devices malfunctioning while patients attempted to change the battery controller at home.
Of the reported cases, 26 resulted in patient death and 19 involved serious injury. However, experts believe this may only represent a small percentage of the actual number of patients affected.
On May 23, 2017, the FDA classified the alert as a Class I recall, the agency’s most serious designation for those products that pose life-threatening danger to consumers.
Abbott & HeartMate II Lawsuits
In what is believed to be the first case filed over the death of a HeartMate II patient, a Louisiana widow sued Thoratec after her husband died from malfunctions suffered while he attempted to change his device controller.
Pete Bush received his HeartMate II LVAD in 2008 and he and his wife were instructed about how to replace the controller in the event of an emergency. Upon hearing multiple alarms from the device one evening in 2012, they attempted to switch controls while seeking the assistance of a nurse. Tragically, however, Pete died from device malfunction in the process.
The lawsuit, originally filed in a Louisiana State Court, was transferred to federal court in 2013 and settled the day before trial was scheduled to begin.
This class action lawsuit, filed in 2014 on behalf of investors of Thoratec, claimed that the company gave false and misleading information to both medical providers and shareholders regarding the safety of the HeartMate II device.
The case alleged that reports of severe blood clot risks from the device, which were not reported by Thoratec, resulted in decreased value to investors.
This case, one of more than 700 filed against Abbott alleging birth defects from their anti-seizure drug Depakote, was filed by the family of a 12-year-old girl afflicted with spina bifida after her mother used the drug during pregnancy.
In 2015, a St. Louis jury awarded the family a combined $38 million in damages on the basis that Abbott didn’t properly warn her mother or her doctor about the birth defect dangers associated with the drug.
In 2012, Abbott Laboratories pled guilty to criminal charges of illegal promotion of its anti-seizure drug Depakote for unapproved uses, and agreed to pay $1.5 billion in fines and penalties as a result.
The settlement concluded a multi-year investigation and charges filed by the Justice Department over the company’s practices.
HeartMate II lawsuit update timeline.
First, you obviously want a lawyer or law firm with significant experience handling cases similar to yours. When damages reach into the millions of dollars, you want to make sure your lawyer is familiar with the science, technology and medical terms associated with your defective device and your injury.
Next, because these cases are fought against multi-billion dollar companies, you want to make sure your lawyer has the resources to finish your case when faced with unforeseen challenges. Even though your lawyer may be located in a different state, they should be able to come to you to meet, travel to all necessary events on your behalf, and cover all costs in advance.
Finally, it is important to ask if your lawyer is handling hundreds of cases similar to yours, or only a few. Medical device manufacturers will know which law firms are the biggest threat based on the number of cases they are handling. This can make a difference in how much you receive in a potential settlement, and how long it takes for the manufacturer to look at your case.
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Contact us today to get more information on the current warnings, recalls and litigation surrounding LVAD heart pumps, and to talk directly with a lawyer at no cost.
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