Abbott Laboratories is being sued over allegations that St. Jude Medical, the Minnesota-based medical device company owned by Abbott, neglected to warn the public and regulators for years that thousands of its defibrillators contained faulty lithium batteries.
The federal lawsuit was filed in northern Illinois on September 18, alleging that St. Jude knew more than 250,000 implantable defibrillators it sold in the United States between 2011 and October 2016 had batteries that could suddenly short out and cause the vitally important devices to lose power with little or no warning. Abbott bought St. Jude three months after the recall, so was therefore responsible for the litigation, reports the Star Tribune.
Lawsuit Seeks Class-Action Status
The lawsuit is seeking class-action status to represent all self-insured and commercial insurance companies and estimates that those insurers collectively paid hundreds of millions of dollars for St. Jude Medical defibrillators. The suit seeks punitive damages as well.
Product liability attorneys at Parker Waichman LLP are actively reviewing potential lawsuits regarding allegedly defective medical devices including St. Jude defibrillators.
Formerly, St. Jude officials have defended their decision to wait until October 2016 to recall hundreds of thousands of the implantable defibrillators, saying executives and medical advisors worked as fast as possible to confirm the rare but serious problem.
The federal lawsuit makes ten claims that include failure to warn about known defects, breach of warranty, negligence, and unjust enrichment. The federal case also includes a claim that St. Jude officials violated Minnesota’s Prevention of Consumer Fraud Act when they “deceptively omitted” long-known facts about the device batteries until last October, the Star Tribune reports.
“If defendants had not omitted … or misrepresented the defects in the recalled devices, physicians would not have used the recalled devices,” the lawsuit says. “Accordingly, plaintiff and the other nationwide class members would not have incurred costs for the recalled devices and the medical costs of device removal and replacement surgery and other related costs.”
Premature Battery Depletion Leads to Deaths
St. Jude received 42 reports, the lawsuit says, showing evidence of premature battery depletion related to the lithium issue between 2011 and 2014. In 2014, St. Jude received a report that the problem had led to a patient’s death. The problem was documented in a journal article in December 2014.
St. Jude Medical made a change to its battery design on May 23, 2015, according to a Star Tribune report, in response to a problem that the company said it identified in 2014. However, the company continued selling the defibrillators that contained the old batteries until early October 2016.
This alludes to the fact that some patients received recall notices just weeks or months following surgery for a problem that St. Jude was aware of for years. St. Jude officials said they did not consider the change in battery design in 2015 to be an acknowledgment that they were aware at the time that the old devices were faulty, but rather, they felt they were taking a device that was performing well and improving on it. The decision to recall the devices in 2016 occurred only after enough cases of lithium battery defects were confirmed internally.
The 2015 design change was approved by the U.S. Food and Drug Administration (FDA). The FDA did not call for an immediate recall as the rate of problems at the time seemed low and was consistent with rates of problems with other issues in other models on the market. The increased rate of premature battery depletions was realized only later, leading to the recall.
The most recent data available was as of May 31, where 616 of the 398,740 affected defibrillators sold worldwide had depleted batteries with no other discernible cause than lithium shorting, St. Jude’s data showed. Two patients died when their defibrillators lost the ability to shock their heart back into a normal rhythm, reports the Star Tribune.
Controversy Over Immediate Device Replacement
Some doctors have remarked they would consider immediate device replacements for patients who are dependent on their defibrillators to also act as pacemakers to keep their hearts beating properly.
Not all affected devices are to be removed from patients, St. Jude’s voluntary recall announced in October. It recommends that patients consult with their doctors and use bedside remote-monitoring devices that analyze remaining battery life.
Affected recall devices include Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra implantable defibrillators made before May 2015, according to the Star Tribune.
However, St. Jude and the FDA do not recommend “prophylactic” replacement of all recalled devices as the replacement surgery has its own risks of potentially serious complications. An October 11 FDA safety communication said, “The rate of complications following replacement surgery are higher than those associated with premature depletion.”
“However, the FDA and St. Jude Medical recognize the need to weigh individual clinical considerations. If the decision is made to replace an affected device based on individual patient circumstances, St. Jude Medical has announced they will provide a replacement device at no cost.”
Have You Been Injured by a St. Jude Defibrillator?
If you or someone you know has sustained injury associated with a defibrillator, you may be eligible for valuable compensation. Parker Waichman personal injury law firm offers free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).