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Two recently released surveys suggest that many heart patients with implanted devices aren’t aware of recent recalls and don’t understand the dangers they might face. The surveys are small, but they point to a lack of understanding among both doctors and patients about heart disease and the devices used to treat it, said Dr. Bruce Wilkoff, director of cardiac and tachyarrhythmia devices at Cleveland Clinic.

“There are fundamental problems with even the physician’s understanding of the situation and an appropriate focus on accurate information,” said Wilkoff, who is familiar with the surveys. Recent recalls of implanted defibrillators have forced some patients to have them removed. The devices deliver jolts to the heart that reset its electrical system when needed.

One of the new surveys found that almost one in five heart patients didn’t know about recent recalls of their devices.

It is expected that these findings will be made public at the Heart Rhythm Society’s annual meeting, in San Francisco, came in a survey of 61 randomly selected patients at the University of Maryland and the Baltimore VA Medical Center. They were asked about recalls between October 2006 and April 2007.

18% didn’t know about any pacemaker or defibrillator recall. About half learned about them through the media, and only 24% heard through their doctor.

More than half said they’d be very worried if their device was recalled.

“We need to do a little better of a job and find better means of talking to our patients,” said survey lead author Dr. Timm-Michael Dickfeld, director of electrophysiology at the Baltimore VA Medical Center. “They seem to like to have the physicians talk to them more, and explain these things more, and not leave it up to the media or the TV to inform them.”

A second survey, by doctors at the University of Oklahoma, asked 165 patients with a variety of heart devices whether they’d want them removed if there was a recall or safety advisory.

Only 5% said they’d want the device removed immediately if there was a “recall,” and 2.5% said they’d want it taken out if there was a “safety advisory.”

The patients gave a variety of answers when asked what they thought the chances were that they’d experience a device recall, with 31% thinking it was one in 100,000.

Dr. Andrea Russo, an electrophysiologist at the University of Pennsylvania, said the results of the Maryland survey suggest that officials should stop using the word “recall” in favor of “safety device.”

“The term ‘recall’ implies that the device will fail dramatically and the failure will be potentially ‘life-threatening,’ with the term implying that it should be ‘taken out,’” she said. The reality, according to her, may be different.

“The types of failures may vary dramatically, and the outcome following ‘failure’ is also quite variable and not necessarily life-threatening,” she said.

A Texas resident is claiming the unexpected shocks he received from a cardiac defibrillator constitute civil battery and caused him such severe anxiety that he is suffering from post traumatic stress and now requires psychiatric care.

Donald Larry Jackson filed a product liability suit against Medtronic on Jan. 18 in the Marshall Division of the Eastern District of Texas. Jackson alleges his implantable cardioverter defibrillator produced “unexpected and medically unnecessary” shocks.

According to the plaintiff’s original complaint, Jackson was implanted with an ICD that has a recalled Sprint Fidelis Lead wire system.

Within the complaint, Jackson claims that since Jan. 20, 2006, he has received electrical shocks by his ICD that have caused him pain, extreme anxiety, fear of death, and “great physical, emotional, and psychological suffering.”

Jackson underwent emergency surgery to replace the ICD but continues to have heart palpitations, anxiety, and “other debilitating injuries.” Further, Jackson claims he is now at an increased risk of cardiovascular events or even death.

The plaintiff is seeking claims of relief for products liability, breach of implied warranty, negligence, intentional infliction of emotional distress, negligent infliction of emotional distress, violation of consumer protection statutes, breach of express warranties, unjust enrichment, battery, and negligent misrepresentation.

The complaint claims the lead wires on the ICD were “unreasonably dangerous” when used in “reasonably expectable ways of handling and consumption” and were “defective, unmerchantable, and unfit for ordinary use.” The plaintiff states that he used the leads in an appropriate manner but this has resulted in severe and life threatening injuries. He believes he will continue to sustain “severe physical injuries and/or death, severe emotional distress, and economic losses and consequential damages” even after removal of the medical device.

The implantable cardioverter defibrillators are placed in patients with life threatening heart conditions and provide detection and correction of irregular or rapid heart rates. The heart rhythm is monitored through lead wires with electrodes that are placed in the heart to provide necessary correction through electrical shock.

Medtronic voluntarily suspended distribution of the Sprint Fidelis Leads (models: 6930, 6931, 6948, and 6949) because of a potential for lead fractures. Medtronic’s decision is based on internal performance data that demonstrates the Sprint Fidelis lead viability is 1.4 percent lower than Medtronic’s Sprint Quattro Leads.

In an FDA statement on the voluntary recall, the FDA states, “When a defibrillator lead is slightly more prone to fracture, it doesn’t mean that every lead will break. Most leads will function well, as is the case with Sprint Fidelis. In the infrequent circumstance where a lead actually breaks, or ‘fractures,’ the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered.”

Doctors and medical experts do not advise that patients replace the leads, as the risks associated with removal far exceed the risk of a lead failure.

Although Medtronic states it is advising individual patients, Jackson states Medtronic did not provide him any notice of the increased fracturing risk.

Despite Medtronic’s voluntary notice of increased fracture risk of the Sprint Fidelis leads to the FDA, Jackson argues Medtronic had a duty to notify the FDA of design flaws and of the devices’ “defective nature.” Jackson also believes that Medtronic intentionally caused him severe emotional distress or acted with reckless disregard for his emotional state and thus caused him “severe emotional trauma, physical consequences and long continued emotional disturbance.”

Moreover, the complaint claims the defendant made “unconscionable or fraudulent representations” regarding the product and that under these “false pretenses” the defendant wrongfully received substantial sums of money. The complaint states that these acts violated the Texas Consumer Protection Act, the Texas Deceptive Trade Practices Act, Minnesota statutes, and violated the laws of Puerto Rico.

The Texas resident asserts that the defendant committed civil battery through “causing a great physical blow” because the shocks constituted “unprivileged physical touching.”

The plaintiff is seeking punitive, exemplary, and compensatory damages, a declaratory judgment, restitution of disgorgement of profits, attorney fees, prejudgment interest and other equitable relief as requested.

Mark & Associates, P.C. announces that it has launched a new website http://www.MedtronicLegalAction.com The website offers defibrillator and pacemaker patients who may have recalled Medtronic Sprint Fidelis defibrillation leads the opportunity to receive a free legal consultation. On October, 15, 2007, Medtronic Inc. announced it was recalling its Sprint Fidelis defibrillation leads from the worldwide market due to a risk of fracture, which can potentially cause a defibrillator or pacemaker to issue unnecessary shocks. To date, Mark & Associates, P.C. has provided over 500 free case evaluations to patients throughout the United States. More information about the Medtronic recall and Mark & Associates, P.C. is available at http://www.youhaverights.com

The recall involves the following Medtronic defibrillation leads:

• Sprint Fidelis 6930

• Sprint Fidelis 6931

• Sprint Fidelis 6948

• Sprint Fidelis 6949

Most defibrillator and pacemaker patients have an identification card that lists the model and serial numbers of their devices and leads. If the identification card contains the numbers 6930, 6931, 6948 or 6949, it is likely that the recipient has a recalled lead. Mark & Associates, P.C. is currently only representing clients who have any one of these recalled defibrillation leads.

Many patients with recalled leads have already been contacted by their doctors and Medtronic. However, many patients with recalled leads have still not received any notification about the recall. Defibrillator and pacemaker patients concerned about their defibrillation leads should contact their physicians immediately.

Patients can request a free legal consultation by completing the submission form on http://www.MedtronicLegalAction.com or by calling Mark & Associates, P.C. at 1-866-9-MEDTRONIC (1-866-963-3876).

About Mark & Associates, P.C.

Mark & Associates, P.C. is a leading personal injury and products liability law firm with offices in Boston, Massachusetts and Long Island, New York. The firm aggressively represents victims of defective pharmaceuticals and medical devices, dangerous consumer products, bad faith insurance denials, toxic exposure and serious auto and common carrier accidents. More information on Mark & Associates, P.C. is available at http://www.youhaverights.com