Man seeks psychiatrist after Medtronic recall

Michelle Massey, East Texas Bureau Jan. 23, 2008, 4:33am

Amy Witherite

MARSHALL -- 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 factures. 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.

Dallas attorneys Amy K. Witherite, Brian A. Eberstein, and Shelly T. Greco of the law firm Eberstein and Witherite, L.L.P. are representing the plaintiff in his allegations.

Medtronic, "a global leader in technology," has not yet responded to Jackson's allegations.

U.S. District Judge T. John Ward is assigned to the litigation.

Case No: 2:08cv00017

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