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In early December, Jerry Jackson received the shock of his life. Or six.

The 63-year-old Mineola resident was sweeping crumbs off the bed where his granddaughter sat when a sudden surge in his chest caused him to twist in agony.

His implanted cardiac defibrillator (ICD) had sent 800 volts of electricity into his heart muscle, a jolt doctors compare to being kicked by a horse. Then it did it again. And again.

“I was hollering every time it hit me,” Jackson said. “It hit me six times, it’s a good wallop. I began to think it wasn’t going to stop.”

As their granddaughter screamed, Mattie Jackson called 911. She assumed her husband was suffering from an extreme rapid heartbeat, a life-threatening episode he had experienced twice in 2004.

The ICD was implanted to shock Jackson when his heartbeat speeds out of control. Instead, it seemed to be killing him.

“I was terrified,” said Mrs. Jackson, her eyes watering as she recalled him shrieking in pain.

At the hospital, doctors found that a wire, or “lead,” running from the matchbox-size defibrillator under his collarbone, had broken inside his heart. The two fractured ends had caused a false electrical impulse and triggered the ICD to shock him.

“It was telling the defibrillator something was happening, so it just went shooting out those pulses,” Jackson explained. “It thought something had happened to my heart.”

He was wheeled into emergency surgery the next morning.

“They took me in, cut me open, pulled out the defibrillator, pulled the wire out and put a new wire (and defibrillator) in,” he said.

Despite his surprise at the ordeal, Jackson said his experience wasn’t a fluke.

He and some 235,000 people worldwide received word in October from Medtronic Inc., the world’s largest ICD maker, saying the wire lead threaded into their hearts to deliver shocks at 800 volts a pop was recalled from the market because of its tendency to fracture.

The Sprint Fidelis lead, a newer streamlined wire issued by Medtronic, was fracturing at a rate of 2.3 percent in 30 months, twice the rate of its predecessor.

Medtronic urged patients to visit their cardiologists and have the defibrillators programmed for tighter self-check alerts. Jackson was one of dozens who met with his cardiologist, Dr. Alex Petrakian of Cardiovascular Associates of East Texas.

Petrakian said Medtronic underestimated the faulty wire’s effect, as he noticed problems much earlier than October, and with more frequency. Of his 65 patients implanted with a Sprint Fidelis lead, Jackson was the eighth to present with a fracture.

“We noticed a problem with that wire before they recalled it, so I stopped using it (in July),” Petrakian said. “It was unusual that there were reports from all over the country about docs having the same problems.”

The possibility of a fracture is frightening, he said. While Jackson was shocked six times, others suffering lead fractures have been shocked double or triple that number.

“Sometimes they present to the hospital after having 20 or 30 shocks,” Petrakian said. “Medtronic said those shocks have actually killed; the shocks themselves have caused the heart to stop.”

Complicating the recall is the recommendation that patients with ICDs not have them surgically removed until they malfunction.

“We don’t recommend going in and replacing those wires if they’re not fractured, because of the risk of the procedure itself, risk of infection and other complications,” Petrakian said.

Scar tissue can quickly envelope a lead, which is threaded into one of the heart’s lower right chambers and screwed into the heart muscle, he said.

Instead of invasive remedies, Medtronic is urging closer monitoring of those Sprint Fidelis patients and is footing the bill for the co-pays, procedures and recovery of complications of related fractures, said Medtronic spokesman Rob Clark.

“This is one of the largest actions ever taken,” Clark said. “We did it proactively, so patients who have Fidelis leads could go into a physician and, in most cases, can have the device reprogrammed; any fractures or weakening that develops, they’ll be able to see that in advance so appropriate action can be taken.”

But 64-year-old Athens resident Ruby Barrett said that doesn’t come close to allaying her fears.

Her ICD (and its recalled lead) was implanted just 39 days prior to Medtronic’s announcement. She was sickened by the news of the recall, she said, and feels helpless, like she’s waiting for her ICD to malfunction.

“I hope to God not, but if anything goes wrong in there I’m probably going to die,” said Barrett, who suffers from congestive heart failure. “I don’t want to go out of here being shocked to death.”

ICDs are revolutionary treatment for patients prone to irregular, slow or fast heartbeats that put them at risk for sudden cardiac arrest. Medtronic estimates some 15,000 people have received life-saving shocks since the equipment’s inception.

Petrakian said he and other cardiovascular surgeons implant some 500 to 600 ICDs each year in East Texas. But the wear and tear on leads is great, he said; the heart is a volatile space.

“Leads don’t last forever,” Petrakian said. “With every heartbeat, the lead is moving. It flexes back and forth, and so you can just imagine, flexing back and forth millions of times puts pressure on the lead.”

Clark agreed. The lead’s design, manipulation of the lead during the implantation procedure, the harsh environment of the heart and the patient’s body type can all contribute to the equipment’s viability, he said.

Medtronic, a $12.3 billion company, reported a 16 percent sales drop in its 2007 fiscal second quarter, about a $150 to $200 million loss, Clark estimated.

But Medtronic is no stranger to working out equipment flaws. This month, the company agreed to spend $114 million to settle 2,682 lawsuits related to an earlier line of ICDs that suffered a potential battery shorting problem announced in February 2005.

Petrakian said a handful of his patients are considering legal action after October’s recall, but said most of it is due to anxiety.

“I’d be anxious about it,” he said. “Having a recalled lead, especially if the incidence is that high.”

Mrs. Jackson said she’s just relieved the lead is gone from her husband’s chest. She’s glad to have gotten through it

The Food and Drug Administration today issued its second safety warning about the fentanyl transdermal system, an adhesive patch that delivers a potent pain medicine through the skin. In July 2005, the agency issued a similar warning to the public and to health care providers, saying that the directions on the product label and on the patient package insert should be followed exactly in order to avoid overdose. FDA has continued to receive reports of deaths and life-threatening side effects after doctors have inappropriately prescribed the patch or patients have incorrectly used it.

In addition, the agency is asking manufacturers of all fentanyl patches to update their product information and to develop a medication guide for patients.

The fentanyl skin patch contains the opioid fentanyl, a potent narcotic. The skin patch was approved by FDA in 1990 for use in patients with persistent, moderate-to-severe pain who have become opioid tolerant – meaning that they have been using another strong opioid narcotic pain medicine around-the-clock, and have been using the medicine regularly for a week or longer. The skin patch is most commonly prescribed for patients with cancer.

Recent reports to FDA describe deaths and life-threatening side effects after doctors and other health care professionals inappropriately prescribed the patch to relieve pain after surgery, for headaches, or for occasional or mild pain in patients who were not opioid tolerant. In other cases, patients used the patch incorrectly: The patients replaced it more frequently than directed in the instructions, applied more patches than prescribed, or applied heat to the patch all resulting in dangerously high fentanyl levels in the blood.

“There is an unmet need to provide patients suffering from chronic pain with safe and effective products that will not only alleviate their pain, but that will also be tolerable when used chronically,” said Bob Rappaport, M.D., FDA’s director of the Division of Anesthesia, Analgesia and Rheumatology Products. “While these products fill an important need, improper use and misuse can be life-threatening. Therefore, it is crucial that doctors prescribe these products appropriately and that patients use them correctly.”

In its Public Health Advisory and Health Care Professional Sheet published today, FDA stressed the following safety information:

• Fentanyl patches are only for patients who are opioid-tolerant and have chronic pain that is not well controlled with other pain medicines. The patches are not to be used to treat sudden, occasional or mild pain, or pain after surgery.
• Health care professionals who prescribe the fentanyl patch, and patients who use it, should be aware of the signs of fentanyl overdose: trouble breathing or slow or shallow breathing; slow heartbeat; severe sleepiness; cold, clammy skin; trouble walking or talking; or feeling faint, dizzy, or confused. If these signs occur, patients should get medical attention right away.
• Patients prescribed the fentanyl patch should tell their doctor, pharmacist and other health care professionals about all the medicines that they take. Some medicines may interact with fentanyl, causing dangerously high fentanyl levels in the blood and life-threatening breathing problems.
• Patients and their caregivers should be told how to use fentanyl patches. This important information, including instructions on how often to apply the patch, reapplying a patch that has fallen off, replacing a patch, and disposing of the patch, is provided in the patient information that comes with the fentanyl patch.
• Heat may increase the amount of fentanyl that reaches the blood and can cause life-threatening breathing problems and death. Patients should not use heat sources such as heating pads, electric blankets, saunas, or heated waterbeds or take hot baths or sunbathe while wearing a patch. A patient or caregiver should call the patient’s doctor right away if the patient has a temperature higher than 102 degrees while wearing a patch.

This information will be reflected in the updated product information new medication guides for patients that manufacturers are being asked by FDA to develop.

The fentanyl skin patch is marketed under the brand name Duragesic by Johnson and Johnson, and generic versions of the product are sold by other manufacturers.

Medtronic Inc. said it reached a $114.1 million settlement agreement to settle lawsuits related to its Marquis line of implanted cardiac defibrillators.

The Minneapolis-based implantable biomedical device maker will settle 2,682 cases for $95.6 million as well as $18.5 million in attorneys’ fees, which will be recorded as a one-time charge in its fiscal third quarter ending in January.

Medtronic said the settlement does not mean it admits liability or the validity of any defenses in the litigation.

“We are pleased to settle these cases and put the matter behind us,” said Pat Mackin, senior vice president and president, Medtronic Cardiac Rhythm Disease Management. “We know the Marquis line of defibrillators continues to provide life-saving therapy for thousands of people around the world, and they remain among the most reliable ICDs ever manufactured by Medtronic.”

In November 2006, a federal judge denied Medtronic’s motion to dismiss more than 350 product-liability lawsuits connected to a voluntary company recall of implantable defibrillator heart devices in February 2005.

Implantable cardioverter defibrillators, or ICDs, provide shocks to stop hearts from potentially dangerous rapid beating. They treat patients at risk for sudden cardiac death, which is the leading natural cause of death in the U.S.

At issue in the product-liability suits was Medtronic’s announcement in February 2005 of a potential battery shorting problem in various Marquis-brand defibrillators. The failure rate was and remains extremely low, but Medtronic voluntarily notified doctors of the issue. In the U.S., 11,000 of the machines were surgically removed and replaced with a different device, and 2,000 more such removals took place overseas.

The FDA did not take regulatory enforcement action regarding the matter but did classify Medtronic’s action as a Class II recall.

Plaintiffs in the suits against Medtronic argued that the company knew for years that there was a potential for product defects but sold its stock of potentially defective devices and didn’t advise patients that safer devices were available. The company has argued that it fulfilled every obligation in terms of reporting the problem, including seeking and receiving FDA approval in 2003 to implement battery design changes.

Medtronic is the largest ICD maker. The other manufacturers include rivals Boston Scientific Corp. and St. Jude Medical Inc.. Guidant Corp., which is now a Boston Scientific unit, also had a high-profile recall.

This fall, Medtronic issued a world-wide recall of heart-defibrillator wires. That drove down sales in its core defibrillator business, which reported a 16% sales drop during its fiscal second quarter to $639 million.

Medtronic pulled the wires, or “leads,” from the world-wide market, a step that affected about 235,000 patients who have the leads implanted in their chests. The Sprint Fidelis lead, used to connect defibrillators to the patient’s heart, has been fracturing at a rate of 2.3% in a 30-month period, more than twice that of an older Medtronic lead, the Sprint Quattro.