Patient Harm by design: justice is unattainable!

  Wall Street Journal

           BUSINESS  

            April 4, 2013, 7:17 p.m. ET

St. Jude Hit by Suits

Cases Challenge Liability Protection Enjoyed by Device Makers

By CHRISTOPHER WEAVER and JENNIFER SMITH

A raft of lawsuits filed Thursday against St. Jude Medical Inc. STJ -0.99% over an implanted heart device could challenge the broad liability protection that medical-device makers have enjoyed since a key Supreme Court ruling in 2008.

The lawsuits, filed both in Los Angeles Superior Court and federal court in the Central District of California, claim that problems with the manufacturing and oversight of Riata defibrillator "leads" injured or killed more than 30 patients. Faulty leads, which connect the heart to defibrillators that zap irregular heart rhythms back to normal, caused the devices to fail or needlessly deliver blasts of electricity, the suits allege.

One plaintiff, Rebecca Clawson, said in an interview that she was shocked several times over 25 minutes while in bed at her Orange County, Calif., home last November. Her lead was surgically removed and doctors said it displayed faulty wiring, said Ms. Clawson, who is 55 years old.

"As a matter of policy, we generally don't comment on pending litigation," a St. Jude spokeswoman said.

If the new cases succeed, they could help reopen a closed-off corner of the law that has left people who believe they were injured by medical devices with little recourse—and tempered the business of both plaintiff and defense lawyers who once earned hefty fees from device cases.

In recent years, the legal landscape has shifted against would-be plaintiffs injured by devices that go through the Food and Drug Administration's premarket approval process, lawyers specializing in device cases say.

The 2008 Supreme Court ruling, Riegel v. Medtronic, MDT -1.78% shielded makers of such devices from most product-liability claims, which are governed by state law, so long as the companies had complied with the federal standards of the FDA, including those for manufacturing, labeling and device monitoring. That meant that even if such devices were later found to be defective, companies are protected from many suits.

A 1976 law governing medical devices generally prohibits states from attempting to regulate devices, which are subject to federal rules, but Riegel broadly interpreted those provisions in a way that plaintiffs' attorneys say made it much harder to pursue claims.

To push cases through, lawyers generally must find state laws that specifically address violations of the FDA's requirements.

"Riegel was basically a graveyard for" device cases, said George Conk, a professor at Fordham Law School in New York and former product-liability attorney. In 2010, an appeals court upheld the dismissal of more than 8,000 cases alleging that a Medtronic Inc. defibrillator lead had injured patients, after the firm argued Riegel protected it. The company, though, had agreed to pay $268 million to settle the cases days earlier.

Medtronic said that without such protections from state law, "there would be no central standard for device safety, effectiveness, testing, labeling and marketing, which would ultimately be detrimental to patients."

Lawyers in the new Riata cases are alleging that St. Jude violated both the FDA's requirements for the company to report device flaws to the agency, along with state product-liability laws, an emerging approach to clearing Riegel's hurdles that has been buttressed by several recent appeals-court rulings.

They will also attempt to show St. Jude erred in manufacturing the devices in accordance with FDA rules, the approach favored in most device cases since Riegel.

The industry defends Riegel and its broad protections. "There is no absolutely safe medical device," said Ralph Hall, a Minnesota lawyer who has worked with device makers. "Making risk-benefit determinations in any design is FDA's job," he said.

St. Jude's Riata problems led to a recall of the leads in late 2011, and researchers have attributed at least 20 deaths to problems with the leads. Wires inside the Riata leads can break through their insulation, becoming exposed and potentially leading to electrical problems.

Some patients with the leads have seen their cases turned down by lawyers. Greg Jessee, 51, the general manager of a hydraulics-repair firm in Portsmouth, Va., was shocked three times before his heart briefly stopped during his son's football game in late 2011. He consulted an attorney last year to consider suing St. Jude, but the lawyer declined the case. "He studied it and came back to me to say he has found no way around" the protections, Mr. Jessee said.

The lawyer, Duncan Garnett, of Newport News, Va., didn't immediately respond to a request for comment.

Since the ruling "we've had numerous clients—including clients who have had Medtronic devices implanted in them—who have been reluctant to bring a case," said Brian J. McCormick Jr., a partner with Sheller PC, a Philadelphia law firm that specializes in cases involving defective products, drugs and medical devices.

Attorneys at large law firms that once made a lucrative business of defending the industry also say the Riegel ruling affected their businesses. "It has narrowed the playing field by 75%," said one defense lawyer specializing in devices who declined to be named because he still represents the industry in some matters.

Appeals courts are now split on the breadth of claims that Riegel blocks. A January ruling, for instance, in the Ninth U.S. Circuit Court of Appeals, which includes California, found Medtronic wasn't protected from liability related to a Medtronic pain-medicine pump malfunction, in part because the plaintiff, a patient named Richard Stengel, alleged the company failed to warn the FDA about known risks.

Medtronic said it disagreed with the January ruling.

The lawyers in the newly filed cases are hoping such rulings could propel their cases.

"What the judges are recognizing now is that there's no recourse for consumers, and that's changing," said Reza Torkzadeh, a Los Angeles attorney representing the plaintiffs in the new cases.

Write to Christopher Weaver at christopher.weaver@wsj.com and Jennifer Smith at jennifer.smith@wsj.com

Joleen Chambers                          
The medical device industry actively obscures the cascade of harm (and cost) when their products do not perform as advertised. Long-term post-market surveillance that is available in other countries via national registries are proprietary silos here in the U.S. Patients cannot access basic information prior to surgery about which devices perform best. Purchasing a toaster oven is more predictable. And when a device fails the debilitated patient is expected to go to federal court to face a lawyered-up industry. The aviation industry stops everything for a battery issue in a new airplane, Lulu-lemon gets national attention for failed fabric in their yoga pants but vaginal surgical mesh, ICD leads, joint replacement failures: silence! Why is the medical device industry "special"? Follow the money and see the cost of the entitlements to this small segment of our national economy! It is costly and immoral.

Patient Harm: Riata ICD leads unreliable

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Agonizing Choices for Heart Patients

By CHRISTOPHER WEAVER

Michael W. Minton has a device in his chest that could save his life by helping his heart beat properly. Or not.

A retired factory worker from Joelton, Tenn., Mr. Minton is one of 79,000 U.S. patients implanted with the troubled Riata defibrillator lead from St. Jude Medical Inc. STJ -0.64% The lead, a set of insulated wires, is threaded into the heart and connected to a defibrillator that zaps the heart into normal rhythm. But in a number of cases, the devices' wires are breaking through their insulation.

Doctors say the protruding wires could be a sign of dangerous electrical problems that could cause the lead to malfunction, shocking or even killing the patient.

Mr. Minton is one of those cases, though his device is still working properly, and now he's faced with a decision: Should he have the failure-prone heart device cut out, even though the procedure carries significant risk, or wait and hope that the Riata holds up.

After seeing an X-ray image of his lead that he said looked like an appliance wire stripped of its insulation, Mr. Minton, 58 years old, decided, "I want that thing out."

A small but growing number of patients are starting to agree. At a handful of institutions, including Vanderbilt University Medical Center, Brigham and Women's Hospital and the Minneapolis Heart Institute, doctors are starting to remove even some functioning Riata leads when the devices show signs of wear. So far, Vanderbilt doctors have used X-rays to identify 29 leads with significant insulation problems, and removed one-third of them, beginning with those that are also malfunctioning.

The full scope of the problem is unknown, though by some counts, involving small groups of patients, as many as one-third of Riata's leads have protruding wires. That lack of clear information creates "much uncertainty for physicians, patients and patients' families," wrote a group of U.S. senators in a May 7 letter seeking details of St. Jude's handling of the Riata situation. St. Jude said it is responding to the letter.

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St. Jude's share price plunged 10% after public attention focused on the Riata leads a month ago. The stock fell 25 cents to $38.88 in 4 p.m. trading Friday on the New York Stock Exchange. Heart-rhythm devices, including defibrillators and leads, made up more than 50% of St. Jude's $5.6 billion in 2011 sales.

The procedure to remove leads, which can tear heart tissue or leave broken pieces of the wire inside veins, is controversial. Guidance from St. Jude, which stopped selling Riata-series leads in 2010, recommends against removing the devices before they malfunction, because the risk of complications is considered high. One study of a favored lead-removal technique, in 2010, found a 1.5% chance of major complications, which can include death.

St. Jude said in a statement that its guidelines were devised with help from an independent physician advisory panel. Physician opinions may differ, and clinical decisions in general should be made on a patient-by-patient basis, it said.

The company will release a 700-patient study in June that could offer doctors more information about the risks of leaving leads with insulation flaws in place. Each patient will be X-rayed to look for the protruding wires, a St. Jude spokeswoman said.

The Heart Rhythm Society, a medical group, hasn't advised doctors whether to remove the leads, and is awaiting further data. Its president, the Cleveland Clinic's Bruce L. Wilkoff said he has removed some leads that didn't have electrical problems.

Defibrillator leads are often bound to the walls of veins and the heart by scar tissue, an obstacle that worsens with time. To remove them, doctors slide sheaths over the wires and scrape the scar tissue away, freeing the lead. The tip of the wires can become anchored in the heart wall, and removing them can tear a hole.

At Vanderbilt, Mr. Minton's doctor, Christopher R. Ellis, said his group decided to recommend to patients the removal of all leads with frayed wires visible on X-rays, even if they work.

Dr. Ellis acknowledged that the Vanderbilt approach is aggressive, but he said the group's rate of complications appears lower than the risk of Riata problems. "I don't see anything good that can happen from leaving all these leads in," he said.

Riata was recalled in December after St. Jude's medical advisers noted a higher-than-normal rate of an insulation failure, called externalization. The leads are also prone to other types of failures, and in March a study linked the devices to 20 deaths caused by short circuits. Not all externalized leads also short circuit, but new data suggests it is a sign of the problem.

In research presented Thursday at a Heart Rhythm Society meeting in Boston, 110 patients at seven hospitals who were checked with X-rays showed a 25% rate of externalized leads. Nearly one-third of those leads also had electrical problems, said Raed Abdelhadi, a Minneapolis Heart Institue doctor who presented the finding. Vanderbilt contributed to the study.

If future studies confirm those problem rates, Dr. Abdelhadi said, "If I were a patient, I'd know what I'd want."

Doctors should await additional data, said Raymond H.M. Schaerf, a Burbank, Calif., surgeon who removes leads, but who has counseled his patients against extractions when leads are functioning properly.

"When doctors get over aggressive, patients suffer more from the extraction than the actual lead," Dr. Schaerf said.

In previous recalls, such as the 2007 recall of Medtronic Inc.'s MDT -1.02% Sprint Fidelis lead, more patients were harmed by overzealous doctors than faulty leads, he said. It is not yet clear how Riata will compare with Fidelis, he said.

Laurence Epstein, chief of cardiac arrhythmia at Brigham and Women's Hospital in Boston, said that because the true risks of Riata are unclear, he leaves the choice up to his patients. After seeing loose wires in their hearts in X-ray images, some choose the extraction, Dr. Epstein said. "People don't like that time-bomb thing," he said.

"If it is externalized, in my mind, the lead has failed," said Dr. Epstein, who like others called for more data to gauge the risk.By nature, Mr. Minton, Dr. Ellis's patient, said he was inclined to deal with his Riata problem upfront, even if the procedure brings its own risks. "I'm not the type to stand in the closet for a couple of hours because there is a tornado warning," he said.

Write to Christopher Weaver at christopher.weaver@wsj.com

A version of this article appeared May 12, 2012, on page B1 in some U.S. editions of The Wall Street Journal, with the headline: Agonizing Choices for Heart Patients.

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