St. Jude Medical Pacemakers & ICDs

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Pirated Pacemaker

March 4, 2007

Pirated pacemaker exposes failings
By Jennifer Ryan, Tribune
March 20, 2005

Blake Hunter’s online pacemaker support group couldn’t believe that a stolen pacemaker made it into the chest of a patient in Mesa after a physician’s practice purchased the device on eBay.

The Pacemaker Club, founded by Hunter, tries to give new pacemaker recipients peace of mind about their devices. But the incident gave some of the club’s 2,100 members a jolt.

"Members of the club thought it was a joke. They didn’t think it could happen, but it happened," said Hunter of New Brunswick, Canada, who holds onto his registration card verifying the make, model and serial number of his pacemaker. "There was disbelief that the system could break down like that."

But it did. And now doctors, hospitals and medical regulators in Arizona are realizing the vulnerabilities in the distribution and sale of medical devices.

No state law addresses who can buy or sell pacemakers or other medical devices regulated by the U.S. Food and Drug Administration, or where buyers can purchase them. State regulators said that limits their jurisdiction in the stolen-pacemaker case and what they can do to protect consumers.

"What would the allegations be and are they a violation of state law? Who knows at this point," said Robert Downey, a spokesman for the Arizona Medical Board, which is investigating the doctor who implanted the stolen pacemaker. "This case could go to a full board hearing, and if they do not find unprofessional conduct, they could dismiss it without any action taken. But you would still have the issue of where do you buy these things."

Advanced Cardiac Specialists, a statewide physicians practice with offices in the East Valley, bought two pacemakers on eBay for $411, according to Sacramento, Calif., police and medical board records. The devices are worth about $6,000 each. Dr. Ashok Garg, a cardiologist with the practice, implanted one of the pacemakers in a patient Dec. 10 at an outpatient treatment center owned by the practice at Mesa General Hospital.

Advanced Cardiac Specialists declined to comment.

When the device failed to work properly, Garg contacted a representative of Medtronic, the pacemaker’s manufacturer, who found that the device was supposed to be at Sutter Memorial Hospital in Sacramento. Hospital staff discovered that four pacemakers were missing and called police.
Two of the devices were traced to Amber Bowen, a special procedure nursing assistant who is accused of selling two of the pacemakers on eBay, said Sacramento police Sgt. Justin Risley. Bowen has been charged with felony embezzlement and grand theft.

The Apache Junction Police Department confiscated the remaining stolen pacemaker from Advanced Cardiac Specialists, but no criminal action will be taken against the practice or its physicians, said detective Christian Ensley. Police cannot prove the medical firm knew the pacemakers were stolen when they purchased them, he said.

"We do not anticipate any Arizona players will be prosecuted criminally," said Ensley, adding that this is the first case of its kind he’s handled. "The Internet just makes the bizarre and unusual a little more readily accessible."

Selling medical devices online is not necessarily illegal, said Brad Stone, an FDA spokesman.

"What is important is that the sale be done in accordance with the Food, Drug and Cosmetic Act, which includes making sure a legitimate prescription is involved, the seller is authorized to sell it and instructions for its use are provided," he said.

While eBay prohibits the sale of stolen property and items sold in violation of federal regulations on its Web site, it is up to buyers and sellers to follow the law, said spokesman Hani Darzy. EBay will remove items when problems are reported by police, the FDA or other sources, but such items cannot be pulled until those reports come in, usually after the products are listed, he said.

"In this case, it appears the listing went through and the sale went through before anybody knew (the pacemakers were) stolen," he said.

Once an FDA-labeled device is in the hands of those who plan to use it, federal oversight typically ends, Stone said. "At that level, it becomes a state or local area of regulation."

But in Arizona, regulators from several state agencies said they would have either limited or no oversight in medical device-related cases. The Arizona Department of Health Services and the Arizona Attorney General’s Office said primary oversight of medical devices comes from the FDA, although both state agencies respond to complaints. The state health department, for example, investigates complaints against the hospitals and other health care facilities it licenses, said spokesman Michael Murphy.

The Arizona State Board of Pharmacy has jurisdiction over prescription-only medical devices, which — unlike pacemakers — typically have prescription drugs packaged with them, said Hal Wand, the board’s executive director.

Sellers of prescription-only medical devices require a wholesale permit from the board. Sellers of other medical devices do not require the board’s authorization. Doctors who buy a device from an unapproved source fall under the jurisdiction of the Arizona Medical Board, said Wand.

But state statutes for unprofessional conduct by a doctor, which govern the medical board, do not address the purchase of medical devices, said Downey, the board’s spokesman. In addition, board investigators found that someone else at Advanced Cardiac Specialists — not Garg — purchased the stolen pacemakers.

"The issue will be did the physician do something wrong, not whether it was a stolen pacemaker," said Downey.

Dr. Richard Heuser, a cardiologist at St. Joseph’s Hospital and Medical Center in Phoenix, said the problem is that a patient received a pacemaker purchased outside of normal distribution channels that contain safeguards.

"I think it brings up a lot of ethical issues," he said.

Rich Fischer, a spokesman for Medtronic, said the company sells and ships the devices only to hospitals, clinics and sales representatives. Although not required by the FDA, the process ensures that pacemakers are tracked to physicians and the patients who receive them in case there’s a recall, he said.

Steve Myers, Garg’s attorney, told the medical board last month that Advanced Cardiac Specialists is not required to have a relationship with Medtronic and purchases pacemakers through online distributors, according to board records.





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