Source: More Than 100 Patients May Have Received Faulty Pacemakers
INDIANAPOLIS (AP) _ More than 100 patients may have received faulty or mislabeled heart pacemakers from a businessman charged with selling used or altered devices, a law enforcement source said Tuesday.
At least 18 patients underwent surgery to remove and replace pacemakers supplied by Michael Walton, 43, who operated at least five businesses out of a Hammond storefront, the source told The Associated Press on condition of anonymity.
Walton was arrested Saturday in Las Vegas after a federal grand jury issued a 13-count indictment against him and six former employees. U.S. Magistrate Robert Johnston on Tuesday ordered Walton returned to Indiana to face a detention hearing.
Walton, who reportedly had been living in Las Vegas about eight months, had no comment as he was led away from court.
His attorney, Brent Stratton of Chicago, said the charges were the work of a disgruntled former employee and Walton would deny all of the allegations.
″I am not aware of any harm that ever came to a patient as a result of Mike’s sales or involvement,″ said Stratton.
U.S. Attorney John Hoehner said no deaths can be directly attributed to Walton’s pacemakers.
″That is due in large measure to the fact that the implantations involve patients of advanced age or who were in grave health,″ Hoehner said by telephone from Dyer, Ind., a Chicago suburb.
Pacemakers are implanted to correct irregular heartbeats using electronic pulses.
The indictment alleges 27 instances between Jan. 3, 1984, and Feb. 16, 1990, in which mislabeled, expired or previously used pacemakers or their insulated wires were sold to hospitals in five states: Indiana, Illinois, Ohio, Michigan and Delaware.
One of the allegedly mislabeled pacemakers was implanted in James Ballard at St. Anthony Medical Center in Crown Point in November 1985, the indictment claims. Ballard died in July 1986 of a heart attack, said his daughter, Pamela Ballard.
″We’ve lost both of our parents in the last six years, and when something like this comes forward you wonder if this had any link to my father’s death,″ Ms. Ballard said.
Investigators seized approximately 100 pacemakers in a February 1990 raid on Walton’s now-defunct Cardiotronics business in Hammond, the source said. Eleven of the pacemakers had been used in other patients, the source said.
The same storefront also was home to other Walton companies, including Coratronics, Corapace Inc., Pacetech Inc. and Pulstar Inc. None of Walton’s companies operates today, Stratton said.
″Quite frankly, the effect of the investigation was to drive him out of business,″ Stratton said.
The indictment claims Walton obtained the pacemakers from 10 manufacturers, none of which is accused of any wrongdoing.
The indictment didn’t say how Walton may have obtained used pacemakers. Hoehner said there are no allegations that hospitals were aware of Walton’s alleged tampering.
The indictment also claims some pacemakers were falsely labeled as being more technically advanced than they were, allowing Walton to sell them for $1,500 to $3,500 more than the legal price.
Physicians in Indiana, Missouri, Illinois, Wisconsin, Michigan, Ohio, southern California, Florida and Delaware were alerted when investigators turned up information that a pacemaker or lead was suspicious, Hoehner said.
The sealed 13-count indictment issued June 11 charged Walton with conspiracy to tamper with consumer products, five counts of tampering with pacemakers, conspiracy to tamper with heart pacemakers and connecting wires, one count of unlawfully offering a gratuity to a physician, three counts of mail fraud and two counts of possession of an implement used to make false identification documents.
If convicted on all counts, Walton could face a maximum sentence of 95 years in prison and a $3.25 million fine.