A Medical Device Daily
Newly released court records show that a consultant to Guidant (Indianapolis) told the company last year that it had an “ethical obligation“ to tell physicians about defects in some of its cardiovascular devices.
According to the New York Times, Dr. Richard Fogoros also told the company officials that their decision to withhold such data was questionable.
In the aftermath of problems reported with certain of the company's implantable cardioverter defibrillators (ICDs) last year, Guidant officials have said they did not publicize the flaws because they believed patients faced greater risks from replacement surgery than from the problems with the ICDs themselves.
In a story in Thursday's Times, Fogoros was reported to have written in one memo that while believing it was acting in the best interests of patients, Guidant had violated a “sacred obligation“ by interposing its medical judgment for theirs. In that same May 18, 2005, memo: “This means that when a tragedy occurs, our decisions will be viewed in the harshest light possible, without any objective consideration of the statistical niceties supporting our actions.“
The memos emerged as part of a product liability lawsuit filed against Guidant in a Texas state court. They were written after Guidant had informed a Minneapolis cardiologist, Dr. Barry Maron, that the type of Guidant ICD that had been implanted in one of his patients who had died after the defibrillator failed had been known to have an electrical flaw that caused it to repeatedly short-circuit.
Following reporting by the Times on the flawed devices, Guidant initiated a series of recalls that now has totaled more than 100,000 units of several models of ICDs.
Former HealthSouth (Birmingham, Alabama) CEO Richard Scrushy will get information on prospective jurors in his upcoming bribery trial, including their races, after complaining that the jury selection process was flawed because there weren't enough blacks in the pool.
Scrushy, who was acquitted last June on charges of masterminding a $2.7 billion accounting fraud at the company he founded, now faces charges that he arranged $500,000 in illegal payments to former Alabama Gov. Don Siegelman as part of a bid to be named to the state's regulatory board for hospitals.
Jury selection for the trial, which will be heard in U.S. District Court in Montgomery, Alabama, begins next month. U.S. Magistrate Judge Charles Coody granted Scrushy's request earlier this week, while saying that he disagreed with Scrushy's contention that blacks were underrepresented in the pool of potential jurors.
Attorneys for Scrushy, who is white, played heavily on his involvement with black churches and causes during last year's trial.
In other Scrushy-related news, he caused a stir in the Houston courtroom where the Enron fraud trial is taking place by sitting in on some of the testimony in the case on Wednesday.
He said he was in town on business and decided to pay a visit to the courtroom to see how the trial was going. “I wanted to hear what this man [former Enron financial chief Andrew Fastow] had to say,“ said Scrushy. “When I was on trial, one of the problems was that people didn't really get to hear what was going on, just what they heard in the media, which was somebody's opinion.“
He told reporters afterward that he was “appalled“ after hearing just a little of Fastow's testimony. “This is horrible that people would do this to a company,“ he said in a hallway outside the courtroom. “It makes me sick.“
Telzuit stock symbol changes
Telzuit Medical Technologies (Orlando, Florida) reported that the Nasdaq has changed the company's stock trading symbol back to TZMT from TZMTE, following the filing of the company's quarterly report on Form 10-QSB for the quarter ended Dec. 31. Telzuit is focused on providing advanced mobile medicine for people worldwide.