Medical Malpractice

• Guidant Consultant Advised Company to Release Defect Data

  Joe Saunders | March 10, 2006 9:40 AM | 0 CommentsOrlando, FL

  A Guidant Corporationconsultant told the medical device company that it had an ethical obligation to inform doctors of defects in its defibrillator device. Dr. Richard N. Fogoros, also told company executives that their decision to withhold such data, while statistically defensible, was questionable. In one of two lengthy memos to Guidant executives, Fogoros wrote that the company violated a...

• Guidant Officials Worried About Device Defects

  Joe Saunders | March 01, 2006 10:47 AM | 0 CommentsOrlando, FL

  When Guidant Corp. came under fire last year for not revealing to doctors it's problems with its medical device, it remained positive in its public announcements. But newly released documents show that, inside Indianapolis-based Guidant, executives were struggling to contain a mounting crisis.The records illustrate how a series of miscalculations by Guidant, like its misreading of doctors'...

• Medical Device Approved in Spite of FDA Objection

  Joe Saunders | February 20, 2006 9:49 AM | 0 CommentsOrlando, FL

  According to an article in the NY Times, "A top federal medical official overruled the unanimous opinion of his scientific staff when he decided last year to approve a pacemaker-like device to treat persistent depression, a Senate committee reported Thursday.The device, the surgically implanted vagus nerve stimulator, had not proved effective against depression in its only clinical trial for...

• Medtronic Continued Selling Defibrillators in Spite of Failures

  Joe Saunders | February 20, 2006 9:10 AM | 0 CommentsOrlando, FL

  Medtronic Inc. continued selling flawed cardiac defibrillators for two years after learning that some of them may suddenly quit working, according to company documents filed in a California lawsuit. After Medtronic last year recalled the devices, 19,000 people had to have surgery for a replacement, said Medtronic spokesman Rob Clark. At least one of them died from post- surgical complications,...

• Guidant Offer to Fix Heart Stent is Inadquate

  Joe Saunders | February 17, 2006 9:20 AM | 0 CommentsOrlando, FL

  Guidant Corp.'s program to pay $2,500 to patients to replace a heart device that has had malfunctions is nowhere near sufficient to cover costs of the procedure. The offer covers only about 10% of the cost of the replacement procedure. How is this fair? How is this the right thing to do?

• FDA Places New Restrictions on Guidant

  Joe Saunders | February 16, 2006 9:10 AM | 0 CommentsOrlando, FL

  New limits imposed by the FDA on Guidant, maker of an implantable heart defibrillator found to be defective, will make it difficult for new products made by the company to be approved for commercial sale, as the agency applies pressure to the company to improve its manufacturing procedures. In the letter, sent a week ago, the agency said Guidant had not fully responded to its concerns about...

• Guidant CEO to Receive $1.5Million Bonus. . . For What?

  Joe Saunders | February 10, 2006 5:52 AM | 0 CommentsOrlando, FL

  Guidant's chief executive will receive a $1.5 million bonus after the acquisition by Boston Scientific is complete, according to documents filed with the U.S. Securities and Exchange Commission. Since June, Guidant has recalled or issued safety advisories on about 88,000 defibrillators and more than 200,000 pacemakers. At least seven deaths have been linked to the faulty devices. I guess that...

• Boston Scientific's Mea Culpa

  Joe Saunders | February 05, 2006 10:05 AM | 0 CommentsOrlando, FL

  Now that Boston Scientific, the maker of medical devices, has been publicly chastised by the FDA, its executives have taken a penitential tone. "It's clear we have not done enough to resolve the issues raised by the F.D.A., "a spokesman, Paul Donovan, said in a statement yesterday, "and we recognize fully that the responsibility to do so lies with us."Already, the F.D.A. has told Boston...

• FDA Sends Warning to Boston Scientific

  Joe Saunders | January 30, 2006 7:10 AM | 0 CommentsOrlando, FL

  Boston Scientific fresh off its acquisition of Guidant Corporation, has been sent a warning letter by the FDA. Federal regulators said they discovered problems in the medical device maker's quality control. FDA officials who announced the warning involving Boston Scientific said it was only the third time in the agency's history it has issued such a broad companywide warning involving a...

• Lawyer Subpoenaed for Guidant Documents

  Joe Saunders | January 29, 2006 11:45 AM | 0 CommentsOrlando, FL

  An attorney suing Guidant Corporation has been ordered by the Justice Department to turn over the documents he received from the company. The subpoena, part of the federal government's investigation into the Indianapolis-based company, requires Texas attorney Bob Hilliard to turn over handwritten notes and PowerPoint slides. He obtained them from the company during preparations for a product...