Posted on January 20, 2006 | New York Times
Guidant Considered Disclosing Device Failures
By Barry Meier The New York Times
FRIDAY, JANUARY 20, 2006
NEW YORK Six months before the Guidant publicly disclosed short-circuits in its heart devices, a debate was apparently going on within the company over whether to alert doctors about such failures, internal company documents suggested.
The documents, released Thursday, appear to indicate that some Guidant executives recommended in January 2005 that the company find a way of tell doctors about the failures posed by a device known as the Contak Renewal, an advanced heart defibrillator. The records, which were disclosed as part of a court proceeding in Texas, include handwritten notes said to have been composed by a top Guidant executive.
Guidant started receiving a small but growing number of reports of short-circuits in Contak Renewals in late 2004, more than two years after it discovered a similar problem in another defibrillator, the Prizm 2 DR. The Guidant records suggest that company executives came close last January to alerting doctors about the Contak Renewal but also that some officers opposed the idea. One executive later reported that the unit's failure rate was not as bad as first feared, the documents show.
Because the records are handwritten and in notes form, it is not clear whether the "recommendation" in them refers directly to the Contak Renewal, though that appears to be the case.
Asked specifically about the issue, Guidant declined to comment or provide explanation. But, in a statement, the company said, "As the documents reflect, the company took responsible action during an ongoing investigation of Renewal and Renewal 2."
It also noted it had "aggressively evaluated product performance and communication thresholds."
Guidant publicly disclosed problems with the Prizm 2 DR and the Contak Renewal last spring after it had come under scrutiny. Seven people are known to have died in connection with short-circuits in the devices; five deaths have involved a Contak Renewal or a related model known as the Contak Renewal 2.
But the number of deaths is probably higher because physicians only recently became aware of the problem. Short-circuits render defibrillators, which are designed to electrically interrupt potentially lethal heart rhythms, useless.
At a minimum, the disclosure of the new Guidant documents is likely to fuel efforts to develop uniform industrywide standards about when and how doctors and patients should be informed by heart device makers about product malfunctions.
A report by a committee formed by Guidant is due out in March and the Heart Rhythm Association, plans to issue recommendations in May.
But the records could also mean more legal problems for Guidant, which is the subject of a takeover battle between Boston Scientific and Johnson & Johnson. Both bidders have previously said that they have reviewed Guidant's legal situation and believed it was manageable.
Guidant is also under investigation by the Food and Drug Administration and the U.S. Justice Department.
The records released in Texas were among hundreds of documents provided to plaintiffs' lawyers in connection with a product liability lawsuit filed against it in a state court.
The records were initially produced under seal, but the case's presiding judge, Judge Jack Hunter of State District Court, cited a Texas law barring the sealing of court records related to safety issues on Thursday and ordered a few pages of internal Guidant records released. He also set the stage for the potential release of more documents; late Thursday, Guidant received a stay of that ruling pending an appeal.
On Wednesday, The New York Times filed a motion in the case seeking the release of any records related to public health and safety. Guidant first told doctors last May about short-circuits in the Prizm 2 after it learned that the newspaper was about to publish a report on the device. In June, it recalled the Prizm 2 DR, the Contak Renewal and the Contak Renewal 2.
The 10 pages of records ordered released included three pages of handwritten notes and seven other pages that reproduce a slide presentation.
Bob Hilliard, a plaintiff lawyer who is suing Guidant on behalf of two patients, said in an interview that the handwritten notes and slides were recently given to him at the end of a pretrial deposition of J. Frederick McCoy, head of Guidant's cardiac device unit.
Hilliard said the handwriting in the notes was consistent with handwriting that McCoy identified during the deposition as his own. Neither McCoy nor his secretary responded to notes sent to McCoy's office for confirmation.
The notes, dated June 22, 2005 , appear to be an annotated timeline that reconstructs company events and decisions involving the Contak Renewal over the course of about two years. In an entry dated Jan. 7, 2005 , the chronology notes a "recommendation," which followed several reports of electrical failures in the Contak Renewals.
"If we can a find a way to communicate on this trend in such a way that it would help physicians manage patients and does not result in patient harm via undue concern, then we should communicate," the entry reads. The same entry noted that one executive was "not on board with this recommendation."
In the wake of Guidant's disclosures last year, many heart specialists have said that they want to know about significant device failure so they, rather than manufacturers, can decide whether the units need to be replaced.
Apart from its statement, Guidant declined to comment on any aspect on the documents. In a recent update to doctors, the company projected, based on laboratory testing, that the rate of short-circuits in the Contak Renewal could 0.7 percent to 1.8 percent, or one to two devices out of every 100 produced.
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