March 21, 2006
Guidant and the Independent Study
Often, when a company commissions an "independent investigation" into its own conduct, some eye-rolling is appropriate, and I imagine there was some of that when Guidant announced that it would commission such a study into its handling of its defibrillators. (Guidant had evidently known of rare but significant flaws for around three years prior to disclosing them to doctors.) To date, Guidant has said it's facing around 150 lawsuits. (The MDL is in Minnesota.)
But this very interesting NYT story suggests that the panel was genuinely independent and, indeed, rather critical of Guidant. The lede from the NYT:
An expert panel commissioned last summer by the Guidant Corporation to review its handling of heart device flaws said yesterday that the company had systematically failed to fully assess patient safety in deciding whether to publicize product failures.
The group found that decisions made by Guidant about how to address or disclose product problems were driven by statistical projections from engineers rather than assessments from doctors about the medical consequences of those failures. The group urged Guidant to create an outside panel of physicians and others who would regularly monitor the safety of its devices and advise the company about when and how to notify doctors and patients about problems.
Guidant has posted the full report (over 100 pages, including the appendices) on their website; the key recommendations start at page 20. On the one hand, it surely provides a blueprint for plaintiffs' counsel; on the other hand, it may be a potent argument against punitive damages if Guidant follows the recommendations. And, most important, it seems to be the right thing to do.
As of this morning, Guidant has posted the title of a press release related to the report, but it links to nothing (and the next consecutively-numbered URL I guessed at results in a 404 error). I'll post a link to the release once it gets posted. (see below)
The Times story provides this as the company's response:
In a statement yesterday, James M. Cornelius, the chief executive of Guidant, which is based in Indianapolis, said it and other makers of heart devices recognized that the environment governing the disclosure of product problems had changed.
"We are taking the necessary steps to improve surveillance of device performance and safety, as well as physician and patient communications," Mr. Cornelius said.
Update: Guidant has posted its response now.
James M. Cornelius, Chairman of the Board and Chief Executive Officer of Guidant Corporation, stated, “I want to express our deep appreciation to the Independent Panel for its careful analysis, as well as for the incisive and thorough recommendations contained in the Panel’s report. The Panel has presented Guidant with a blueprint for improvement and enhancement of our postmarket evaluation of product reliability and communications procedures regarding the performance and safety of our devices. We intend to implement the recommendations to further benefit patients and physicians. We are already working closely with Boston Scientific to ensure a smooth transition of these recommendations following the completion of the pending merger between Guidant and Boston Scientific.”
* * *
“Guidant has already begun to implement changes that will address some of these recommendations, including taking steps to provide enhanced information through the expanded Product Performance Report we now make available to physicians and patients on our website. This Guidant initiative will be supplemented by additional communication recommendations made by the Panel. And, as an immediate response to one of the Panel’s major recommendations, the company is actively recruiting for the newly created position of Chief Medical and Patient Safety Officer at CRM, a physician who will be responsible for overseeing all issues relating to patient safety,” Cornelius continued.
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