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Court Orders Guidant To Release Documents

Judge Grants Public Citizen Motion to Unseal Pricing Data

October 25, 2006

• Device Maker Charged With Unlawful Clinical Trials • Medtronic To Disclose Payments To Doctors • Medtronic Withdaws Defibrillator Wires • Guidant Settles Defibrillator Charges For $16.7 Million • Court Orders Guidant To Release Documents • FDA Warns Guidant About Its Heart Devices • Spitzer Sues Guidant for Hiding Defibrillator Defect • FDA Report Addresses Heart Device Malfunctions • Potentially Harmful Medical Devices Should Be Recalled, Public Citizen Tells FDA • FDA Knew Of Pacemaker Problems Before Recall • Guidant To Resume Defibrillator Sales • Guidant Recalls Pacemakers • Guidant Pacemakers May Be Recalled • FDA Upgrades Guidant Recalls • Guidant Finds More Defibrillator Problems • FDA Recalls Guidant Implantable Defibrillators • Company Withheld News of Flaw in Defibrillator • Medicare To Cover More Defibrillators

The pacemaker manufacturer Guidant must make public judicial records from a case involving the pricing of its products in response to a Public Citizen motion to unseal the documents, according to a federal judge's ruling.

The sealed summary judgment records were from the recently settled Cardiac Pacemakers v. Aspen II Holding Co., in which two subsidiaries of Guidant that produce and sell controversial cardiac rhythm management devices sued the health care consulting company Aspen Health Care Metrics for publishing information about the prices of Guidant's pacemakers.

Guidant had defended the filing of the papers supporting summary judgment under seal but provided no documentation of a need for secrecy.

Paul Alan Levy, an attorney for Public Citizen, argued before Judge Donovan Frank of the U.S. District Court for the District of Minnesota that the information was highly important to the public interest and should be unsealed.

Frank ruled Tuesday that Guidant must release all of the summary judgment briefs and most of the supporting affidavits, while allowing most of the supporting exhibits to remain sealed for reasons that he did not sufficiently explain.

In its motion, Public Citizen asserted that Guidant's efforts to suppress publication of its products' prices hinders efforts at maintaining price transparency and threatens to foster the artificial elevation of prices, possibly limiting public access to affordable health care.

Guidant's attempts to keep court records secret also deny other hospitals, purchasing organizations and health care industry actors who are subject to Guidant's lawsuit threats access to vital information to better prepare their own defense.

"This is a partial win for health care consumers over corporate secrecy," said Levy. "Unfortunately, although Judge Frank has ordered the release of a significant amount of material, the methods he has used -- extensive in chambers review without requiring Guidant to make a public showing of evidence of its need for confidentiality -- sets a poor precedent for future cases. An appeal may be necessary to ensure that future cases are handled correctly."

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