Heart Device's Export Blocked

FDA Questions Rhythm Stabilizers From One Guidant Plant

The Food and Drug Administration has told Guidant Corp., a maker of medical devices, that it will not approve new contracts to export heart-rhythm stabilizers made in its Minnesota plant until the company can prove that its products are being properly made.

In a warning letter from the agency, the troubled company was also informed that it had to make significant improvements in its manufacturing practices before any additional company devices could be approved for sale.

Guidant acknowledged in a statement on its Web site that it received the formal FDA warning Dec. 23, and that it outlined quality-control issues at its St. Paul plant. The warning letter covered a broad range of still-uncorrected problems first identified by the FDA during a September inspection.

But, Guidant said in its statement that it has "taken a broad, thorough and systemic review of its quality system and has made substantial steps toward addressing all" of the FDA's concerns. The company has fulfilled 90 percent of its upgrade commitments, the statement said.

The intensive FDA inspection followed a series of recalls and warnings issued for Guidant's heart defibrillators and pacemakers because of reported malfunctions, some of them fatal. Federal and state officials are investigating the company, which faces dozens of lawsuits over its recalls.

After the inspection, FDA officials said that the company did not properly warn doctors about software problems that caused some pacemakers to malfunction, that company quality control was ineffective at several levels, and that record-keeping was poor.

FDA spokesman Jason Brodsky said that while Guidant remains out of compliance with good manufacturing practices at the St. Paul plant, the agency had no additional product warnings yesterday for patients and their doctors.

"We're working with the company now to bring them into compliance," Brodsky said. "There are significant manufacturing concerns, but we have no new recommendations for use of the products."

Brodsky said that the FDA's refusal to issue new export certificates for the plant or to approve new device applications is not a new regulatory action but rather a consequence of the plant remaining out of good manufacturing compliance.

In the warning letter to Guidant, Minneapolis District Director W. Charles Becoat said that the company had submitted five letters since early September outlining its plans to improve the St. Paul plant. Nonetheless, he wrote, "You have failed to address all of the significant violations . . . and will receive additional correspondence detailing the inadequacy of your response."

The company's devices are implanted in cardiac patients and use electric shocks to correct faltering heartbeats. While the problems of some implanted defibrillators and pacemakers have tarnished the industry, agency and industry officials say that failure rates remain low and the devices are often lifesaving.

Guidant's manufacturing problems have emerged as two larger companies -- Johnson & Johnson Co. and Boston Scientific Corp. -- have negotiated to buy the company. Johnson & Johnson reduced its offer by almost 20 percent after the problems arose, and then Boston Scientific countered with an offer similar to the initial one from Johnson & Johnson.

Guidant stock dropped by almost 3.5 percent yesterday on the New York Stock Exchange. The decline was the biggest since the price fell almost 5 percent last month after New York Attorney General Eliot L. Spitzer accused the company of misleading doctors about a design flaw in its defibrillators.