Hospitals' unquenchable thirst for drug-eluting stents was threatened with a drought earlier this month when Boston Scientific Corp. voluntarily recalled 85,000 of its Taxus stents.
Boston Scientific's curse was at least initially Johnson & Johnson's blessing. The question last week was whether the abrupt pause would send hospitals running back to J&J's Cypher drug-eluting stent, which was plagued with customer complaints of supply problems and inflexible pricing after its exclusive introduction in the U.S. in April 2003 (March 15, p. 12).
"We have the capacity to make as many stents as needed and will ramp up production to meet any additional customer needs," Rick Anderson, president of the cardiology division of Cordis, the J&J company that manufactures the Cypher, said in a written statement.
The recall, which created a potential public relations disaster for a company that aggressively markets itself on the quality of its products, highlighted how quickly fortunes can fly south for healthcare organizations when patient safety is even perceived to be compromised.
"Obviously, we had a quality problem here that we moved quickly to address," said Paul Donovan, a Boston Scientific spokesman. "Our strategy here is full disclosure, full openness, complete transparency and full communication with our customers."
Of the 1,200 catheterization laboratories that Boston Scientific supplies, 18 have temporarily removed all Taxus stents from their shelves, Donovan said.
At the time of the recall, 323-bed Munroe Regional Medical Center in Ocala, Fla., which implants about 120 stents per month, had 65 Taxus stents and 16 Express2 stents on its shelves, said Earline Piscitelli, the hospital's vice president of corporate development. Munroe had some J&J stents, but before the recall it was using the Boston Scientific product about 90% of the time because of pricing, she said. Munroe had enough Cypher stents to ride out the recall without interruption, and a decision has yet to be made on which stents the hospital would purchase going forward, Piscitelli said. "But our contract with Boston Scientific would favor them once this problem has been resolved," she said. Patients were concerned and asking questions, but physicians were reassuring them that there was no further cause for worry, she said.
Boston Scientific's grab for a 75% share of the drug-eluting stent market since its launch in the U.S. in March was jolted by a problem with balloon deflation during coronary angioplasty procedures, resulting in one death and 18 serious injuries. A similar problem with its Express2 bare-metal stent system resulted in two deaths and 25 serious injuries and the recall of 11,000 of the older generation stents. The recall postponed plans for announcement of the company's second-quarter financial results by one week until July 26, and officials said they expected the calamity would decrease its sales by $45 million (July 19, p. 4).
Boston Scientific generally sells the Taxus, list-priced at $2,950, on consignment, so the company advised hospitals to return the recalled items for replacement within a week of the July 16 recall, Donovan said. An April 20 change in the inspection process at the company's manufacturing plant in Maple Grove, Minn., stopped the flow of faulty stents to hospital shelves. In addition, stents made after May 13 should be completely free of the problem because of a subsequent change in the manufacturing process, Donovan said.
Donovan estimated that 50,000 Taxus stents without the problem were already on hospital shelves at the time of the recall. In total, the company has implanted 500,000 Taxus stents worldwide. The recall did not affect patients who had already undergone an angioplasty procedure because the problem is with the delivery system at the time of insertion.
The Food and Drug Administration was monitoring the recall, said Gladys Rodriguez, director of one of the agency's enforcement divisions.
Hospitals, which initially welcomed the entry of a strong and productive competitor to the Cypher, were taking a wait-and-see position toward the Boston Scientific recall. "I think the issue is the damage it's done to the confidence of physicians using the product," said Ken Millecker, director of cardiology contracts at Broadlane, a group purchasing organization. Broadlane hospitals are using drug-eluting stents as much as 85% of the time, and about 75% of their purchases had shifted to Boston Scientific from J&J because of the perception that the Taxus was more flexible and easier to work with, he said. "I think (Boston Scientific) has a major PR issue on its hands, but I think they will overcome it," Millecker said.
The Health Alliance of Greater Cincinnati, which has three hospitals offering cardiovascular services, has been purchasing a roughly equal number of stents from each company, employing drug-eluting stents 80% of the time throughout the six-hospital system, said Jeffery Morneault, the system's vice president of cardiovascular services. Morneault declined to discuss the system's volume of angioplasty procedures but said that about 70% of the Taxus stents on its shelves were recalled. The Health Alliance plans to continue to use the Taxus stents after complying with the recall. Physicians decide which stent to use, and "physicians haven't expressed any concern to me," Morneault said.
Still, Morneault said he is reserving opinion on how Boston Scientific has handled the problem. "I want to make sure it's a limited problem and that they've corrected the problem," he said.