Through much of this year, Sulzer Medica (Winterthur, Switzerland) has been at the center of swirling product liability news, attempting to fend off 1,800 individual lawsuits filed over its hip and knee implants with a single $780 million payout to the collective plaintiffs. As this issue of The BBI Newsletter went to press, the company was awaiting a Nov. 29 court hearing of that strategy, continuing to say that being forced to fight the many lawsuits filed against it individually would force it into bankruptcy. Additionally, as part of that strategy, it is attempting to distance itself from Sulzer Orthopedics (Austin, Texas), the company unit that produced those implants and which has since been spun off from the parent.
This past month, another international conglomerate, Baxter International (Deerfield, Illinois), has been thrown into its own product liability war, this time in the dialysis treatment sector. A class action lawsuit has been filed in the U.S. against Baxter, charging it with the deaths of at least 50 people, the majority in four countries in Europe, the result of being treated with a faulty dialyzer.
When the first deaths were reported in October and connected with Baxter's equipment, the company denied any connection, saying that its own testing had shown the dialysis equipment not to be faulty.
However, the company then did an about-face in mid-November, issuing a statement saying that it had uncovered what it characterized as a "key finding" implicating three batches of dialyzers in those fatalities. The company said that "preliminary tests" had uncovered problems with a processing fluid produced in its Ronneby, Sweden, facility. That finding came from what Baxter called a "comprehensive investigation" of the dialyzer product and that the fluid "may have played a role" in the deaths. And it identified three batches of dialyzer filters that apparently were faulty, with the specific filter product line acquired as part of Baxter's purchase of Althin Medical (Lund, Sweden) for $130 million in March. With its confirmation of the dialysis filter problems, Baxter said it will take a charge of up to $140 million to cover the costs of discontinuing the product line, for litigation and for other related costs, though the bulk of potential payouts to injured parties is expected to be made by the company's insurers.
Harry Kraemer Jr., chairman and chief executive officer of Baxter, last month said that while there was still "substantive gaps in information" concerning the products, the company was taking the step of making public its findings and was halting manufacture of the filters "in the interest of patient safety [as] the most prudent course of action." He said that the halt in manufacturing will be permanent. Baxter acquired the A and AF filter lines through its acquisition of Althin Medical.
The FDA has launched its own investigation of the filters. While rank-and-file staff of the agency would not provide specific details concerning their findings, David Feigal, director of the agency's Center for Devices and Radiological Health, told The New York Times that perfluorohydrocarbon materials used in manufacturing the devices apparently entered the bloodstream of the patients being treated. This may have created gas bubbles that then led to the deaths.
In a related development, Gambro AB (Stockholm, Sweden), another key player in the dialysis sector, said that it will halt the use of perfluorohydrocarbon fluid used in the manufacturing of its dialyzers in its Gottingen, Germany, facility. Gambro said that there have been no problems or complaints as a result of using this material in what it called "the integrity testing" of its dialyzer filter devices, but that it was taking the action as a precautionary measure and a result of "inquiries and questions" prompted by Baxter's difficulties.
Use of the perfluorohydrocarbon material, Gambro said, "is restricted to this factory and to these dialyzer types and involves less than 3% of this plant production volume, that is less than 0.3% of Gambro's total production of dialyzers." Other procedures for manufacturing the dialyzers will remain unchanged, the company said.
First AbioCor patient suffers stroke
After a series of successes for the AbioCor artificial heart, its first recipient, Robert Tools, suffered a stroke in mid-November, that event essentially marking the first setback in the five-patient trial of the device made by Abiomed (Danvers, Massachusetts). As a result of the stroke, Tools was having breathing difficulties and was placed on a ventilator. This was the first indication of a significant neurological problem for Tools since the implantation, according to Lynn Simon, MD, the patient's neurologist. Following the stroke, Tools was having difficulty communicating and while Simon was hopeful of his still having some language ability, he said, "It's too soon to guess at this point."
The setback came after a period when Tools had been making good progress in recovery. He had been traveling outside the hospital, giving interviews on television, showing improvement in general organ function and putting on weight. His physicians had been predicting the possibility of his being moved to a rehabilitation center and then living outside the hospital, a possibility greatly dimmed by this recent development.
In a statement issued by Abiomed shortly after the stroke was reported, the company expressed its concern for what it called "this new challenge" for Tools, but added, "If fighting spirit can make a difference, we know that Bob will make the fullest possible recovery." The company said it had not identified the specific cause of the stroke, but offered the theory that the inability to provide Tools with anticoagulation therapy may have been one cause. That therapy could not be delivered for a period of time because of his problems with gastrointestinal bleeding following the implant of the heart.
The company said that it did not believe Tools' stroke would disrupt the progress of the AbioCor trial. Abiomed reported that the second recipient of the AbioCor heart, Tom Christerson, also implanted at Jewish Hospital, was continuing to make good progress despite earlier reports of a fever. Christerson, according to Abiomed, was gaining strength, "sitting up each day and lifting his arms and legs off the bed."
The five patients implanted with the AbioCor heart complete enrollment in the initial human clinical trial. The other three implants have taken place at the Texas Heart Institute of St. Luke's Episcopal Hos- pital (Houston, Texas), UCLA Medical Center (Westwood, California) and MCP Hahnemann University Hospital (Philadelphia, Pennsylvania). Last month, Abiomed reported that University Medical Center (Tucson, Arizona) had been added as a U.S. trial site.
The company also named three sites – North Rhine-Westphalia Heart Center (Bad Oeynhausen, Germany), Heart Lung Center Utrecht (Utrecht, the Netherlands) and Lund University Hospital (Lund, Sweden) – for a European clinical trial of the AbioCor, expected to start within the next six months.
Emergency services select Survivalink
Cardiac Science (Irvine, California) reported that a group of police, fire and emergency medical service agencies will purchase 325 of its Survivalink automated external defibrillators (AEDs). The Florida State Highway Patrol purchased 37 AEDs for use in police and trooper vehicles, bringing the total of its Survivalink AEDs in service to 124. The city of Cedar Rapids, Iowa, selected Cardiac Science to equip its police department with 41 AEDs. The other agencies making purchases include the Cook County (Illinois) Sheriff Department, the Collin County (Texas) Sheriff Department and the state of Wisconsin Department of Justice. Oklahoma-based police departments who purchased AEDs include the Custer County Sheriff's Department, Clinton Police Department and Weatherford Police Department.
Fire and emergency medical services deployments of Cardiac Science AEDs include the city of Boston, Akron (Ohio) Fire Department, the Hartsfield International Airport fire department (Atlanta, Georgia), the Baton Rouge (Louisiana)Volunteer Fire Department and Porter County (Indiana) EMS. The 40 AED units purchased by the city of Boston are part of a 1,100-unit contract won earlier this year. These initial units are being deployed in city ambulances and by its paramedic bike service, which acts as a safeguard at the Boston Marathon, concerts and other public events.
The company estimates that, nationwide, only about 20% of fire engines and 5% of police and sheriff vehicles are currently equipped with AEDs. Raymond Cohen, president and CEO of Cardiac Science, said, "Widespread deployment of AEDs by police and firefighting agencies could prevent many of the 350,000 annual deaths attributed to sudden cardiac arrest."
The value of AEDs in the airport environment has been demonstrated by American Airlines (Dallas/Ft. worth, Texas), which recently reported that more than two dozen people are alive because of the presence of the devices on its aircraft, with the latest "save" coming on Oct. 31 at a boarding gate in Chicago. American, which uses AEDs from Heartstream (Seattle, Washington), now a unit of Philips Medical Systems, was the first domestic airline to equip its entire fleet with AEDs, the first installed in May 1997. Since then, 27 people have had their lives extended due to the availability of an onboard defibrillator, the airline said.
Cohesion in 20% workforce cut
Cohesion Technologies (Palo Alto, California) said last month that it will reduce its staff of 80 by about 20%, or 16 people. The company said that most of the cutbacks will come in its research and development division. The company makes biosurgical products, including surgical hemostats, sealants and adhesion prevention barriers, and said that it plans greater focus of resources on its first two products: CoStasis surgical hemostat and CoSeal surgical sealant. The company expects to record a fourth quarter charge of from $500,000 to $600,000 related to the restructuring but sees potential savings in administrative and R&D costs of about $1.5 million annually.
William Mavity, president and chief executive officer of Cohesion, called the reductions "difficult" but "necessary to take advantage of the substantial potential represented by our two most advanced technology platforms." He said that the intent is to move from a discovery orientation to commercial sales and is planning "to add resources in operations, sales and marketing in preparation for direct U.S. sales of CoSeal in 2002." The products produced by Cohesion address a market estimated at $1.5 billion in value worldwide.