US Pacemaker Manufacturer Faces British LawsuitAug 30, 2003 | bmj.bmjjournals.com
St Jude Medical, a major manufacturer of heart valves and pacemakers, is to face a lawsuit in Britain over its Silzone heart valves, which were discontinued after a recall in January 2000.
The Minnesota based company, which is already the target of class action lawsuits over Silzone in the United States and Canada, is to be sued in London's High Court by Billy McCombe of Northern Ireland. Mr McCombe's wife, Myrtle, died in July 1998, aged 44, 10 weeks after receiving a Silzone mitral valve implant.
The Silzone valve is a variant of the standard St Jude valve, with a silver coating on the sewing cuff used for attachment. The silver was meant to discourage bacterial infection and reduce the rate of endocarditis, one of the most common and dangerous complications of artificial valve implantation. Silzone valves were approved in the United Kingdom in 1997.
About 37 000 Silzone valves were implanted worldwide, including about 1300 in the United Kingdom, 10 000 in the United States, and 2300 in Canada. Most of the rest were implanted in Europe.
Solicitors for Mr McCombe, say the device was not adequately studied before marketing. They also cite a confidential document, written by a member of St Jude's marketing advisory panel, that describes Europe as "the guinea pig continent."
Richard Meeran, a partner at Leigh, Day & Co, said: "It is hard to see how St Jude can defend this case. The Consumer Protection Act imposes strict liability on manufacturers. Many people in this country may potentially have been seriously harmed by this product."
Peter Gove, vice president of St. Jude Medical, told the BMJ that he believed that the British claim had less merit than lawsuits under way in the United States and Canada, where six provincial health ministries are among the plaintiffs. "Mrs McCombe had a thrombus, which is a risk associated with all heart implants and all heart surgery. The Canadian and American suits concern paravalvular leak, which was the problem identified in the AVERT study we commissioned to monitor this device in the patient population."
In the AVERT study, eight patients in the Silzone treatment arm had to have their implant removed because of paravalvular leak, compared with one patient in the group using standard St Jude valves. In January 2000, the study's independent board suspended further enrolment. The company issued a recall of valves that had not yet been implanted. Patients with implanted valves have been advised to keep them.
Other problems have been reported. In Britain, the Medical Devices Agency issued an advisory warning in November 1999 about a "high rate of early thromboembolic complications," including stroke.
Peter Gove says media reports that his company is resigned to paying out over Silzone are wrong: "We regard the issue as unresolved." He said that product testing complied with international testing standards and the Food and Drug Administration's guidance on heart valves. "To this day, no one really knows what was wrong with the valve."