Cypher Drug Coated Stents Cause Blood Clots, Says Johnson & Johnson
Admission Part of Company's Legal Maneuvering in Patent Infringement CaseOct 1, 2007 | Parker Waichman LLP
Drug coated stents manufactured by Johnson & Johnson run a high risk of causing blood clots. That claim was made by Johnson & Johnson itself, in an attempt to convince a court that its drug coated Cypher stents did not infringe on another company’s patent.
Drug coated stents were approved by the Food & Drug Administration in 2003. The stents are meant to keep blood vessels open after an angioplasty. Stents are lattice-like devices that act like scaffolding to hold a blood vessel open. The drug coating is supposed to keep scar tissue from closing the artery, a common problem with the bare metal version. However, this also prevents the artery from growing around the stent, and creates an ideal place for blood clots to form.
In 2006 the Cleveland Clinic published an analysis of fourteen stent studies covering more than 6,000 patients that found those with drug coated stents were four to five times more likely to suffer from blood clots than those implanted with bare metal stents. But those findings have been disputed by all of the manufacturers of drug coated stents – including Johnson & Johnson. Over the past year, the company has repeatedly asserted that its Cypher stent is no more likely to cause blood clots than bare metal varieties.
But in order to fight a patent infringement lawsuit filed against it by Boston Scientific, Johnson & Johnson tried to use the blood clot risk posed by drug eluting stents to its advantage. Boston Scientific manufacturers the Taxus drug coated stent. Taxus and Cypher are the only two drug eluting stents available in the US. Two years ago, a jury found that Johnson & Johnson had infringed on Boston Scientific's patent for Taxus.
During an appeal of the jury’s findings, Johnson & Johnson claimed that Boston Scientific’s patent only covers stents with a coating that does not cause clots. Johnson & Johnson claimed evidence that Cypher causes blood clots might suggest it does not infringe on the Boston Scientific patent.
Unfortunately for Johnson & Johnson, the judge hearing the appeal did not agree with this legal analysis. According to the New York Times, the judge found Johnson & Johnson’s claims “too speculative” to dismiss Boston Scientific’s patent claim or order a new trial into whether Johnson & Johnson infringed it
While the judge agreed that there was evidence that drug coated stents cause blood clots, she said research has not concluded if the clotting risk stemmed from the drugs eluted by the stents, or some other aspect in the devices’ design.