A New Jersey medical device company that manufactures pediatric heart valves, conduits and patches used in heart surgery is fighting the U. S. Food and Drug Administration in court, stating that the federal agency wrongly quarantined about 1 million of its product parts because of concerns over sterility and health risks.
According to an article last week in the New Jersey Star Ledger , Shelhigh suffered a setback on May 30 when a federal judge made a ruling refusing to release the devices seized by FDA in April. The judge stated that he would not determine whether those devices met safety standards without a hearing, which he said he will schedule soon.
Meanwhile, there is a virtual war of words going on between the federal officials and Shelhigh, which is a small company with 50 or so employees. Most of the company’s devices are exported to Europe, particularly Italy and Spain. According to this newspaper article, federal officials claim in court papers that Shelhigh used a poorly constructed and maintained clean room, and failed to properly test the sterility of products.
But Shelhigh officials are quick to deny those allegations. They lashed back at the FDA claiming that this “irresponsible act” on the part of the federal agency “has caused a substantial amount of confusion in the hospital market and is putting patients’ health at risk in the process.”
It is not at all surprising to me that the device company has adopted this fighting stance. It is a risky position to be in, but not altogether uncommon. Drug manufacturers usually buckle in pretty quickly when it comes to recalls, if only to avoid lengthy court battles and the negative publicity. But device manufacturers seem bolder. In 2005, Utah Medical Products Inc., a company that makes electro-surgical products, won a similar battle against the FDA. The federal agency decided not to pursue an appeal in that case.
Will Shelhigh win its battle against the feds? We’ll have to wait and watch. There are some facts that make you wonder. According to another article in the New Jersey paper,
Spanish regulators last month recommended that surgeons in that country consider not using Shelhigh products because of problems experienced in 1997 involving seven pericardial patches and three heart valves, two of them fatal.
I would hope that the FDA pursues this company to the very end. This is a company that is absolutely mandated to maintain the highest quality when it comes to its products. Lives are at stake here. I’d say that if Shelhigh ends up winning in court, the FDA should certainly consider appealing it this time. If you have a legal complaint against defective drugs or devices, call me, John Bisnar of Bisnar Chase Personal Injury Attorneys at 1-800-259-6373.