Shelhigh Fighting the FDA

Union, NJIn a response to the US Food and Drug Administration's seizure of its tissue-based products, Shelhigh is going to court to retrieve its inventory. In April, after the FDA expressed concern about their sterility, U.S. Marshals seized the products, which are used in open-heart surgery.

Among the products seized by the FDA are pediatric heart valves, surgical patches, and arterial grafts.

Last week, the FDA requested Shelhigh recall its products. Shelhigh refused to do so, stating that it "has no intention to initiate a recall." The company has said that the FDA's concerns are unfounded and unproven and they are challenging the FDA's actions in the courts.

The FDA has filed a civil complaint against Shelhigh following an investigation of the company. Shelhigh is accused of manufacturing products in poorly constructed and maintained rooms, failure to monitor for contamination, failure to test products of sterility, and failure to support product expiration dates.

According to court documents, "...the methods used in, and the facilities and controls used for, their manufacture, packing, storage, and installation are not in conformity with current good manufacturing practice requirements for devices as set forth in the QS regulation, 21 CFR Part 820." Furthermore, the FDA alleges that Shelhigh allowed at least four lots of devices that failed their sterility testing to be released for distribution in the past two years. According to the FDA, 7.4% of samples tested in 2005 and 5.7% tested in 2006 failed sterility testing.

Additionally, the FDA argues that Shelhigh has not adequately validated the No-React detoxification process, which is used by the company on all devices after they are sterilized.

Shelhigh was scheduled for an emergency hearing on May 14 after it requested that some of the boxes of quarantined materials be released for export to Spain and Italy. However, that hearing was delayed fifteen minutes after the scheduled start time, with no reason given. The hearing will now take place on May 15.

If you have a Shelhigh device implanted and are concerned about its sterility, talk to a doctor to discuss your options. If you believe you have been harmed by a Shelhigh product, contact a lawyer.