Shelhigh Medical Devices Legal News Articles & Interviews

Union, NJ Shelhigh Medical Devices, the Union, NJ, manufacturer of tissue-based medical devices, virtually shut down by court order in a lawsuit started by the Food and Drug Administration in April, wants to keep you in the dark. Shelhigh wants you to believe that its products won't cause infection in surgery patients, and that it has been framed by the mean old FDA.

Union, NJ If you listen to the makers of Shelhigh Medical Devices, the company which was virtually shut down by the Food and Drug Administration in April of this year, you would think the company is a poor innocent victim of a vendetta by the FDA—that the potential for infection from its products and lawsuits by the injured has all been manufactured out of thin air.

Union, NJ At least two New Jersey hospitals indicated they had stopped using Shelhigh Medical Devices immediately after reports of the product seizures surfaced: Robert Wood Johnson University Hospital in New Brunswick NJ, and Hackensack University Medical Centre.

Union, NJ In the continuing saga of Shelhigh Medical Devices, the maker of heart valves and surgical grafts has resumed a phased-in manufacturing schedule and has agreed to an embargo on further distribution of its medical products until independent inspections of its manufacturing facilities and processes are complete.

Newark, NJ: In response to references about warning letters dating back 7 years in the FDA's complaint filed in New Jersey US District Court to initiate the seizure of all products made by device maker Shelhigh, on its web site, the company claims the old letters don't count.

Newark, NJ: In a New Jersey court hearing on May 15, 2007, US District Court Judge William Martini informed medical device maker Shelhigh that it was unlikely that he will allow the release of any inventory seized by US Marshals at its Union City plant, after the FDA found "significant deficiencies in the company's manufacturing processes."

Union, NJ Insomuch as the U.S. Food and Drug Administration has been castigated for inaction and slow response to issues affecting the public health, it appears to have shown some clout in recent weeks with regard to Shelhigh implants.

Newark, NJ: Medical product manufacturer Shelhigh is trying a new legal tactic in court. Embroiled in a bitter battle with the U.S. Food and Drug Administration over the safety of its products, Shelhigh lawyers have gone from crying, "foul" to crying, "broke".

Union, NJ In 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.

Washington, DC: On April 17, 2007, the FDA issued a press release to announce that US Marshals had seized all implantable medical devices from Shelhigh, Inc, in Union, NJ, after finding "significant deficiencies in the company's manufacturing processes."