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Shelhigh Medical Devices Legal News Articles & Interviews

The Shelhigh Story: Lawsuits, Infections and Spin-Doctoring Part II

August 9, 2007. By Brenda Frohloff.
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.
Read [ The Shelhigh Story: Lawsuits, Infections and Spin-Doctoring Part II ]

The Shelhigh Story: Lawsuits, Infections and Spin-Doctoring Part I

August 7, 2007. By Brenda Frohloff.
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.
Read [ The Shelhigh Story: Lawsuits, Infections and Spin-Doctoring Part I ]

Shelhigh Medical Devices agrees to FDA Terms - Part Two

Shelhigh Medical Devices agrees to FDA Terms  -  Part Two July 18, 2007. By Gordon Gibb.
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.
Read [ Shelhigh Medical Devices agrees to FDA Terms - Part Two ]

Shelhigh Medical Devices Agrees to FDA Terms

July 16, 2007. By Gordon Gibb.
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.
Read [ Shelhigh Medical Devices Agrees to FDA Terms ]

Battle of Device Maker Shelhigh and FDA Rages On - Part II

Battle of Device Maker Shelhigh and FDA Rages On - Part II June 2, 2007. By Evelyn Pringle.
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.
Read [ Battle of Device Maker Shelhigh and FDA Rages On - Part II ]

Battle of Device Maker Shelhigh and FDA Rages On Part I

Battle of Device Maker Shelhigh and FDA Rages On Part I May 31, 2007. By Evelyn Pringle.
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."
Read [ Battle of Device Maker Shelhigh and FDA Rages On Part I ]

Shelhigh and the FDA: David vs. Goliath

Shelhigh and the FDA: David vs. Goliath May 29, 2007. By Gordon Gibb.
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.
Read [ Shelhigh and the FDA: David vs. Goliath ]

Shelhigh Tries a New Tactic

May 22, 2007. By Nate Hendley.
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".
Read [ Shelhigh Tries a New Tactic ]

Shelhigh Fighting the FDA

May 16, 2007. By Heidi Turner.
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.
Read [ Shelhigh Fighting the FDA ]

Shelhigh and FDA play Blame Game over Sale of Contaminated Devices

May 15, 2007. By Evelyn Pringle.
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."
Read [ Shelhigh and FDA play Blame Game over Sale of Contaminated Devices ]


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