MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Seized Shelhigh Devices Won't Be Released Yet

A federal judge refused to grant Shelhigh Inc.'s request that the government release the tissue-based devices it seized last month because of concerns about sterility. Judge William Martini said he could not rule whether Shelhigh's devices met GMP standards without holding a hearing, reports the Star-Ledger of Newark, NJ. He said that hearing will come as soon as possible.

Shelhigh executives say the company's future is in jeopardy if it cannot export the seized devices. The judge urged both sides to try to reach a settlement, using a mediator if possible. But, as we predicted, Shelhigh has hired Larry Pilot to help in its defense. Companies who seek out Pilot often do so because he is willing to take on FDA in court. Shelhigh also rejected FDA's request to recall devices it already shipped to hospitals. That's not an indicator of being willing to settle, either.  

Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.