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

Union, NJShelhigh 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.

But it turns out you can't trust what Shelhigh says at all—about the FDA's complaints or about an agreement reached with the FDA in court about a month ago.

Shelhigh is a manufacturer and distributor of tissue-based medical devices, implanted in patients during surgery, including during organ transplant operations. On April 17, the FDA had U.S. Marshals seize all devices at the company's plant in Union pursuant to a court order granted that same day. That order was founded on facts alleged in an 11-page written statement (the "Complaint") filed by the FDA.

In Part 1 of this article, I set out the misinformation campaign Shelhigh launched with its press release the day after the seizure.

And here's the story on Shelhigh's white-wash of the settlement it reached with the FDA in June.

Shelhigh's press release said, in effect, that all was settled by their hiring independent investigators to look into the plant practices, and they were now in the process of getting their products approved and out the door again. They also said that the FDA confirmed there had been no recall of Shelhigh products.

No recall? Isn't a complete shut-down of a business worse than a recall?

In fact, the Consent Order, granted by a judge June 22, runs to 23 pages, and features costly and onerous hoops for Shelhigh to jump through before it can even begin to manufacture or ship out product again. Here are a few of the requirements set out in the order, which just give you a taste of the entire thing:

1. The seized devices are "condemned" and forfeited to the United States.


2. Shelhigh has to post a penal bond of $1.5 million just to keep going in the lawsuit, and trying to recover the devices.


3. Shelhigh can't ship anything, anywhere, until the FDA gives its approval.


4. Shelhigh has to give the FDA a detailed written plan as to its attempt to recondition the seized devices and anything manufactured at the plant since April 17 and bring them into compliance. If this plan isn't followed through within 60 days from the filing of the $1.5 million bond, the government will destroy all the seized inventory.


5. Shelhigh has to pay all the government costs related to this seizure, the lawsuit and the many inspections called for by the order.



READ MORE LEGAL NEWS

• 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

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6. Shelhigh can't manufacture any new product until the FDA has approved the plan and the new manufacturing methods and protocols.


7. Shelhigh has to have an outside expert conduct an independent audit of the plant at least once a year, the auditor to report directly to the FDA.


8. If Shelhigh doesn't comply with any of the terms of the consent order, the FDA can again shut them down, issue a recall order, or use any of its many resources to lock up the company.


9. Shelhigh's plant remains in a state of absolute scrutiny under the FDA microscope for the foreseeable future.

And again, this is just a sample of the requirements set out in the consent order.

Caveat emptor means buyer beware. When it comes to Shelhigh, the buyer should beware of the story the company is trying to sell.