Shelhigh Tries a New Tactic

Newark, NJMedical 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".

Appearing in U.S. District Court in Newark, NJ on May 15, Shelhigh lawyer Daniel Jarcho pleaded with a federal judge to permit the overseas export of the company's product line. Jarcho argued that Shelhigh might be forced into bankruptcy if it is unable to ship heart valves and other impounded products to distributors waiting in Italy and Spain. Should Shelhigh go bust, 50 employees would lose their jobs, the lawyer warned.



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U.S. District Judge William J. Martini seemed unmoved. He indicated it would not be business as usual at Shelhigh anytime soon.

On April 17, U.S. Marshals and investigators from the FDA raided Shelhigh's manufacturing plant in Union, NJ. Agents placed all implantable medical devices made by the company under quarantine.

"The United States Marshal's Service did not physically remove the products from the facility, but instead, 'seized them in place," explains a "Questions and Answers" sheet on Shelhigh published May 2 by the FDA. "Shelhigh cannot remove, attempt to remove or in any way interfere with the products at the facility without the prior written permission of the U.S. Marshal."

Considering the federal government's charges against Shelhigh, such permission seems highly unlikely.

"Shelhigh's violations include: manufacturing products in a facility with a poorly constructed and poorly maintained clean room where sterilized devices are further processed; failing to adequately monitor critical manufacturing environments for possible microbial contamination; failing to properly test products for sterility and fever-causing contaminants; and failing to scientifically support product expiration dates," stated an FDA press release issued April 17.

Shelhigh's product line includes pediatric heart valves, surgical patches, annuloplasty rings (which are used to help repair heart valves), etc.

The FDA sent warning letters to Shelhigh in 2000 and 2005, citing many of the same concerns that led to the product seizure. FDA inspectors toured the Shelhigh manufacturing facility in the fall of 2006.

Since the Union raid, the FDA and Shelhigh representatives have been locked in a high-stakes battle. The struggle has involved a series of duelling press releases between the federal government and the struggling New Jersey medical manufacturer.

On May 3, for example, Shelhigh issued a "Response to the FDA Questions and Answer Document". In the "Response", Shelhigh officials accused the federal government of hypocrisy. The officials pointed out that the FDA allowed Shelhigh to continue selling its products throughout last year's inspection process.

"If the FDA truly believes what it claimed, then the FDA is negligent and guilty of professional misconduct for permitting the use of Shelhigh products during the 10 weeks when two (or) three FDA inspectors were present at the Shelhigh facility and for four months afterwards," reads Shelhigh's reply.

After the Newark court hearing, Shelhigh founder and Chief Scientific Officer Dr. Shlomo Gabbay remained equally defiant.

"We're back in business if we can export," Dr. Gabbay was quoted as saying in The New Jersey Star Ledger. "We're trying to export to keep the company afloat."

A ruling from Judge Martini is expected some time this week as to whether Shelhigh can export its goods to Europe.