A New Jersey-based company that makes tissue-based products used in open-heart surgeries is embroiled in a heated court battle and war of words with the Food and Drug Administration (FDA). This tension between Shelhigh and the FDA began April 17 when the federal regulatory agency pulled about 1 million parts at the company's plant in New Jersey after a 10-week inspection of the facility in the fall of 2006.
According to the civil complaint that the FDA filed in the U.S. District Court in Newark, the company violated several federal safety manufacturing standards. FDA officials say that the manufactured products were placed in a poorly constructed and maintained clean room, that Shelhigh did not properly inspect the products for possible microbial contamination, that they did not follow procedures to test products for sterility and that the company was not able to scientifically support their product expiration dates.
These products include pediatric heart valves, conduits for blood flow, surgical patches, arterial grafts and annuloplasty rings for repairing heart valves. FDA officials said that since these devices were placed in seriously ill patients their sterility is absolutely vital to prevent infection in those patients. An FDA press release states that Shelhigh's own records indicate that a number of sterility test failures occurred and that its testing and retesting procedures were not properly carried out, but Shelhigh officials are saying that is not true.
In fact, Shelhigh managers are taking an aggressive stance against the FDA allegations and have indicated that they aren't giving in any time soon. They vehemently deny that there is anything wrong with their products, a majority of which is exported to European countries such as Italy and Spain. Company officials say the FDA lacks evidence to prove that the products have malfunctioned or caused any injuries or fatalities in patients. Shelhigh valves are reportedly used in heart patients of all age groups - infants, older children, adults and seniors.
Shelhigh defied a formal FDA request earlier this month to recall these products. Shlomo Gabbay, the company's CEO and chief science officer, says his company "has no intention to initiate the recall," according to an article published in the New Jersey Star-Ledger, which has been following the latest developments in this saga very closely. The newspaper quotes Gabbay, who maintains that the FDA has no facts to support its claims against his company.
"The FDA should understand that it must prove its allegations before it can make a request and their newest statements do not provide any further factual support for their claims," he told the Star-Ledger.
Apparently, this defiance on the part of Shelhigh is reflective of a trend. While drug makers are quick to recall a defective drug, device manufacturers are more contentious. Drug companies usually want to avoid lengthy court battles and the negative publicity associated with such episodes. But not these device makers, recent news reports say. In 2005, the FDA demanded a recall from Utah Medical Products, Inc., a Salt Lake City manufacturer of a variety of medical devices used in obstetrics, gynecology, neonatal intensive care, urology, electro-surgery and blood pressure monitoring.
As with Shelhigh, FDA inspectors said the Utah company was not complying with federal quality control standards and demanded a recall. But Utah Medical fought the recall and won what was considered an improbable victory against the federal agency. The FDA did not appeal that court decision.
In the case of Shelhigh, however, there are some other facts that have come to light. According to a May 16 article in the Star-Ledger, court papers show Spanish regulators last month recommended that surgeons in that country consider not using Shelhigh products because of problems in 1997 with seven pericardial patches and three incidents involving the company's heart valves, two of them fatal.
Last week, Shelhigh suffered a setback when a federal judge declined to release the products in FDA's possession. The judge said in a five-page opinion that he could not determine whether the devices met those standards without first holding a hearing. The judge assured Shelhigh's attorneys that he would set the date for such a hearing soon and also encourage the opposing sides to engage in mediation and arrive at a settlement. Shelhigh attorneys are pushing for a quick decision because the company gets 70 percent of its sales from exports. They say the company could go belly up and lay off its 50 employees if it cannot satisfy the demands of its overseas distributors. Attorneys for the company also say that Shelhigh is "clinging to its life" and bankruptcy is looming large.
Experts who have watched FDA actions in the past, say Shelhigh's fighting stance is extremely risky. The FDA, they say, has the power to put a company out of business and that the regulatory agencies in Europe and the United States are more in tune with each other now than they were ever before.
Among the products that the FDA asked that Shelhigh recall, include the following:
Medical devices manufactured by Shelhigh include: Pericardial Patch, No-React Pericardial Patch, No-React PneumoPledgets, No-React VascuPatch, No-React Tissue Repair Patch/UroPatch, Pulmonic Valve Conduit No-React Treated, No-React Dura Shield, BioRing (annuloplasty ring), No-React EnCuff Patch, No-React Stentless Valve Conduit, Internal Mammary Artery, Gold perforated patches, Pre Curved Aortic Patch (Open), NR2000 SemiStented aortic tricuspid valve, BioConduit stentless valve, NR900A tricuspid valve, MitroFast Mitral Valve Repair System, BioMitral tricuspid valve and Injectable Pulmonic Valve System.
The FDA is asking that consumers report adverse reactions or quality problems experienced with the use of these products to their MedWatch Adverse Event Reporting program either online, fax (800-332-0178), or regular mail (use postage-paid FDA form 3500 available on the FDA website, and mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
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