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