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