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