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Napoli Bern Ripka, LLP Blog

Blog Category:

Medical Devices

    8/21/2008
    Paul Napoli
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    Lawsuit Issued do to Use of Illegal Kickbacks for Medical Devices

    Intermedics-McCullough, a Pennsylvania medical supply manufacturer, is suing six other manufacturers for using illegal kickbacks to sell their medical devices to medical institutions, hospitals, and doctors alike. Intermedics-McCullough is stating that the manufacturers are offering these illegal kickbacks to have exclusive rights for their products to be sold despite the fact that they are more costly and are inferior to McCullough’s products. The medical devices in question are those in the orthopedic industry, specifically manufacturing replacement hip, knee, and joint implants. The six medical device manufacturers involved in the lawsuit are Zimmer Inc & Zimmer Holdings Inc, DuPuy Orthopedics & Biomet Inc, all of Warsaw, Ind, Smith and Nephew Inc. Of Memphis, Tenn.; Stryker Orthopedics of Mahweh, N.J and Stryker Inc of Kalamazoo, Mich.


                Unfortunately these types of illegal kickbacks are more common than one might think. The revealing of the illegal kickbacks came from a federal investigation in New Jersey that found the six manufacturers in questions made worthwhile payments to doctors to get them to exclusively sell their products and recommend them to patients. Some of the companies in question agreed to over a $300 million dollar settlement. Since the settlement has come to a close, “some members of Congress have pushed for laws that would require better disclosure of payments made to doctors. The Physician Payments Sunshine Act, for example, would require companies to disclose all gifts, fees or other compensation of more than $500 a year.”


                The reason why offering illegal kickbacks to doctors and hospitals is so harmful is because it offers an incentive for doctors to commit medical malpractice. Once a medical device is pushed on doctors for a large monetary amount, all bets are off and recommendations that might not be the best for the patients will be made. This type of behavior is indicative to someone who makes unethical decisions, which is not an appealing trait to have as a doctor. Since doctors are receiving a large amount of money for exclusively using the manufacturers products, they are going to recommend that product to patients even if it not the right medical device for the job. Doctors have even been known to recommend the medical device even if it will do good or even cause harm to a patient. This yupe of behavior is unacceptable and if you think you may have been recommended a medical device that was backed by illegal kickbacks, then contact medical malpractice lawyers at Napoli Bern Ripka LLP today.


    If you or a loved one has been victim to medical malpractice due to medical devices being recommended to you because of kickbacks, contact a medical malpractice lawyer at Napoli Bern Ripka LLP. For they have the experience and knowledge to stand up to the insurance giants and the pharmaceutical companies. Instances of medical malpractice due to ill recommendations for medical devices is an emotional and trying time, in which you need the best support around to help you through. Napoli Bern Ripka LLP will be able to stand up for your rights while doing everything in their power to gain the compensation that you deserve. Contact a medical malpractice attorney today, to get back what was taken from you and help the illegal practices from medical manufacturers and doctors alike.


    For the full article on illegal kickbacks click here

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    Labels: FDA napolibern.com, New York City,
    8/5/2008
    Oguz Ozdemir
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    List of Drugs, Medical Devices, and Procedures that Medicare no Longer offers Released


    The first ever list of drugs, medical devices, and procedures that Medicare patients will no longer be able to access were released by The Centers for Medicare and Medicaid Services. The list of medical products and services was posted on the CMS website that provided this information to what would become in the upcoming year something of a downer for many. The Centers for Medicare and Medicaid Services determines which drugs, devices, and procedures will be on the list for Medicare Patients to receive or use. They have a large amount of power in the Medicare field that warrants much research. Since the decisions what to and what not to put on the list affect many people, all members of the public will able to provide CMS with their thoughts and recommendations.


                The Centers for Medicare and Medicaid Services impacts not only Medicare patients, but also private insurance companies tend to adopt the same principles, recommendations, and policies as Medicaid. Ultimately the list of drugs, medical devices, and procedures that are up to be evaluated, “all appear to either have some controversy about them … [or] they are topics that there isn’t a whole lot of evidence as to what their exact use is in all circumstances,” CMS Chief Medical Officer Barry Straube said. The Food and Drug Administration (FDA) have not even approved some of the products on the list yet, he noted. One of the drugs that are on the top of the list for consideration is Amgen’s anti-anemia drug. Also known as Epogen, Procrit, or Aranesp, is sold under Johnson & Johnson in which the FDA gave warning to instruct the company to put stronger warnings on its labels. The CMS and FDA have suggested that evidence against the drugs proves it to be dangerous when issued to cancer patients.


    Much consideration is placed on the issue if new technology is available and ready to be implemented in the Medicaid system. If this is true, the new medical product and or service will be distributed throughout the nation. Straube also said, “We have no plans right now to change the national coverage-versus-local coverage decision process,” noting that CMS lacks the financial resources to take over for the regional contractors. This list of potential topics allows the MCD to attempt to be more willing to get the views of others while also getting ideas on how to execute these new policies. By putting out this list early the CMS intends to give companies time to arrange its strategy and give the capital markets the ability to evaluate the severity it will have on national policies, their own companies, and competitors. However the chance that the CMS must take is that its preview of the list may evoke chaos among competitors.


    Product liability and medial device malfunction go hand in hand. Therefore it pays to have a lawyer experienced in both arenas. At Napoli Bern Ripka LLP, there is over 40 years of combined experience in dealing with cases regarding faulty medical devices. They have experience in dealing with large corporations and insurance companies that seem to intimidate others. Contact Napoli Bern Ripka LLP so they can help you gain the compensation that you deserve, not what is offered.



    For the full article click here

     

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    Labels: FDA, napolibern.com, New York City
    7/19/2008
    Paul Napoli
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    FDA Warning: CT Scans May Cause Medical Device Malfunction

    CT scans, also known as computer tomography, is a medical imagining method used to used to generate a three-dimensional image of the inside of an object from a large series of two-dimensional X-ray images taken around a single axis of rotation. However, recently the FDA warned CT scan administrators that the use of a CT scan could cause peacemakers, defibrillators, and other electronic medical devices to malfunction. This is causing a big stir in the medical industry because the use of CT scans are very prevalent in testing for different conditions using tying to people who currently use these types of medical devices. Some of the malfunctions that the medical devices incurred include unintended shocks from neurostimulators, malfunctions of insulin infusion pumps, and transient changes in pacemaker output pulse rate.
        After issuing this warning, reports came into the FDA saying that there were no deaths attributed to possibly CT scans causing malfunctions to persons currently using these medical devices. "It is possible that this interference is being reported more frequently now because of the increased utilization of CT, the higher dose-rate capability of newer CT machines, an increase in the number of patients with implanted and externally worn electronic medical devices, and better reporting systems," the FDA said. It is important to get this information out to the public about medical devices that are malfunctioning because it is a big risk to have these types of occurrences happening everyday. Medical devices that are defective could cause devastating affects to the user, ending in further complications and fatalities.
        Some devices that could be affected by the CT scanner include: retinal implants, cochlear implants, cardiac pacemakers, implantable cardiac defibrillators, neurostimulators, and drug infusion pumps. What the FDA is planning to do to get this information out is to issue a public health notice making sure that the public is aware of the reports on the matter. When putting CT scanner in use, the FDA recommends "the operator should use CT scout views to determine if implanted or externally worn electronic medical devices are present and if so, their location relative to the programmed scans range." Other operations musts include: getting rid of external devices out of the rang of the scanner, questioning the patients and asking them if it is possible to temporarily turn off their medical devices, and to minimize exposure to the ct scan by using a low frequency.
        Patients currently using one of the devices affected by the CT scan, and needs a scan should be very observant of the rules and make sure pay attention to all of the precautions. Product liability and medial device malfunction go hand in hand. Therefore it pays to have a lawyer experienced in both arenas. At Napoli Bern Ripka, there is over 40 years of combined experience in dealing with cases regarding faulty medical devices. They have experience in dealing with large corporations and insurance companies that seem to intimidate others. Contact Napoli Bern Ripka so they can help you gain the compensation that you deserve, not what is offered.

    For the full article and more information     click here

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    Labels: FDA napolibern.com, New York City,
    7/8/2008
    Oguz Ozdemir
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    Faulty Software in Medical Devices

    A flaw in a computer code caused a drug pump to administer heavy overdoses - led to a recall, warnings and rewriting of the equipment's software. The discovery also illustrated a new threat behind some lifesaving medical devices. This was found after a routine piece of medical equipment started mysteriously killing hospital patients a few years ago. Microprocessors run everything from patient monitors to artificial pancreases, and potential software flaws are a growing concern. A product might not malfunction because it was poorly designed or badly made - the traditional suspects - but because the computer code running it includes a mistake. The impact of that glitch can be increasingly serious because the latest automation is removing the doctors and nurses who watched for machine mix-ups.


    When there are flaws in a medical device’s design and/or manufacturing, it can cause injury and even death. A patient looks to these medical devices for help, but in some cases the devices end up hurting rather than helping. The FDA is responsible for the approval and oversight of these devices, and when flaws arise, major problems arise as well. When a patient with a heart murmur is relying on their pacemaker to keep them alive, the workings of the device is crucial to the life of the patient. What would happen if a pacemaker stopped working and left the patient without the support that they needed? In a situation like this, it is important to have a lawyer that has the experience in dealing with large insurance companies, corporations, and the government.


    Of 23 recalls last year that the FDA classified as life-threatening, three involved faulty software. Manufacturers test and inspect the software on their products, such as dialysis systems and patient monitors, before putting devices on the market. But they've been slow to follow the FDA in adopting new forensic technology because it is costly and still evolving, industry officials say. As a result, FDA software specialists are amassing evidence to show companies the value of the new testing. Meanwhile, traditional software checks, while good at detecting some flaws, are not thorough enough to find every mistake, according to computer scientists.


    The FDA created the forensic software unit in 2004 which employs about 10 mathematicians, computer scientists and a physicist who once designed military satellites About two years ago, Fitzgerald recalled, the forensic software team was assigned to investigate a dialysis machine, in use for two decades, that suddenly began malfunctioning on patients with terminal illnesses. The team investigated but could not find a problem with the software. Six months passed before the manufacturer finally found a defect that only mattered when the machine worked nonstop, as it did on the terminally ill. "We declared the software innocent," Fitzgerald said.


    Product liability and medial device malfunction go hand in hand. Therefore it pays to have a lawyer experienced in both arenas. At Napoli Bern Ripka, there is over 60 years of combined experience in dealing with cases regarding faulty medical devices. They have experience in dealing with large corporations and insurance companies that seem to intimidate others.

    Read More about "Faulty Software in Medical Devices"


    Labels: napolibern.com New York City
    6/25/2008
    Oguz Ozdemir
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    Medical Devices

    When there are flaws in a medical device’s design and/or manufacturing, it can cause injury and even death. A patient looks to these medical devices for help, but in some cases the devices end up hurting rather than helping. The FDA is responsible for the approval and oversight of these devices, and when flaws arise, major problems arise as well. When a patient with a heart murmur is relying on their pacemaker to keep them alive, the workings of the device is crucial to the life of the patient. What would happen if a pacemaker stopped working and left the patient without the support that they needed? In a situation like this, it is important to have a lawyer that has the experience in dealing with large insurance companies, corporations, and the government.


                A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory .Some common medical devices that is useful for diagnostic and therapeutic purposes include:  medical thermometers, blood sugar meters, surgical sutures and X-ray machines. The FDA has recognized three classes of medical devices based on the level of control necessary to ensure the safety and effectiveness of the device. Class 1: general controls (bedpans, examination gloves, & elastic bandages), Class 2: general controls with special controls (surgical needles, wheelchairs, & x-ray machines), Class 3: general controls with premarket approval (replacement heart valves, silicone gel filled breast implants, & implantable pacemaker). The classification procedures are described in the Code of Federal Regulations.


                Product liability and medial device malfunction go hand in hand. Therefore it pays to have a lawyer experienced in both arenas. At Napoli Bern Ripka, there is over 40 years of combined experience in dealing with cases regarding faulty medical devices. They have experience in dealing with large corporations and insurance companies that seem to intimidate others.

    Read More about "Medical Devices"


    Labels: napolibern.com New York City

 

 

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