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Articles Posted in Drugs And Medical Devices

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Our bodies are amazing creations. The bones, muscles, nerves and organs work together in harmony to keep us breathing, digesting and moving seamlessly. Sometimes, though, that harmony isn’t so perfect. Conditions like arthritis or osteoporosis, or serious injuries, can mean that we need to replace one of our original parts with a man-made medical device.

As our population ages, such replacement surgeries are becoming more and more common, particularly involving knees and hips, two of the most often used joints that also bear the majority of our weight. Many people who undergo total knee or hip replacements (or less invasive procedures like hip resurfacing or partial replacements) successfully recover from the surgery and go on to live active lifestyles with much less pain than before.

Others aren’t so lucky, though. In recent years, there have been massive recalls of knee and hip replacement products as studies and anecdotal evidence have shown that these faulty devices are doing much more harm than good when implanted in patients’ bodies.

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In the last 11 years over 600 medical devices have been approved for use in humans by a procedure referred to as 501(k). The 501(k) is a process whereby devices used in cardiovascular care, neurology, obstetrics and gynecology, and most areas of medical device production can be approved with very little oversight.

The benefit of this easier and less demanding approval process is that incremental improvements of previously approved medical devices can be brought to market quicker and for less money. However, it can also act as a shield protecting manufacturers from liability when they produce defective products that are inserted into patient’s bodies.

The FDA safety-surveillance strategy has been to rely on hospitals and physicians to report medical device failures. This reporting system fails to identify medical product defects until there have been extensive reports of failures. Also, it requires that an extensive analytic review be done as reports of failure are made.

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Texan’s injured by medical errors are very often denied access to the Courts. Texas voters have allowed the Texas Legislature to cap non-economic recoveries in medical malpractice cases at a maximum of $250,000.00. Therefore, when a non-employed, retired or young Texan is killed by the negligence of a medical provider the most that can be recovered is $250,000.00 plus the cost of any medical treatment. The recovered cost of the medical treatment will then have to be turned over to whoever paid the bills such as Medicare or a private insurance company. It is often not economically feasible to pursue a medical malpractice case when the legal costs can approach and sometimes exceed $100,000.00 leaving only $150,000.00, or less, to pay attorney fees and provide for the injured person’s recovery.

The $250,000.00 cap on non-economic damages makes it economically advantageous for a medical provider to have a severely injured person die quickly from the medical error versus survive and have a lifetime of medical treatment. We are not suggesting and do not believe that any medical provider would let a patient die to avoid a large malpractice award, it is the imposition of the very low cap that makes possible the absurd results in potential recoveries.

Moreover, these caps are an arbitrary number designed to “prevent frivolous cases” from being pursued. However, frivolous cases are not deterred; rather truly injured people must suffer. A beautiful, young girl, scarred for life by a physician’s negligence, can only recover $250,000.00 notwithstanding in many cases there are scars and injuries that cannot be corrected, and will remain for life.

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On March 6, 2009 in an article entitled “Political Lobbying Drove FDA Process” the Wall Street Journal chronicled how a medical device manufacturer had its product that is intended to be implanted into patients knees quickly approved because of its lobbying efforts. The medical device had the normal review and investigation short circuited.

Medical devices can get quick approval if the device is similar to a product already on the market. The rational is that the first product went through a vigorous review and had studies backing its efficacy and safety; therefore a second product (a copy cat of sorts) shouldn’t have to go through the vigorous studies and review. This fast-track review is called a 510(k) by the FDA, and is intended to be used only when similar products have already been reviewed and approved. This 510(k) fast-track review saves companies money and speeds products to the market where profits can sooner be realized.

The Wall Street Journal Article reported on how ReGen Biologics Inc. was able to have its Menaflex knee device quickly approved through the 510(k) fast track review even though some within the FDA did not believe that it should qualify for the fast track review process and instead should have had to go through a more vigorous vetting process. According to the article, the head of the FDA, when asked about the 510(k) allowance for this particular product, was quoted as saying “There’s something wrong with how that decision was made.” This provides more evidence that consumers need to be able to pursue claims against manufacturers of faulty medical devices if they are injured. The Government Accountability Office, in January, issued a statement indicating that the FDA is too quick to allow 510(k) approvals. Quite simply, the FDA is incapable of monitoring all of the products they are supposed to oversee.

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The Food and Drug Administration (FDA) is responsible for researching and approving new medicines, staying abreast of those medicines on the market, regulating medical devices, and monitoring and ensuring the safety of approximately 80% of our food supply. Most people don’t realize the FDA also regulates many devices that emit radiation such as cell phones, computer monitors, as well as a host of other products. The FDA also regulates cosmetics and many products used in the production of food, including animal feed.

With the globalization of food and drug production it is no surprise to find that the FDA has been unable to do its job as mandated. The FDA’s budget has essentially been flat for years even though many managers and administrators in the FDA have called for a doubling of their budget. Recently an article published March 14, 2009 in the New England Journal of Medicine pointed out the difficulties faced by the FDA. The article entitled “A To-Do List for the New FDA Commissioner” points out many of the difficulties faced by an increasing workload at the FDA and suggests many changes that need to be addressed.

The primary focus of the FDA is the protection of the United States consumer. It is obvious that the FDA is not capable of monitoring all of the products under its umbrella that are made in the United States and certainly not those entering the U.S from foreign countries such as China. With the FDA stretched beyond its limit and the Federal Budget unable to fully fund the FDA an obvious choice is to remove the private lawsuit protections that medical device makers and drug manufacturers have taken advantage of in the past. Congress originally attempted to essentially grant immunity to drug and device manufacturers in many circumstances, if the FDA had approved a product. Inasmuch as the FDA cannot properly research and evaluate every product, private consumer litigation is the only avenue to seek redress from harmful drugs and devices. Legislation has been introduced in the current session of Congress to accomplish this task. We as a country need to either fully fund the FDA or allow consumer protection lawsuits. Innocent people are being harmed or killed by unsafe food, drugs or medical devices and many of those harmed currently have no relief in the courts.

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Drug Companies appear to have too much influence over the regulatory governmental agencies that are supposed to determine whether a drug is effective and safe.

Federal Regulators with the Food and Drug Administration (the “FDA”) admitted that they should not have “uninvited” a leading cardiologist to a panel that was going to decide whether to approve a cardiovascular anticlotting drug (prasugrel hydrochloride) made by Eli Lilly & Co. As was reported in the Wall Street Journal this week, Dr. Sanjay Kaul is a well known cardiologist that had been critical of Eli Lilly’s drug prasugrel and Dr. Kaul had even written several articles critical of the new drug. Dr. Kaul was scheduled to participate in the FDA committee meeting that was assigned with the task of reviewing the drug and deciding whether to grant FDA approval to Eli Lilly & Co. to manufacture and sell the drug. Prasugrel, according the Wall Street Journal article (“FDA Says it Erred on Doctor“, Favole, J., February 24, 2009), has been linked to dangerous internal bleeding.

The all day meeting of the Cardiovascular and Renal Drugs Advisory Committee was scheduled for February 3, 2009 in Maryland. In the days prior to the scheduled meeting Eli Lilly contacted certain FDA managers and questioned the decision to have Dr. Kaul’s included on the panel because of his published articles critical of the new drug. Apparently, following the calls from the drug manufacturer, FDA managers told Dr. Kaul to not take his flight from Los Angeles to Maryland; he was essentially told he was not welcome at the meeting.

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Federal regulatory agencies have become increasingly lax in their enforcement of rules and regulation that have been enacted to protect consumers. Many agencies have relied upon self regulation and enforcement which is essentially no regulation. The recent meltdown in the United States financial sector is some evidence that companies and individuals cannot be left to self-regulate.

It’s a sad fact that federal regulatory agencies have become to closely aligned to the industries they are supposed to regulate for the public’s well-being.

One of the most important regulatory agencies, the U.S. Food and Drug Administration (FDA), has become particularly lax in ensuring the health and safety of those who take medication and rely on properly functioning medical devices.

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The Food and Drug Administration (FDA) has recently classified a “warning” sent out by Medtronic, Inc. to health professionals as a Class 1 recall. A Class 1 recall is the most serious type of recall order issued and involves situations in which there is a reasonable probability that use of the product will cause serious injury or death. The device being recalled is an implantable pump that delivers drugs into the body. The product technical name is: Medtronic Neuromodulation INDURA One-Piece (IP) Intrathecal Catheters, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit. This is an illustration of a typical intrathecal medicine delivery system.

Patients receive infused drugs (typically for pain management) through the pump, and it was recently reported in the Minneapolis Star-Tribune that 83 patients have been identified as having pumps with improper connections, and one patient has died.

Patients are urged to immediately contact their physicians regarding these devices. The connections, if improper, can cause leaking of pain medication into the body, with the potential for fatal overdose.

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We were excited to learn about the new Food and Drug Administration (FDA) list of drugs being investigated. We often get calls from medical patients who suffered severe injuries potentially from prescription medicines. Often it is impossible to determine whether the FDA is investigating the adverse event or even whether the medical issue was an adverse event caused by the prescription drug.

The Food and Drug Administration (FDA) started a new program where they will list on their website drugs that they are investigating for possible side effects. The change in policy of providing advance warnings is meant to warn patients and health care professionals about possible side effects. The current list of 20 drugs is varied and includes potential side effects ranging from heart attacks and cancer to Purple Glove Syndrome which can result in the amputation of a patient’s arms.

Being on the list doesn’t mean that it has been determined that the drug has the side effect being investigated; also, not being on the list doesn’t mean that a particular drug doesn’t have side effects. The list is merely an advance warning that a particular side effect is being investigated. Any decisions about whether to take a particular medicine should be made after consulting with our health care provider.

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The Food and Drug Administration (FDA) is obligated to monitor our nation’s food supply for safety as well as evaluate and approve for sale in the United States prescription drugs and medical devices. However, recent reports of large scale outbreaks of food poisoning, dangerous drugs causing death and injury as well as tampering with chemicals imported from China that were used in the drug manufacturing process have called into question the FDA’s ability to protect consumers.

The New England Journal of Medicine recently published an article that questioned whether the FDA can adequately monitor and evaluate the prescription drugs being approved. Also, members of the House of Representatives jointly sent a letter on February 4, 2008 to an officer of the Eli Lilly Company stating that the decrease in Funding for the FDA over the past 35 years has forced a 78% reduction in food inspections and that their scientific core has been eroded to the point that they can no longer fulfill its core regulatory functions.

During the current election year cycle and while listening to the debates it is important to remember that the Federal Government has many important fundamental functions one of which is to keep its citizens safe. The FDA is currently unable to perform its functions and is therefore placing everyone at risk of death or injury from dangerous food, drugs and medical devices.