Posted on May 21, 2014 in Defective Medical Devices

There is no shortage in advertisements seeking those who have been injured during the use of medications or medical devices. As a result, the FDA is pushing for stronger guidelines when it comes to the postmarket surveillance of these products in an effort to reduce the number of defective devices used by patients.

The reason for this action is to lower the number of recalls and reduce injury to patients. Postmarket surveillance is important because most drugs are approved based on clinical trials of the products. Clinical trials apply to a small control group that are selected by the manufacturer. This control usually does not have other medical ailments besides the one that the drug is designed to treat. Yet this will not be true of the general populous.

Postmarket surveillance then continues to monitor the performance and safety of the drug or product once it is released to the general populous who may have addition and varied medical conditions. Information is gathered through various databases, event monitoring for prescriptions, and patient registries. It is then gathered and compared through data mining and will be further be reviewed to uncover any potentially dangerous safety concerns.

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 Posted on May 15, 2014 in Defective Medical Devices

Drug companies have attempted to capitalize on a market of men interested in improving their libido and life satisfaction with a treatment known as Low-T testosterone therapy. But that treatment is raising eyebrows from the FDA. With increased scrutiny surrounding defective medical devices and treatments amidst reports of heart problems from patients who have undergone the therapy, the FDA stands poised to evaluate the manufacturing companies.

Two studies about such therapies have already found that the treatment increases the risk of heart attack, stroke, and death. A patient contemplating receiving the therapy should fully investigate the claims from other patients and really consider whether it is worth taking on such a major risk.

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 Posted on May 12, 2014 in Illinois Defective Medical Products Lawyer

Official warnings have been handed out to several companies advertising autism therapies and cures. Five total treatments were flagged in the statement from the FDA, which was announced during Autism Awareness Month. While some of the therapies are noted as useful medical therapies, there have not been scientific studies that show a connection to autism improvement. Giving families false hope is just negative impact of companies peddling defective medical devices or treatments.

One treatment, known as hyperbaric oxygen therapy, deploys a pressure chamber to administer high oxygen levels to a patient. Although it is widely used for decompression sickness, there is no research that it is an effective or safe treatment for autism. Chelation therapies, too, have been criticized because patients may suffer from kidney failure or even death through the process in which heavy metals are drawn out of the body.

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 Posted on May 07, 2014 in Illinois Defective Medical Products Lawyer

The total number of defective medical device recalls in the past decade represents a significant increase, and it raises the question of whether more people are reporting issues or if there are simply more design defects putting patients at risk. Defective devices can injure patients and cause serious physical and mental repercussions when the device does not operate properly.

There are several reasons behind the increase recall numbers, according to Steve Silverman, director of the medical device compliance center at the FDA. Educational workshops and tough FDA inspections have increased the number of devices being pulled from the market, although many of these devices have already caused numerous patient problems long before they are officially recalled. Easier processes for reporting an increased belief in the importance of journaling problems early could be partly behind the increased recalls. However, the jump still raises overall concerns about device safety.

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 Posted on May 05, 2014 in Defective Medical Devices

The FDA recently launched a comprehensive investigation into the “low T” testosterone therapy program. Early research indicates that men may face a higher risk of premature death, stroke, or heart attacks by undergoing this therapy. This is just the latest in a string of defective medical devices and treatments, being investigated by the government, that end up harming patients. For some patients, it is too little, too late.

The evaluation of the therapy was launched after two large studies were found to increase the likelihood of a cardiovascular incident. The federal agency is now exploring whether the possible benefits of the therapy are outweighed by the potential negative impacts on the male patients who use it. At present, these drugs are only advised for men who have low T and a linked medical condition. However, research shows that some men may be undergoing the therapy without actually needing it.

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 Posted on April 29, 2014 in Defective Medical Devices

While all of the different artificial hip implants on the market carry some form of wear risk, those that are made with metal-on-metal are some of the most dangerous out there. This is because of their unique structure, and these additional concerns can create problems and pains for patients who have had them installed.

In these hip implants, the metal cup and metal ball slide against one another while the patient is walking or running. As a result, small metal particles can be released into the body of the wearer. Corrosion at this connection is also cause for concern, because the small metal particles that have been corroded may release these materials into the bloodstream. Sadly, too many metal hip implant patients learn this too late. The FDA notes that there is actually no way to prevent some metal particles from being produced as a wearer uses their device.

There are reports in orthopedic literature and from international agencies about the dangers of these hip implants, and yet doctors still continue to use them for patients in need of hip replacement. Many patients who have received metal-on-metal hip implants have experienced some problem afterwards, and some of those cases required revision surgery. Between noticing the problem and getting the surgery, some patients continued to suffer.

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 Posted on April 25, 2014 in Drugs

Pharmaceutical giant GlaxoSmithKline has come under fire in recent years for paying doctors to promote drugs, according to Mercola.com. The practice is, surprisingly, a legal one, and “widespread in the drug industry.” At the end of 2013, however, Glaxo announced that it would stop the practice, as well as stop “compensating its sales representatives based on the number of prescriptions that doctors write,” according to Mercola. One such drug promoted by Glaxo to doctors was Avandia, a diabetes pill that was banned in Europe in 2010.

In 2011, according to Bloomberg News, GlaxoSmithKline “agreed to pay $3 billion to resolve U.S. criminal and civil investigations into whether the U.K. company marketed drugs for unapproved and other matters.” Despite the fact that Avandia had been banned in Europe, the FDA did not do so, though access to the drug was restricted. At the end of last year, however, several of those restrictions had been removed, according to a different Mercola article.

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 Posted on April 23, 2014 in Medical Malpractice

Florida became the most recent state this month to overturn caps that limit payouts a person can receive in a medical malpractice suit. According to the Miami Herald and as reported in the Washington Post, the court found that “limits on payouts in some wrongful death suits violate both the federal and state constitutions.” Additionally, a 2007 report found that these types of caps not only resulted in unconstitutional rulings, but also in fewer and lower payouts in suits not defined by the caps. Caps on medical malpractice suits, according to the Washington Post, have been lifted in nine other states as of April 1.

The Illinois Supreme Court overturned caps on medical malpractice suits as far back as 2010, according to the New York Times, as one of the first states to do so. The court, according to the Times, decided that the 2005 law that allowed caps on medical malpractice payouts “violated the state Constitution's separation of powers clause by imposing decisions that should reserved for judges and juries.” The cap was not low, however—before the overturn, the cap was $500,000 “for non-economic damages in verdicts against doctors and $1 million in cases against hospitals.”

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 Posted on April 23, 2014 in Defective Medical Devices

Consumers and patients who have been in injured by defective devices or other unsafe products frequently report these issues to the FDA, as they should. Recent cases relating to defective medical devices as well as products outside the realm of healthcare demonstrate that while it's the federal government's job to investigate these claims and promote safe standards across the board, this process is often a lengthy one.

In some cases, manufacturers appear to act as if they can get away with unsafe products, leaving individuals at high risk while continuing to make a profit. In terms of medical devices, heart defibrillators, vaginal mesh implants, and knee and hip implants are just a few examples of products that were designed to help actually harming patients.

In the consumer sector, both GM and Toyota have recalled high numbers of automobiles after serious reports of driver injury and even death. In all these cases, the government frequently finds that the manufacturer knew about the dangers long before a recall or product fix was implemented.

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 Posted on April 19, 2014 in Defective Medical Devices

Finding out that you or a loved one has suffered injuries or requires additional procedures to correct problems from a defective medical device is frustrating. There are certain steps you need to take to protect yourself and to have the best chance of getting the company to recall or fix defective devices.

The Corporate Whistleblower Center believes that defective medical devices are a problem more pervasive than many people realize. Recent reports from the Justice Department show that heart defibrillators made by Guidant post a serious risk to those using them. The company manufactured Prizm 2 and Renewal 1 and 2 devices that led to a problem known as arcing. The device will detect an irregular heartbeat and administer a shock, but then the electrical pulse will arc back to the device, too. When this happens, the device actually short circuits and becomes ineffective, leaving the user at high risk.

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