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.

Continue Reading ››

 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.

Continue Reading ››

 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.

Continue Reading ››

 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.

Continue Reading ››

 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.”

Continue Reading ››

 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.

Continue Reading ››

 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.

Continue Reading ››

 Posted on April 15,2014 in Defective Medical Devices

A new report from the Food & Drug Administration's Center for Devices and Radiological Health says that defective devices have spiraled out of control in the last decade. Between 2003 and 2012, device recalls have increased by 97 percent. Defective medical devices have caused injuries, pain, and complications for patients who use them.

The report indicates that the most common causes for recalls are software problems, nonconforming material, component issues, or device design defects. The government agency put most of the responsibility on device manufacturers, saying with some careful inspection and research it could be possible to prevent up to 400 recalls every year.

The FDA has increased its focus on the medical device industry after numerous complaints and allegations indicated a string of problems with devices. Some patients discovered too late that devices didn't work properly, putting them at risk of injury or death.

Continue Reading ››

 Posted on April 10,2014 in FDA

Medical device recalls are on the rise, with patients reporting injuries and problems from defective products more often than ever. The most serious of all FDA recalls is known as a Class I, since that indicates a situation where there is a reasonable chance that exposure to or use of a product could lead to major health consequences or death.

The FDA recently completed a research project and report to explore the upward trend of defective device recalls. While there were only 7 defective device Class I recalls in 2003, that number increased to 52 in 2012. When a firm submits a correction or recall of a product to the FDA, the company is responsible for reporting the injuries and deaths at that time. Deaths were reported by 25 percent of companies involved in Class I recalls.

The FDA identified the six most likely kinds of devices to be recalled. These included infusion pumps, automated external defibrillators, ventilators, blood glucose and other system tests, catheters, and implanted pumps.

Continue Reading ››

 Posted on April 07,2014 in Defective Medical Devices

New data shows that a company manufacturing cochlear implants distributed defective products to adults and children for many years. Unfortunately, this is just one example of defective medical devices that cause injury to people all over the world.

The second largest manufacturer of cochlear implants across the globe, Advanced Bionics, knew that there were issues with their HiRes 90K implants from the beginning. Early users of the product discovered shocks and pain and excess moisture inside the implants. Sadly, some of those early users are still feeling the impacts of defects today.

One such patient is Grace Bagadiong. Grace has an undiagnosed medical condition that has taken away her ability to use her arms, walk, or breathe on her own. As a toddler, Grace became totally deaf. Her doctors recommended a cochlear implant surgery as the only route for Grace to ever hear again. In 2005, Grace received a HiRes 90K implant, but her parents received a surprising letter just a few months later. The letter explained that Grace's implant was being recalled after numerous failures were reported, including patients who were shocked in the head by the device.

Continue Reading ››