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dangerous drugs, FDA approval, Chicago liability attorneysOriginally developed to protect consumers, the U.S. Food and Drug Administration is responsible for monitoring and investigating the safety, efficacy, and security of drugs and medical equipment used and prescribed in the United States. But patient advocates, federal auditors, and health-policy experts have been voicing concerns over the FDA’s monitoring and surveillance systems since the 1990s. Now, with the number of defective drug and medical equipment injuries and deaths mounting, lawmakers are looking for a way to step in and take over.

FDA’s Concerning Failures Exposed

Over the years, the FDA has been cited for a number of failures in the way they approve and oversee the drugs and equipment they are responsible for monitoring. Part of the problem relates to outdated or inaccurate data. The system’s self-reporting reliance is another. All lead to one very concerning conclusion: their shortcomings are causing injuries and deaths to innocent people.

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FDA recall, scope cleaning machine, Chicago personal injury lawyersDoctors and surgeons rely heavily on medical devices to ensure patient safety. Unfortunately, there is an alarming number of defective medical devices out there. When physicians learn the truth, they are often disturbed and upset, but it is the patients who pay the ultimate price—with their health, their wellbeing, and sometimes even their lives. Such may be the case with the FDA’s recent recalls on nearly 2,800 Custom Ultrasonics machines.

Custom Ultrasonics’ Previous Bar from the FDA

Trusted by hospitals and medical clinics throughout the United States, Custom Ultrasonics’ endoscope reprocessing devices are intended to kill the bacteria and microorganisms found on flexible endoscopes after a procedure, enabling safe re-use of the expensive and important medical equipment.

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Zofran congenital heart defects, Chicago prescription drug defect lawyerParents want their infants and children to be healthy and thrive. It can be a devastating blow when they find out their child may or will have a life-long condition that may be life threatening. Congenital heart defects are heart problems that develop before the child is born and are often referred to as a hole in the heart.  Congenital heart defects can lead to heart failure, high blood pressure, infection, or other problems from the moment they are born or later on in life. In some cases, the congenital heart defect is caused by defective drugs, such as Zofran.

Zofran is manufactured by GlaxoSmithKline and has been approved by the Federal Drug Administration (FDA) for use as an anti-nausea medication for cancer patients going through chemotherapy. It has not been approved, or ever tested or studied, as an anti-nausea drug for pregnant women. This has not stopped GlaxoSmithKline from marketing Zofran for “off-label” use to hospitals and consumers as an anti-nausea medication for pregnant women with severe morning sickness, according to a report from the Department of Justice.

A mother from Oakland, California, filed a lawsuit against GlaxoSmithKline, stating they knew about the negative side effects Zofran caused during the prenatal stages of growth in infants and still marketed the drug to pregnant women. She alleged that the use of Zofran during her pregnancy caused her son’s supraventricular tachycardia, a serious heart defect. Supraventricular tachycardia (SVT) causes the heart to beat too fast or irregularly. It causes an insufficient about of blood supply throughout the body. SVT is treated with medication, surgery, or a combination of both and in the future may cause heart failure.

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superbug product liability, Chicago personal injury lawyerIn the last several months, two hospitals in California have reported outbreaks of what officials are referring to as the CRE superbug. At Ronald Reagan UCLA Medical Center in Los Angeles, two patients died after being infected and five others continue to receive treatment. Medical officials have reached out to nearly 180 additional patients who may have been exposed at the facility. The outbreak has been traced to a particular medical device, which federal regulators are, so far, reluctant to pull from the market.

Carbapanem-resistant enterobacteriaceae, or CRE, is a bacterial pathogen which can cause infections resistant to most antibiotic treatment. Certain bacteria, such as E. coli,  which are common to the human digestive system, can evolve and become carbapanem-resistant, resulting in strains of CRE potentially producing infections that are very difficult to treat. The Centers for Disease Control and Prevention (CDC) acknowledges the dangers inherent to CRE infections and has reported that the superbug may be fatal in up to 50 percent of infected patients.

Each of the infected UCLA patients had undergone a relatively minor endoscopic procedure utilizing a device known as a duodenoscope. More than half a million patients each year have similar procedures done with the device, which is an imaging tool used to detect and diagnose issues in the upper small intestines, gall bladder, and pancreas. A particular duodensoscope at UCLA, however, was found to be the source of the CRE exposure, according hospital officials. A subsequent CRE outbreak at Cedars-Sinai Medical Center, also in Los Angeles, is currently being investigated to confirm that a similar device was to blame.

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pulmonary embolism, Cook IVC, Chicago product liability lawyerCook Inferior Vena Cava (IVC) filters have been found to be ineffective at stopping blood clots in many cases. Cook IVC filters are designed to stop blood clots traveling to the lungs through a small device inserted into the vein.

The filters are used in patients at risk of having the veins or arteries in their lungs blocked by blood clots, a condition known as a pulmonary embolism. Companies that produce products that cause consumers serious injury or death are held responsible for product liability, the legal responsibility the company incurs for producing or selling a faulty product.

The Cook IVC filter is the oldest filter approved for use and designed to be removed after 12 weeks or the risk of a pulmonary embolism has passed. An investigation into the filters found that serious complications could arise from use or prolonged use of IVC filters, including:

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herbal supplement product liability, Chicago personal injury lawyerIn an independent test by the New York State Attorney General’s office, it was found that four major retailers’ name brand herbal supplements did not contain the herbs listed. Instead, the supplements contained filler ingredients, some of which may cause allergic reactions.  Mislabeling products is considered a product liability issue. For example, if you are allergic to an ingredient in the product or you have an adverse side effect because it is not labeled correctly, the product manufacturer is responsible for compensating you, the consumer.

The New York State Attorney General’s office sent Wal-Mart, Walgreen’s, GNC, and Target a “Cease and Desist Notification” to pull the named products in the notification off their shelves and explain their process about how they verify the ingredients on the labels of the listed supplements. The tests found that four out of five products did not contain any of the herbs listed on their labels. The tests did find fillers, such as wheat, asparagus, powered rice, and house plants, in the supplements.

Supplements are not regulated by the Food and Drug Administration (FDA) like prescription medications are. They are not required to go through the same rigorous testing that prescriptions are before they are sold to consumers. Supplement regulation is based on an honor system that operates with the understanding that the manufacturer is being truthful about what ingredients are in the product and the labeling on the product is true.

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laproscopic surgery risk for women, FDA morcellator recallA hysterectomy ranks second behind a cesarean section ("C-section") as the most frequently performed medical procedure women undergo. In fact, the National Women’s Health Network lists statistics reporting an estimated 600,000 hysterectomies performed every year.  It is common for laparoscopic power morcellators to be used during this type of surgery as well as for myomectomies (removal of uterine fibroids). Unfortunately, nearly 1 in 350 women who undergo one of these two surgeries has unsuspected uterine cancerous tissue.

The use of laparoscopic power morcellators during either of these procedures puts women at risk of having previously undetected cancerous cells spread throughout the abdomen and pelvis. The FDA recently updated its safety alert regarding these medical devices and warns against their use during a hysterectomy or myomectomy in the majority of women. The administration emphasizes that laparoscopic power morcellators should not be used in women with suspected or known uterine cancer.

The FDA has also issued a guidance document with a manufacturer recommendation to update product labeling to include specific safety information through a boxed warning. The boxed warning advises that laparoscopic power morcellators should not be used:

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