Articles Posted in Products Liability

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Back in January of 2000, the manufacturer St. Jude voluntarily recalled its Silzone mechanical heart valves. St. Jude did not think it necessary for patients to undergo surgery to replace the valves. There were 36,000 Silzone valves implanted through out the world, with hundreds implanted into patients in the Atlanta Metropolitan area.

Mechanically, the St. Jude valves were seemingly all right. Therefore, the problem was not with the functioning ability of the valve but the problem was with the coating on areas of the valve. Silver was used in the making of the Silzone so to lessen the chance of infection. However, the silver reportedly leaked, which could have caused heart failure.

Additionally, in a trial called the Artificial Valve Endocarditis Reduction Trial (AVERT) an increased risk of stroke was reported. Though the chance of stroke is relatively low, the study did find a higher incidence of paravalvular leakage in patients with the valve implant.

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The FDA has announced that safety changes are going to be made on the labels of some of the most popular cholesterol drugs known as statins. The changes are primarily intended to warn patients of the increased risk for type 2 diabetes mellitus. Hyperglycemia, an increase in blood sugar levels, has been reported with the use of statins.

It is also necessary for this class of cholesterol lowering drugs to carry warnings concerning the possibility for short-term memory and cognitive problems. Certain brain-related problems has been linked to statin use. Therefore, statin labels will now have information about patients having episodes of confusion and memory loss.

These changes that will effect Atlanta residents include: Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin). And combination drugs include: Avicor (lovastatin/niacin extended release), Simcor (simvastatin/niacin extended release), and Vytorin (simvastatin/ezetimibe).

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A lawsuit has been filed on behalf of consumers claiming that deceptive advertising influenced their decision to by “Shape-Ups” by Sketchers. The lawsuit is seeking monetary damages for consumers who paid a “premium price” for Sketchers “Shape-Ups” based on ads on television, the Internet, and print. The ads, which had appeared in the Atlanta area, publicized the health benefits of the shoes.

However, the lawsuit contends that the shoes do not have any additional health benefits. But they cause a serious risk of injury because of their distinct bottom sole, the complaint added. The lawsuit also seeks to prevent Sketchers from continuing its “deceptive and unlawful advertising”.

Federal Trade Commission is also investigating Sketchers’ toning shoes. In September, Reebok and the FTC came to a $25 million settlement for making similar claims about its own type of toning shoes. It is estimated that Sketchers could be fined as much as $75 million. The lawsuit claims that Sketchers advertised that “Shape-Ups” offers benefits “without setting foot in a gym”.

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For many residence of the Atlanta metropolitan area who are experiencing shoulder pain, pain pumps can offer a feeling of comfort. However, the apparatus can also cause serious and permanent injury. According to the American Academy of Orthopedic Surgeons, the use of pain pumps might be linked to Postarthroscopic glenohumeral chondrolysis (PAGCL).

In the Auburn Citizen, Dr. Dale Buchberger, noted how amazing the shoulder is due large impart to its complexity. According to Dr. Buchberger, the shoulder needs to be stiff enough to stay together and loose enough to work correctly. And he also noted that this equilibrium poses trouble not only for people who are involved in “shoulder dominant” sports, but also the public as a whole.

Various injuries can intensify the usual pain an older person may experience. For example, a dislocation can occur when someone falls while his/her arm is extended. Dislocation means that the ball has come out of its socket. This kind of injury creates a larger risk to the elderly population as the bone or cartilage can fracture or tear.

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More lawsuits have been filed against Fosamax despite Merck, the pharmaceutical company that manufactures Fosamax, having won several victories in previous lawsuits. Earlier lawsuits and the current ones all allege side effects such as dead jaw and femur fractures.

The latest lawsuit has been filed on behalf of women who claim that Merck overstated the advantages of taking Fosamax. Both women began taking Fosamax believing that it would strengthen their bones and prevent bone fractures, however, they claim that Fosamax increased their chance of injury by causing their bones to deteriorate.

At present, the courts are hearing Fosamax bellwether trials. So far, five trials have concluded with Fosamax winning four and plaintiffs winning one. $8 million was awarded to the plaintiff who won but another judge who considered the award too much later reduced it.

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The New Journal of Medicine has learned that children whose mother’s took Depakote before birth had notably lower I.Q. scores than children whose mother’s took other types of anti-seizure medication during pregnancy. New York Times also reported that three year old children who were exposed to valproate, the generic form of Depakote, while in the womb had I.Q. scores that were nine points lesser than three year olds who were exposed to lamotrigine.

For most infants, I.Q. scores were related to their mothers’ I.Q. scores but not when it came to the children who were exposed to vaproate. Thus the researchers concluded, “In utero exposure to valproate was associated with poorer congnitive outcomes than was exposure to other commonly used antiepileptic drugs.” What’s more, the result of valproate on the children’s I.Q. depended on the amount taken. These findings are similar to the findings of researchers in the United Kingdom.

Researchers have also found that Depakote use has shown an increase in congenital malformations in comparison with other antiepileptic medications. Another study found that the use of valproic acid by pregnant women in their first trimesters is linked with spina bifida. Other birth defects associated with valproic acid were atrial spetal, cleft palate, and craniosynostosis.

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Accutane is a medication that is used to treat acute acne. It was first marketed in Atlanta in 1982. Since then, over 16 million patients throughout the world have used Accutane. However, Accutane was withdrawn from the US in 2009, but the drug is still available in foreign countries and in the US in generic forms.

Accutane has been linked to several serious side effects such as birth defects and suicide. It has recently been linked to inflammatory bowel disease and Crohn’s disease. Abdominal discomfort, bloody stool, loss of appetite, severe diarrhea, ulcers, and weight loss are all symptoms of Crohn’s disease.

Unfortunately, there is no cure for Crohn’s disease and treatment varies from person to person. Therefore, instead of trying to cure the patient of the disease, doctors try to relieve its symptoms. Common treatment for Crohn’s disease includes anti-inflammatory medication, special diet, and surgery to remove damaged intestinal tissue.

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Bextra’s connection to side effects like Stevens-Johnson Syndrome continues to present a problem for hundreds of patients in the Atlanta area and thousands throughout the country who were prescribed and used the medication.

The FDA requested Pfizer to remove Bextra from the US market in April 2005. The request was made in light of the fact that the risks of Bextra usage to patients far outweighed the medications possible benefit.

Though the FDA stressed the risk of harmful cardiovascular events, which are commonly associated with non-steroidal anti-inflammatory drugs (NSAIDs), the FDA recognized that Bextra use showed a greater chance of experiencing serious skin reactions such as Steven-Johnson Syndrome.

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Acoustic neuromas is a type of cancer that researches have found to be five times more likely to develop in children and young teenagers who use cell phones. Researchers of this study also found that people who didn’t use cell phones until they were in their twenties were only twice as likely to develop the cancer. Acoustic neuromas can cause deafness.

It is believed by researchers of the study that children 12 years old and younger should only use cell phones in the event of an emergency and that hands-free phones or headsets are best used by teens. Incidentally, the National Agency for Research on Cancer has categorized cell phones as a category 2B. Other carcinogenic compounds classified, as category 2B is gas engine exhaust and the pesticide DDT.

Most experts claim that it is not possible to presuppose the long-term health risks associated with cell phone use because it can take decades for cancer to develop. And studies haven’t followed people for more than one decade. The information from the study will be sent to the World Health Organization to be reviewed and for potential guidelines on cell phone use to be implemented.

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Faulty respirators that can result in the user developing illnesses like asbestos mesothelioma and asbestosis continue to be found in the Atlanta area. These respirators are supposed to protect the wearer by getting rid of contaminants in the air. But even with industry policies prepared and employed by the National Institute for Occupational Safety and Health and Center for Disease Control design flaws continue to be found.

Faulty respirators are worse than not wearing a respirator at all because it gives workers a falls sense of security that they are safe from asbestos so the wearer is more likely to put him or herself into more dangerous situations.

It is estimated that over 84,000 lawsuits have been filed against 3M due to faulty respirators failing to filter out asbestos and other toxins. And American Optical has had 140,000 claims filed against it where claimants have alleged that their respirators were responsible for asbestos-related diseases in wearers.