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Last year, a Supreme Court ruling came down that will affect thousands of Americans, even if they were not aware of the ruling. Building on a ruling that declared manufacturers of medical devices could, in some cases, enjoy immunity status if the device turned out to be defective, last year's case determined that no patient could challenge a manufacturer in state court if it had been approved at the federal level. According to Forbes, the ruling is a big win for medical product manufacturers and a loss for American consumers.

The ruling, which, according to Forbes, outlines that “state lawsuits claiming drugmakers failed to adequately design their medicines cannot proceed because they are pre-empted by federal law,” was based on a 2004 incident in which a New Hampshire woman was left unable to see, work, or eat without a feeding tube. The woman had taken a generic non-steroidal anti-inflammatory, but later developed Stevens-Johnson Syndrome and toxic epidermal necrolysis. A lower court ruling awarded her $21 million in damages. The manufacturer of the drug, Mutual Pharmaceutical, argued that the decision should be overturned because the FDA had already approved the drug.

Mutual pointed to a 2011 ruling which determined that generic drugs were not required to change product labeling if alerted to side effects of which they were not previously aware.

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In 2012, the FDA received almost 900,000 adverse event and medical error reports from consumers—but only 5 per cent of those reports concerned children less than 18 years of age.

However, reporting adverse effects in pediatrics can help shed important light on these products, especially since most pediatric clinical trials only contain a small number of patients. In addition, a product may be studied in one age group and approved for widespread use but affect another age group in a different way.

Because of this, the FDA has issued steps you can take to report any adverse effects a child has experienced. In 2007, the FDA received reports of serious side effects in children who were exposed to prescription topical testosterone gel products. The contact was accidental, resulting when a child came in contact with the skin of an adult male who was using this product. However, from these complaints the FDA was able to work with testosterone gel manufacturers to create a safer product and identify places on the body where the gel could be safely applied to minimize child contact. They were also able to create stronger warning labels.

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According to the FDA, a federal judge declared that a Californian company must stop manufacturing drugs and dietary supplements for domestic commerce—at least until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act.

Titan Medical Enterprises, Inc. continuously failed to comply with Good Manufacturing Practice for drugs or Good Manufacturing Practice for dietary supplements. In addition, the company violated the Act by distributing unapproved new drugs.

Between 2001 and 2012, Titan Medical Enterprises, Inc. had been inspected by the FDA nine times and was found to be in violation of the Good Manufacturing Practice for drugs by failing to establish an adequate written testing program to assess the stability of finished products and failing to establish and follow adequate laboratory controls. The owner, James L. McDaniel, was given written notice in 2003 about the violations.

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Apnea in Greek means “without breath”. When a person has sleep apnea their breathing involuntarily stops while they are sleeping. This stopping can happen hundreds of times up to a minute or longer at a time. Most of the time the person is not aware of their breathing stopping hence making death a quiet inevitable occurrence when not treated. Statistics show that one out of fifteen people have some sort of case of sleep apnea. However, one out of fifty go undiagnosed. Effects of undiagnosed sleep apnea leads to tiredness, lack of focus during the day, as well as have four times the risk of a stroke and three times to have heart disease. This disease became national news when Reggie White, great defensive-end for the National Football League, December 26, 2004, due to sleep apnea.

Fisher & Paykel Healthcare Reusable Breathing Circuit has been voluntarily recalled because of the products defective tubes. This class I recall states there are small pin holes in the tubes. Normally, tests are given to each machine prior to patient use to make sure air is not escaping by a standard leak test. If there is a gas leak it can lead to a loss of pressure. Using a defective device can lead to death.

If you have a Fisher & Paykel Healthcare Reusable Breathing Circuit cpap machine, please find a way to get the standard test to check for the leak. If your machine is defective contact a lawyer in Northern Illinois who can assist you in the process.

According to a recent article published by www.massdevice.com, St. Jude's has recalled their Amplatzer TorqVue FX delivery system because of concerns about fractures in the core wire.

The FDA has issued the highest-risk label on the recall of the delivery system produced by St. Jude Medical.

St. Jude recalled one component of the delivery system because a certain part may fracture, which could cause adverse consequences or even death, according to an FDA report.

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