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Cymbalta is a multi-use prescription drug most commonly used as an anti-depressant. Despite several clinical trials during the approval process of Cymbalta that alleged Cymbalta caused depression in otherwise healthy patients, the U.S. Food and Drug Administration did not recall the drug for use as an anti-depressant, according to the New York Times. Most tellingly, the suicide of 19-year-old drug tester Traci Johnson, who had no other symptoms of depression, brought the issues with Cymbalta to wider attention. Four years after this negative publicity, in 2008, Eli Lilly, the manufacturer of Cymbalta, sought to have the drug approved for treatment for chronic pain, especially in patients suffering from Fibromyalgia. The drug was not approved for such use in 2008. It would eventually be approved for such treatment in 2010, according to another article in the New York Times.

Cymbalta has been back in the news recently, as several lawsuits have been brought against Eli Lilly by patients using Cymbalta as an antidepressant. These patients claim to have experienced “brain zaps and other side effects” when attempting to stop taking the drug, according to Law360.com. Yet Eli Lilly representatives have responded to the claims by saying that medical professionals were made well aware of the risks when prescribing Cymbalta to their patients, and thus the fault does not lie with the drug manufacturer for failing to make patients aware of the risks of use.

According to Law360.com, Lilly earned $18 billion from 2004 to 2011 for the sales of Cymbalta. Like other antidepressants, patients are discouraged from suddenly stopping to take Cymbalta, as this can lead to serious conditions, either physical (ie: nausea, headache) or emotional (ie: irritability, anxiety, nightmares). The complaint alleges that if patients had known how difficult it would be to stop taking Cymbalta, they would never have started to take it in the first place.

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Although medical device manufacturers are supposed to vet their creations extensively before putting them on the market, some products get in the hands of caregivers or patients when there are dangerous consequences or bugs that haven't been addressed.

If you have been injured by a defective medical device, you could suffer pain, complications, and possibly even have to undergo treatment for whatever problems the device caused. After getting medical treatment for the issue, you need to consult with a defective medical device attorney about your case to ensure that you receive any compensation you deserve, and that the device will not continue to cause issues for other people.

There's another step you should take if you are concerned about the product issues affecting other patients. When device manufacturers or government regulators are not aware of an existing problem, there is more of a chance that other patients could be hurt by the device. That's why the Food and Drug Administration maintains a reporting program for these dangerous products.

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Posted on in Drugs

When many patients are diagnosed with a treatable but expensive disease, they turn to generic drugs as a solution. With superstores such as WalMart carrying the availability torch when it comes to generic brand pills, it's no surprise that, according to the New York Times, “now account for 80 percent of all prescriptions in the United States.” Not only are generic drugs cheaper, they're also more likely to be carried by pharmacies that don't require health insurance and offer a store-specific spending plan. Earlier this year, however, a case that is “enough to make anyone squeamish,” according to the New York Times, resulted in a ruling that Supreme Court ruling that generic drug-makers couldn't be sued for bad reactions to their products. While name brand drug-makers are still held responsible for the quality of their products, generic drugs no longer are considered under the same tight restrictions.

In 2004, Karen Bartlett, according to the Times, “developed a rare but severe reaction to” a pain pill prescribed to treat shoulder pain. “Within weeks of taking the drug,” the Times reports, “her skin began to slough off until nearly two-thirds of it was gone.” She sued Mutual Pharmaceutical Company, the manufacturer of the generic drug, and an appeals court upheld a 2010 verdict that awarded Bartlett $21 million in damages.

In 2011, the Supreme Court “severely limited the conditions under which consumers of generic drugs could sue the manufacturers,” because generic drugs, reports the Times, are exempt from the same FDA regulations as their name-brand counterparts. In June of this year, the Supreme Court revisited the argument. According to Reuters News Service, the Court decided that generic drug-makers were indeed not liable to the same extent as name-brand drug-makers, “a decision that consumer advocates called a blow to patient safety.”

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In 1983, the FDA approved Depakote to treat certain issues with the central nervous system. It has successfully treated or controlled such disorders as epileptic seizures and episodes of manic or bipolar behavior. This medicine can also be prescribed for migraine headaches. It is primarily used as a mood stabilizer and anti-convulsant, which has also provided relief for certain off label conditions.

After years of tests and research, there have been recent studies that have identified issues with this medication. Unfortunately, this is a far too common, because even the vigorous tests that were run by the FDA can miss potentially fatal side effects. In 2009, the FDA warned pregnant mothers about certain congenital birth defects such as a cleft palate, spina bifida, malformed hands and autism.

Again, in 2011, the FDA notified consumers of other possible side effects. The results of studies by Emory University have given cognitive tests to children from 3 to 6 years old. The results have shown that children of mothers who took Depakote while pregnant tended to score lower on IQ tests than mothers who took other anti-seizure medications during pregnancy.

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Back in 2010, the FDA sent an open warning letter to DePuy Orthopaedics Inc., because the company had started producing and marketing their metal-to-metal joint replacement device Trumatch without an FDA approval. The company was also marketing a hip replacement device in cases where it had no approval for doing so.

In case of the metal-to-metal joint device, it was possible for people to get the device installed, because the company started offering the device for sale. However, since there was no FDA approval, this should have never happened. The warning letter to the company clearly explains that they had no approval, and thus they broke the law by offering the product for sale.

A product released to the public without FDA approval is a perfect example of a device that can cause serious problems patients who purchase such a product as part of their treatment. If a person were to suffer from serious problems with a medical device that was not FDA approved, this would certainly mean the victim would be a candidate eligible for compensation.

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