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Product Liability Lawsuits 
Tuesday, October 14, 2008, 03:25 AM - Product Liability
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Product liability lawsuits typically arise out of a manufacturer or vendor's responsibility to compensate customers for injuries that have been caused by defective merchandise that has been sold. Individuals who have been harmed by an unsafe product frequently have a cause of action against the person who designed, manufactured, sold, or distributed the product.

In the United States, a number of consumers have hailed the astronomical increase in the amount of product liability litigation as an effective tool for consumer protection. The law, as a result, has changed from caveat emptor (let the buyer beware) to strict liability for any manufacturing defects that make a product unreasonably dangerous.

While consumer advocates feel that product liability lawsuits are excellent for protecting consumers, manufacturers and others who distribute and sell products are of the opinion that product liability lawsuits have added to the cost of goods sold. Businesses, as a result, have sought tort reform from state legislators and Congress in an effort to reduce the damage awards.

In the majority of jurisdictions, the cause of action a plaintiff can use can be from one of four different theories: negligence, breach of warranty, misrepresentation, and strict tort liability.

Negligence is the failure to exercise proper or ordinary care as a reasonable person would. It means that a person who had a legal obligation to act in some way either omitted the act that should have been performed or acted in a way that he or she should not have.

Manufacturers can be held liable for negligence if the plaintiff can prove a lack of reasonable care in the production, design, or assembly of the harmful product. As an example, a manufacturing company can be found to be negligent if the employees did not perform their jobs correctly or if management approved improper procedures. These are particularly dangerous actions when they result in an unsafe product.

Breach of warranty is when a seller fails to fulfill the terms of a promise, claim, or representation made in regards to the quality or type of product used. The law makes the assumption that a seller gives some sort of warranty on goods sold and that he or she must stand behind the assertions.

Misrepresentation is something that relates more to the advertising and sales promotion of a product. It refers to the process of giving consumers false security about the safety of a particular product. This is usually done by drawing attention away from the hazards of its use.

Strict liability hinges on extending the responsibility of the vender or manufacturer to all individuals who might be injured by the product, even in the absence of fault. Injured guests, bystanders, or others who have no direct relationship to a product may sue for damages caused by the product. The injured party must prove that the product was defective, the defect proximately caused the injury, and the defect made the product excessively dangerous.

By: Joseph Devine
For more information on product liability lawsuits and mass tort, please visit http://www.medtroniclawsuitattorney.com.
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Another SSRI Linked to Birth Defects. 
Saturday, July 7, 2007, 01:46 AM - Product Liability
For years, certain link to birth defects in the infants born to women who took the drugs during their pregnancy. According to an article published in the New England Journal of Medicine, research shows that "infants born to mothers who took Zoloft (generic sertraline) or other SSRIs (selective serotonin reuptake inhibitors) after the 20th week of pregnancy were six times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy."

Infants born with PPHN have difficulty making the transition from breathing inside the womb to normal breathing after delivery. This difficulty often leads to respiratory failure that requires use of a ventilator. Research has found that SSRI's accumulate in the adult's lungs and serotonin can cause the proliferation of certain muscle cells. This may explain the drug's effect on the fetus. Between 10-20% of babies born with this condition do not survive.

The drug company that manufactures Zoloft, Pfizer Incorporated, promotes the drug for disorders besides depression, so many women may be taking the drug who have never even been diagnosed with depression. Zoloft is also prescribed to treat social anxiety disorder, panic disorder, post-traumatic stress disorder, premenstrual dysphoric disorder, and obsessive-compulsive disorder.

The fact that women can become dependent on Zoloft and other SSRI's presents yet another problem. Medicines associated with withdrawal symptoms can be very problematic for patients, and stopping these drugs is something that needs to be closely monitored by a physician. However, continuing to take Zoloft presents the additional problem of the infant going through withdrawal after he is born.

Research shows that nearly one-third of all infants born to women taking SSRIs show symptoms of withdrawal including tremors, high-pitched crying, sleep disturbances, and gastrointestinal problems. A startling 13% of 60 newborns exposed to SSRIs showed severe symptoms of withdrawal.

If you are a pregnant woman taking Zoloft or any other SSRI, you should contact your physician immediately. If you are a woman who took Zoloft while you were pregnant and your child suffers from PPHN, you may have a legitimate legal claim against the manufacturer of Zoloft.

Many people assume that because a drug is prescribed by a physician, it is safe; unfortunately, that is not always the case. And, even though the FDA screens drugs before they are released to the general public, dangerous side effects sometimes don't become apparent for years after the drugs have been approved.

By: Lynn Fugaro
If you or a loved one has suffered adverse side effects after taking Zoloft or any other dangerous drug in Colorado, please contact the Dangerous Drugs Attorney Andrew T. Brake, P.C..

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Zelnorm Recalled by FDA, Linked to Heart Problems and Stroke. 
Monday, May 21, 2007, 08:12 PM - Product Liability
At The Law Offices of Michael A. DeMayo, L.L.P., we work tirelessly to keep a pulse on the most recent news and information that may affect our clients. One area that we are particularly attentive to is the area of dangerous drugs. Most recently our focus has been on Zelnorm.

On March 30, 2007 the FDA issued an advisory informing the public that Novartis is complying with an FDA request to suspend marketing of Zelnorm. This request was made as a result of the drug being linked to an increased risk of heart attack, stroke and unstable angina.

Just a few days later, on April 2, 2007 the FDA took stronger action and removed Zelnorm from the market subsequent to analyzing the results of an extensive study of the drug’s performance. The analysis included data gleaned from more than 18,000 patients, most of whom were treated with Zelnorm but some of whom received a placebo. The conclusion was that the benefits of the drug do not outweigh the risks. Those risks include serious cardiovascular adverse events such as heart attacks and strokes. Zelnorm has also been linked to severe cases of diarrhea, ischemic colitis and potentially death.

Zelnorm was initially marketed in the U.S. from August of 2002 through March 2004. During that period the FDA adverse reporting system did receive reports of patients who experienced serious adverse events. These reports included 21 that presented with serious consequences for diarrhea, 20 patients that were diagnosed with ischemic colitis and 3 patients diagnosed with other types of intestinal ischemia. In some patients, these adverse events have led to hospitalization, surgery and even death.

Since being approved by the FDA in 2002, Zelnorm, manufactured by Swiss drug maker Novartis AG, has been prescribed as a short term medication for women coping with irritable bowel syndrome. The primary symptom is constipation. The drug increases the movement of stools through the bowels. It does not cure irritable bowel syndrome but it has been shown to help the condition in some regards.

Zelnorm was marketed in 55 countries and was the first drug the FDA approved for the treatment of irritable bowel syndrome. Prior to being recalled it was under prescription to about 500,000 people and in 2006 alone the drug generated just under five hundred million dollars in revenues for the company.

The FDA made the following announcements in its Public Health Advisory:

· Patients being treated with Zelnorm should contact their physician to discuss alternative treatments for their condition.
· Patients who are taking Zelnorm should seek immediate medical treatment if they experience any of the following symptoms: severe chest pain, shortness of breath, dizziness, any known symptoms of a heart attack or stroke.
· Physicians who prescribe Zelnorm should work with their patients to find appropriate alternative treatments.

By: Sara Goldstein
If you or someone you know has been taking Zelnorm, we suggest that you follow up with your health care provider as soon as possible. If you or a loved one has suffered from the side effects of Zelnorm, contact the dangerous drug lawyers at the Law Offices of Michael A. DeMayo, L.L.P. to schedule your free initial consultation. You can visit our website at http://www.demayolaw.com or you can call us at 704-333-1000 or toll free at 877-333-1000.

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Permax Heart Valve Damage. 
Saturday, April 28, 2007, 06:19 PM - Product Liability
Evidence of Permax heart valve damage has increased following a new study published in the March 2007 issue of the medical journal Archives of Neurology. This study provides further support of the problems linked to Permax. Heart valve damage was found to increase with long-term use of the drug. The purpose of this study was to compare Permax patients with those treated with the drugs Mirapex and Requip.

The Federal Drug Administration (FDA) first became aware of Permax heart valve injury problems in 2002. Permax (peroglide) has been on the market since 1989. Permax has been prescribed to treat Parkinson's patients and people suffering from Restless Legs Syndrome. A black box warning was added to the drug's label in 2006 as a result of increasing concern over Permax heart valve damage side effects.

Recent studies were conducted in Britain and Italy to evaluate serious concerns that Permax heart valve damage occurred with long-term use of the drug. In the British study, 11,417 people were given Permax. The test subjects were 37 times more likely to develop heart problems. The Italian study involved 155 Parkinson's patients who were taking Permax. Heart valve damage was reported in 23.4% of the people taking the drug in that study.

The Mayo Clinic has also reported problems with Permax heart valve injury. According to a report by doctors at the Mayo Clinic, three patients who took Permax for three to seven years suffered serious heart valve damage. Two of the patients had significant heart damage requiring valve replacement surgery. The Mayo Clinic doctors recommended that given the dangers associated with Permax, patients with heart problems should not take the drug.

Permax heart valve damage symptoms include chest pain, shortness of breath and swelling of the feet and ankles. In some cases, patients with serious heart valve injuries can require heart valve replacement or if left untreated, the patient may suffer heart failure resulting in death.

Heart valve damage inhibits valves from opening or closing. There are two primary types of heart valve disease. Stenosis (obstruction) occurs when a valve opening becomes narrowed, making it difficult do pump blood throughout the body. Regurgitation (insufficiency) is when a valve is prevented from completely closing causing the blood to leak backward instead of flowing forward.

On March 29, 2007, following the increasing evidence of Permax heart valve damage problems, the FDA announced a Permax recall. In light of the recall, the FDA is prompting patients currently taking the drug to discuss alternative treatment options with their doctor and monitor for possible Permax heart valve injury problems.

By: Steve Fields
To learn more about Permax Heart Valve Damage please visit our website. Our team of Permax lawyers represents clients in Minnesota, Wisconsin, Iowa, Arizona, North Dakota and South Dakota.

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