Posted on October 22,2014 in Defective Prescription Drugs

Defective drug manufacturers that have not properly tested products or have been found to market illegally with misleading statements are facing the consequences of lawsuits. When someone is the victim of taking a defective drug, they can suffer medical, emotional, and financial hardships as a result.

The FDA issued a press release last year that said the manufacturer of Risperdal, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, was fined $2.2 billion for the illegal promotion of its drug to males under the age of 18. Risperdal marketing material highlighted symptoms the drug can be used for while minimizing warnings about its safety. The FDA stood firm by its commitment to prevent and fight all forms of health care fraud and hold responsible parties accountable.

Risperdal is labeled as an antipsychotic medication, but has been linked to gynecomastia, an enlargement of male breast tissue and increased levels of prolactin, a hormone that can stimulate milk production. In an article from the Wall Street Journal, a Duke psychiatrist reported that for 70 percent of the cases he analyzed, Risperdal had the strongest connection to gynecomastia in minors among any of the newer antipsychotic drugs.

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 Posted on October 15,2014 in Defective Prescription Drugs

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.

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 Posted on October 11,2014 in Defective Prescription Drugs

Sometimes prominent drugs are recalled and no one knows about it. This was the case with a 2010 Food and Drug Administration (FDA) recall of the birth control Yaz, a contraceptive approved by the FDA for use among women as young as 14 years old. Yaz and Beyaz—a similar FDA-approved medication made by the same manufacturer, Berlex, Inc.—hit the market when it was approved in 2006, according to Drugs.com. Beyaz is primarily used to treat acne, while Yaz is marketed as the contraceptive. The only warnings on the Yaz website for either drug alert women who smoke and women over the age of 35 to increased risks of blood clot or stroke when taking the drug.

The trouble for the popular contraceptive came in 2010, when lawsuits started to pop up across the country alleging that women who were on the medication experienced a much higher rate of blood clots than the manufacturer had described. Bayer, the parent company for Yaz, was sued in 1,100 lawsuits that year, according to CBSNews.com. When Bayer began to face these lawsuits, Yaz was its best-selling product, according to CBS. As a result, one may think that a recall of the product would have been widely publicized. Not so.

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 Posted on October 09,2014 in Defective Prescription Drugs

Xarelto is a blood thinner prescribed to patients at high risk of blood clots or strokes and is widely prescribed by the medical community. It can also be used to treat pulmonary embolism and can be used to reduce the risk of clotting in a person who has just undergone joint replacement surgery. According to the Xarelto website, more than 9 million people worldwide have been prescribed Xarelto for various reasons. The only people not recommended to take the drug, according to the website, are people who have artificial heart valves or abnormal types of bleeding. Yet the drug has come under fire lately after many patients and the loved ones of patients complained that the drug resulted in hemorrhaging in otherwise healthy users of the drug.

According to WebMD.com, hemorrhaging is a common side effect that can accompany the less common side effects of taking Xarelto, which can include, but are not limited to:

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 Posted on October 04,2014 in Drugs

Abilify is the name brand of the medication aripirazole. Aripirazole is the medicine used to treat mental disorders such as bipolar disorder, severe mental depression and schizophrenia. No evidence has been released that proves that the drug does not do what it is intended to do, but there are some unexpected side effects of taking this medication about which many patients have filed lawsuits. These unexpected side effects primarily include the development or exacerbation of compulsive behavior, according to the British Journal of Psychology, sometimes in patients in whom compulsive behavior had not bee observed prior to taking Abilify.

When the drug first hit the market, the U.S. Food and Drug Administration (FDA) made no warnings that the medicine could induce compulsive behavior. According to the FDA, possible side effects of Abilify included high blood sugar and neuroleptic malignant syndrome (NMS). NMS can result in “high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure.” Because Abilify functions as an anti-depressant, the FDA also made note that the medicine could lead to increased thoughts of suicide during initial stages of being on the medication.

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 Posted on October 02,2014 in Defective Medical Devices

Surgical mesh was developed in the mid-20th century as a way to treat hernias. The implant was originally intended to be placed beneath the skin to patch the hole in the abdomen and block intestines and other tissues from protruding, according to the U.S. Food and Drug Administration. It can be made from either biological or synthetic materials. Recently, manufacturers of surgical mesh began marketing it as a means to prevent organ prolapse into the vaginas of women. It can be implanted after a hysterectomy or as a separate procedure. Women often experience a weakening of pelvic muscles after pregnancy and childbirth, which can lead to organ prolapse. About one-third of surgeries performed to prevent organ prolapse in women in 2010 used transvaginal mesh as a means to prevent further prolapse.

It may seem a wonder procedure, but the procedure of implantation and the implant itself can have so many negative side effects it may not be the best cure. According to a Bloomberg wire article published in The Daily Record, one manufacturer, Endo Health Solutions Inc., was ordered earlier this year to pay $830 million in damages to resolve lawsuits brought against it by women who had undergone a transvaginal mesh implant procedure. Women allege that the implant “failed to support internal organs and caused incontinence,” according to The Daily Record.

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 Posted on September 29,2014 in Arlington Heights Defective Medical Device Attorney

A recent report shows the number of recalled medical devices continuing to increase. In response, many watchdog and consumer protection groups are aiming to make stricter requirements for medical devices.

A “cadre of insurers and other healthcare stakeholders” is urging the U.S. Food and Drug Administration (FDA) to “establish more registries to monitor and report performance” of medical devices being used in the U.S. market, according to MassDevice.com.

This cadre is requesting that the medtech registries be updated to enable more detailed information-gathering on devices that have been cleared or approved. Hence, this would help to ensure that complications resulting from the use or implementation of a faulty device would be recorded as soon as possible. This could help alleviate scenarios in which faulty medical devices are used, even after the first reports of failure.

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 Posted on September 24,2014 in Defective Medical Devices

When complicated medical technology hits the market and is adopted by medical professionals, issues with associated surgeries are bound to occur. There are several reasons for this, and difficulties with the manufacturing of the product itself are not the only ones. By some reports, the U.S. Food and Drug Administration (FDA) does not always fully vet products before they are released to the public. Hence, many devices end up recalled. According to The Wall Street Journal, the number of recalled devices continues to increase each year, and have in fact increased by almost 50 percent between 2003 and 2012.

Manufacturer recalls, not mandated by the FDA, often come too late to those who have already used the recalled device. One such example occurred in 2007 via the Metronic recall of defibrillator wires. These wires had been implanted in more than a quarter-million patients before the recall was issued, and thus resulted in a handful of patient deaths. However, Wanda Moebius, a senior vice president at the industry trade group AdvaMed, told The Wall Street Journal that medical device companies are taking a more patient-centric and cautious approach to FDA reporting.

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 Posted on September 19,2014 in Defective Prescription Drugs

Products liability covers a large range of products and can include intangible property such as pets, gas leaks, and real estate. Defective medical products are one of the most damaging types of products liability. Examples of defective medical products include those that were not fully vetted for compatibility with the body, those with side effects more severe than the disease they are supposed to alleviate, and those that cause unexpected additional issues for the patient. Product liability for defective medical products does not only refer to the product itself, but also to the way in which the product was distributed and used.

According to the Legal Information Institute at the Cornell University Law School, there are three main types of product defects. These include design defects, manufacturing defects, and marketing defects. A defect in marketing, in regards to a medical device, includes instructions for patient use.

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 Posted on September 15,2014 in Defective Medical Devices

In August, two U.S. senators began pressing the Food and Drug Administration (FDA) to take power morcellators off the American medical device market. According to the FDA, laparoscopic power morcellators are used to help remove tissue through small incision sites, and are most commonly used in hysterectomies or during the surgical removal of uterine fibroids (myomectomy).

The FDA clearly states that when used for either purpose, the morcellators “poses a risk of spreading unsuspected cancerous tissue” beyond the uterus and into the bloodstream. As such, the agency discourages the use of morcellators but does not outright forbid their implementation. This is what New York Senators Chuck Schumer and Kirsten Gillibrand are attempting to quell.

According to an article in Modern Heathcare, in August Senators Schumer and Gillibrand wrote a letter to the FDA requesting that the agency to remove the morcellator devices from the market. The letter, reports Modern Healthcare, cites a recent survey done at Boston's Brigham and Women's Hospital which found that women who had morcellators implemented were at a nine times higher risk of having the cancer spread than what was communicated to them at the time of surgery.

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