Posted on December 19, 2012 in Defective Medical Devices

Every year approximately one million people receive an artificial knee or hip, making it a $7 billion dollar industry. However, many patients eventually have to have a second surgery because the original replacement was faulty or recalled.

Because of this, a panel of medical experts believes the FDA should create a new process when approving devices. The current review is called a 501(k) and helps approve products that are similar to others already approved and on the market. The average time for a new device to be approved is 10 months—which the panel thinks is too short.

It was suggested that instead of the streamlined review, the FDA should mandate each device maker proves the moderate-risk (also known as Class II) products are safe and effective. Although this complex process may take more time, it could prove beneficial. Annually, 83 percent of the 700 devices recalled are Class II.

The top lobbying group in the artificial device industry does not believe a change is necessary. The FDA also states that the 501(k) is effective, mentioning in this ABC article that it has brought about a “robust medical device industry in the U.S. and…lower-risk devices to the market for patients who need them.”

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 Posted on December 17, 2012 in Defective Drugs & Treatments

A recent recall of the drug atorvastatin, the generic form of Lipitor, has left many consumers confused as to what they should do with the bottles of the medication they have sitting in their medicine cabinets. Ranbaxy Pharmaceuticals, which produces the drug, have directed pharmacists not to dispense the drug because it may contain specks of glass. But the recall was only directed at the retail level, and the company has given no direction to patients who may have bottles of the contaminated drug in their medicine cabinets. According to a statement issued on the company's website, the recall is being taken “with the full knowledge” of the U.S. Food and Drug Administration.

Headquartered in India, Ranbaxy Pharmaceuticals is one of the biggest pharmaceutical companies in the world. In the past, the FDA has accused the company of “a pattern of systemic fraudulent conduct” over a period of years for fabricating data in drug applications, taking shortcuts in crucial quality tests, and violating numerous additional manufacturing standards. In 2008, the federal agency banned Ranbaxy from importing over 30 different drug products into the U.S. That ban still stands today.

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 Posted on December 15, 2012 in Defective Medical Devices

Researchers that are from the Cincinnati Children's Hospital Medical Center have studied children that either have a pacemaker (40 patients) or an implanted defibrillator (133 patients). The researchers have been assessing the patients' quality of life compared to other children that have congenital heart disease and children that are healthy.

The children in the study, ages 8 to 18 years old, and their parents were each asked to complete a quality of life questionnaire. Children with heart devices and parents who have children with heart devices, when compared to the children and parents without heart devices, were reported to have significantly lower quality of life scores. Similarly, these parents' and children's scores were also lower than the scores for children and parents with children that have more severe heart disease, but no device.

Major factors that affect the quality of life for children, included things like self-perception, self-worth, and athletic capability.

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 Posted on December 12, 2012 in Defective Medical Devices

A medical device is defined as a product which is used for medical purposes in patients, in diagnosis, in therapy, or in surgery, according to an online definition. Although medical devices are meant to aid medical professionals in improving the health of their patients, hundreds of medical devices are recalled each year.

Whether a manufacturer was overeager to put their device on the market and rushed the production without putting it through adequate tests first, or the instructions were poorly written and the device was too commonly misused, there are defective medical device injuries every day. However, if you find a problem with your medical device, it is critical that you report it not only to your doctor, but also to the FDA.

The FDA has a website called MedWatch that is specifically for reporting these injuries and defects, and it contains information on exactly how to report them. The website states, “In order to keep effective medical products available on the market, the FDA relies on the voluntary reporting of these events.”

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