Posted on June 25,2013 in Defective Medical Devices

Every year, the FDA recalls medical devices that are deemed unsafe or that don't function properly. In 2012, 50 medical devices were recalled throughout the year, and 2013 is no different. Early in May, five medical devices were recalled.

On May 1^st, two different medical devices were recalled. The first was from Hospira Inc. The GemStar Infusion System was recalled. It is used in intravenous, arterial, subcutaneous, short-term epidural infusion and parental administration of general IV fluids, medications, nutritional foods and blood products, according to the FDA. It can be used in the home or hospital. It was recalled because of battery leakage.

The second medical device that was recalled was from Newport Medical Instruments, Inc. The HT70 and HT70 Plus Ventilators were recalled because it went into internal backup battery sooner than expected. They are used to provide positive pressure mechanical ventilator support.

Three medical devices were recalled on May 7^th.

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 Posted on June 19,2013 in Defective Medical Devices

Though medical devices are meant to help those who need them to live healthy and productive lives, there are risks involved in the use of a medical device. If the device does not work properly, is not used properly, or begins to break down, it can cause more problems for the person using it. The following will help you understand what makes a medical product defective, and what to do if you encounter a defective device.

In order to bring up the issue of a defective medical device in a court of law, it must be defective in one of the two following ways:

1. The design is defective. This means that if the device is in proper condition and is used according to the directions, it will be harmful to the user.
2. The product is defective. This means that the device was designed in a way that would help the user, however it was poorly constructed, and does not work properly.

Understanding these two definitions of a defective device can help you determine whether or not you have a case. Contact an Illinois defective medical devices lawyer today with questions.

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 Posted on June 12,2013 in Defective Medical Devices

When purchasing a medical product, it is expected that the product will be safe, functioning, and helpful. The Food and Drug Administration exists to regulate the safety of these products. However, when a product is found to be unsafe after it has been used by the public, the FDA can post product recalls.

A multi-state recall of drug products that were supposed to be guaranteed sterile by the Nora Apothecary & Alternative Therapies pharmacy has been announced. These products are not yet expired, but since they were compounded and delivered on or before Friday, April 19, 2013, the pharmacy cannot guarantee they are safe. Quality control process is to blame, as well as the fact they were not able to keep the sterility assurance during a recent FDA inspection.

Though there have been no reports of injury or illness, they chose to announce a voluntary recall as a precaution in order to insure no issues do arise. According to the press release that announced the recall, “Patients are at increased risk for serious infections in the event a sterile product is compromised.”

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 Posted on June 07,2013 in American Psychiatric Association

Chances are you know someone who suffers from mental illness. That someone may even be you. Yet, knowing about mental illness is not the same as understanding mental illness. An increasing awareness about mental health issues fuels a need for healthy dialogue and proper education. Mental illness impacts many – from government officials to day laborers – and the community continues to grow. Earlier this month, President Obama and Vice President Biden hosted a National Conference on Mental Health. The event, held at the White House, focused on increasing communication, understanding and awareness about mental health issues.

“We commend the Administration's efforts through this national dialogue to focus attention and resources on important mental health issues and the need to eliminate stigma and improve access to quality care for all individuals who need mental health services,” said Jeffrey Lieberman, M.D., President of the American Psychiatric Association (APA).

Mental Health Treatment Drug Concerns

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 Posted on June 03,2013 in Drugs

The U.S. Food and Drug Administration (FDA) controls what drugs may be sold or prescribed to the public. If a prescription drug is proven to cause dangerous side effects, FDA may remove it from the market. Also, the FDA may ask the manufacturer to withdraw a drug when the drug is not used in treatment anymore. There are a number of reasons why the FDA sometimes chooses to remove a drug off the market, according to this article. Here are two of them.

Many drugs on the market cause side effects that are well documented. In fact, known side effects lead to more injuries and fatalities than unknown ones. However, some adverse effects only happen rarely which makes predicting them difficult. Normally, drugs are tested rigorously before they end up in the market allowing the more common side effects to be detected. But rare problems do not necessarily show up in these tests and dangerous drugs manage to get in the market.

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 Posted on May 30,2013 in Defective Medical Devices

So many people put their lives in the hands of medical professionals. In turn, medical professionals rely on medical devices to assist in the care of patients. Without these devices, care would be limited. Having equipment that works properly is critical, as it can be used in a life and death situation.

Recently, the Maquet SERVO-I ventilator battery module was recalled by the FDA. These battery types are important because they allow healthcare professionals and patients to be mobile as opposed to being near an electricity source. Ventilator units are used to monitor and treat people with respiratory issues. If for any reason this medical equipment should fail to operate, it could cost a patient's life.

The FDA reports that the reason for the recall is due to reports that some battery packs distributed after the first of the year had shorter a battery life than expected. This can cause the ventilator to shut down which is something the hospital cannot afford to happen. If this were to happen, it could cause serious health complications, which could include death and that, could lead to a malpractice suit.

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 Posted on May 27,2013 in Drugs

According to a recent article published by Forbes, it has been discovered that dietary supplements have made up over half of all FDA Class 1 drug recalls between 2004 and 2012. “Class 1” means that the supplements contained ingredients that have a potential to “cause serious adverse health consequences or death.”

The St. Michael's Hospital research team determined that between January 2004 and December 2012, 51% of drugs subjected to a Class 1 recall were in fact dietary supplements. Most of these recalls took place after 2008 for what was said to be unknown reasons.

The categories of supplements with the highest recalls were developed for (1) sexual enhancement, (2) bodybuilding, and (3) weight loss. Sexual enhancement supplements accounted for 40% of all Class 1 recalls.

What makes the supplement industry unique is that they do not require FDA approval before being sold. There are currently approximately 65,000 dietary supplements on the market in the United States.

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 Posted on May 23,2013 in Drugs

A few short weeks ago, Allergan spent close to $1 billion on rights to a new drug for treating migraine headaches. However, the FDA has already rejected his product. A recent New York Times article has taken a closer look at the ordeal.

According to Allergan, the Food and Drug Administration rejected the new drug, called Levadex, due to concerns about the manufacturing of the inhaler that is required to dispense it.

Levadex is a unique kind of migraine drug that uses an inhaler. The inhaler is very similar to those used for asthma.

It was back in January that Allergan initially accepted the price of $958 million in order to acquire MAP Pharmaceuticals, which is the company that developed Levadex. This deal closed in March.

This wasn't the first time the FDA has rejected Levadex. In March 2012 it was also declined approval due to, again, concerns about the inhaler. MAP was confident that Levadex would be approved the second time around, as illustrated by Allergan's agreement to purchase the company before waiting for the FDA's official second decision.

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 Posted on May 19,2013 in American Psychiatric Association

The New York Times recently reported on new data from the Center of Disease Control (CDC) which reveals that nearly one in five high school age boys in the United States have received a medical diagnosis of attention deficit hyperactivity disorder (A.D.H.D.).

A.D.H.D. is a result of abnormal chemical levels in the brain that impair a person's impulse control and attention skills. About two-thirds of those with a current diagnosis receive prescriptions for stimulants like Ritalin or Adderall, which have been shown to lead to addiction, anxiety and occasionally psychosis.

The CDC also reports that an estimated 6.4 million children, between the ages 4 through 17, have been diagnosed with A.D.H.D., an increase of 16 percent since 2007 and 41 percent over the past ten years.

Medical experts predict the numbers will increase even more dramatically as the American Psychiatric Association plans to change the definition of A.D.H.D. which will allow more people to receive the diagnosis and treatment. There is growing concern in the medical community that the diagnosis and medications used for treatment are being overused in children.

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 Posted on May 16,2013 in Drugs

A decade ago, Medicare experienced an expansion to make it easier for people to get the drugs that they need. In fact, Congress decided to increase funding to Medicare by billions of dollars to reach this goal. But it is possible that the fix worked too well.

Now Propublica has completed an investigation of this new system and found some interesting safety issues. By reviewing four years of prescription data, they have shown that large quantities of meds were given to Medicare patients without considering the possible side effects. There is also evidence of doctors continually prescribing medicines that they shouldn't according to FDA regulations.

Although Medicaid is good about policing the drugs given to its subscribers, Medicare does not do it at all. According to the director, Jonathan Blum, Medicare concedes to each physician's judgments rather than regulate the prescriptions given to seniors and disabled people.

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