Posted on October 08, 2013 in Drugs

Doctors spend years studying medicine before they are allowed to make care decisions. Even once they receive their doctoral degrees, they work underneath doctors with tenure and on the job experience. Yet the fear of lawsuits makes most doctors practice defensive medicine. That means that instead of focusing on helping a patient, these doctors are practice medicine to avoid legal action.

Defensive medicine is when doctors second guess their initial diagnosis. Instead of treating the condition that the symptoms point to, the doctor will order additional tests, procedures and other diagnosis tools to rule out other possible options. Defensive medicine can also mean that doctors avoid certain patients or procedures that are high-risk.

It might not seem to be commonplace but it is. Jackson Healthcare, a large healthcare staffing agency, said that 75 percent of doctors practice defensive medicine. Even though it would seem that over testing is a good practice, especially since the high stakes associated with healthcare, but the opposite might be true.

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 Posted on October 03, 2013 in Defective Medical Devices

With the government shutdown looming over Washington and numerous federal locations across the country, the Consumer Product Safety Commission (CPSC) announced that their inspectors would be told to stay home as well. The Food and Drug Administration, which holds the responsibility for inspecting the food eaten all around the nation, suspended their regular inspections and monitoring activities for imported food and drugs. Illinois residents may receive injuries as the result of recalled or dangerous products, which may lead to an increasing number of personal injury lawsuits.

The Center for Disease Control and Prevention officially furloughed nearly 70% of their existing staff, with the remaining personnel expressing concern about their ability to respond to any disease or food outbreaks. Since the length of the shutdown is currently unknown, there could be dire consequences from the shutdown that won't even be known for weeks or months after it's resolved. With the CPSC for the most part offline, the lack of reviewing and monitoring activities will lead to a pileup of work to be completed when the government returns to work. In the meantime, consumers across America could be interacting with dangerous products.

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 Posted on September 26, 2013 in FDA

Our law firm uses this forum to help keep readers informed of U.S. Food and Drug Administration (FDA) recalls. When the FDA does issue a recall, the also 'classify' it – Class I, Class II or Class III, depending on the hazard involved.

But what exactly are the differences between those three FDA recall classifications?

According to the FDA's website, when the agency determines that a product is either defective or potentially harmful, either directly from the manufacturer of the product or by doctor/patient complaints, recalling the product is the most effective way to protect patients.

The majority of recalls are voluntary. Either a company discovers a defective or problem and recalls a product on its own or will announce a recall after the FDA raises concerns. Only in rare cases will FDA request a recall.

A Class I recall is the most serious and is issued when a dangerous or defective product could predictably cause serious injury or death.

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 Posted on September 22, 2013 in Illinois Defective Medical Products Lawyer

A nasty fungal meningitis outbreak in Tennessee has left several families and patients reeling with new injuries sustained after a tainted steroid shot was administered in several facilities across the state, according to The Tennessean. One of the recent lawsuits to be filed due to this incident was filed on behalf of Major Adam Ziegler, 33. Major Ziegler is a veteran of wars in both Iraq and Afghanistan. His 49-page complaint, according to The Tennessean, states that the continued nerve damage in his feet and legs, incurred by the tainted steroid, has “negatively impacted his military career.”

Yet Major Ziegler is luckier than some of his counterparts. One lawsuit was filed “for the family of retired Nashville school librarian Earline Williams, one of the early victims to die in the nationwide fungal meningitis outbreak.” The outbreak first rocked medical facilities across the country in October of last year, and according to The Tennessean, the recent “flurry of lawsuits comes as a one-year deadline is approaching to assert claims under Tennessee's health care and product liability laws.”

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 Posted on September 18, 2013 in FDA

Despite the rising number of lawsuits being brought against pharmaceutical giants, the Food and Drug Administration (FDA) recently announced that it will continue to increase the number of drugs it fast-tracks for approval, according to NaturalNews.com. The approval-acceleration program is known as “Fast Track, Accelerated Approval and Priority Review,” according to NaturalNews, “which is really just a fraudulent shortcut method for drug companies to rush potentially-deadly new drugs to market without appropriate regulatory review.” Such drugs that the FDA plans to put into this program, according to NaturalNews, include obesity treatments, antibiotics, and cancer treatments. Oftentimes these drugs will get an FDA seal of approval without having undergone extensive clinical trials. They'd also have “smaller sample sizes and entail shorter duration periods” of trials, according to NaturalNews.

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 Posted on September 14, 2013 in FDA

The U.S. Food and Drug Administration (FDA) has issued a Class I recall on the Stryker Spine OASYS Midline Occiput Plate. The device is used as an implant in spinal surgeries. The products affected were distributed between April 23, 2010 and February 12, 2013. The plate is designed to stabilize the junction between the occipital bone and vertebrae in the cervical spine.

In May, Stryker had issued an Urgent Medical Device Recall requesting physicians and hospitals to immediately stop using or distributing the product because of reports they had received of fractures of the pin that connects the implant's tulip head to the plate body. In June the company notified surgeons to perform routine clinical and radiographic evaluations for patients who have the implants.

If post-operative fracture occurs in the plate pin, serious side-effects can occur, including blood loss, nerve injury and the necessity of a revision surgery to attempt to replace a fractured implant. The FDA is warning physicians to watch for patients who may be experiencing pain, weakness, or numbness as symptoms of a pin fracture.

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 Posted on September 11, 2013 in Defective Medical Devices

A net-like implant made of plastic that is put into the vagina is raising concerns around the country due to patient complications. The mesh was created to alleviate pelvic organ prolapse as well as stress urinary incontinence, two issues that tend to affect women after childbirth, menopause, or a hysterectomy. Pelvic organ prolapse involves the weakening of pelvic muscles, causing the organs to drop into the vagina. Unfortunately, this mesh creation has cause serious pain and problems for many patients, many of whom are now taking legal action.

The transvaginal implant procedure was developed for its ease in comparison with abdominal insertion, but many of these products are not reliable or safe for the patient. Some common problems for patients who have undergone a transvaginal mesh procedure include organ perforation, vaginal tissue erosion, and infection. Even though many women came forward to report their issues, for many the manufacturer did not act quickly enough. Currently, there are approximately 23,000 lawsuits filed filed just in West Virginia, with additional suits pending in other states.

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 Posted on September 08, 2013 in Defective Medical Devices

Having an attorney in defective medical devices cases is important, and having the right attorney can mean the difference between a successful and unsuccessful case. Medical device lawsuits are complicated and highly technical. Moreover, defendants in these cases are usually large medical device manufacturers who have high profile attorneys on retainer. Plaintiffs, thus, have to be careful in choosing an attorney. They must ensure that the attorney not only understands the complexities of medical device lawsuits, but he or she also is experienced in federal and state litigation.

A good attorney will prepare for a case may involve more than one litigation forum. Take Richard's case, for example. Richard sued Medtronic in state court when a medical device that it manufactured rendered him a paraplegic.

Though Richard had a strong case, a judge dismissed it right at the start after defendant's attorneys filed a motion to dismiss the case arguing that a federal law governed this area of law, which meant that a state court could not hear it.

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 Posted on September 05, 2013 in Defective Medical Devices

Nova Diabetes Care engaged in an aggressive campaign to recall blood sugar test strips because of a potential defect that causes the strips to provide incorrect readings. The devices were sold in the United States as well as in 13 other countries and Puerto Rico, and the recall applies to strips marketed under the name of Max Blood Glucose Test Strips and Nova Max Plus Glucose Meter Kits.

This unfortunate news can have serious repercussions for diabetics, whom already have their hands full managing a condition that requires constant care. The strips can cause false readings, which in turn, could cause people to administer the incorrect dose of insulin. Insulin plays an important part in controlling blood sugar levels, and it occurs naturally in the body. Those suffering from diabetes, however, are unable to produce normal levels of insulin naturally and have to rely on diabetes testing kits. These kits measure the blood sugar concentration in the blood and inform the user of whether they have too much sugar, thus requiring an insulin injection, or whether they have too little sugar, in which case they would need less insulin and more foods rich in sugar.

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 Posted on August 30, 2013 in FDA

The US Food and Drug Administration (FDA) recently announced a Class I recall of Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

The affected products were manufactured between May 1998 and June 2013, and were distributed from April 1999 through June 2013. The pumps contain and administer prescribed drugs to a specific site inside the patient's body, and are used to treat primary or metastatic cancer, chronic pain, and severe spasticity.

According to a recall alert issued by the agency, within these pumps are feedthroughs, acting as components that provide an electronically insulated path for current flow from the electronic circuitry to the motor. An electronic short can occur if, over time, ions from drug solution, combined with humidity, permeate the drug pathway tubing inside the pump and interact with the feedthrough.

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