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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 Posted on August 26,2013 in Dietary Supplements

Two US Senators recently introduced the Dietary Supplement Labeling Act of 2013. Sen. Richard Blumenthal (D-Conn.) and Sen. Dick Durbin (D-Ill.) say the law is needed to help oversee the ever growing list of dangerous dietary supplements and herbal medications that can cause adverse reactions in people who take these products, but are on the market totally unregulated by the federal Food and Drug Administration (FDA).

The Journal of the American Medical Association reported in its April issue that many supplement manufacturers have purposely added illegal weight-loss chemicals, sexual-enhancement and bodybuilding compounds or other additives, such as excessive caffeine, in their products. These companies are not required to disclose and don't disclose these ingredients on product labels, leaving many consumers unaware of what they are actually ingesting.

“Consumers don't know some dietary supplements are unsafe until they're in the hospital, and by that time it's too late,” says Sen. Blumenthal. He says the bill would require these companies to provide more information about contents on product labels and would also give more authority to FDA by requiring manufacturers to register their products and the ingredients. Manufacturers would also have to provide proof of health-benefit claims.

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 Posted on August 22,2013 in Defective Medical Devices

When you're injured or ill and have a surgery to address the injury or illness, the last thing on your mind is dealing with a lawsuit after the fact. In fact, common sense dictates that after a traumatic event such as this, the most important step to recovery is to rest and avoid stressful endeavors—such as a lawsuit. Yet if you undergo a botched surgery, or have an implanted medical device that goes haywire, the most important thing you can do is address the issue right away. The longer you wait, even if it means disrupting recovery, the less chance you'll have at getting compensated for the financial, physical, and emotional hardship that can result from a bad surgery or defective medical device.

It's not only up to the patient to report a defective medical device, however. According to the Food and Drug Administration (FDA), which handles recalls of food, products, and goods that are deemed detrimental or dangerous, it is mandatory for a manufacturer to recall any device that the agency reports. According to the FDA, “the Medical Device Reporting (MDR) regulation contains mandatory requirements for manufacturers, importers, and user facilities to report significant medical device adverse events to the FDA.”

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 Posted on August 14,2013 in Defective Medical Devices

Medical devices often get a lot of press when they malfunction, and rightly so: the impacts of a defective device are far-reaching and produce lifelong problems for the victim patients. Until recently, very little attention was given to the privacy related to these devices, until a New Zealand man showed how simple it was to hack an insulin pump.

Barnaby Jack was able to hack into an insulin pump from 300 feet away, wirelessly ordering the machine to deliver a lethal dose of insulin to a mannequin. Insulin pumps aren't the only medical devices suspected of security weaknesses; until he passed away, Jack was scheduled to shock a pacemaker at another conference in Las Vegas. Luckily for the makers of these medical devices, Jack was able to show that weaknesses exist without harming any real patients. Put into the wrong hands, however, these hacking skills could compromise the health and life of a patient before the patient even realizes what is happening.

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 Posted on August 08,2013 in Defective Medical Devices

Product liability law is a highly specialized niche of tort law that enables injured plaintiffs to hold those responsible, usually large corporations with even larger law firms, accountable for their actions. In order to bring an action based on product liability, plaintiffs must pigeonhole their claim into at least one of the product liability theories. The main theories of liability are:

1. Manufacturing defect,
2. Defective design, and
3. Improper warning.

Manufacturing defect liability arises from an inherent defect in a product that causes an injury. Design defect liability stems from a flaw in the way a product is designed to operate. Lastly, improper warning liability stem from inadequate disclosures of the risks associated with the products.

Each of these theories, in turn, requires plaintiffs support them through factual allegations that support the elements of each of these theories. At times, a case may involve more than one product liability theory. For example, take the Mirena birth control device, which became popular because once implanted, it can act be effective for up to five years. However, problems arose, which involved the device becoming dislodged and traveling around a person's body. In one instance, it traveled all the way into the pelvic area.

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 Posted on August 03,2013 in Defective Medical Devices

With the boom in medical technology, product liability law has become an important tool in ensuring that progress does not come at the price of innocent lives. Product liability cases are difficult to prove, however.

A case premised on product liability requires the plaintiff to show that:

1. they suffered physical, emotional or financial injury (often, it is all three);
2. the product was defective in its manufacturing, design or warnings;
3. the defect caused the injury; and
4. the product was being used as intended at the time.

Of these four elements, proving that the product was defective requires an experienced product liability attorney who is familiar with complex medical devices. Take the daVinci robot, for example; a mechanized surgical device that allows doctors to perform surgical procedures form thousands of miles away.

As more doctors use this robot, there are a growing number of cases involving unintended complications during surgery. Even though the device's pinpoint accuracy is impressive, it may come with a hefty price, including sliced blood vessels, patients being hit in the face, and even some deaths.

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