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 26, 2013 in Defective Drugs & Treatments

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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 Posted on July 30, 2013 in Defective Medical Devices

As a patient, you expect that you'll be safe every time you enter a doctor's office or operating room. In some cases, you're handing over your life to the doctors and medical professionals responsible for your care. The newest craze in medicine is the use of robots, generally managed by physicians themselves. When accidents happen, however, it can become necessary to meet with an Illinois personal injury attorney for representation. Unfortunately, errors in robotic surgery are just as common, and can have serious impacts on the patients involved.

That was certainly the case for Oregon's Heidi Carlson, who felt months of pain in her abdomen and hip after her September 2012 hysterectomy. The robot system used in her surgery was developed by da Vinci surgical system. After her procedure was complete, Carlson started experiencing serious pain in her hip and notified her doctor.

Her physician directed her to complete physical therapy, acupuncture, and even injections, but none of these fixes stopped her pain. After several months of Carlson insisting that the pain was still bothering her, the doctor finally arranged for a CT scan. The scan uncovered the source of her discomfort: a pen tip sized piece of metal that was left behind in the surgery process. The metal piece was grinding against her hip, resulting in serious and ongoing pain for the patient.

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 Posted on July 23, 2013 in Defective Medical Devices

Hip replacements are one of the most common and yet complicated bone revision surgeries a patient can undergo. According to the University of Missouri Medical Center, “the ideal time for surgery is when other measures, such as medicines, exercise, weight loss, and alternative therapies no longer work.” A hip replacement should be undergone only when hip pain causes a limp and interferes with the enjoyment or ability to complete everyday activities. The University of Missouri Medical Center reports that while neither a metal nor a plastic hip replacement can fully “replicated the complexity, intricate engineering, and healing ability of the human body,” replacement joints, either metal or plastic, are indeed feats of modern science and can, in most cases, bring the patient back to near-full mobility. “Many patients,” the Center states, “experience complete resolution of their pre-surgery pain and discomfort.”

And yet despite these many optimistic benefits, hip replacements are among some of the recalled products in the medical world. In March 2013, according to the New York Times, a Los Angeles jury “ordered Johnson & Johnson to pay more than $8.3 million in damages to a Montana man in the first of more than 10,000 lawsuits pending against the medical products maker in connection with a now-recalled artificial hip.” Another replacement hip manufacturer came under fire this summer when a Chicago woman, according to Chicago CBS Local, became one of hundreds of patients to sue Stryker Medical Devices for a different type of faulty hip replacement.

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 Posted on July 20, 2013 in Defective Drugs & Treatments

At the end of June, medical drug manufacturer Fresenius Kabi issued a "voluntary, user-level product recall of 4 lots of benztropine mesylate injection," according to ModernMedicine.com. The drug is used in several different types of Parkinson's therapy, in addition to the control of "extrapyramidal disorders due to neuroleptic drugs," according to ModernMedicine. While no consumers have yet to file a suit against the company, the manufacturer recalled the product because of the risk that there were glass particles in the vials, which are injected into patients. Each vial is a 2mL single dose, meaning that several thousands of patients could be affected. "Customers who received the recalled vials are being notified and instructed to return any unused product to Fresenius Kabi USA," according to ModernMedicine.com.

The Food and Drug Administration (FDA), which monitors all product recalls in several different consumer areas, reports that the first ship date of any of the recalled vials was in May 2012. According to the FDA, "the administration of a glass particulate," such as that which could be present in the recalled vials, "if present in a paranatal drug, poses a potential safety risk to patients." These risks can be as dangerous as pulmonary emboli, a life-threatening condition. According to the FDA, "there have also been reports in the literature of particulate possibly causing phlebitis, mechanical lock of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli." Any patients with a preexisting medical condition (such as Parkinson's) would be at a greater risk for contracting one of these subsequent conditions possible because of vial contamination.

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