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 25, 2013 in FDA

Two products extremely popular for use in dialysis treatments, NaturaLyte and GranuFlo, were created by Fresenius Medical Care Holdings. These products have been named in numerous lawsuits recently, since there are side effects that can lead to serious medical problems and conditions for patients getting dialysis treatment. If you have been the victim of a defective medical device or medical malpractice, you need to speak with a personal injury attorney.

Unfortunately, many lives around the country are destroyed by the mistakes made in medicine. The outcome of a defective medical device complication may impact the life of the patient and his or her loved ones for the remainder of the patient's life.

Plaintiffs in the cases have alleged that the company failed to label and warn patients about the implications of the products. Some of the reported issues included strokes, heart attacks, sudden cardiac deaths, and cardio-pulmonary arrest. Patients seeking assistance with dialysis may have seen an improvement in their original conditions only to suffer from serious side effects of NaturaLyte and GranuFlo.

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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 Drugs

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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 Posted on July 16, 2013 in Defective Medical Devices

The latest concern to rip though the field of medical devices is regarding the security placed within those devices. Recent pranks have demonstrated that it's extremely easy to hack into these devices and alter the controls, presenting a safety risk to the patients depending on these defective medical devices. The Center For Internet Security is a nonprofit group that provides advice to government agencies and private companies, and the group has announced the development of guidelines for medical device manufacturers to consider in the development and refinement of their products.

The goal of the report is to help manufacturers reduce malfunctions coming from computer viruses and to protect the confidentiality and integrity of the data connected to these devices. With some simple protection tips, individuals using critical machines can feel safer about the devices they use every day. The organization has requested information and cooperation from hospitals and medical professionals around the country in the development of these guidelines.

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 Posted on July 12, 2013 in Defective Medical Devices

Pain medication is given to patients to relieve pain and to make patient care better. At times, medical devices are implanted in a patient's body that administers pain medication and can be regulated by the physician if necessary. This is beneficial to the person because it removes the concern of missing the time to take the medication or the possibility of taking the wrong dosage. But, when these implanted medical devices don't work properly, a patient's health becomes compromised.

The FDA recently recalled two such pumps: Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps. The reported reason was for a potential short in the electrical wiring of the device. This short in the electrical currency could cause the devices to stall which could lead to a drop in the administration of medications. If this were to happen, a patient's could also experience withdrawal symptoms and or their symptoms of the underlying condition could return. This reduction in pain therapy could adversely affect the patient's health, which could lead to death.

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 Posted on July 06, 2013 in Defective Medical Devices

Respironics, a subsidiary of Phillips, has recently received the FDA's highest-risk label for a recall that has affected over 19,000 V60 ventilators. These ventilators were pulled due to potentially dangerous power management software.

These V60 ventilators are used to aid with breathing in the hospital or at home for those patients who face “respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea.” The devices got the Class 1 status recall due to a “situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

California-based Respironics originally recalled its V60 ventilators when they discovered a major issue with their power management software. The devices were often shutting down suddenly, which ends the flow of ventilator support to a patient, without sounding any sort of alarm.

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