Posted on February 25, 2014 in Defective Medical Devices

Although medical device manufacturers are supposed to vet their creations extensively before putting them on the market, some products get in the hands of caregivers or patients when there are dangerous consequences or bugs that haven't been addressed.

If you have been injured by a defective medical device, you could suffer pain, complications, and possibly even have to undergo treatment for whatever problems the device caused. After getting medical treatment for the issue, you need to consult with a defective medical device attorney about your case to ensure that you receive any compensation you deserve, and that the device will not continue to cause issues for other people.

There's another step you should take if you are concerned about the product issues affecting other patients. When device manufacturers or government regulators are not aware of an existing problem, there is more of a chance that other patients could be hurt by the device. That's why the Food and Drug Administration maintains a reporting program for these dangerous products.

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 Posted on February 22, 2014 in Defective Medical Devices

Although adult defective medical devices make the news more often, some of the most dangerous devices are those intended for use with children. With so many products and medical devices on the market for children, it can be difficult for parents to stay on stop of which devices are safe to use with infants.

When your child is injured as a result of a defective device, you may be entitled to compensation. You should schedule a consultation with a personal injury attorney for more information about your case.

The Perrigo Company recently issued a recall for 18 batches of the infant syringe/acetaminophen combination package when it was discovered that some syringes had no markings for dosage. Without a proper dosage meter, the chances of a parent or caregiver accidentally giving the baby too much medicine could result in problems for the child.

This medicine is an over the counter product sold at retail outlets around the country. The medication is intended for use with infants who are suffering from minor aches and pains. If you are a parent who believes you may have received a defective syringe, report your concerns to the FDA.

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 Posted on February 18, 2014 in Defective Medical Devices

According to Science Daily, “hundreds of thousands of hip and knee replacement surgeries are performed in the United States each year.” While these procedures are generally very effective at reducing pain and restoring mobility, there is a high rate of failure of these devices. There is such a high rate of failure, in fact, that Dr. Geoffrey Westrich told Science Daily that he's “seen a sharp increase in the number of people coming in for a second hip or knee replacement, called a revision surgery.” These devices are prone to failure so often that people seeking revision surgery is nothing out of the ordinary. Considering the amount of pain and suffering and general immobility that generally accompanies a replacement surgery like this, the high rate of revision surgery is alarming.

According to Dr. Westrich there are several things a patient who has undergone a hip or knee replacement should look for to ensure that he or she does not need a revision surgery. These include, but are not limited to:

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 Posted on February 14, 2014 in Defective Medical Devices

Every month the Food and Drug Administration (FDA) recalls several products and devices as unsafe for consumption. Many of these never make news, and very few of these ever make a big splash in the mainstream media. This makes determining whether or not you've been affected by a defective product or device difficult.

According to a University of Akron publication, proving that a defective medical device has negatively affected you can be tricky. “The courts seem reluctant,” the paper states,” to find liability without a clear showing of negligence, whether the defendant is the doctor, the hospital, or the manufacturer of the product.” Regardless of FDA efforts to list and regulate the use of devices deemed defective or harmful, thousands of patients are still affected every year.

In 2008, Congressional hearings were held to determine regulatory procedure for medical devices, in an effort to curb the number of people affected each year. The FDA first received the governmental mandate to regulate medical devices in the 1970s. At that time, according to the U.S. Governmental Printing Office (GPO), the Medical Device Amendment was approved, “a statute whose explicit purpose was, 'to provide for the safety and effectiveness of medical devices.'” The law was revisited in Congress in 2008 after the Supreme Court decided in Riegel vs. Medtronic Inc. that “this law preempts State tort claims when a medical device causes harm.” In 2008, concerned members of Congress stated that this ruling “means complete immunity from lawsuits for corporations that endanger consumers with unsafe devices.”

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 Posted on February 04, 2014 in Defective Medical Devices

Doctors stated that veteran Eddie Creed's death last year was the result of throat cancer, but some journalistic investigations have revealed that there may be more to the story regarding a defective medical device. Creed had been using a medical device called Infusomat, a device which had actually been recalled a month before he started using it.

The Seattle Veterans Hospital had been paid a visit by the device manufacturers, who assured nurses and staff that updates were coming out soon for a faulty plastic clip. On this promise, medical staff continued to use the device even though the FDA had posted warnings about possible safety concerns.

Infusomat was listed as a Class I recall, the most dangerous classification that the Food and Drug Administration can use for labeling. This recall doesn't make it mandatory for an immediate recall, but it serves as a notice that someone could be gravely injured or kill if the product continues to be used. Class II recalls are those that might generate a short-term health problem, and Class III recalls are for products that violate FDA laws but won't cause immediate harm.

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 Posted on January 26, 2014 in Defective Drugs & Treatments

In a recent article in MedicineNet, it was revealed that over 1 million people per year are injured from what's referred to as "medication errors." Per the National Coordinating Council for Medication Error Reporting and Prevention (NCMERP), a medication error is defined as:

"Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer…related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use."

According to the United States Food and Drug Administration (FDA), the agency which oversees medication errors through reporting from drug companies, the most common error is the administration of improper doses of medication. The FDA, using statistics of medication errors which were fatal, from 1993 to 1998, concluded that 41 percent of those fatal errors were from patients receiving the wrong dosage. About half of the patients who received fatal doses in that time frame were 60 years or older.

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 Posted on January 19, 2014 in Defective Medical Devices

An intrauterine device (IUD) is a commonly preferred method of birth control used by many women, suggested for use in women who have had at least one child. According to WebMD, “an IUD is a small, T-shaped plastic device that is wrapped in copper or contains hormones.” It is implanted into the uterus by a medical professional, and stays in place, releasing hormones on a schedule for up to five years. Mirena is a popular hormonal IUD that “releases levonorgestrel, which is a form of the hormone progestin.” It is expected to be quite an effective method of birth control—according to WebMD, it “prevents fertilization by damaging or killing sperm.”

About one year ago, however, it was announced that the side effects of Mirena were severe enough to issue widespread warnings about its use. According to the Adverse Events Report and as reported by PRWeb.com, “the FDA has disclosed receiving over 45,000 AERS reports of women suffering complications while using the Mirena IUD.” The severe side effects reported by Mirena users included “device expulsion, device dislocation, and vaginal hemorrhage. In more than 6 percent of cases, patients required hospitalization or surgery,” PRWeb.com reports.

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 Posted on January 14, 2014 in Defective Drugs & Treatments

In late December, a previously healthy 28-year-old man from North Carolina experienced liver failure that required a transplant after several weeks of using a dietary supplement called Mass Destruction. According to their website, the "U.S. Food and Drug Administration is advising consumers to immediately stop using" this product, "marketed as a dietary supplement for muscle growth." The supplement, which contains at least one synthetic anabolic steroid, has been linked to the liver failure of the North Carolina man. "Liver injury is generally known to be a possible outcome of using products that contain anabolic steroids and steroid-like substances," according to the FDA. The product's ingredients are "undergoing further analysis" by the agency.

The supplement is sold in stores, gyms, and online, but it was not immediately apparent who the manufacturer of Mass Destruction was, according to the FDA. It is manufactured for Blunt Force Nutrition, a distributor based in Sims, North Carolina. According to the FDA, "consumers who suspect they are experiencing problems associated with Mass Destruction or other body building products should consult a health care professional." Possible symptoms of liver failure and other health risks posed by such supplements can include fatigue, discolored urine, and abdominal or back pain.

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 Posted on January 11, 2014 in Defective Medical Devices

Medtronic Inc. devised a bone graft device known as Infuse Bone Graft, which hit the market in 2011. As of mid-2013, the Infuse had been used in millions of surgeries across the nation, touted as a safer alternative to a bone graft after spinal surgery. According to Bloomberg News, however, the Infuse “works no better than a graft and carries side effects including an increased risk of cancer, two independent reviews found.” These studies were originally published in the Annals of Internal Medicine, Bloomberg reports, and were commissioned by Medtronic Inc. “after the product's risk-benefit profile was called to question by research linking it to male sterility, infections, and cancer,” Bloomberg News reports.

In mid-2013, shares for Medtronic, “the world's biggest maker of spinal treatments,” fell 1.1 percent after having gained 39 percent since 2012, reports Bloomberg. Part of the controversy stemmed from the fact that, according to Medscape, “several harmful side effects of using [Infuse] in spinal fusion surgery went unreported in the published articles supporting the safety and efficacy of that product.” Data presented by Medtronic as to the safety of Infuse were at complete odds with data compiled from similar studies by the FDA. According to Medscape, “the FDA data show there was increased radiculitis, an increased number of leg pain events, increased infection rates, and an increased chance of sterility.”

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 Posted on January 08, 2014 in Defective Medical Devices

In an attempt to settle thousands of defective medical device lawsuits over its recalled hip implants, Johnson & Johnson subsidiary DePuy has agreed to pay at least $2.47 billion. Patients have told a judge while outlining an accord, however, that the final settlement may be worth more than $4 billion total.

The global health care company recalled 93,000 defective ASR hip implants in 2010. Doctors and patients began complaining that the implants are weak and internal company documents have shown that 37 percent of the implants fail within 5 years.

The ASR implants were approved for sale in 2005 and consisted of a new metal-on-metal design that DePuy advertised would last 20 years and offer a wider range of motion than traditional hip implants. When they fail, however, the implants could cause dislocations, and debris from the device can get stuck in the soft tissue surrounding the joint as well as the muscles and ligaments.

This is the second large judgment against Johnson & Johnson and its subsidiaries in the past month. The company was recently ordered to pay $2.2 billion by the United States Justice Department in order to settle criminal and civil claims that the company marketed the prescription medication Risperdal to patients it was not approved to treat. The company has also been accused of paying doctors and pharmacists kickbacks for additional prescriptions.

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