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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 Posted on January 03, 2014 in Defective Medical Devices

The United States Food and Drug Administration (FDA) has announced that two chemicals that are used in heart stress tests can cause heart attacks and can also cause death. The chemicals, Adenoscan and Lexiscan, are both manufactured by Astellas Pharma US Inc.

Heart stress tests are performed on patients who are unable to exercise. When conducting a test, physicians inject the patient with the chemicals. These chemicals actually cause the heart to stress, allowing pictures of the heart to be taken to see where low blood flow is occurring and if there is any area of damage to the organ.

Adenoscan and Lexiscan actually dilate the arteries in the heart. This dilating causes the increase in the blood flow and this is how obstructions in the arteries are found during the test. But as the blood flow is increasing in the unblocked arteries, it is actually decreasing in the blocked ones and the FDA says this is what can cause a heart attack.

As part of its warning, the FDA said resuscitation equipment should be on site when testing is being done to a patient, as well as fully trained staff.

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 Posted on December 31, 2013 in Defective Medical Devices

A lot has been noted about the dangers of transvaginal mesh implants, most commonly used for pelvic organ prolapse repair and/or stress urinary incontinence, according to the U.S. Food and Drug Administration (FDA). Transvaginal mesh is only one type of surgical mesh used however—a device generally implanted to “repair weakened or damaged tissue.” Another common use for surgical mesh devices is for the repair of hernias. Hernia repair, according to the Wall Street Journal, is “one of the most common surgical procedures [yet it] carries a risk many patients don't consider: chronic pain after surgery.”

According to the Wall Street Journal, more than one-third of patients who undergo hernia repair suffer “long-term chronic pain and restricted movement after surgery.” This type of pain is similar to that experienced by women who have had transvaginal mesh implants, but because a hernia operation is a much more common procedure, this type of device affects more patients. Synthetic mesh, “though better than traditional sutures at reinforcing the abdominal wall, can irritate nerves and carry a slightly higher risk of infection,” according to the Wall Street Journal.

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 Posted on December 26, 2013 in Defective Drugs & Treatments

The NuvaRing, a contraceptive device originally marketed as a safe alternative to traditional birth control pills has not been officially recalled, despite rumors that it has been. According to PR Newswire, at the beginning of this year the trial date for 1,000 lawsuits involving the device was extended, "feeding rumors that the vaginal ring contraceptive's manufacturer, Merck, may be ready to enter settlements negotiations," reports PR Newswire. Approximately 1.5 million women worldwide use the device despite increased risk.

The increased risks of NuvaRing include increased chance of blood clots, pulmonary embolism, and strokes. According to the Huffington Post, the FDA, after clinical trials in which "a healthy woman in her 20s had developed a blood clot—a surprising occurrence that an investigator determined was probably related to the birth control device," said that the manufacturer needed to include warnings with the NuvaRing packaging. Manufacturer Organon, "adamantly opposed such a statement," according to the Huffington Post.

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