Posted on March 27, 2013 in Defective Medical Devices

In 2012, the FDA received almost 900,000 adverse event and medical error reports from consumers—but only 5 per cent of those reports concerned children less than 18 years of age.

However, reporting adverse effects in pediatrics can help shed important light on these products, especially since most pediatric clinical trials only contain a small number of patients. In addition, a product may be studied in one age group and approved for widespread use but affect another age group in a different way.

Because of this, the FDA has issued steps you can take to report any adverse effects a child has experienced. In 2007, the FDA received reports of serious side effects in children who were exposed to prescription topical testosterone gel products. The contact was accidental, resulting when a child came in contact with the skin of an adult male who was using this product. However, from these complaints the FDA was able to work with testosterone gel manufacturers to create a safer product and identify places on the body where the gel could be safely applied to minimize child contact. They were also able to create stronger warning labels.

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 Posted on March 24, 2013 in Defective Medical Devices

A recent New York Times report has revealed that Johnson & Johnson, makers of the hip implant device Articular Surface Replacement (ASR), became aware that its all-metal hip replacement device had an alarmingly high failure rate, not long after the company issued a recall for the device. The company's analysis showed that the device would fail within five years in nearly 40 percent of patients.

This analysis also found that over the next few years, the implant is likely to fail prematurely in thousands more patients. This is in addition to the thousands who have already had painful and costly medical procedures to replace the defective implants.

The Times reports that not only didn't Johnson & Johnson release this information; they were discovering it at a time when they were publicly dismissing the same kind of findings by a British implant registry.

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 Posted on March 21, 2013 in Defective Drugs & Treatments

The Food and Drug Administration (FDA) recently announced a recall for one Lot (# 12G468) of Ferrous Sulfate Tablets, 325 mg, because these tablets may actually contain Meclizine HCl 25 mg tablets. Meclizine HCl is given for the treatment of nausea and vomiting. According to the FDA's press release, ingesting Meclizine HCl 25 mg as Ferrous Sulfate 325 mg "may cause serious side effects to those who consume alcohol or other sedatives, those with a pre-existing CNS disorder, those with imprinted kidney or liver function, the elderly, nursing infants of lactating mothers who received the drug and newborns of mothers who received the drug immediately before childbirth."

The problem was discovered by a pharmacist, who complained to the manufacturer of the Ferrous Sulfate, Advance Pharmaceutical Inc. The company immediately issued a voluntary recall. The tablets were sold with the label Rugby Natural Iron Supplement Ferrous Sulfate in 100 count bottles. The lot of Rugby Ferrous Sulfate is 12G468 and expires on 7/14.

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 Posted on March 18, 2013 in Defective Medical Devices

According to the FDA, a federal judge declared that a Californian company must stop manufacturing drugs and dietary supplements for domestic commerce—at least until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act.

Titan Medical Enterprises, Inc. continuously failed to comply with Good Manufacturing Practice for drugs or Good Manufacturing Practice for dietary supplements. In addition, the company violated the Act by distributing unapproved new drugs.

Between 2001 and 2012, Titan Medical Enterprises, Inc. had been inspected by the FDA nine times and was found to be in violation of the Good Manufacturing Practice for drugs by failing to establish an adequate written testing program to assess the stability of finished products and failing to establish and follow adequate laboratory controls. The owner, James L. McDaniel, was given written notice in 2003 about the violations.

In 2007, the Good Manufacturing Practice for dietary supplements went into effect. Based on the company's size, the regulations were to be put into practice throughout the next three years. In 2010, 2011, and 2012, the FDA found Titan Medical Enterprises, Inc. to not be in compliance with various parts of the Act. These violations included failing to verify that a subset of finished dietary supplement batches met product specifications and failing to adequately confirm the identity of dietary supplement components.

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 Posted on March 15, 2013 in Defective Medical Devices

At the end of February, Johnson & Johnson subsidiary Ethicon lost a landmark case in New Jersey, resulting in a $3.35 million payout to a South Dakota woman, according to Bloomberg News. Linda Gross, 47, sued Johnson & Johnson for failing to warn her of “the risks tied to its Gynecare Prolift vaginal mesh implant,” and for fraudulently misleading her. After constant pain and 18 operations sustained because of the implantation, Gross and her husband filed the lawsuit. The Atlantic City jury found that Johnson & Johnson “failed to tell physicians and women the truth about the catastrophic complications that can result from the Prolift,” not that the company defectively designed the mesh.

Gross was the first to file a lawsuit, one of 2,100 to be filed over the vaginal mesh implant. The company, according to Bloomberg, “will now weigh punitive damages that may total as much as $16.75 million.” Gross was awarded $1.1 million for pain and suffering, $180,000 for lost wages, $500,000 for future lost wages, $385,000 for past medical treatment, $1 million for future medical treatment, and $180,000 for her husband's loss of companionship and conjugal affections.

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 Posted on March 12, 2013 in Defective Drugs & Treatments

A new Dutch study suggests that elderly people who use psychiatric drugs may have an increased risk for falling, according to the Chicago Tribune. Senior citizens who took medications including antidepressants and anti-psychotics were twice as likely to have fallen three or more times in the previous year. Although the study can't prove that the effects of the drugs directly caused more falls, psychiatric drugs often have side effects, including changes in thinking, attention and blood pressure levels, which may put seniors at higher risk for falling.

Elderly people are particularly prone to falls, which can cause hip fractures, severe injuries or even death. In 2009, over 20,000 American seniors died from fall injuries, according to the Centers for Disease Control and Prevention. Doctors recommend that psychiatric drugs should be avoided for elderly patients who also have other risk factors for falling.

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 Posted on March 08, 2013 in Defective Medical Devices

At the end of January, according to beforeitsnews.com, Johnson & Johnson was facing a slew of claims regarding a hip replacement the company developed “that had several design defects.” The hip replacement, manufactured by Johnson & Johnson subsidiary DePuy Orthopedics, is suspected to have leaked toxic debris into patients' bloodstreams. There were also stability issues with the replacement, according to beforeitsnews.com, and “instead of notifying doctors and patients, the company allegedly kept silent.”

The first cases to go to trial will be in California, but there are 10,000 pending suits across the country. The first trial began early this year in Los Angeles, and the gist of the suit “alleges that DuPuy knew about the risks of the product, but deliberately hid them.” If found liable, the company will face billions of dollars in damages. The designers at DuPuy claim that they “evaluated the risk and found it to be a minimum.” Hip recipients and their lawyers rejected an out-of-court settlement of $200,000 offered by Johnson & Johnson.

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 Posted on March 02, 2013 in Defective Medical Devices

In January 2013, according to the Federal Register, Volume 78, the Food and Drug Administration proposed for the first time that the scleral plug should be classified as a Class II (special controls) medical device. The development of a scleral plug was first announced in a medical journal in 1994, and was initially described as a device that “released drugs into the vitreous after being implanted and fixed at the pars plana.” The scleral plug, according to the Federal Register, is also a device “used to provide temporary closure of a scleral incision during an ophthalmic surgical procedure.”

Now, 21 years later, the scleral plug is finally being classified as a Class II device. The only scleral plugs that will be exempt from premarket notifications, according to the Federal Register, are those made of surgical grade stainless steel, “with our without coating in gold, silver, or titanium.”

According to the Food and Drug Administration, Class I devices are subject to the lease regulation, while Class II devices “are those for which general controls alone are insufficient to assure safety and effectiveness.” Examples of special controls include, but are not limited to: postmarket surveillance, mandatory performance standards, and special labeling requirements. Yet even Class II devices do not require premarket approval—premarket approval is left for Class III devices. An example of a Class III device is a pacemaker.

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 Posted on February 28, 2013 in Defective Medical Devices

Many families are still feeling the effects of a bad steroid shot that was administered to people in northern Indiana and the Chicago-land area. According to a USA Today article, “as many as 13,000 people received steroid shots suspected in a national meningitis outbreak,” but it wasn't, and still isn't, clear just how many people are in danger. The shot was administered to people in the back, for pain, and a large proportion of the people who received the shots are elderly. This puts them at an even greater risk of contracting meningitis, because their bodies are less likely to be able to fight off the disease.

More than 100 people were infected, and more than 8 people died after contracting the deadly disease. “Investigators suspect a steroid medication made by a specialty pharmacy may to be blame,” according to the USA Today. The infection is fungal meningitis, a rarely seen form of the disease, and was first diagnosed in Tennessee. It wasn't long before the cases spread to Michigan, Virginia, Indiana, Florida, Maryland, Minnesota, North Carolina, and Ohio.

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 Posted on February 25, 2013 in Defective Medical Devices

Apnea in Greek means “without breath”. When a person has sleep apnea their breathing involuntarily stops while they are sleeping. This stopping can happen hundreds of times up to a minute or longer at a time. Most of the time the person is not aware of their breathing stopping hence making death a quiet inevitable occurrence when not treated. Statistics show that one out of fifteen people have some sort of case of sleep apnea. However, one out of fifty go undiagnosed. Effects of undiagnosed sleep apnea leads to tiredness, lack of focus during the day, as well as have four times the risk of a stroke and three times to have heart disease. This disease became national news when Reggie White, great defensive-end for the National Football League, December 26, 2004, due to sleep apnea.

Fisher & Paykel Healthcare Reusable Breathing Circuit has been voluntarily recalled because of the products defective tubes. This class I recall states there are small pin holes in the tubes. Normally, tests are given to each machine prior to patient use to make sure air is not escaping by a standard leak test. If there is a gas leak it can lead to a loss of pressure. Using a defective device can lead to death.

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