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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 Posted on February 23,2013 in Drugs

Recently, Natural Standard posted an article stating that Rugby Natural Ferrous Sulfate Iron Supplements have been recalled.

The U.S. Food and Drug Administration (FDA) have issued a consumer warning for the iron supplement listed above, which is manufactured by Advance Pharmaceutical Inc.

Iron is an essential mineral to the human body and is a major component of proteins that aid in oxygen transport as well as metabolism. According to the World Health Organization, iron deficiency is the largest international nutritional disorder. In particular, a vegan diet has a tendency to lead to a deficiency of necessary minerals, such as calcium, iron, and zinc.

25 milligram Meclizine Hydrochloride tablets were recently found in one of the iron supplement bottles by a pharmacist. These tablets have the potential to create troublesome side effects when taken with alcohol or other sedatives, and also in individuals with nervous system diseases, the elderly, and nursing infants. Meclizine Hydrochloride can cause drowsiness, confusion, coma, a drop in blood pressure, and difficulty breathing.

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 Posted on February 20,2013 in Defective Medical Devices

According to a recent article published by www.massdevice.com, St. Jude's has recalled their Amplatzer TorqVue FX delivery system because of concerns about fractures in the core wire.

The FDA has issued the highest-risk label on the recall of the delivery system produced by St. Jude Medical.

St. Jude recalled one component of the delivery system because a certain part may fracture, which could cause adverse consequences or even death, according to an FDA report.

The purpose of the Amplatzer device is to treat a condition called patent foramen ovale, in which a naturally occurring hole in the heart fails to close after birth. This open hole has the potential to allow blood clots to travel from one side of the heart to the other and then to the brain, which could cause a stroke.

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 Posted on February 18,2013 in Birth Defects

The firm is currently undergoing an investigation of Zoloft birth defect lawsuits for the families who had a child born with congenital abnormality that is allegedly associated with their mother's use of Zoloft during her pregnancy.

Federal Zoloft lawsuits are continuing to move forward in the multidistrict litigation that is underway in the U.S. District Court, in the Eastern District of Pennsylvania, according to Bernstein Liebhard LLP. Dated Jan. 17, the Pretrial Order states that the Court has established a protocol to select Zoloft suits for the early Bellwether trials. The Order also directs the Plaintiffs' Steering Committee to select 12 Zoloft birth defect claims from the total to include in the Early Discovery Group, no later than Feb. 15. The attorneys for Pfizer, Inc. as well, have been instructed to select a total of 13 cases for the Group no later than Feb. 25.

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 Posted on February 15,2013 in Defective Medical Devices

The new lead free implantable heart defibrillator, invented by Boston Scientific Corp, should not be used on a regular basis until more data is available, according to a story in the Chicago Tribune. Defibrillator leads have often caused problems for device makers. Boston Scientific bought the new technology, known as a subcutaneous implantable cardioverter-defibrillator, or S-ICD, last year. “The S-ICD has not yet been shown to be safe and effective in a diverse patient population,” said Robert Hauser of the Minneapolis Heart Institute. He also pointed out that the lead free defibrillator is not even as good as the traditional ICDs that have leads.

According to Hauser, the new technology shows a lot of promise and could fill important gaps, especially in countries where facilities to implant traditional devices do not exist. However, it is necessary to obtain more data first in order to ensure the safety of the device. “Unless critical questions with regard to safety and efficacy in primary and secondary prevention are addressed, the S-ICD should be confined to certain subgroups,” Hauser said.

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 Posted on February 12,2013 in Drugs

The FDA is now requiring sleep aids such as Ambien, Ambien CR, Edluar and Zolpimist to lower their dosage. Zolpidem, an ingredient in these brands, may remain in the blood the next morning in high enough levels to impair certain activities that require alertness.

Zolpidem is eliminated slower from women's bloodstreams, so the FDA is notifying manufacturers to lower the recommended dose for women—and they suggest lowering it for men as well. Especially in the extended-release form, zolpidem can cause problems the following morning for some activities, such as driving.

The FDA says in this article from January 10 that dosage for women should be cut in half (from 10mg to 5mg in immediate release pills, and 12.5mg to 6.25mg in extended-release) and the lowest possible dosage should always be used, regardless of sex. In addition, any patient that has complex tasks in the morning should talk to their health care professional to see if a sleep aid is the best choice for their lifestyle.

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 Posted on February 08,2013 in Birth Control

Yahoo! Finance is reporting that the scheduled May 2013 trial date in the multidistrict NuvaRing litigation, which is currently pending before the U.S. District Court, Eastern District of Missouri, has been postponed. This latest continuance of the trial proceedings has resulted in rumors that Merck, the manufacturer of the vaginal ring contraceptive, is preparing to enter into settlement negotiations. Not only does this development raise the potential for much-needed financial relief for women injured by using NuvaRing, but it also leaves open the possibility that even more lawsuits will be added to the more than 1,000 NuvaRing lawsuits that already are pending.

NuvaRing was the first vaginal hormonal contraceptive device approved by the U.S. Food & Drug Administration (FDA) in 2001. The ring works by releasing a low dose of synthetic progestin and estrogen over a period of three weeks. Starting in May, 2007, consumers began to file complaints in jurisdictions nationwide claiming dangerous side effects from using the medical device. Studies in 2009 and 2011 reveal that using NuvaRing considerably increases the risk of serious blood clots, including a 56% increased risk of deep vein thrombosis and pulmonary embolism over those women who use regular birth control pills. To date, the FDA has received almost 5,000 adverse event reports from users of NuvaRing. Nonetheless, NuvaRing has not been recalled from U.S. markets, and 1.5 million women worldwide continue to use NuvaRing.

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 Posted on February 04,2013 in Defective Medical Devices

Bloomberg Businessweek is reporting that Minnesota-based St. Jude Medical has received a warning letter from the U.S. Food & Drug Administration (FDA) regarding its implantable heart defibrillators, which it manufactures at a plant in Sylmar, California. These heart defibrillators are medical devices that can be implanted in a person's chest in order to correct abnormal or dangerous heart rhythms.

FDA's concerns arose when inspectors visited the plant in October, 2012, and allegedly found inconsistencies in the defibrillator manufacturing process and quality-control procedures. St. Jude claims that it is working to fix the problems identified by the FDA. In the meantime, the FDA will not approve any new product lines to be manufactured at the California plant until the problems are completely resolved. However, neither the heart defibrillators nor any other St. Jude product has been recalled by the FDA.

Unfortunately, these are not the first problems that St. Jude has encountered in recent years. In late 2011, St. Jude recalled its Rialta wires, which are used to attach the defibrillator to the heart, due to concerns about the insulation of the wires. In 2012, the medical device company recalled two other defibrillator wires, QuickSite and QuickFlex, amidst similar quality concerns. Currently, about 79,000 Rialta wires are implanted in U.S. patients. The FDA previously ordered St. Jude to conduct a three-year study of the wires in order to determine the risk of insulation failure.

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