Posted on April 20, 2013 in Defective Medical Devices

According to a recent article, Parker Waichman LLP filed a lawsuit on behalf of a New York woman. The woman was implanted with the Aris-Transobturator Sling System, which is a transvaginal mesh device intended to correct pelvic organ prolapse and stress urinary incontinence. It has been claimed that the device is defective and only caused more injuries. The Plaintiff is suing for pain and suffering, emotional distress, and economic loss.

Parker Waichman LLP is dedicated to protecting the rights of victims injured by defective medical devices. They have filed a lawsuit based on the fact that a transvaginal mesh implant, manufactured by Coloplast, caused injuries in a New York woman. Their lawsuit was filed on January 28th. The case is currently pending alongside many similar ones.

According to the Plaintiff's complaint, she received the Aris-Transobturator Sling System in February of 2008. Since then, she has suffered many complications, which she claims have been caused by the transvaginal mesh. The lawsuit claims that this device was defectively designed and poses a very serious risk of injury to women. The suit also alleges that the Defendants knew of the risks of the device but failed to adequately warn the Plaintiff, her doctor, or the public.

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 Posted on April 15, 2013 in Defective Medical Devices

Johnson & Johnson's DePuy orthopedic unit was ordered to pay $8.3 million in damages in a trial over artificial metal hips that were found to be defective, the Chicago Tribune reported on March 8. A Los Angeles jury ordered Depuy to pay over $338,000 in medical costs and $8 million for pain and suffering to Loren Kransky.

DePuy recalled the defective metal hips three years ago when it was found that the devices did not function as expected. Almost 100,000 ASR metal hips had been sold before the recall. “We believe ASR XL was properly designed, and that DePuy's actions concerning the product were appropriate and responsible,” said DePuy spokeswoman Loire Gawreluk. The company is planning to appeal the court's decision.

The defective metal hip resulted in increased levels of cobalt and chromium in Kransky, causing pain and suffering. Depuy's lawyers argued that it is not known what levels of metals may cause pain and harm to patients and claimed that Kransky's other medical problems, for example his diabetes and heart disease, were the actual source of his suffering.

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 Posted on April 12, 2013 in Defective Medical Devices

A new trend in operating rooms across the United States and the world is a robot named Da Vinci. This expensive multi-armed machine was approved by the FDA nearly four years ago to assist with highly dangerous surgeries like prostate removal, heart valve replacement and the transplantation of organs. In fact, nearly 400,000 surgeries have been performed with da Vinci across the United States, which is three times the number of robot assisted surgeries four years ago.

The robotic system is controlled by a surgeon who sits at a computer screen away from the patient. Advocates of using these robots have claimed that it removes the human element of shaky hands and also decreases recovery time for surgeries with large incisions.

But now, there has been a plethora of problems being reported about the da Vinci robot. Problems include times when a robotic hand wouldn't let go of a person's tissue during a surgery, or another incident when an arm of da Vinci repeatedly slapped a patient in the face. There have also been deaths that have happened during surgeries.

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 Posted on April 09, 2013 in Birth Defects

In 1983, the FDA approved Depakote to treat certain issues with the central nervous system. It has successfully treated or controlled such disorders as epileptic seizures and episodes of manic or bipolar behavior. This medicine can also be prescribed for migraine headaches. It is primarily used as a mood stabilizer and anti-convulsant, which has also provided relief for certain off label conditions.

After years of tests and research, there have been recent studies that have identified issues with this medication. Unfortunately, this is a far too common, because even the vigorous tests that were run by the FDA can miss potentially fatal side effects. In 2009, the FDA warned pregnant mothers about certain congenital birth defects such as a cleft palate, spina bifida, malformed hands and autism.

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 Posted on April 06, 2013 in Drugs

Modafinil is a medication that was created to treat shift work sleep disorder, narcolepsy and excessive sleepiness during the day as created by sleep apnea. This drug is only approved by the FDA to treat those symptoms. It works in a similar manner as a stimulant but because its effects on the human bodies are different, it is often referred to as a “wakefulness promoting agent”.

Yet, there has been an alarming increase in the usage of Modafinil for off-label disorders such as multiple sclerosis and depression. This is according to a new study initiated by Dr. David Claman and other colleagues from the University of California in San Francisco. From 2002 to 2009, this team took data from national Modafinil prescriptions and came to certain conclusions.

The results were staggering as the amount of prescriptions grew from nearly 60,000 to over 550,000. People receiving this medication for off-label conditions caused 89% of the increase. The side effects of the medication include headaches, drowsiness, stomach issues and dizziness. There have also been some cases of serious allergic reactions to the liver.

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 Posted on April 03, 2013 in Drugs

People take over the counter pills for many ailments like headaches, colds and allergies. With summer coming up just around the corner, people also take dietary supplements to assist in weight loss to look better in their swimsuits. Also wedding season is beginning soon, when brides try desperately hard to look good in their dresses on the best nights of their lives. The bad news is that some defective drugs are on the shelves while they are being checked by the FDA.

A company in California named Green Planet, Inc. announced a voluntary recall of one of their products on March 11^th of this year after being sold to distributors and wholesalers from October 2012 up until the recall. The product was a diet pill marketed as the “Night Bullet”. It was found to contain small amounts of a prescription drug used to treat erectile dysfunction. This recall comes on the heels of the final test run on this supplement by the Food & Drug Association when the trace amounts were noticed.

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 Posted on March 30, 2013 in Birth Defects

Recently, it was discovered in a study that Depakote use by pregnant women could cause lower IQ scores in their offspring. This is the latest of several suspected Depakote side effects that are ending in lawsuits.

Depakote is also known as valproate and is used extensively to help treat and manage epileptic seizures. It is also prescribed to treat manic depressive disorder, including bipolar disorder, which seems to be growing in occurrence each decade.

Depakote is also prescribed to treat problematic migraine headaches, a condition that has also increased in occurrence across North America in both genders.

One plaintiff of the birth defect lawsuit, however, claims that his mother ingested valproate for the first months of pregnancy and he was subsequently born with Spina Bifida, which he blames on the medication.

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 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 Drugs

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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