Posted on May 13,2013 in Drugs

Azithromycin, also known as Zithromax, Zmax, or Z-pack, is a best-selling antibiotic used to treat many ailments. It is most frequently prescribed to treat middle ear infections, pneumonia, typhoid, bronchitis, strep throat, and sinusitis. It has also used for treatment of certain sexually transmitted infections (cervicitis, nongonococcal urethritis, and Chlamydia). Its primary use in recent years has been to aid in fighting bacterial infections in infants or people who have weaker immune systems.

Every drug package lists its side effects, and the ones reported most often with the use of azithromycin were diarrhea, abdominal pain, nausea, and vomiting. However, a new finding by the FDA in 2013 shows that this drug may cause changes in a heart's electrical activity—which in turn may lead to a deadly heart rhythm. The patients that face this risk the most are those with existing heart conditions—slower-than-normal heart rate, an arrhythmia (or those taking certain medications for their arrhythmia —existing QT interval prolongation, and those with low blood levels of potassium and magnesium.

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 Posted on May 07,2013 in Defective Medical Devices

According to a story reported by Law360, expert testimony has began in cases regarding the lawsuits that are being levied against Johnson & Johnson. DePuy, Inc is a subsidiary of the Johnson & Johnson company.

Although the ASR XL metal hip has been recalled, Tony Nargol, testified that the prosthesis was safe and that the continued use of the product can be totally justified. Nargol is an orthopedic surgeon who was selected as an expert witness to testify in the case.

There are currently over 10,000 lawsuits that have been filed against the manufacturer alleging that the ASR products are defective and unsafe. The surgeon also testified that out of 243 surgeries where the ASR products were used, only three of those cases required surgical reentry. He also stated that the reentries were not because of the product itself but the way that it was used.

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 Posted on May 03,2013 in Defective Medical Devices

The ability to bring claims for defective medical device injuries will be possible again with the Medical Device Safety Act.

The 2009 supreme court case Wyeth vs. Levine also led to the reunion of the drug manufacturers and the device manufacturers. The case “confirmed that the Food and Drug Administration (FDA) marketing approval of all prescription drugs does still not (prevent) patients' state-law claims seeking damages for harm caused by those products.” The Wyeth court case touched on the main reasons for creating the Medical Device Safety Act.

The Medical Device Safety Act was in direct response to a 2008 Supreme Court decision in which the FDA's pre-market approval of medical devices would protect the manufacturer of the device for almost all liabilities through preemption, a legal doctrine. This decision also stopped an important protection of consumers.

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 Posted on April 28,2013 in Drugs

The U.S. Food and Drug Administration (FDA) recently issued an update to a prior warning they issued regarding the administration of codeine to children.

In August 2012, the FDA warned that there were some children that shouldn't be prescribed codeine after a tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome because it could lead to rare, but life-threatening adverse events or death.

Codeine is an opioid pain reliever and is converted to morphine by the liver. Some children are “ultra-rapid metabolizers of codeine” and this can cause the liver to convert codeine into life-threatening amounts of morphine in the body, leading to a fatal morphine overdose.

At the time of their original warning, the FDA had received three reports of children's deaths and one case of severe respiratory depression. The children were between two and five years old.

Since then, a review of the FDA database has determined that from 1969 to May 1, 2012, there were ten deaths and three overdoses associated with codeine. Many of these children were recovering from a surgery to remove their tonsils or adenoids.

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 Posted on April 24,2013 in Defective Medical Devices

As if Johnson & Johnson didn't have enough problems with their hip implant device Articular Surface Replacement (ASR), now the U.S. Food and Drug Administration (FDA) has announced a Class I recall for another orthopedic device made by the manufacturer – LPS Diaphyseal Sleeve. The device is used in reconstructive knee surgeries and is being recalled because of the potential for fractures that the device poses.

A Class I recall is the most serious recall that the FDA can issue and typically involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. In its announcement, the FDA said fractures of the device that occur at the taper joint of the sleeve could cause soft tissue to become compromised and result in infection, function loss, limb loss, or death.

The FDA has received ten reports of the product malfunctioning. Reports included six fractures and 4 incidents where the product loosened up. DePuy, Johnson & Johnson's orthopedic medical device division, and makers of both this device and the ARS, has issued an Urgent Medical Device Recall to healthcare providers to stop using the recalled units immediately and return unused devises to DePuy.

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 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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