Medical Injury Lawyer Blog : Houston Medical Injury Lawyer & Attorney : Arnold & Itkin Law Firm : Pharmaceutical Injuries, Medical Devices : Texas, Dallas, Fort Worth, San Antonio

McNeil Consumer Healthcare and the FDA are notifying consumers that McNeil is expanding its recent drug recall of TYLENOL Arthritis Pain Caplets to include all lots of 100 count bottles with the red EZ-OPEN CAP.

Last month, five lots of the product were recalled after consumers reported unusual moldy, musty, or mildew-like odors associated with nausea, stomach pain, vomiting and diarrhea. The odor is caused by the chemical 2,4,6-tribromoanisole, which is believed to be created through the breakdown of a chemical used to treat wooden pallets that were used for transporting and storing packaging materials.

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The U.S. Food and Drug Administration (FDA) announced a Class I recall of a brain catheter manufactured by Medtronic Inc. due to failures in the device that may result in serious medical injuries.

In February, Medtronic recalled the BioGlide Ventricular Snap Shunt Catheters that are used to drain excess brain fluid into another part of the body. The catheter is often used in the treatment of hydrocephalus, a condition in which excessive fluid forms in the brain. The company received reports that the catheters are prone to disconnecting. According to Medtronic, such failures could cause:

• Vomiting
• Nausea
• Fatigue
• Headache
• Seizures
• Visual problems

Although the company says it has not received reports of death or serious injuries connected to the use of the catheters, the FDA has classified the recall a Class I. Generally, such a recall is issued when there is “a reasonable probability” that the use of a product can result in serious injuries or death. 3,000 catheters, distributed between 2000 & 2009 are affected by the recall.

The company has received nine reports of the catheter disconnecting. In these instances, the catheters disconnected from the snap base assembly, resulting in the need for emergency revision surgery.

The recall involves the following models of the catheter:

• Inner Vision Snap Shunt Ventricular Catheter BioGlide (R: 25.44, 1.15, 4.73%) Catalog Number 27782
• Snap Shunt Ventricular BioGlide(R: 25.44, 1.15,  4.73%) Catalog Number 27802
• Snap Shunt Ventricular Catheter BioGlide (R: 25.44, 1.15, 4.73%) Catalog Number 27708

Patents who have questions have been asked to contact their doctors or the company.

Defective Medical Devices Can Cause Serious Injuries

By the time a medical device is found to have a serious defect, it is often too late for patients who have been injured, sometimes fatally, by their use. It is the job of the FDA and medical device companies to keep patients informed and to protect consumers from dangerous medical products. 

If you or a loved one has been injured by the use of a defective medical device, a medical injury lawyer can help you recover compensation for your injuries. Contact an experienced medical injury attorney at Arnold & Itkin LLP for a free evaluation of your case.

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The U.S. Food and Drug Administration (FDA) has issued a Class I recall for Baxter International's Colleague infusion pumps, but a prominent consumer advocacy group is criticizing the agency for its delay in issuing the recall.

The recall was made concerning Single and Triple Channel Volumetric Infusion Pumps, which are used to deliver fluids and drugs to patients. There is a malfunction in the battery and software of the device that can cause an interruption in the infusion. This defect is serious enough to cause injury or death, therefore, the recall assigned is a Class I.

In January, Baxter sent a letter to customers informing them of the failures in the pumps. The warning included an alert that the pump could overheat, resulting in fire and smoke if not properly cleaned. The letter also underscored the importance of proper battery care, pointing out that failure to do so could cause the device to malfunction.

Baxter issued a press release announcing the recall on March 11th; the FDA posted a recall notice on its website the same day, a full seven weeks after Baxter sent the letter to customers. The FDA has come under fire by Public Citizen for its delay in issuing the recall of the drug pump. The criticism is not new – medical injury lawyers have insisted that the FDA issue recall notices quickly and on its own, rather than waiting for companies to act first.

Colleague infusion pumps have been linked to safety issues for years. The FDA, in fact, has issued at least 7 Class I recalls for the pumps. The company stopped sales of the pump in the U.S. in 2005, but at least 200,000 of the pumps are currently in use in hospitals and nursing homes across the country. The malfunctioning, which can cause the pumps to stop pumping and overheat, has been blamed for at least 19 deaths. Sidney Wolfe, the director of the Health Research Group of Public Citizen has demanded that all existing Colleague Infusion pumps be removed from the facilities that continue to use them to deliver fluids and medication to patients. Baxter, however, insists that a full withdrawal, including removal of pumps currently in use, would lead to a shortage in the market.

Delayed Recalls Increase Risk of Medical Injuries

Thousands of patients in hospitals and nursing homes around the country are at risk due to defective medical devices like Colleague Infusion pumps that they depend on to receive lifesaving drugs and fluids. It is outrageous that these pumps continue to be used, even after the manufacturer admitted the device has serious flaws.

If you've suffered injuries due to the use of a defective medical device, contact a medical injury lawyer at Arnold & Itkin LLP for a free evaluation of your claim.

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Generic drug manufacturer, Ethex Corporation, has suspended the manufacturing and sales of dozens of defective pharmaceutical drugs from its line, including several brands of isosorbide mononitrate, amlodipine and nitroglycerin, among others.

The company, which is a subsidiary of St. Louis-based KV Pharmaceuticals, took the step after inspections of the company's facilities by the U.S. Food and Drug Administration. This second massive recall comes just a few months after the company announced a recall of some of its products in 2008. The earlier recalls were the result of several anomalies in the manufacturing of drugs, including oversized tablets that contained twice the required amount of the drug. The extra sized tablets included Morphine Sulphate Extended Release, Morphine Sulphate Immediate Release, Propafenone HCI, Isosorbide Mononitrate Extended Release, Hydromorphone HCI tablets, and Dextroamphetamine Sulphate. There have been several medical injury lawsuits already filed against the company related to morphine over-dosage, due to the oversized morphine tablets. Morphine over-dosage can lead to decelerated heart beat, disorientation, confusion, lightheadedness, fainting and convulsions.

The new recall by Ethex includes almost the entire line of drugs manufactured by the company. The products recalled include generic versions of the pain killer OxyContin, anti-depressant medication Toprol XL and cough medicines.  Most of the drugs have been recalled from wholesale agencies, while some have also been recalled from retailers.  A press release issued by the company asks patients who are using the medications to continue using them due to the health risks of suddenly stopping the medication. The company has also asked patients to consult with their doctors and be observant for any side effects; any side effects noticed should be reported through the FDA's MedWatch program.

Hiring a Medical Injury Lawyer

When it comes to injuries caused by unsafe pharmaceutical drugs, it is important to save the bottles or containers of the medication. We advise you to discontinue use of the medication after consulting with your doctor and talk to a medical injury lawyer. It's important to hire an attorney who has an established record of pursuing and winning claims against major pharmaceutical companies. The medical injury lawyers at Arnold & Itkin LLP have successfully represented dozens of victims of unsafe pharmaceutical drugs. 

If you have been injured by the use of a defective drug, contact a medical injury lawyer at Arnold & Itkin LLP for a free evaluation of your claim.

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Terumo Cardiovascular Systems (Terumo CVS) has issued an urgent worldwide recall of its Tenderflow™ Pediatric Arterial Cannulae, a defective medical device, involving 21 lot codes (see information below). Terumo received five reports of difficulty retracting the introducer from the cannula. When the introducer cannot be retracted from the cannula, the cannula must be removed and replaced, a process that may lead to aortic damage, blood loss and/or death.

Tenderflow™ Pediatric Arterial Cannula Catalog and Lot Numbers Affected

When and how is the device used?

An arterial cannula is a disposable tube inserted in the aorta during many cardiac bypass surgery procedures and is used to perfuse the ascending aorta. The cannula is inserted using an introducer, which stabilizes the cannula during insertion and is then removed.

Where was the defective device distributed?

Terumo Cardiovascular Systems Corporation is a global manufacturer and marketer of medical devices for cardiac and vascular surgery. Terumo CVS distributed this product directly to 68 U.S. hospitals, and has notified all of the hospitals of the voluntary recall in a letter dated Oct. 16, 2008. The product was also distributed from distribution centers in Australia, Canada and Europe.

Terumo recalls the defective medical device

Terumo informed the U.S. Food and Drug Administration of this recall. The notification letter recommended that customers not use the product unless it is medically necessary.

Injured by the Terumo Arterial Cannula?

If you or a loved one have been injured by this dangerous medical device, you may be entitled to compensation from those responsible. Medical device manufacturers have an obligation to manufacture and distribute safe products. When they fail to do this, a medical injury lawyer can hold them accountable. If you have questions, contact a medical injury lawyer today for a free initial consultation. We can help you understand your options for claiming compensation.

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CSI, USA, Inc. issued a voluntary nationwide consumer product recall of all lots of 1 ounce (28 g) tubes of 10% Benzoyl Peroxide Acne Cream with the following names: "DG Maximum Strength Acne Medicated Gel" (sold at Dollar General); "Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication" (sold at Kroger); and "Equate: Medicated Acne Gel" (sold at WalMart).

These defective medical products are being recalled because samples of the products were found to contain bacteria identified as "Burkholderia Cepacia," formerly known as Pseudomonas Cepacia.

After conducting a thorough assessment, the company concluded that the risk of illness in healthy individuals following use of this product is very low. However, there could be an increased health risk of infections for individuals with cuts, scrapes, rashes or other compromised skin conditions; or those with weakened or suppressed immune systems.

When medical product manufacturers make and distribute dangerous or defective products, innocent people can be harmed. The skilled attorneys at Arnold & Itkin LLP can hold them accountable. If you have questions or would like to speak to an attorney, contact a defective medical products lawyer today. Initial consulation is free.

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Ethex Corp and FDA notified healthcare professionals of a voluntary recall of five generic products:

• Propafenone HCl Tablets
• Isosorbide Mononitrate Extended Release Tablets
• Morphine Sulfate Extended Release Tablets
• Morphine Sulfate Immediate Release Tablets
• Dextroamphetamine Sulfate Tablets

The products were recalled because they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient that could result in patients receiving as much as twice the expected dosage of these drugs, which could cause serious or life-threatening consequences.

Overdoses can include arrhythmias and low blood pressure with Propafenone HCl; fainting and low blood pressure with Isosorbide Mononitrate; respiratory depression and low blood pressure with Morphine Sulfate; and rapid heart rate and high blood pressure with Dextroamphetamine Sulfate. Patients who experience any adverse reactions to these drugs should contact their healthcare professional immediately. See the manufacturer's drug recall notice for specific lot numbers of the products affected by this recall.

The side effects associated with these dangerous drugs are serious and life threatening. Consumers who experience any adverse reactions to these drugs should contact their physician and/or healthcare provider immediately. If you are a loved one have been serious injured by one of these defective pharmaceutical drugs, you should contact a medical injury lawyer to learn more about your options for claiming compensation you may be due.

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Implantable Cardiac Defibrillators (ICD) marketed by Guidant Corp. have been recalled because of a device malfunction that can lead to potentially fatal consequences.  On June 17, 2005, in the first of multiple recalls, the FDA issued a nationwide notification of recall of certain Guident implantable defibrillators because of short circuiting issues that could lead to a failure of the device to deliver a life-saving shock when it was supposed to.

A later recall issued on April 5, 2007 recalled defective defibrillators and pacemakers marketed by Boston Scientific/Guidant claiming the devices were subject to rapid battery depletion and premature device failure.

Because defibrillators and pacemakers are used to preserve the lives of persons who depend on them, the failure of these devices can lead to very serious injuries and death.

More information on the defective Guidant Defibrilltor recalls can be found on our Medical Injury Lawyer website.

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