April 30th, 2013|
April 30, 2013
The U.S. Food and Drug Administration (FDA) announced the voluntary recall of the Zilver® PTX® Drug Eluting Stent manufactured by Cook Medical due to malfunctions that could compromise patient safety.
The device is a expanding metal mesh tube that is coated with a medication. The device is used to keep arteries in the body from narrowing and is commonly used in the treatment of Peripheral Artery Disease. The affected devices were sold worldwide between December of 2012 and April of 2013.
The product was declared a Defective Medical Device after the FDA received reports of two serious adverse events, including one death, related to the use of the product.
According to an FDA press release, the problem is that the catheter tip can separate from the rest of the device, which can cause the catheter tip to become lodged in the artery and block blood flow. This can result in numerous health problems including thrombosis and cardiac arrest.
Those who are in possession of the affected products have been instructed to halt use of the devices immediately and to quarantine any remaining stock of the product.
Ferrer, Poirot & Wansbrough and their team of Dallas Personal Injury Attorneys recognize the risks that can be posed through the use of certain medical devices. The firm encourages anyone who has been injured through the use of a recalled product to discuss their legal rights with an attorney.
March 12th, 2013|
March 12, 2013
In the wake of a massive recall of defective hip replacement devices manufactured by Johnson & Johnson (J&J) and its subsidiaries, federal officials are investigating whether the company participated in illegal marketing practices.
Several lawsuits filed against J&J allege they knew of problems with the DePuy ASR Hip Resurfacing System and the ASR XL Acetabular System, but continued marketing the products until 2009. At that time, the U.S. Food and Drug Administration began receiving reports of the devices’ failures and a recall was issued.
The primary reason for the DePuy Hip Replacement Recall seemed to be premature wear. The devices were supposed to last for roughly 10 to 20 years; however, one in eight patients reported needing the device replaced within five years. This premature wear also led to many patients suffering from a condition known as metallosis. This can occur when small pieces of metal are rubbed off the device by friction and then absorbed into the bloodstream. The condition can cause a patient to suffer numerous autoimmune problems.
According to the Star-Tribune, the current investigation into illegal marketing practices comes on the heels of the company paying $84.7 million in fines stemming from allegations of kickbacks being offered to doctors for using the company’s products.
The Dallas Personal Injury Lawyers with the law firm of Ferrer, Poirot & Wansbrough are happy to see action being taken to better protect patients from illegally marketed healthcare products.
June 19th, 2012|
June 19, 2012
Infusion pumps are a vital piece of equipment in medical facilities to deliver fluids, medications, and nutrients to patients by use of a slow drip. However, the Food and Drug Administration (FDA) is considering a certain type of infusion pump a Defective Medical Device due to flow levels being affected by sudden mechanical failure.
According to a press release from the FDA, the SIGMA Spectrum Infusion Pump Model 35700 can stop working at any moment, causing flow levels to fluctuate between completely blocked and free flowing with no alarm sounding. This could cause serious injury or death to a patient.
Although the original recall was issued on September 15, 2010, for serial numbers on the units ranging from 706497 to 724065, the recall was updated this past Friday to include all serial numbers ranging from 700000 to 794213.
Officials say that the use of these pumps should be halted immediately. SIGMA should then be contacted in order to have the unit serviced or replaced.
Any adverse events resulting from use of the infusion pumps should be reported to the FDA’s MedWatch program immediately.
The Drug Injury Lawyers with Ferrer, Poirot & Wansbrough understand the adverse effects that failure of an infusion pump could have on patients, from not receiving medications at all to overdoses. That is why they suggest contacting an experienced attorney if you have suffered an injury because of a defective medical device.
January 8th, 2009|
January 8, 2009
The FDA reported that a defective medical device that was used to perform eye surgery has been recalled.
Advanced Medical Optics, Inc. recalled its product Healon D due to reports of defective medical device injuries following use of the product during eye surgery.
The defective medical device Healon D is an ophthalmic viscosurgical device which maintains space in the eye during eye surgery.
Patients reported defective medical device injuries such as inflammation and Toxic Anterior Segment Syndrome.
Texas patients who had eye surgery using Healon D could be victims of Texas defective medical device injuries.
The Texas defective product lawyers at Ferrer, Poirot & Wansbrough can help if you have been injured by a defective medical device.
November 6th, 2008|
November 6, 2008
Thorteca Corporation has issued a warning regarding the HeartMate II Left Ventricular Assist Systems (HM II LVAS) with Catalogue No. 1355 or 102139, due to the risk of defective medical device injuries.
The device’s percutaneous lead which connects the device to the systems controller could wear overtime and cause interruption in the pump function, further causing serious injuries or death due to defective medical devices.
The devices responsible for the possible defective medical device injuries were distributed to 153 hospitals and distributors in the United States.
Texas patients who had the devices used on them in Texas hospitals could experience Texas defective medical device injuries if the devices are not properly replaced.
The defective product attorneys at Ferrer, Poirot & Wansbrough can help if you have been injured in an accident
March 7th, 2008|
The Supreme Court recently handed down a ruling regarding defective medical devices that may have serious ramification for the victims of Texas defective medical product injuries. A Texas defective medical device injury can be life-altering and extremely painful; injuries suffered from devices that were negligently manufactured—such as an artificial hip implant laden with bacteria or a painkiller patch that leaks and exposes users to harmful levels of dangerous drugs—can even result in death.
The Supreme Court ruled that a medical device manufacturer, despite if one of their devices is later proven to be defective, is not liable for damages to a harmed individual if the device was originally approved by the Food and Drug Administration (FDA). This ruling comes as a huge surprise to most Americans, who expect our courts to be able to help us if we fall victim to a Texas defective medical device injury.
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