December 1st, 2015|
When Medical Devices Fail
Before the U.S. Food and Drug Administration (FDA) approves a medical device, the product must undergo rigorous testing. However, problems with medical device are often discovered after the product is released to the public.
One of the most common issues with medical devices is abnormal wear and breakage of the device. The attorneys at Ferrer, Poirot & Wansbrough want to share just a few of the high-profile cases involving medical products linked to an increased risk of patient injury.
Rotablator System Breakage
Boston Scientific Corp. has recalled its RotaWire Elite Guidewire and wireClip Torquer Guidewire as part of a system that is used to clear clogged arteries and improve blood flow. The recall was initiated after reports began to surface that the wires could break free from the device, causing perforations. The Boston Globe says that at least one patient has died as a result of the malfunction.
An inferior vena cava (IVC) filter is a spider-like device implanted into the largest artery of the body to prevent blood clots from reaching the heart or lungs. The wiry legs of the device have been known to break free though, causing a number of serious health complications.
Hip Replacement Devices
A number of metal-on-metal hip implant devices have been recalled after they were found to prematurely wear out, causing users to suffer pain, inflammation, swelling, and a condition known as metallosis. Many of these cases resulted in the filing of a hip recall lawsuit.
Know Your Rights
If a defective medical product has harmed you, it’s important to be aware of your legal rights. You can learn more about your rights and what you can do to protect them by visiting our website.
February 17th, 2015|
When the Stryker metal-on-metal hip replacement came on to the market, it was expected to offer patients a long-term and lasting solution to their hip problems. However, the device failed in many cases, leaving patients in pain and in need of corrective surgery.
In response, many of the patients who experienced hip failure or painful side effects filed hip recall lawsuits to get compensation for the damages they suffered. Bloomberg Business reports a settlement was reached in Nov. 2014 that established a more than $billion trust to be used to pay restitution to patients who experienced complications with their Stryker hip devices. This means each patient could receive more than $300,000 in compensation.
Those who filed hip recall lawsuits aren’t the only ones who may qualify for compensation, though. A stipulation in the settlement says that anyone who underwent surgery to correct problems caused by the Stryker device prior to the settlement date are eligible to file for compensation. Anyone who underwent a corrective procedure after the settlement date may not qualify for compensation through this particular lawsuit but are still entitled to file a lawsuit of their own.
The defective medical device lawyers at Ferrer, Poirot & Wansbrough understand the difference this compensation can make in the lives of patients harmed by Stryker hip replacement devices. We are hopeful the settlement will help bring closure to the pain and suffering these individuals have endured over the years.
October 29th, 2013|
October 29, 2013
The Defective Medical Device Lawyers with Ferrer, Poirot & Wansbrough explain manufacturers of medical devices have a responsibility to ensure the safety of the products they introduce to the market. Any failure to do so that results in a patient’s death or serious injury can result in action being taken against the company.
One such action is when the U.S. Food and Drug Administration (FDA) issues warnings to the public about the use of the product. One such warning was recently issued in regards to the St. Jude Amplatzer Atrial Septal Occluder (ASO). The device is used to close holes developed in patient’s hearts; however, in some cases, the device has caused the tissue surrounding it to die and erode, resulting in a need for immediate corrective surgery. These adverse health events have been found to occur in as many as 3 out of every 1,000 patients who have the devices implanted in their bodies.
In response, the FDA has issued several recommendations to both patients and doctors who are considering the use of the device. The agency has also ordered the product’s manufacturer to conduct a study into the product’s safety risks.
The law firm’s team of attorneys is aware of how devastating a Defective Medical Device Injury can be. That is why the firm is here to answer any questions those who have been harmed by such a device may have. Contact us today for a free consultation of your case.
July 23rd, 2013|
July 23, 2013
The U.S. Food and Drug Administration (FDA) recently announced the Class II recall of Intuitive Surgical’s da Vinci Surgical System robots. Records show that 30 of the units may not have been properly tested before being received for use by customers.
The devices have been lauded as a technological breakthrough in surgical procedures because it allows surgeons to perform delicate procedures in a more efficient and less invasive manner. Complaints have been filed though, saying that the device may not be safe.
Some patients have experienced serious burns and other injuries that were either caused by a malfunction in the machine or by doctor’s error. At least 70 deaths have been associated with the use of the robot since 2009.
Now, the FDA has launched the da Vinci Surgical Robot Recall after several parts were determined to have not met the testing standards established by the FDA. According to an article from Bloomberg News, this was the result of a data recorder failing to take note of testing results.
Those who are in possession of an affected unit have been contacted by Intuitive to have corrective action taken with the machine. Any adverse events associated with the use of an affected device should be reported to the FDA immediately.
The Defective Medical Device Attorneys with Ferrer, Poirot & Wansbrough are here to answer any questions an individual may have if they were the victim of a botched procedure using the da Vinci Surgical System.
July 16th, 2013|
July 16, 2013
Each year, there are numerous cases of people who are injured as the result of using a Defective Medical Device—including children.
A press release from the U.S. Food and Drug Administration (FDA) recently discussed these dangers, what they are doing to fix the problem, and what consumers should do in the event they discover a fault in a piece of medical equipment they require.
The agency explains that children are especially prone to injuries that are caused by medical devices because of factors such as frequency of use and lack of experience operating the device. Experts say most children tend to experience a treatment using a medical device at some point in childhood. Furthermore, children and adult caregivers may not be capable of operating a device or recognizing the warning signs that a device may fail.
The FDA is combating this problem by implementing stringent regulations and setting up a consumer reporting system.
Individuals who are harmed through the use of a defective medical device are being urged to contact the FDA in order to report the problem they experienced, so the information can be used to determine the potential risks a product may pose.
The Medical Product Liability Lawyers with Ferrer, Poirot & Wansbrough would also urge those who are injured to contact an attorney to discuss their legal rights.
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.
Click here to read more http://www.tennessean.com/apps/pbcs.dll/article?AID=/20080227/BUSINESS/802270409
January 28th, 2008|
A North Carolina company has issued a nationwide recall of heparin and saline pre-filled syringes because people in several states have become seriously ill due to a bacterial infection found in the syringes. The syringes are used for a variety of home medical uses, such as cleaning out catheter tubes.
The bacterial contaminant is known as Serratia marcescens, which according to the Food and Drug Administration (FDA), “could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.”
The bacteria can potentially cause serious Texas personal injury and death.
Click here to read more http://www.fda.gov/oc/po/firmrecalls/am2pat01_08.html